An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Terminated

CT.gov ID

NCT01168856

Collaborator

(none)

734

Enrollment

126

Locations

Duration (Months)

5.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic

Study Design

Study Type:

Observational

Actual Enrollment :

734 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Cohort

Outcome Measures

Primary Outcome Measures

Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3 [Month 3]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6 [Month 6]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9 [Month 9]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12 [Month 12]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18 [Month 18]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
HCV RNA Levels in Resistance Monitoring Arm at Month 3 [Month 3]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
HCV RNA Levels in Resistance Monitoring Arm at Month 6 [Month 6]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
HCV RNA Levels in Resistance Monitoring Arm at Month 9 [Month 9]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
HCV RNA Levels in Resistance Monitoring Arm at Month 12 [Month 12]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
HCV RNA Levels in Resistance Monitoring Arm at Month 18 [Month 18]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3 [Month 3]
Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.
Systolic Blood Pressure in Resistance Monitoring Arm at Month 6 [Month 6]
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Systolic Blood Pressure in Resistance Monitoring Arm at Month 9 [Month 9]
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12 [Month 12]
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18 [Month 18]
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3 [Month 3]
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6 [Month 6]
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9 [Month 9]
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12 [Month 12]
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18 [Month 18]
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Mean Pulse Rate in Resistance Monitoring Arm at Month 3 [Month 3]
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Mean Pulse Rate in Resistance Monitoring Arm at Month 6 [Month 6]
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Mean Pulse Rate in Resistance Monitoring Arm at Month 9 [Month 9]
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Mean Pulse Rate in Resistance Monitoring Arm at Month 12 [Month 12]
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Mean Pulse Rate in Resistance Monitoring Arm at Month 18 [Month 18]
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm [Up to 18 months]
Percentage of participants who received any anti-HCV medication during the monitoring period was reported.
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6 [Month 6]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12 [Month 12]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24 [Month 24]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36 [Month 36]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6 [Month 6]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12 [Month 12]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24 [Month 24]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36 [Month 36]
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 [Month 6]
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 [Month 12]
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 [Month 24]
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 [Month 36]
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 [Month 6]
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 [Month 12]
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 [Month 24]
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 [Month 36]
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6 [Month 6]
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12 [Month 12]
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24 [Month 24]
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36 [Month 36]
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing [Month 3-18]
Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
Number of Participants With DNV Resistance Status-Clonal Sequencing [Month 3-18]
Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing [Month 3-18]
Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing [Month 3-18]
Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.
Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing [Month 3-18]
Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
Number of Participants With STV Resistance Status-Clonal Sequencing [Month 3-18]
Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688. Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 [Month 18]
Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

adult patients, >/=18 years of age
chronic hepatitis C
participation in Roche DAA treatment protocol for CHC infection
DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response >/= 20 weeks after last dose of study medication in donor study

Exclusion Criteria:

For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA
For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	La Jolla	California	United States	92037-1030
2	Long Beach	California	United States	90822
3	Sacramento	California	United States	95817
4	Sacramento	California	United States	95825
5	San Diego	California	United States	92103-8465
6	San Francisco	California	United States	94115
7	Aurora	Colorado	United States	80045
8	Englewood	Colorado	United States	80113
9	Bradenton	Florida	United States	34209
10	Atlanta	Georgia	United States	30309
11	Decatur	Georgia	United States	30033
12	Marietta	Georgia	United States	30060
13	Honolulu	Hawaii	United States	96814
14	Chicago	Illinois	United States	60637
15	Indianapolis	Indiana	United States	46202
16	Kansas City	Kansas	United States	66160-7222
17	New Orleans	Louisiana	United States	70112
18	Detroit	Michigan	United States	48202
19	Kansas City	Missouri	United States	64131
20	Lebanon	New Hampshire	United States	03756
21	Hillsborough	New Jersey	United States	08844
22	Newark	New Jersey	United States	07102
23	Manhasset	New York	United States	11030
24	New York	New York	United States	10003
25	New York	New York	United States	10021
26	Providence	Rhode Island	United States	02905
27	Nashville	Tennessee	United States	37211
28	Dallas	Texas	United States	75246
29	Houston	Texas	United States	77030
30	San Antonio	Texas	United States	78212
31	San Antonio	Texas	United States	78234
32	Newport News	Virginia	United States	23602
33	Richmond	Virginia	United States	23249
34	Vancouver	Washington	United States	98604
35	Darlinghurst	New South Wales	Australia	2010
36	Kingswood	New South Wales	Australia	2747
37	Sydney	New South Wales	Australia	2050
38	Westmead	New South Wales	Australia	2145
39	Greenslopes	Queensland	Australia	4120
40	Herston	Queensland	Australia	4029
41	Woolloongabba	Queensland	Australia	4102
42	Adelaide	South Australia	Australia	5000
43	Melbourne	Victoria	Australia	3181
44	Melbourne	Victoria	Australia	3186
45	Wien		Austria	1080
46	Salvador	BA	Brazil	40210-341
47	Porto Alegre	RS	Brazil	90035-003
48	Ribeirao Preto	SP	Brazil	14049-900
49	Calgary	Alberta	Canada	T2N 4Z6
50	Edmonton	Alberta	Canada	T6G 2B7
51	Edmonton	Alberta	Canada	T6L5X8
52	Vancouver	British Columbia	Canada	V5Z 1H2
53	Vancouver	British Columbia	Canada	V5Z 1M9
54	Vancouver	British Columbia	Canada	V6Z 2C7
55	Vancouver	British Columbia	Canada	V6Z 2K5
56	Victoria	British Columbia	Canada	V8V 3P9
57	Winnipeg	Manitoba	Canada	R3E 3P4
58	London	Ontario	Canada	N6A 5A5
59	Ottawa	Ontario	Canada	K1H 8L6
60	Toronto	Ontario	Canada	M5G 1L7
61	Toronto	Ontario	Canada	M5T 2S8
62	Montreal	Quebec	Canada	H3A 1A1
63	Clichy		France	92118
64	Creteil		France	94010
65	Lille		France	59037
66	Marseille		France	13285
67	Montpellier		France	34094
68	Montpellier		France	34295
69	Nice		France	06202
70	Paris		France	75651
71	Paris		France	75679
72	Pessac		France	33604
73	Rennes		France	35033
74	Toulouse		France	31059
75	Vandoeuvre-les-nancy		France	54511
76	Berlin		Germany	10969
77	Berlin		Germany	13353
78	Frankfurt Am Main		Germany	60590
79	Hamburg		Germany	20099
80	Hannover		Germany	30625
81	Muenchen		Germany	81377
82	Napoli	Campania	Italy	80131
83	Bologna	Emilia-Romagna	Italy	40138
84	Milano	Lombardia	Italy	20121
85	Milano	Lombardia	Italy	20162
86	Pavia	Lombardia	Italy	27100
87	Torino	Piemonte	Italy	10126
88	Bari	Puglia	Italy	70124
89	Pisa	Toscana	Italy	56124
90	Guadalajara		Mexico	44280
91	Guadalajara		Mexico	44650
92	Monterrey		Mexico	64710
93	Christchurch		New Zealand	8011
94	Dunedin		New Zealand	9016
95	Grafton		New Zealand	1010
96	Bydgoszcz		Poland	85-030
97	Chorzow		Poland	41-500
98	Lodz		Poland	91-357
99	Myslowice		Poland	41-400
100	Warszawa		Poland	01-201
101	Warszawa		Poland	02-507
102	Wrocław		Poland	50-349
103	Łodz		Poland	91-347
104	San Juan		Puerto Rico	00927
105	Bratislava		Slovakia	831 01
106	Badalona	Barcelona	Spain	08915
107	Santander	Cantabria	Spain	39008
108	Palma de Mallorca	Islas Baleares	Spain	07010
109	La Coruna	La Coruña	Spain	15006
110	La Laguna	Tenerife	Spain	38320
111	Barcelona		Spain	08003
112	Barcelona		Spain	08035
113	Madrid		Spain	28029
114	Madrid		Spain	28034
115	Madrid		Spain	28222
116	Pontevedra		Spain	36071
117	Sevilla		Spain	41014
118	Valencia		Spain	46014
119	Dorset		United Kingdom	BH7 7DW
120	Dundee		United Kingdom	DD1 9SY
121	London		United Kingdom	E1 1BB
122	London		United Kingdom	SE5 9RS
123	London		United Kingdom	SW17 0QT
124	London		United Kingdom	W2 1NY
125	Manchester		United Kingdom	M8 5RB
126	Nottingham		United Kingdom	NG7 2UH

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01168856

Other Study ID Numbers:

NV22688
2009-016560-36

First Posted:

Jul 23, 2010

Last Update Posted:

Mar 11, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details	Participants from following studies were enrolled: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094].
Pre-assignment Detail	This study was terminated early and participants discontinued due to study termination were included under reason "unspecified" in the participant flow.

Arm/Group Title	Resistance Monitoring Arm	Sustained Virological Response (SVR) Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Period Title: Overall Study
STARTED	176	558
COMPLETED	158	215
NOT COMPLETED	18	343

Baseline Characteristics

Arm/Group Title	Resistance Monitoring Arm	SVR Durability Monitoring Arm	Total
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.	Total of all reporting groups
Overall Participants	172	552	724
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.1 (8.48)	51.0 (10.79)	51.2 (10.29)
Sex: Female, Male (Count of Participants)
Female	47 27.3%	222 40.2%	269 37.2%
Male	125 72.7%	330 59.8%	455 62.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description
Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 3.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	114
Number [Percentage of participants]	99.1 57.6%

2. Primary Outcome

Title	Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	137
Number [Percentage of participants]	99.3 57.7%

3. Primary Outcome

Title	Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 9

Outcome Measure Data

Analysis Population Description
Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 9.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	129
Number [Percentage of participants]	99.2 57.7%

4. Primary Outcome

Title	Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	123
Number [Percentage of participants]	99.2 57.7%

5. Primary Outcome

Title	Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 18.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	113
Number [Percentage of participants]	100 58.1%

6. Primary Outcome

Title	HCV RNA Levels in Resistance Monitoring Arm at Month 3
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 3.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	113
Mean (Standard Deviation) [IU/mL]	3922296 (5111469)

7. Primary Outcome

Title	HCV RNA Levels in Resistance Monitoring Arm at Month 6
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	136
Mean (Standard Deviation) [IU/mL]	4369148 (6803658)

8. Primary Outcome

Title	HCV RNA Levels in Resistance Monitoring Arm at Month 9
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 9

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 9.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	128
Mean (Standard Deviation) [IU/mL]	5016299 (7235510)

9. Primary Outcome

Title	HCV RNA Levels in Resistance Monitoring Arm at Month 12
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	122
Mean (Standard Deviation) [IU/mL]	4955311 (6595493)

10. Primary Outcome

Title	HCV RNA Levels in Resistance Monitoring Arm at Month 18
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 18.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	113
Mean (Standard Deviation) [IU/mL]	4830852 (6621059)

11. Primary Outcome

Title	Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3
Description	Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	111
Mean (Standard Deviation) [mmHg]	128.1 (16.15)

12. Primary Outcome

Title	Systolic Blood Pressure in Resistance Monitoring Arm at Month 6
Description	Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	134
Mean (Standard Deviation) [mmHg]	126.0 (16.58)

13. Primary Outcome

Title	Systolic Blood Pressure in Resistance Monitoring Arm at Month 9
Description	Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 9

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	128
Mean (Standard Deviation) [mmHg]	126.9 (15.48)

14. Primary Outcome

Title	Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12
Description	Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	122
Mean (Standard Deviation) [mmHg]	127.1 (14.97)

15. Primary Outcome

Title	Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18
Description	Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	114
Mean (Standard Deviation) [mmHg]	130.3 (17.53)

16. Primary Outcome

Title	Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3
Description	Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	111
Mean (Standard Deviation) [mmHg]	79.8 (10.67)

17. Primary Outcome

Title	Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6
Description	Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	134
Mean (Standard Deviation) [mmHg]	78.0 (10.60)

18. Primary Outcome

Title	Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9
Description	Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 9

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	128
Mean (Standard Deviation) [mmHg]	78.5 (9.60)

19. Primary Outcome

Title	Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12
Description	Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	122
Mean (Standard Deviation) [mmHg]	77.7 (9.92)

20. Primary Outcome

Title	Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18
Description	Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	114
Mean (Standard Deviation) [mmHg]	79.3 (9.77)

21. Primary Outcome

Title	Mean Pulse Rate in Resistance Monitoring Arm at Month 3
Description	Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	111
Mean (Standard Deviation) [Beats per minute]	70.6 (9.89)

22. Primary Outcome

Title	Mean Pulse Rate in Resistance Monitoring Arm at Month 6
Description	Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	134
Mean (Standard Deviation) [Beats per minute]	71.1 (10.14)

23. Primary Outcome

Title	Mean Pulse Rate in Resistance Monitoring Arm at Month 9
Description	Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time Frame	Month 9

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	128
Mean (Standard Deviation) [Beats per minute]	70.3 (12.08)

24. Primary Outcome

Title	Mean Pulse Rate in Resistance Monitoring Arm at Month 12
Description	Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	122
Mean (Standard Deviation) [Beats per minute]	70.3 (10.68)

25. Primary Outcome

Title	Mean Pulse Rate in Resistance Monitoring Arm at Month 18
Description	Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time Frame	Month 18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	114
Mean (Standard Deviation) [Beats per minute]	70.8 (10.75)

26. Primary Outcome

Title	Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm
Description	Percentage of participants who received any anti-HCV medication during the monitoring period was reported.
Time Frame	Up to 18 months

Outcome Measure Data

Analysis Population Description
Resistance monitoring population.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Measure Participants	172
Number [Percentage of participants]	1.2 0.7%

27. Primary Outcome

Title	Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	505
Number [Percentage of participants]	0.2 0.1%

28. Primary Outcome

Title	Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	516
Number [Percentage of participants]	0 0%

29. Primary Outcome

Title	Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 24.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	416
Number [Percentage of participants]	0 0%

30. Primary Outcome

Title	Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 36.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	214
Number [Percentage of participants]	0 0%

31. Primary Outcome

Title	Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	1
Mean (Standard Deviation) [IU/mL]	896000

32. Primary Outcome

Title	Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.

Arm/Group Title

SVR Durability Monitoring Arm

Arm/Group Description

Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.

Measure Participants

33. Primary Outcome

Title	Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 24.

Arm/Group Title

SVR Durability Monitoring Arm

Arm/Group Description

Measure Participants

34. Primary Outcome

Title	Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36
Description	Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 36.

Arm/Group Title

SVR Durability Monitoring Arm

Arm/Group Description

Measure Participants

35. Primary Outcome

Title	Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
Description	Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	493
Mean (Standard Deviation) [mmHg]	126.8 (16.83)

36. Primary Outcome

Title	Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
Description	Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	511
Mean (Standard Deviation) [mmHg]	127.4 (16.66)

37. Primary Outcome

Title	Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
Description	Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	411
Mean (Standard Deviation) [mmHg]	128.0 (15.56)

38. Primary Outcome

Title	Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
Description	Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	209
Mean (Standard Deviation) [mmHg]	130.1 (16.68)

39. Primary Outcome

Title	Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
Description	Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	493
Mean (Standard Deviation) [mmHg]	77.9 (10.67)

40. Primary Outcome

Title	Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
Description	Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	511
Mean (Standard Deviation) [mmHg]	78.0 (10.31)

41. Primary Outcome

Title	Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
Description	Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	411
Mean (Standard Deviation) [mmHg]	78.3 (10.28)

42. Primary Outcome

Title	Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
Description	Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	209
Mean (Standard Deviation) [mmHg]	78.3 (10.11)

43. Primary Outcome

Title	Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6
Description	Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	493
Mean (Standard Deviation) [Beats per minute]	72.0 (10.41)

44. Primary Outcome

Title	Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12
Description	Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	511
Mean (Standard Deviation) [Beats per minute]	72.9 (9.61)

45. Primary Outcome

Title	Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24
Description	Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	411
Mean (Standard Deviation) [Beats per minute]	72.7 (10.45)

46. Primary Outcome

Title	Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36
Description	Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description
SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.

Arm/Group Title	SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Measure Participants	209
Mean (Standard Deviation) [Beats per minute]	73.0 (11.10)

47. Primary Outcome

Title	Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing
Description	Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
Time Frame	Month 3-18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
Measure Participants	162
NP22660 Category 1	3 1.7%
NP22660 Category 2	0 0%
NP22660 Category 3	1 0.6%
NP27946 Category 1	1 0.6%
NP27946 Category 2	3 1.7%
NP27946 Category 3	1 0.6%
NV21075 Category 1	4 2.3%
NV21075 Category 2	1 0.6%
NV21075 Category 3	1 0.6%
NP28266 Category 1	4 2.3%
NP28266 Category 2	1 0.6%
NP28266 Category 3	6 3.5%
NV22776 Category 1	17 9.9%
NV22776 Category 2	6 3.5%
NV22776 Category 3	6 3.5%
PP25213 Category 1	37 21.5%
PP25213 Category 2	11 6.4%
PP25213 Category 3	1 0.6%
WV21913 Category 1	33 19.2%
WV21913 Category 2	11 6.4%
WV21913 Category 3	14 8.1%

48. Primary Outcome

Title	Number of Participants With DNV Resistance Status-Clonal Sequencing
Description	Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.
Time Frame	Month 3-18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
Measure Participants	125
NP27946 Category 1	1 0.6%
NP27946 Category 2	0 0%
NP27946 Category 3	0 0%
NP22660 Category 1	3 1.7%
NP22660 Category 2	0 0%
NP22660 Category 3	1 0.6%
NV21075 Category 1	2 1.2%
NV21075 Category 2	2 1.2%
NV21075 Category 3	1 0.6%
NP28266 Category 1	3 1.7%
NP28266 Category 2	1 0.6%
NP28266 Category 3	4 2.3%
NV22776 Category 1	9 5.2%
NV22776 Category 2	8 4.7%
NV22776 Category 3	6 3.5%
PP25213 Category 1	21 12.2%
PP25213 Category 2	16 9.3%
PP25213 Category 3	1 0.6%
WV21913 Category 1	25 14.5%
WV21913 Category 2	8 4.7%
WV21913 Category 3	13 7.6%

49. Primary Outcome

Title	Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing
Description	Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
Time Frame	Month 3-18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
Measure Participants	9
TVR study NV22779 Category 1	3 1.7%
TVR study NV22779 Category 2	1 0.6%
TVR study NV22779 Category 3	1 0.6%
BOC study NV22780 Category 1	3 1.7%
BOC study NV22780 Category 2	0 0%
BOC study NV22780 Category 3	1 0.6%

50. Primary Outcome

Title	Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing
Description	Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.
Time Frame	Month 3-18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
Measure Participants	8
TVR study NV22779 Category 1	2 1.2%
TVR study NV22779 Category 2	1 0.6%
TVR study NV22779 Category 3	1 0.6%
BOC study NV22780 Category 1	1 0.6%
BOC study NV22780 Category 2	2 1.2%
BOC study NV22780 Category 3	1 0.6%

51. Primary Outcome

Title	Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing
Description	Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
Time Frame	Month 3-18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in the following donor protocol: NP28266 [NCT01628094]. Patients had developed STV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
Measure Participants	11
NP28266 Category 1	5 2.9%
NP28266 Category 2	3 1.7%
NP28266 Category 3	3 1.7%

52. Primary Outcome

Title	Number of Participants With STV Resistance Status-Clonal Sequencing
Description	Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688. Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.
Time Frame	Month 3-18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population. Here, n1=total number of participants with loss of STV resistance in NV22688 (by population sequencing). n2= total number of participants who had no STV resistance at the end of donor study they experienced a viral relapse in NV22688.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
Measure Participants	8
NP28266 Category 1	1 0.6%
NP28266 Category 2	4 2.3%
NP28266 Category 3	1 0.6%
NP28266 Category 4	2 1.2%

53. Primary Outcome

Title	Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688
Description	Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.
Time Frame	Month 18

Outcome Measure Data

Analysis Population Description
Resistance monitoring population.

Arm/Group Title	Resistance Monitoring Arm
Arm/Group Description	Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV20536 [NCT00869661], WV21913 [NCT01331850], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], NP28266 [NCT01628094]. None of the enrolled patients had developed MCB-associated resistant mutation(s) in donor protocol. Participants were monitored up to 18 months.
Measure Participants	110
NV20536	1 0.6%
NV27780	2 1.2%
NP27946	3 1.7%
NV27779	5 2.9%
NP28266	6 3.5%
WV21913	44 25.6%
PP25213	49 28.5%

Adverse Events

	Resistance Monitoring Arm		SVR Durability Monitoring Arm
Time Frame	Up to 36 Months
Adverse Event Reporting Description	Only adverse events (AEs) and serious adverse events (SAEs) related to protocol defined blood sampling procedures were collected.

Arm/Group Title	Resistance Monitoring Arm		SVR Durability Monitoring Arm
Arm/Group Description	Participants enrolled into this study were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations.		Participants enrolled into this study were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had Achieved Sustained Virological Response (SVR-24), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test more than or equal to (≥) 20 weeks after the last dose of study medication.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Resistance Monitoring Arm		SVR Durability Monitoring Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/172 (0%)		0/552 (0%)
Other (Not Including Serious) Adverse Events
	Resistance Monitoring Arm		SVR Durability Monitoring Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/172 (0.6%)		0/552 (0%)
General disorders
VENIPUNCTURE SITE BRUISE	1/172 (0.6%)	1	0/552 (0%)	0

Limitations/Caveats

Investigators were notified of the early termination of study in Jan2015 due to the completion of assessment for resistance monitoring arm and were encouraged to complete scheduled visits until Apr2015 for participants enrolled in SVR durability arm.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

Name/Title	Medical Communications
Organization	Hoffmann-La Roche
Phone	800-821-8590
Email	genentech@druginfo.com

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01168856

Other Study ID Numbers:

NV22688
2009-016560-36

First Posted:

Jul 23, 2010

Last Update Posted:

Mar 11, 2016

Last Verified:

Feb 1, 2016

An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

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