8-Week Regimen Safe, Effective for HIV/HCV Co-infection
An 8-week regimen of ledipasvir (LDV) and sofosbuvir (SOF) safely and effectively treated hepatitis C (HCV) in individuals with human immunodeficiency virus (HIV), according to the results of a recent clinical trial.
The trial included 27 participants with HIV and HCV genotypes 1 (n=26) or 4 (n=1). All participants were receiving antiretrovirals, and had a median baseline HCV RNA of 1,490,000 IU/mL and median baseline CD4+T cell count of 561 cells/mm3.
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For 8 weeks, participants received LDV and SOF. The sustained virologic response (SVR) at 12 weeks was assessed as the primary endpoint and adverse events were reported. In addition, the researchers determined the non-inferiority of LDV and SOF by comparing the achieved SVR to the study-defined historical SVR rate of 60%, which was achieved with 24 to 48 weeks of pegylated interferon and weight based ribavirin.
After 12 weeks, 100% of participants achieved SVR.
Additionally, a grade 2 or higher adverse event occurred in 10 participants (37%), but no nephrotoxicity was reported.
“An 8-week course of LDV/SOF achieved 100% SVR12 in this trial of HIV-infected men with acute genotype 1 or 4 HCV infection, regardless of baseline HCV RNA. No renal toxicity was noted in participants on boosted [tenofovir disoproxil fumarate]-inclusive HIV regimens,” the researchers concluded. “These data support an 8-week duration of LDV/SOF 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). Presented at: AASLD Liver Meeting 2017; October 20-24, 2017; Washington, DC. Abstract 196.