Phase 2 Completed N=50 Randomized Treatment

Directly Observed Therapy for HCV in Chennai, India

Hepatitis C, Chronic

Source: ClinicalTrials.gov NCT02541409 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcomePrimary: HCV Treatment Completion — 22; 22 Participants

Summary

The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24 weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited setting. The investigators will compare treatment completion rates among 50 persons chronically infected with HCV who will be randomized to receive either 1) 12 weeks of sofosbuvir (SOF) + ribavirin (RBV) + pegylated interferon alfa-2a (PEG); or 2) 24 weeks of SOF + RBV. Treatment will be delivered daily by field workers at a location of a participants choosing. Secondary objectives are 1) To compare the efficacy of SOF+RBV with or without PEG as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (SVR12); 2) To evaluate the safety and tolerability of SOF+RBV with or without PEG; 3) To assess the impact of SVR12 on insulin resistance.

Outcome Measures

Outcome	Result	p-value
PRIMARY HCV Treatment Completion	22; 22	—
SECONDARY Sustained Virologic Response (SVR)	22; 15	—
SECONDARY Serious Adverse Events	0; 0	—
SECONDARY Change in Insulin Resistance	1.2; 0.2	—

Eligibility Criteria

Inclusion Criteria

Willing/able to provide consent
Age ≥ 18
Chronic HCV (HCV RNA positive)
Resident of Chennai and can provide locator information
If co-infected with HIV, must have CD4 (Cluster of Differentation 4) > 350 cells/mm3 and either: 1) ART naïve or 2) if on ART be on a tenofovir-containing regimen. If a participant's CD4 drops below 350 cells/μl (threshold for treatment in India), will have to initiate a tenofovir-containing regimen (current standard of care).
Participants must have the following at screening:
Alanine Aminotransferase (ALT) ≤ 10 x the upper limit of normal (ULN)
Aspartate Aminotransferase (AST) ≤ 10 x ULN
Hemoglobin ≥ 12 g/dl for males and 11 g/dl for females
International normalized ratio (INR) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
Albumin ≥ 3 g/dl
Direct bilirubin ≤ 1.5 x ULN
Creatinine clearance ≥ 60 ml/min (Cockgroft-Gault Equation)
Alpha fetoprotein 50 years of age with cessation (for ≥12 months) of previously occurring menses
Of childbearing potential and negative urine pregnancy test prior to randomization and agree to one of the following from 3 weeks prior to Baseline/Day 1 until 6 months after the last dose of RBV.
Complete abstinence from intercourse.

Consistent use of approved methods of birth control in addition to a male partner who correctly uses a condom from 3 weeks prior to Baseline/Day 1 until 6 months after the last dose of RBV.
Male participants must agree to consistently and correctly use a condom. If their female partner is of childbearing potential, their partner must agree to use one of the study approved non-hormonal methods of birth control or a hormone-containing contraceptive, from the date of screening until 7 months after their last dose of RBV
Male participants must agree to refrain from sperm donation for at least 7 months after the last dose of RBV.
Of generally good health as determined by the investigator.
Able to comply with the dosing instructions for study drug administration and willing to complete the study schedule of assessments.

Exclusion Criteria

Pregnant/nursing female or male with pregnant/nursing female partner.
Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage, MELD 10 mg/day)
Use of any prohibited concomitant medications within 28 days of the Baseline/Day 1 visit.
Contraindications to RBV therapy or PEG/RBV
Known hypersensitivity to RBV or PEG, the metabolites or formulation excipients
Additional exclusion criteria related to Aim 1 regimen
Pre-existing 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.
Presence of autoimmune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis).
History of clinical significant retinal disease.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02541409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.