Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]
Status:
Completed
Trial end date:
2018-11-02
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborators:
National Institute on Drug Abuse (NIDA) YR Gaitonde Centre for AIDS Research and Education