SAN DIEGO, CA—Researchers at IDWeek 2015 presented positive efficacy data for the grazoprevir/elbasvir (EBR/GZR) regimen for patients co-infected with hepatitis C virus (HCV) and HIV.
The regimen yielded “high rates of SVR (sustained virologic response) in patients with HIV/HCV co-infection,” reported Heather Platt, MD, of Merck, New Brunswick, New Jersey. “These were comparable response rates to other studies in HCV mono-infected patients, and comparable response rates in cirrhotic and non-cirrhotic patients.”
None of the HCV/HIV co-infected study participants died or experienced serious drug-related adverse effects, Dr. Platt reported.
“With low rates of adverse events, once-daily administration, and suitability for use in patients also receiving antiretroviral therapy, EBR/GZR represents a highly effective treatment option for patients with HCV/HIV co-infection,” she concluded.
Ribavirin offered no advantage to patients receiving EBR/GZR, Dr. Platt noted.
Grazoprevir is a HCV NS3/4 protease inhibitor and elbasvir is a HCV NS5A inhibitor. The analysis included patients with HIV/HCV co-infection enrolled in three Phase 2/3 trials evaluating grazoprevir 100mg and elbasvir 50mg with or without ribavirin. Co-infected patients who were HCV-treatment-naïve and/or pegylated interferon/ribavirin treatment-experienced received grazoprevir/ribavirin for 12 or 16 weeks. (Analysis of treatment-naïve patients’ data was limited to 12 weeks; treatment-experienced data was analyzed for patients who underwent EBR/GZR therapy for 12 and 16 weeks.) All of the patients were maintained on a stable antiretroviral therapy consisting of: tenofovir or abacavir + lamivudine or emtricitabine + raltegravir, dolutegravir, or rilpivirine. In addition, all patients had CD4 >200 cells/mm3 and undetectable HIV RNA or were HIV treatment-naïve with CD4+ >500 cells/mm3 and HIV RNA <50,000 copies/mL.
The primary efficacy endpoint was sustained virologic response at follow-up Week 12 (SVR12; HCV RNA <15 IU/mL). For treatment-naïve patients with HIV/HCV co-infection, SVR12 was observed in 94.0% of the group vs. 94.8% of those with HCV mono-infection in the EBR/GZR treatment group. For treatment-experienced patients with HIV/HCV co-infection, SVR12 was observed in 100.0% of the group vs. 91.5% of those with HCV mono-infection in the EBR/GZR group at Week 12.
Findings from the study demonstrated that treatment with EBR/GZR without ribavirin led to high efficacy in HIV/HCV co-infected patients that was comparable to HCV mono-infected patients for HCV GT1-, GT4-, and GT6- infections, Dr. Platt concluded.