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Sofosbuvir/ribavirin benefited Japanese patients with HCV genotype 2

A majority of treatment-naive and previously treated Japanese patients with hepatitis C virus genotype 2a infection achieved a sustained virologic response at 12 weeks after therapy with sofosbuvir and ribavirin, according to study results.

“Genotype 2 [HCV] accounts for up to 30% of chronic HCV infections in Japan,” the researchers wrote. “The standard of care for patients with genotype 2 HCV — peginterferon and ribavirin for 24 weeks — is poorly tolerated, especially among older patients and those with advanced liver disease. … As a result, many Japanese patients with chronic HCV genotype 2 infection have no available treatment options and are thus at risk for worsening of liver disease and complications of cirrhosis, including hepatocellular carcinoma.”

In a phase 3 trial, researchers assigned 90 treatment-naive patients and 63 previously treated patients with chronic HCV genotype 2a to 400 mg sofosbuvir (Sovaldi, Gilead) once daily with weight-based ribavirin twice daily for 12 weeks to determine whether it was a safe and effective course of treatment.

Sixty percent of patients had HCV genotype 2a, 22% were aged at least 65 years and 11% had evidence of cirrhosis.

Among all patients, 97% achieved an SVR at 12 weeks; 88 of the 90 treatment-naive patients and 60 of the 63 previously treated patients. All treatment-naive patients with and eight of nine previously treated patients with cirrhosis achieved SVR (100% vs. 89%). Among patients aged at least 65 years, 94% achieved SVR.

Adverse events were experienced by 73% of patients. However, no patient discontinued treatment due to an adverse event. The most common adverse events were nasopharyngitis, anemia and headache.

None of the patients relapsed post-treatment and all patients who achieved SVR at 12 weeks maintained SVR through 24 weeks.

“Treatment with the all-oral, interferon-free combination of sofosbuvir and [ribavirin] resulted in high rates of [SVR] in both treatment-naive and previously treated Japanese patients with chronic genotype 2 HCV infection,” the researchers concluded. “The degree of antiviral efficacy coupled with a favorable safety and tolerability profile, including patients with cirrhosis and those aged 65 and older, suggest that this combination may fill an important unmet medical need in Japan.”

Disclosure: The study was supported by Gilead Sciences.