BOSTON — Harvoni was safe and effective for the treatment of patients with HIV with acute hepatitis C virus infection, according to a Late Breaker presented at CROI 2016.
“We are all familiar with this fixed dosed combination for treatment of hepatitis C. However, there is currently no approved DAA therapy for patients with acute hepatitis C virus infection, including those with HIV coinfection,” Jürgen K. Rockstroh, MD, professor of medicine, University of Bonn, Germany, said during his presentation. “The aim of the study was to determine the efficacy of a shorter treatment cycle of the fixed dosed combination measured by the proportion of patients who had an SVR 12 weeks after treatment ended and to evaluate safety and mobility of the combination as assessed by review of cumulative data.”
Jürgen K. Rockstroh
Twenty-six patients with HIV who had acute HCV for less than 24 weeks were included and received either HIV antiretroviral (ARV) therapy with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) or no treatment for 6 weeks. Seventy-three percent of patients had HCV genotype 1a infection (n = 19) and 27% had genotype 4 (n = 7). All of the patients were male, 92% were white, 54% had IL28B non-CC and 96% were undergoing ARV therapy (96%).
The median baseline HCV RNA was 5.4 log10 IU/mL. The primary endpoint of the study was sustained viral response, defined through HCV RNA levels.
Overall, every patient completed therapy and 85% achieved SVR at 4 weeks (n = 22). All patients who had HCV RNA less than 6.9 log10 IU/mL at baseline achieved SVR4. Four treatment failures were observed, of which 3 patients relapsed and one patient experienced reinfection with a different HCV strain, according to Rockstroh.
The treatment regimen was safe and well-tolerated. A majority of patients experienced only mild or moderate adverse events (85%). One patient experienced serious adverse events unrelated to the treatment regimen. No patients discontinued treatment, died or experienced HIV rebound.
“Treatment with ledipasvir and sofosbuvir for 6 weeks resulted in 77% SVR12 rate in patients with HIV and acute HCV,” Rockstroh concluded. “Acutely HCV-infected patients with a higher viral load should be considered for longer duration of therapy.” – by Melinda Stevens
Rockstroh JK, et al. Abstract #154LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2016; Boston.
Disclosure: Rockstroh reports consulting and speaking for Abbott, AbbVie, Bioner, Bristol-Myers Squibb, Cipla, Gilead Sciences, Janssen, Merck and ViiV.