This article is more than 5 years old. Information may no longer be current.

Harvoni yields high SVR rates in patients coinfected with HCV/HIV

After treatment with Harvoni for hepatitis C virus infection, high rates of sustained virologic response were observed in treatment-naive patients coinfected with hepatitis C virus infection and HIV, according to data from a phase 2b pilot study.

“In this study, we evaluated the rates of SVR following a 12-week treatment regimen of a fixed-dose combination of ledipasvir and sofosbuvir in patients coinfected with HCV genotype 1 and HIV who were not previously treated for HCV,” the researchers wrote.

Fifty noncirrhotic patients were enrolled in the study after being recruited from HCV clinics in the District of Columbia. All patients received a combination pill of Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) for 12 weeks at the NIH Clinical Center from June 2013 to September 2014. Thirty-seven patients were receiving antiretroviral therapy for HIV at the time of the study.

Overall, 49 patients (98%; 95% CI, 89-100) achieved SVR at 12 weeks. One patient experienced relapse at 4 weeks that displayed resistance to NS5A inhibitors (ledipasvir). All patients reached virologic suppression lower than the lower limit of quantification by 4 weeks of treatment. Both groups of patients showed decline in HCV RNA and the median overall treatment effect was similar (99.98% for both).

There were no deaths or discontinuation of the study due to treatment. The most common adverse events experienced by patients were grade 1 in severity and included nasal congestion, fatigue and headache.

“In this open-label, uncontrolled, nonrandomized trial, the combination of ledipasvir and sofosbuvir was associated with high rates of SVR in participants coinfected with HCV genotype 1 and HIV, similar to that observed in patients monoinfected with HCV genotype 1,” the researchers wrote. “These results show for the first time, to our knowledge, that an interferon- and ribavirin-free therapy is associated with high SVR rates in patients coinfected with HCV and HIV.” – by Melinda Stevens

Disclosure: The study was partially funded by a Collaborative Research and Development Agreement between the NIH and Gilead Sciences. Please see the full study for a full list of authors’ relevant financial disclosures.