Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03480932
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), YR Gaitonde Centre for AIDS Research and Education (Other)
• Enrollment: 150
• Location: 1
• Arms: 3
• Actual Duration (Months): 9
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

The primary objective of this pilot trial is to compare the efficacy, measured as sustained virologic response (SVR) at least 12 weeks after completion of therapy, across three study regimens/delivery modalities: Arm 1 - 4 weeks of sofosbuvir (SOF) + daclatasvir (DAC) + pegylated interferon alfa-2a (PEG) delivered using directly observed therapy (DOT); Arm 2 - 12 weeks of SOF+DAC delivered using DOT; and Arm 3 - 12 weeks of SOF+DAC delivered as per standard of care (monthly dispensation with no DOT). Secondary objectives are 1)To compare the cost per SVR for each of the three study arms; 2) To compare adherence among persons across the three study arms; 3) To evaluate the safety, tolerability and acceptability of treatment in the three arms.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: Sofosbuvir; Drug: Daclatasvir; Drug: Pegylated Interferon alfa-2a	Phase 2/Phase 3

Detailed Description

This will be a non-blinded randomized clinical trial with 150 participants randomized at a 1:1:1 allocation ratio to one of three treatment arms.

Arm 1: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach

Arm 2: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach

Arm 3: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)

Pegylated-interferon alfa-2a (PEG) will be delivered subcutaneously once weekly. Sofosbuvir (SOF) and Daclatasvir (DAC) will be taken orally once daily for the entire study period.

The study will take place at the YR Gaitonde Centre for AIDS Education (YRG) and Johns Hopkins University (JHU) Collaborative Integrated Care Center (YRG-JHU ICC) located within the premises of the Chattisgarh Institute of Medical Sciences (CIMS) in Bilaspur in the state of Chattisgarh, India.

Participants will be recruited from the YRG-JHU ICC in Bilaspur, which currently has 514 registered HCV antibody positive clients. The Bilaspur ICC is in the Chattisgarh Institute for Medical Sciences (CIMS).

The primary outcome will be sustained virologic response (SVR12). Secondary outcomes include cost per SVR12, adherence, safety and tolerability.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Role of Pegylated Interferon in Combination With Direct Acting Antivirals (DAAs) to Cure Hepatitis C As Soon As Possible (ASAP) - Hepatitis C [ASAP-C]
• Actual Study Start Date: Feb 2, 2018
• Actual Primary Completion Date: Nov 2, 2018
• Actual Study Completion Date: Nov 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SOF+DAC+PEG Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach	Drug: Sofosbuvir; Direct acting antiviral agent used for the treatment of hepatitis C; Other Names: Sovaldi Hepcvir MyHep Hepcinat Resof SoviHep ; Drug: Daclatasvir; Direct acting antiviral agent used for the treatment of hepatitis C; Other Names: Daklinza Natdac Daclahep Dacihep Hepdac Mydekla ; Drug: Pegylated Interferon alfa-2a; Antiviral agent used for the treatment of hepatitis C; Other Names: Pegasys Taspiance
Active Comparator: SOF+DAC, DOT Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach	Drug: Sofosbuvir; Direct acting antiviral agent used for the treatment of hepatitis C; Other Names: Sovaldi Hepcvir MyHep Hepcinat Resof SoviHep ; Drug: Daclatasvir; Direct acting antiviral agent used for the treatment of hepatitis C; Other Names: Daklinza Natdac Daclahep Dacihep Hepdac Mydekla
Active Comparator: SOF+DAC, standard Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)	Drug: Sofosbuvir; Direct acting antiviral agent used for the treatment of hepatitis C; Other Names: Sovaldi Hepcvir MyHep Hepcinat Resof SoviHep ; Drug: Daclatasvir; Direct acting antiviral agent used for the treatment of hepatitis C; Other Names: Daklinza Natdac Daclahep Dacihep Hepdac Mydekla

Outcome Measures

Primary Outcome Measures

1. SVR12 [12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC]

   Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion

Secondary Outcome Measures

1. Serious Adverse Events [16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC]

   Number of participants with treatment-related serious adverse events by laboratory tests and physician examination

2. Medication Adherence [4 weeks for SOF+DAC+PEG and 12 weeks for SOF+DAC]

   Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Willing and able to provide written informed consent

2. Age ≥ 18 years

3. Documented evidence of chronic HCV infection (HCV RNA positive)

4. Participant is a resident of Bilaspur and can provide locator information that can be verified by one of the study staff

5. If participant is co-infected with HIV, he/she must have a cluster of differentiation 4 (CD4) > 350 cells/mm3 and be either: 1) antiretroviral therapy (ART) naïve or 2) on ART be on a tenofovir-containing regimen. If a subject's CD4 drops below 350 cells/μl (current threshold for HIV treatment in India), he/she will be able to initiate ART but we will ensure that the subject starts on a tenofovir-containing regimen, which is currently the standard for persons newly initiating ART in India.

6. Subjects must have the following laboratory parameters at screening:

7. alanine aminotransferase (ALT) ≤ 10 x the upper limit of normal (ULN)

8. aspartate aminotransferase (AST) ≤ 10 x ULN

9. Hemoglobin ≥ 10 g/dl for male and 9 g/dl for female subjects

10. International normalized ratio (INR) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR

11. Albumin ≥ 3 g/dl

12. Direct bilirubin ≤ 1.5 x ULN

13. Creatinine clearance ≥ 30 ml/min as calculated by the Cockcroft-Gault Equation

14. Alpha fetoprotein < 50 ng/ml

15. Absolute neutrophil count (ANC) ≥ 1,500/μL

16. Platelets ≥ 90,000/μL

17. Thyroid stimulating hormone (TSH) ≤ ULN

18. FIB-4 <3.25. FIB-4 is a non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) which is calculated as the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis.) Participants with a FIB-4 >3.25 will be referred to the medical gastroenterology department for further assessment for cirrhosis. If cirrhosis is ruled out by medical gastroenterology, participants can be rescreened for the study.

19. A female subject is eligible to enroll in the study if it is confirmed that she is:

20. Not pregnant or nursing

21. Not of childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 50 years of age with cessation (for ≥12 months) of previously occurring menses)

22. Of childbearing potential (i.e., women who have not had a hysterectomy, both ovaries removed or medically documented ovarian failure). [NOTE: Women ≤50 years of age with amenorrhea will be considered to be of childbearing potential.] These women must have a negative urine pregnancy test at screening and a negative urine pregnancy test on the Baseline /Day 1 visit prior to randomization and agree to one of the following modes of contraception for the duration of treatment and 12 weeks thereafter.

• Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, sumptothermal, post-ovulation methods) is NOT permitted.

or

1. Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from 3 weeks prior to Baseline/Day 1 until the end of treatment. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone containing contraceptive prior to screening may continue their contraceptive regimen in addition to the study specified methods of birth control.

• intrauterine device (IUD) with a documented failure rate of less than 1% per year

• female barrier method: cervical cap or diaphragm with spermicidal agent

• tubal sterilization

• vasectomy in male partner

1. Subjects must be of generally good health as determined by the investigator.

2. Subjects must be able to comply with the dosing instructions for study drug administration and be willing to complete the study schedule of assessments.

Exclusion Criteria:

1. Pregnant or nursing female

2. Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage, model for end-stage liver disease (MELD)<12)

3. Prior treatment for hepatitis C virus infection

4. Infection with hepatitis B virus (HBsAg positive)

5. Chronic use of systematically administered immunosuppressive agents (e.g., prednisone equivalent >10 mg/day)

6. Use of any prohibited concomitant medications within 28 days of the Baseline/Day 1 visit.

7. Contraindications to PEG

8. Known hypersensitivity to the metabolites or formulation excipients of PEG (for Arm 1 subjects)

9. Active significant psychiatric condition(s) including severe depression, severe bipolar disorder and schizophrenia. Other psychiatric disorders are permitted if the condition is well controlled with a stable treatment regimen for ≥ 1 year from screening, or inactive for ≥ 1 year from screening.

10. Presence of autoimmune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, psoriasis of greater than mild severity)

11. History of clinical significant retinal disease

12. Clinical evidence of cirrhosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	YR Gaitonde Centre for AIDS Education and Johns Hopkins University Collaborative Integrated Care Center (YRG-JHU ICC)	Bilaspur	Chhattisgarh	India	495009

Sponsors and Collaborators

• Johns Hopkins Bloomberg School of Public Health
• National Institute on Drug Abuse (NIDA)
• YR Gaitonde Centre for AIDS Research and Education

Investigators

• Principal Investigator: Shruti Mehta, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 25, 2018

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT03480932
• Other Study ID Numbers: R01DA026727; R01DA026727
• First Posted: Mar 29, 2018
• Last Update Posted: May 18, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Johns Hopkins Bloomberg School of Public Health: directly observed therapy; sofosbuvir; daclatasvir; pegylated interferon; resource-limited setting
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Sofosbuvir

Study Results

Participant Flow

Arm/Group Title	SOF+DAC+PEG	SOF+DAC, DOT	SOF+DAC, Standard
Arm/Group Description	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses) Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Period Title: Overall Study
STARTED	50	50	50
COMPLETED	47	45	45
NOT COMPLETED	3	5	5

Baseline Characteristics

Arm/Group Title	SOF+DAC+PEG	SOF+DAC, DOT	SOF+DAC, Standard	Total
Arm/Group Description	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses) Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C	Total of all reporting groups
Overall Participants	50	50	50	150
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	25	26	25	25
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	50 100%	50 100%	50 100%	150 100%
Race/Ethnicity, Customized (Count of Participants)
Indian	50 100%	50 100%	50 100%	150 100%
Region of Enrollment (participants) [Number]
India	50 100%	50 100%	50 100%	150 100%
Educational attainment (Count of Participants)
None	3 6%	2 4%	6 12%	11 7.3%
Primary school	19 38%	16 32%	15 30%	50 33.3%
Secondary school	9 18%	20 40%	17 34%	46 30.7%
At least high school	19 38%	12 24%	12 24%	43 28.7%
Employment (Count of Participants)
Monthly wages	19 38%	16 32%	12 24%	47 31.3%
Weekly wages	5 10%	8 16%	3 6%	16 10.7%
Daily wages	22 44%	25 50%	28 56%	75 50%
Unemployment	3 6%	1 2%	7 14%	11 7.3%
Missing	1 2%	0 0%	0 0%	1 0.7%
Marital status (Count of Participants)
Never married	31 62%	32 64%	30 60%	93 62%
Currently married	15 30%	13 26%	17 34%	45 30%
Separated	0 0%	1 2%	0 0%	1 0.7%
Living with partner	4 8%	4 8%	3 6%	11 7.3%
Injection drug use frequency in prior month (Count of Participants)
None	3 6%	5 10%	4 8%	12 8%
Once a week to less than twice a week	24 48%	17 34%	22 44%	63 42%
Twice a week to six times a week	15 30%	15 30%	18 36%	48 32%
Daily	8 16%	13 26%	6 12%	27 18%
Non-injection drug use in prior month (Count of Participants)
Count of Participants [Participants]	42 84%	38 76%	41 82%	121 80.7%
Alcohol use (Count of Participants)
No/mild use	46 92%	47 94%	45 90%	138 92%
Harmful/hazardous use	3 6%	2 4%	5 10%	10 6.7%
Alcohol dependence	1 2%	1 2%	0 0%	2 1.3%
Depressive symptoms (Count of Participants)
None	37 74%	28 56%	31 62%	96 64%
Mild	10 20%	17 34%	15 30%	42 28%
Moderate	3 6%	5 10%	3 6%	11 7.3%
Moderately severe to severe	0 0%	0 0%	1 2%	1 0.7%
Quality of life (Self-rated health scale (0-100))) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Self-rated health scale (0-100))]	90	78	80	80
HIV-infected (Count of Participants)
Count of Participants [Participants]	0 0%	1 2%	0 0%	1 0.7%
Median HCV RNA (log 10 copies/ml) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [log 10 copies/ml]	5.4	5.6	5.7	5.6
Median calculated fibrosis score (FIB-4) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	0.69	0.68	0.73	0.68

Outcome Measures

1. Primary Outcome

Title	SVR12
Description	Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion
Time Frame	12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	SOF+DAC+PEG	SOF+DAC, DOT	SOF+DAC, Standard
Arm/Group Description	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses) Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Measure Participants	50	50	50
Count of Participants [Participants]	26 52%	30 60%	17 34%

2. Secondary Outcome

Title	Serious Adverse Events
Description	Number of participants with treatment-related serious adverse events by laboratory tests and physician examination
Time Frame	16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	SOF+DAC+PEG	SOF+DAC, DOT	SOF+DAC, Standard
Arm/Group Description	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses) Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Measure Participants	50	50	50
Count of Participants [Participants]	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Medication Adherence
Description	Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence
Time Frame	4 weeks for SOF+DAC+PEG and 12 weeks for SOF+DAC

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	SOF+DAC+PEG	SOF+DAC, DOT	SOF+DAC, Standard
Arm/Group Description	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses) Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Measure Participants	50	50	50
Count of Participants [Participants]	35 70%	31 62%	10 20%

Adverse Events

Time Frame	16 weeks for Arm 1 and 24 weeks for ARms 2 and 3
Arm/Group Title	SOF+DAC+PEG		SOF+DAC, DOT		SOF+DAC, Standard
Arm/Group Description	Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C		Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C		Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses) Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
All Cause Mortality
	SOF+DAC+PEG		SOF+DAC, DOT		SOF+DAC, Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)		0/50 (0%)
Serious Adverse Events
	SOF+DAC+PEG		SOF+DAC, DOT		SOF+DAC, Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	SOF+DAC+PEG		SOF+DAC, DOT		SOF+DAC, Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)		0/50 (0%)

Limitations/Caveats

Adherence measurements differ by arm (Arm 1 and 2 included daily observation of doses). Adherence assessment for Arm 3 based on participant completing a visit to pick up medication refill.

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.