HIV-1 Infection Clinical Trial
Official title:
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute HCV in HIV-1 Infected Individuals (SWIFT-C)
Early identification of acute HCV infection is essential to prevent chronic infections and
the long-term liver disease complications that may occur. Early identification and treatment
of HCV during the acute phase can result in significantly higher response rates with shorter
durations of therapy.
Pegylated-interferon alfa (PEG-IFN) was the typical treatment for HCV infection. Participants
subcutaneously inject PEG-IFN where the average duration of treatment was approximately 20
weeks. With the advancement of direct-acting antivirals (DAAs), it was possible to see if a
new DAA might be non-inferior compared to (PEG-IFN).
The study was designed to see if a fixed-dose combination tablet can replace the old HCV
treatments by being more effective, safer and better tolerated in HIV-infected participants
with new HCV infection. The study was a Phase I, open-label, two cohort clinical trial, in
which 44 acutely HCV-infected HIV-1 positive participants were enrolled. Participants in each
cohort were evaluated in two steps: on treatment (Step 1) and follow-up after discontinuing
study treatment (Step 2). The cohorts were enrolled sequentially. Participants in Cohort 1
were enrolled and administered oral Sofosbuvir (SOF) in combination with weight-based
ribavirin (RBV). Participants in Cohort 2 were enrolled and administered an oral fixed dose
combination of Ledipasvir/Sofosbuvir (LDV/SOF).
The first cohort opened with SOF/RBV treatment for 12 weeks and accrued 17 participants. All
participants under Cohort 1 were to visit the clinical site at weeks 0, 1, 2, 4, 8, and 12
when on treatment (Step 1), then visit the clinical site again at 2, 4, 8, 12 and 24 weeks
during follow-up after discontinuing study treatment (Step 2).
The second cohort opened for an 8-week treatment of LDV/SOF and included at least 27
subjects. All participants under Cohort 2 were to visit the clinical site at weeks 0, 1, 2,
4, and 8 when on treatment (Step 1), then visit the clinical site again at 2, 4, 8, 12 and 24
weeks during follow-up after discontinuing study treatment (Step 2).
Both cohorts were monitored for safety and HCV viral load response while the participants
were on treatment.
The primary objective did not compare the cohorts together; instead, each study cohort was
formally assessed for efficacy with sustained virologic response 12 weeks after treatment
based on non-inferiority criteria compared to a historical SVR rate of 60% separately.
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