TURQUOISE-CPB: A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02219477
• Collaborator: (none)
• Enrollment: 36
• Arms: 3
• Actual Duration (Months): 27.3

Study Details

Study Description

Brief Summary

The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus	Drug: ombitasvir/paritaprevir/ritonavir; Drug: dasabuvir; Drug: ribavirin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB)
• Actual Study Start Date: Nov 24, 2014
• Actual Primary Completion Date: Jun 13, 2016
• Actual Study Completion Date: Mar 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: GT1B ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants	Drug: ombitasvir/paritaprevir/ritonavir; tablet; paritaprevir co-formulated with ritonavir and ombitasvir; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir also known as norvir ; Drug: dasabuvir; tablet; Other Names: ABT-333 ; Drug: ribavirin; tablet
Experimental: Group 2: GT1 Non-B ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants	Drug: ombitasvir/paritaprevir/ritonavir; tablet; paritaprevir co-formulated with ritonavir and ombitasvir; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir also known as norvir ; Drug: dasabuvir; tablet; Other Names: ABT-333 ; Drug: ribavirin; tablet
Experimental: Group 3: GT4 ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants	Drug: ombitasvir/paritaprevir/ritonavir; tablet; paritaprevir co-formulated with ritonavir and ombitasvir; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir also known as norvir ; Drug: ribavirin; tablet

Outcome Measures

Primary Outcome Measures

1. Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2 [12 weeks after the last actual dose of study drug]

   SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.

Secondary Outcome Measures

1. Percentage of Participants With SVR12 in Group 3 [12 weeks after the last actual dose of study drug]

   SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures.

2. Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure [Up to 24 weeks during treatment]

   On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window.

3. Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12 [Up to 12 weeks after the last actual dose of study drug]

   Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method.

4. Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests [Up to post-treatment Week 12]

   Improvement was defined as: increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein increase of more than 15*10^9/L from baseline to post-treatment Week 12 in platelet count decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio.

5. Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest [Up to post-treatment Week 12]

   The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12.

6. Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score [Up to post-treatment Week 12]

   The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.

7. Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score [Up to post-treatment Week 12]

   MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. HCV GT1- or GT4-infection defined as: positive for anti-HCV Ab, HCV RNA > 1,000 IU/mL and laboratory result indicating HCV GT1 or GT4 infection at Screening.

2. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., computed tomography [CT] scan or magnetic resonance imaging [MRI]).

3. Child-Pugh Score of 7 - 9, inclusive, at time of Screening.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).

3. Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).

4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as CT scan or MRI within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI).

5. Any current or past evidence of Child-Pugh C classification.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Eric Cohen, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02219477
• Other Study ID Numbers: M14-227; 2014-001477-13
• First Posted: Aug 19, 2014
• Last Update Posted: Jul 11, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by AbbVie: Cirrhosis; Hepatitis C; Child-Pugh B; Hepatitis C Genotype 4; Interferon-Free; Hepatitis C Genotype 1; Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus
• Additional relevant MeSH terms: Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis; Ritonavir; Ribavirin

Study Results

Participant Flow

Arm/Group Title	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
Period Title: Overall Study
STARTED	9	24	3
COMPLETED	9	22	2
NOT COMPLETED	0	2	1

Baseline Characteristics

Arm/Group Title	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4	Total
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants	Total of all reporting groups
Overall Participants	9	24	3	36
Age, Customized (Count of Participants)
< 65 years	7 77.8%	20 83.3%	2 66.7%	29 80.6%
>= 65 years	2 22.2%	4 16.7%	1 33.3%	7 19.4%
Sex: Female, Male (Count of Participants)
Female	2 22.2%	7 29.2%	1 33.3%	10 27.8%
Male	7 77.8%	17 70.8%	2 66.7%	26 72.2%

Outcome Measures

1. Primary Outcome

Title	Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2
Description	SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.

Arm/Group Title	Group 1: GT1B	Group 2: GT1 Non-B
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
Measure Participants	9	24
Number (95% Confidence Interval) [percentage of participants]	100 1111.1%	95.8 399.2%

2. Secondary Outcome

Title	Percentage of Participants With SVR12 in Group 3
Description	SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.

Arm/Group Title	Group 3: GT4
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
Measure Participants	3
Number [percentage of participants]	66.7 741.1%

3. Secondary Outcome

Title	Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure
Description	On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window.
Time Frame	Up to 24 weeks during treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population: all participants who received at least 1 dose of study drug.

Arm/Group Title	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
Measure Participants	9	24	3
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%

4. Secondary Outcome

Title	Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12
Description	Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method.
Time Frame	Up to 12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Intent to treat population: all participants who received at least 1 dose of study drug and who had an assessment.

Arm/Group Title	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
Measure Participants	7	19	2
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests
Description	Improvement was defined as: increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein increase of more than 15*10^9/L from baseline to post-treatment Week 12 in platelet count decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio.
Time Frame	Up to post-treatment Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12 for the respective parameter.

Arm/Group Title	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
Measure Participants	9	22	2
Albumin	77.8 864.4%	77.3 322.1%	50.0 1666.7%
Bilirubin	66.7 741.1%	72.7 302.9%	100 3333.3%
Alpha-fetoprotein	33.3 370%
Platelet count	22.2 246.7%	14.3 59.6%	0 0%
International normalized ratio	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest
Description	The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12.
Time Frame	Up to post-treatment Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.

Arm/Group Title	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
Measure Participants	9	22	2
Number [percentage of participants]	0 0%	9.1 37.9%	50.0 1666.7%

7. Secondary Outcome

Title	Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score
Description	The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.
Time Frame	Up to post-treatment Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.

Arm/Group Title	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
Measure Participants	9	22	2
Number [percentage of participants]	66.7 741.1%	54.5 227.1%	50.0 1666.7%

8. Secondary Outcome

Title	Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score
Description	MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.
Time Frame	Up to post-treatment Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.

Arm/Group Title	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
Measure Participants	8	21	2
Number [percentage of participants]	87.5 972.2%	61.9 257.9%	100 3333.3%

Adverse Events

Time Frame	Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
Adverse Event Reporting Description	A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
Arm/Group Title	Group 1: GT1B		Group 2: GT1 Non-B		Group 3: GT4
Arm/Group Description	ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants		ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants		ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
All Cause Mortality
	Group 1: GT1B		Group 2: GT1 Non-B		Group 3: GT4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1: GT1B		Group 2: GT1 Non-B		Group 3: GT4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		10/24 (41.7%)		1/3 (33.3%)
Blood and lymphatic system disorders
ANAEMIA	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
PANCYTOPENIA	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
Gastrointestinal disorders
ABDOMINAL PAIN UPPER	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
ASCITES	1/9 (11.1%)		1/24 (4.2%)		1/3 (33.3%)
DIARRHOEA	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
HAEMATEMESIS	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
HAEMATOCHEZIA	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
OESOPHAGEAL VARICES HAEMORRHAGE	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
VOMITING	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
Hepatobiliary disorders
HEPATIC FAILURE	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
HYPERBILIRUBINAEMIA	1/9 (11.1%)		1/24 (4.2%)		1/3 (33.3%)
Infections and infestations
PERITONITIS BACTERIAL	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
POST PROCEDURAL COMPLICATION	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
Metabolism and nutrition disorders
DEHYDRATION	0/9 (0%)		1/24 (4.2%)		1/3 (33.3%)
ELECTROLYTE IMBALANCE	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
HYPONATRAEMIA	0/9 (0%)		1/24 (4.2%)		1/3 (33.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
Nervous system disorders
HAEMORRHAGE INTRACRANIAL	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
HEPATIC ENCEPHALOPATHY	0/9 (0%)		2/24 (8.3%)		1/3 (33.3%)
SYNCOPE	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
Psychiatric disorders
ANXIETY	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
Renal and urinary disorders
RENAL FAILURE	0/9 (0%)		1/24 (4.2%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: GT1B		Group 2: GT1 Non-B		Group 3: GT4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/9 (88.9%)		24/24 (100%)		3/3 (100%)
Blood and lymphatic system disorders
ANAEMIA	2/9 (22.2%)		6/24 (25%)		0/3 (0%)
LEUKOCYTOSIS	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
PANCYTOPENIA	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
Cardiac disorders
TACHYCARDIA	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
Gastrointestinal disorders
ABDOMINAL PAIN	0/9 (0%)		3/24 (12.5%)		3/3 (100%)
ABDOMINAL PAIN UPPER	0/9 (0%)		3/24 (12.5%)		1/3 (33.3%)
ASCITES	0/9 (0%)		8/24 (33.3%)		1/3 (33.3%)
CONSTIPATION	0/9 (0%)		5/24 (20.8%)		0/3 (0%)
DIARRHOEA	3/9 (33.3%)		10/24 (41.7%)		1/3 (33.3%)
FLATULENCE	0/9 (0%)		2/24 (8.3%)		1/3 (33.3%)
NAUSEA	2/9 (22.2%)		13/24 (54.2%)		2/3 (66.7%)
VARICES OESOPHAGEAL	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
VOMITING	1/9 (11.1%)		6/24 (25%)		1/3 (33.3%)
General disorders
ASTHENIA	0/9 (0%)		4/24 (16.7%)		1/3 (33.3%)
CHILLS	1/9 (11.1%)		2/24 (8.3%)		0/3 (0%)
FATIGUE	3/9 (33.3%)		11/24 (45.8%)		2/3 (66.7%)
OEDEMA PERIPHERAL	0/9 (0%)		6/24 (25%)		1/3 (33.3%)
PYREXIA	1/9 (11.1%)		3/24 (12.5%)		0/3 (0%)
Hepatobiliary disorders
BILE DUCT STENOSIS	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
HYPERBILIRUBINAEMIA	2/9 (22.2%)		3/24 (12.5%)		1/3 (33.3%)
JAUNDICE	2/9 (22.2%)		2/24 (8.3%)		1/3 (33.3%)
OCULAR ICTERUS	2/9 (22.2%)		5/24 (20.8%)		0/3 (0%)
Infections and infestations
CYSTITIS	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
DIVERTICULITIS	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
FUNGAL INFECTION	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
GASTROENTERITIS	0/9 (0%)		1/24 (4.2%)		1/3 (33.3%)
NASOPHARYNGITIS	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
SOFT TISSUE INFECTION	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
STAPHYLOCOCCAL INFECTION	0/9 (0%)		1/24 (4.2%)		1/3 (33.3%)
URINARY TRACT INFECTION	0/9 (0%)		2/24 (8.3%)		1/3 (33.3%)
Injury, poisoning and procedural complications
CONTUSION	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
FALL	0/9 (0%)		3/24 (12.5%)		0/3 (0%)
Investigations
BLOOD CREATININE INCREASED	1/9 (11.1%)		0/24 (0%)		0/3 (0%)
CREATININE RENAL CLEARANCE DECREASED	1/9 (11.1%)		2/24 (8.3%)		0/3 (0%)
HAEMOGLOBIN DECREASED	1/9 (11.1%)		3/24 (12.5%)		1/3 (33.3%)
WEIGHT INCREASED	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
Metabolism and nutrition disorders
DECREASED APPETITE	0/9 (0%)		5/24 (20.8%)		0/3 (0%)
HYPERKALAEMIA	0/9 (0%)		2/24 (8.3%)		1/3 (33.3%)
HYPERURICAEMIA	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
HYPOKALAEMIA	0/9 (0%)		3/24 (12.5%)		1/3 (33.3%)
HYPOMAGNESAEMIA	0/9 (0%)		3/24 (12.5%)		0/3 (0%)
HYPONATRAEMIA	1/9 (11.1%)		7/24 (29.2%)		1/3 (33.3%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	1/9 (11.1%)		2/24 (8.3%)		0/3 (0%)
BACK PAIN	1/9 (11.1%)		2/24 (8.3%)		0/3 (0%)
FISTULA	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
MUSCLE SPASMS	0/9 (0%)		6/24 (25%)		0/3 (0%)
MUSCULOSKELETAL CHEST PAIN	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
Nervous system disorders
DIZZINESS	1/9 (11.1%)		7/24 (29.2%)		2/3 (66.7%)
HEADACHE	1/9 (11.1%)		5/24 (20.8%)		0/3 (0%)
HEPATIC ENCEPHALOPATHY	1/9 (11.1%)		4/24 (16.7%)		1/3 (33.3%)
HYPERAESTHESIA	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
HYPOTONIA	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
PARAESTHESIA	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
RADIAL NERVE PALSY	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
SYNCOPE	0/9 (0%)		1/24 (4.2%)		1/3 (33.3%)
TREMOR	1/9 (11.1%)		3/24 (12.5%)		0/3 (0%)
Psychiatric disorders
ANXIETY	1/9 (11.1%)		1/24 (4.2%)		0/3 (0%)
DEPRESSED MOOD	0/9 (0%)		1/24 (4.2%)		1/3 (33.3%)
INSOMNIA	0/9 (0%)		6/24 (25%)		2/3 (66.7%)
IRRITABILITY	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
MOOD SWINGS	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
PANIC ATTACK	0/9 (0%)		0/24 (0%)		2/3 (66.7%)
Reproductive system and breast disorders
BREAST PAIN	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
EJACULATION FAILURE	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
ERECTILE DYSFUNCTION	0/9 (0%)		0/24 (0%)		1/3 (33.3%)
Respiratory, thoracic and mediastinal disorders
COUGH	3/9 (33.3%)		1/24 (4.2%)		0/3 (0%)
DYSPNOEA	0/9 (0%)		2/24 (8.3%)		1/3 (33.3%)
PRODUCTIVE COUGH	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
Skin and subcutaneous tissue disorders
PRURITUS	1/9 (11.1%)		7/24 (29.2%)		1/3 (33.3%)
PRURITUS GENERALISED	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
RASH	0/9 (0%)		7/24 (29.2%)		1/3 (33.3%)
RASH GENERALISED	0/9 (0%)		2/24 (8.3%)		0/3 (0%)
Vascular disorders
HYPERTENSION	1/9 (11.1%)		0/24 (0%)		0/3 (0%)
HYPOTENSION	0/9 (0%)		3/24 (12.5%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

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

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