September 10, 2015
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Sovaldi/ribavirin yields high SVR for Egyptians with HCV genotype 4

A combination regimen of Sovaldi and ribavirin was safe and effective for treating hepatitis C virus genotype 4 infection among Egyptian patients, according to study data.

“A well-tolerated, all-oral, interferon-free regimen with a high rate of sustained virologic response could have a major impact on the prevalence and incidence of HCV in Egypt,” the researchers wrote.

Between March 2013 and August 2014, researchers randomly assigned treatment-naive (n = 49) and treatment-experienced (n = 54) patients with HCV genotype 4 to a regimen of 400 mg Sovaldi (sofosbuvir, Gilead Sciences) and between 1,000 mg and 1,200 mg ribavirin daily for 12 weeks (n = 52) or 24 weeks (n = 51). The patients were randomly assigned based on their previous treatment experience and if there was evidence of cirrhosis. Seventeen percent of the patients had cirrhosis at baseline. One patient in the 24-week group was lost to follow-up and did not complete treatment.

Overall, 77% of patients achieved a sustained virologic response at 12 weeks and 90% met SVR at 24 weeks. The patients with cirrhosis had lower rates of SVR in the 12-week group (63%) and the 24-week group (78%) compared with patients without cirrhosis (80% at 12 weeks, 93% at 24 weeks).

The most common adverse events were fatigue, insomnia, headache and anemia. Two patients in the 24-week group experienced serious AEs; one had treatment-related dyspnea, and the other had cerebral ischemia that was not treatment-related. No AEs led to treatment discontinuation.

“Treatment with the all-oral regimen of sofosbuvir and ribavirin resulted in a high rate of SVR among patients with genotype 4 HCV in Egypt,” the researchers concluded. – by Melinda Stevens

Disclosure: Doss reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.