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Sovaldi plus ribavirin yields high SVR12 in veterans with HCV genotype 2

Veterans with hepatitis C virus genotype 2 infection treated with Sovaldi plus ribavirin showed high sustained virologic response rates 12 weeks post-treatment, according to the results of a phase 4 clinical trial.

“This prospective clinical trial of VA patients demonstrated an overall SVR rate of 79%, and represents the largest group of HCV genotype 2 patients with cirrhosis studies in a prospective trial of sofosbuvir and ribavirin to date,” Samuel B. Ho, MD, of the VA San Diego Healthcare System, and colleagues wrote.

Treatment-naive (n = 47) and treatment-experienced (n = 19) veterans with chronic HCV genotype 2 infection and compensated cirrhosis from 15 different Department of Veterans Affairs clinical sites were enrolled and given 400 mg of Sovaldi (sofosbuvir, Gilead Sciences) plus between 1,000 and 1,200 mg of ribavirin per day in divided doses for 12 weeks.

All veterans had at least one comorbidity: 35% had depression, 24% had post-traumatic stress disorder and 30% had anxiety disorder. In addition, 29% were current substance users.

Fifty-two veterans achieved an SVR12 (79%; 95% CI, 67-88), of which 16 were treatment- experienced (84%; 95% CI, 60-97) and 36 were treatment-naive (77%; 95% CI, 62-88).

The researchers noted that more veterans who were treatment-experienced reached SVR, but this was not statistically significant.

SVR12 rates were 78% for veterans with depression (95% CI, 56-93), 94% for veterans with post-traumatic stress disorder (95% CI, 70 to >99%) and 89% in current substance users (95% CI, 67-99).

In the entire veteran population, 83% had more than 80% adherence to sofosbuvir (n = 55). Of the veterans with less than 80% adherence, 55% achieved SVR12 (95% CI, 23-83) compared with 84% of veterans with over 80% adherence (95% CI, 71-92).

Eleven percent of patients discontinued treatment early (n = 7); three as a result of adverse events. The most common adverse events were fatigue, anemia, nausea and headache. Serious adverse events were observed in eight patients, of which two (anemia and nausea) were considered to be related to study treatment.

“These data suggest that VA patients may expect to achieve similar results to those in registration trials in the [direct-acting antiviral] era, despite high comorbidities and ongoing substance abuse,” the researchers concluded. – by Melinda Stevens

Disclosure: Ho reports research and grant support from Genetech, Inc. and Gilead Sciences, served on the advisory board for Gilead Sciences, and has been a speaker for AbbVie and Prime Education, Inc. Please see the full study for a list of all other researchers’ relevant financial disclosures.