Effectiveness of Ledipasvir/Sofosbuvir for Acute HCV Infection in HIV
No renal toxicity was noted in participants on boosted TDF-inclusive HIV regimens.
An 8-week regimen of ledipasvir plus sofosbuvir treatment for acute hepatitis C in HIV-infected individuals resulted in a 100% sustained virologic response rate, according to the results of a study reported at the 2017 American Association for the Study of Liver Diseases meeting.
In the SWIFT-C multicenter clinical trial, the efficacy and safety of ledipasvir plus sofosbuvir were evaluated in 27 patients with hepatitis C and HIV co-infection (median age 46 years; 100% male; 33% Hispanic; 81% never used intravenous drugs). Patients had acute hepatitis C infection diagnosed within 24 weeks of study enrollment, and genotypes 1 (96% of patients) and 4 (4%) were included.
At baseline, median hepatitis C RNA was 1,490,000 IU/mL, and 22% of patients had a high baseline RNA (>6 million IU/mL). All patients were receiving antiretroviral agents, and HIV-1 RNA level was below the lower limit of quantitation.
All patients completed the 8 weeks of ledipasvir and sofosbuvir. At 12 weeks posttreatment, the sustained virologic response (SVR) rate was 100% (90% CI, 90%-100%). According to the study authors, the SVR rate was superior to the historical rate of 60% achieved with pegylated interferon and ribavirin.
Grade 2 or higher adverse events occurred in 37% of participants. No adverse events related to nephrotoxicity were reported, and no events related to renal toxicity were reported for patients receiving the antiretroviral tenofovir.
The study authors concluded that, “these data support an 8-week duration of [ledipasvir plus sofosbuvir] in the treatment of acute HCV infection in HIV-infected persons.”
Naggie S, Fierer DS, Hughes M, et al. 100% SVR with 8 weeks of ledipasvir/sofosbuvir in HIV-infected men with acute HCV infection: results from the SWIFT-C trial (sofosbuvir-containing regimens without interferon for treatment of acute HCV in HIV-1 infected individuals). [AASLD abstract 196]. Hepatology. 2017;66:1-148. doi:10.1002/hep.29500