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SVR similar with, without ribavirin after Harvoni treatment for HCV

The addition of ribavirin to 12 weeks of Harvoni showed little therapeutic benefit in patients undergoing retreatment for hepatitis C after failing to achieve sustained virologic response with a prior NS5A inhibitor-containing regimen, according to recently published data.

“Chronic hepatitis C virus (HCV) infection affects approximately 180 million people worldwide and is a major cause of chronic liver disease, which can progress to cirrhosis, with and without hepatocellular carcinoma (HCC),” Hiroki Ikeda, MD, from the St. Marianna University, Japan, and colleagues wrote. “Treatment of HCV infection has progressed rapidly since the development of direct acting antiviral-agents (DAAs).”

Ikeda and colleagues enrolled 29 patients with chronic HCV genotype 1b who had not achieved SVR after 24 weeks of therapy with Daklinza (daclatasvir, Bristol-Myers Squibb) and asunaprevir (Bristol-Myers Squibb). Patients received treatment with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) for 12 weeks; 15 patients also received ribavirin.

Nineteen patients had advanced fibrosis according to a Fibrosis-4 index of 3.25 or higher and 18 patients had the TT genotype of the IL28B gene. One patient had been exposed to the NS3 protease inhibitor Olysio (simeprevir, Janssen).

All patients completed treatment and 24 weeks of posttreatment follow-up. The overall SVR rate was 66%. Patients treated with ledipasvir/sofosbuvir and ribavirin had an SVR rate of 67%.

In patients with mild fibrosis, the SVR rate was 80%, whereas patients with advanced fibrosis had an SVR rate of 58%. Patients with IL28B single nucleotide polymorphisms (SNPs) had lower SVR rates than those without: 78% for those with TT genotype, 50% for those with TG genotype, and 40% for those with GG genotype.

The researchers observed higher odds for SVR (OR = 6.53; 95% CI, 1.19-35.5) among patients with two or more of the following factors: FIB-4 index less than 3.25, relapse after prior treatment with daclatasvir and asunaprevir, IL28B SNP of the TT genotype, and less than three NS5A resistance-associated substitutions (RASs).

“Using univariate analyses, we analyzed the pretreatment factors affecting virological response. The virological response appeared to be affected by the number of NS5A RAS but the effect was not significant,” the researchers wrote. “In respect of host-related factors, IL28B SNP, FIB-4 index and response to prior [daclatasvir plus asunaprevir] also were not identified as predictive factors; however, combination of these factors enabled the prediction of SVR24. These results are similar to previous reports and confirm the importance of host-related factors.” – by Talitha Bennett

Disclosure: Healio.com/Hepatology was unable to determine relevant financial disclosures at the time of publication.