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Short-term Sovaldi plus ribavirin treatments ineffective

Six weeks of Sovaldi with ribavirin produced “sub-optimal” results in patients with hepatitis C, according to research published in Hepatology.

“The potential for broad access to highly effective, well tolerated [interferon-free] DAA regimens has stimulated discussion around HCV treatment-as-prevention and subsequent HCV elimination,” Marianne Martinello, MBBS, FRACP, of the Viral Hepatitis Clinical Research Program, Kirby Institute in Australia, and colleagues wrote. “This study conclusively demonstrates that while on-treatment virological suppression was achieved in the majority, a high proportion of participants demonstrated post-treatment relapse.”

For this open-label study, 19 patients with HCV for less than 12 months received 400 mg/day of Sovaldi (sofosbuvir, Gilead Sciences). Those who weighed less than 75 kg received 1,000 mg/day of ribavirin; those weighing more received 1,200 mg/day. Patients received both medications for 6 weeks; only one patient did not finish the regimen, according to researchers.

“Adherence to therapy was high, by pill count and self-reported questionnaire,” Martinello and colleagues wrote. “Consistent with self-reported adherence, when sampled, all participants had detectable ribavirin plasma concentrations on treatment.”

Patients had an estimated infection time of 37 weeks (interquartile ranges: 27-41) at the study’s onset and their median HCV RNA of 5.4 log₁₀ IU/mL (interquartile ranges: 4.4-6.8). Researchers let onsite investigators determine HCV treatment start dates and its suitability on a case-by-case basis.

The primary endpoint was sustained virologic response after 12 weeks, post-treatment. Secondary virological endpoints included end of treatment response; serum HCV RNA below the lower limit of quantitation at post-treatment week 4 (SVR4); and serum HCV RNA below the lower limit of quantitation at post-treatment week 24 (SVR24). Though 89% of participants had non quantifiable HCV RNA after 6 weeks of treatment, only 32% reached SVR12 while 68% had treatment failure. Using intention-to-treat analysis, SVR4 was 42% and SVR24 was 37%.

“Baseline HCV RNA … and subsequent rapid viral suppression … were associated with SVR12, which supports further research with more potent DAA regimens in recent HCV infection,” researchers wrote. “In this cohort, while those participants achieving SVR12 did have significantly lower HCV RNA at baseline, spontaneous clearance was unlikely given the median duration of HCV infection of 37 weeks.” – by Janel Miller

Disclosures: Martinello reports receiving speaking payments from AbbVie. Please see the study for a list of all other researchers’ relevant financial disclosures.