NCT02128217

Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection

Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute HCV in HIV-1 Infected Individuals (SWIFT-C)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• HIV-1 Infection
• Hepatitis

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Participants received one 400 mg tablet of sofosbuvir (SOF) orally every morning with food
DRUG	Ribavirin	Participants received weight-based ribavirin RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.
DRUG	Ledipasvir/Sofosbuvir	Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of Ledipasvir (LDV) and 400 mg of SOF.

Timeline

• Start date: 2014-05-30
• Primary completion: 2017-02-28
• Completion: 2017-05-09
• First posted: 2014-05-01
• Last updated: 2018-04-27
• Results posted: 2018-03-30

Locations

12 sites across 1 country: United States