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

Sovaldi plus ribavirin safe for Korean patients with HCV genotype 2

In a phase 3b study, treatment with Sovaldi plus ribavirin, an interferon-free regimen, was safe and effective for Korean patients with chronic hepatitis C virus genotype 2 infection.

Korean patients with chronic HCV genotype 2 (n = 129), both treatment-naive (n = 105) and –experienced (n = 24) were assigned a treatment regimen of Sovaldi (sofosbuvir, Gilead Sciences) plus ribavirin for 12 weeks. Approximately 38% to 46% of the Korean population has chronic HCV, according to the research, and there are currently no approved treatments in Korea that are interferon-free.

“In Korea, patients with chronic hepatitis C virus infection are typically treated with pegylated interferon-alfa plus ribavirin, but interferons are contraindicated in many patients and are often poorly tolerated, particularly by the elderly and those with advanced liver disease,” the researchers wrote.

Overall, 97% of all patients achieved a sustained virologic response 12 weeks post-treatment (n = 125). Of these patients, 96% were treatment-naïve (n = 104) and 100% were treatment-experienced.

Only two patients experienced virologic failure during treatment, with one being a total treatment failure and one being a relapsed episode. No patients discontinued treatment due to an adverse event. Overall, 68% of patients experienced at least one adverse event, with the most common being headache (18%) and pruritus (15%). Grade 3 adverse events were experienced by 5% of patients and 12% experienced grade 3 laboratory abnormalities. No grade 4 events were reported.

“The efficacy and safety outcomes observed in this Korean cohort are comparable to those reported in the Western phase 3 trials and the Japanese phase 3 study of patients with chronic genotype 2 HCV infection,” the researchers concluded. – by Melinda Stevens

Disclosure: Ahn reports serving on the advisory board and being a lecturer for Bristol-Myers Squibb and Gilead Sciences. Please see the full study for a list of all other authors’ relevant financial disclosures.