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Harvoni shows promise for HCV genotype 4
Phase 2a trial results suggest treatment with the combination regimen Harvoni yielded high rates of sustained virologic response and was well-tolerated in patients with hepatitis C virus genotype 4 infection.
“Pending validation by larger trials, the results of our study suggest that the use of 12 weeks of [Harvoni (ledipasvir/sofosbuvir, Gilead Sciences)] is effective for the treatment of HCV genotype 4,” Shyam Kottilil, MBBS, PhD, co-director of the Institute of Human Virology’s Clinical Research Unit at the University of Maryland, and colleagues wrote. “A safe and simple, single-pill regimen will be ideal to treat large numbers of patients and therefore affect the global hepatitis genotype 4 epidemic.”
HCV genotype 4 causes between 8% and 13% of HCV infections, and is predominant in the Middle East and Africa. “Simple, well-tolerated treatments for HCV genotype 4 are particularly crucial in view of the high concentration of this genotype in low-income countries,” the researchers wrote.
Shyam Kottilil
Kottilil and colleagues sequentially enrolled 21 patients with HCV genotype 4 at the NIH Clinical Center in Bethesda, Maryland, who were either treatment naive or interferon-treatment experienced. Patients received a single dose of the combination regimen of 90 mg ledipasvir and 400 mg sofosbuvir once daily. One patient, who refused to follow the drug protocol and withdrew from the study, was included in the intention-to-treat analysis. Patients with HIV and hepatitis B virus infection were excluded from the study.
Twenty patients completed the 12-week treatment and achieved SVR12 (95% CI, 76-100), including seven patients with cirrhosis, the researchers wrote.
Ledipasvir/sofosbuvir was well-tolerated, and the most common adverse events, which were mild, were diarrhea, fatigue, nausea and upper respiratory infections. No serious adverse events, grade 3 or 4 adverse events or deaths occurred, according to the researchers.
“This simple, well-tolerated treatment for HCV genotype 4 holds promise to substantially improve and simplify the treatment of HCV in the low-resource countries where this virus genotype is concentrated,” they wrote. – by Colleen Owens
Disclosure: Kottilil reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.