Sofosbuvir-ribavirin works against HCV genotype 2 in real-world

Last Updated: 2016-07-29

By Will Boggs MD

NEW YORK (Reuters Health) - The combination of sofosbuvir and ribavirin is effective for treating hepatitis C virus (HCV) genotype 2 in real-world, clinical practice, the HCV-TARGET study confirms.

The combination is currently recommended for most patients with HCV genotype 2 infection by U.S., Canadian, and European guidelines. There is limited information, however, about its use in usual clinical practice.

Dr. Tania M. Welzel from Goethe University Hospital in Frankfurt, Germany, and colleagues from 44 academic and 17 community medical centers in North America and Europe investigated the effectiveness and tolerability of sofosbuvir and ribavirin in 361 sequentially enrolled patients (median age, 59 years) with chronic HCV genotype 2 infection who were treated in routine clinical practice.

Overall, 88.2% of evaluable patients had sustained virological response at 12 weeks (SVR12), and 92.2% of patients treated according to protocol achieved SVR12, the researchers report in Gut, online July 13.

In the evaluable population, SVR12 was 91.0% in patients without cirrhosis treated for 12 weeks and 92.9% in similar patients treated for 16 weeks, whereas SVR12 rates for patients with cirrhosis were 79.0% when treated for 12 weeks and 83.3% when treated for 16 weeks.

Results in the per-protocol population were even better: 93.9% and 100% of patients without cirrhosis and 86.0% and 87.0% of patients with cirrhosis who received 12 or 16 weeks of treatment, respectively, achieved a SVR12.

These results were comparable to those reported in phase 3 clinical trials for patients without cirrhosis, but were lower than those reported for patients with cirrhosis.

Despite the large number of patients with cirrhosis in this study, it remains unclear, the researchers note, whether treatment prolongation from 12 to 16 weeks has a significant impact.

Only 2.8% (10/361) of patients discontinued treatment prematurely due to an adverse event, including eight patients with cirrhosis. Most adverse events corresponded to those previously reported in the pivotal phase 3 studies.

Lower serum albumin levels and lower ribavirin doses at baseline were associated with significantly lower SVR12 rates in a multivariate analysis.

"Recent studies showed that combined sofosbuvir and valpatasvir (ASTRAL-1, ASTRAL-2) yielded SVR12 rates of up to 100% in patients with genotype 2 and cirrhosis, so that the combination of sofosbuvir and a genotype 2-active NS5A inhibitor for 12 weeks may be preferable to sofosbuvir and ribavirin for more than 12 weeks in patients with genotype 2 and liver cirrhosis," the researchers conclude.

Dr. Wan-Long Chuang from Kaohsiung Medical University in Taiwan, who recently reported similar effectiveness of this regimen among Taiwanese patients, said, "These results were not so surprising, although the SVR rates were slightly lower than that reported in Asian countries."

However, the findings that patients with lower serum albumin levels and lower dose of ribavirin at baseline had lower SVR12 rates is new, he told Reuters Health by email.

"The main message physicians should take away from this report is that sofosbuvir and ribavirin are safe and effective for treatment of patients with HCV genotype 2 infection. Whether the cirrhotic patients should receive the treatment duration extending to 16 weeks or not needs further randomized and adequately powered studies," Dr. Chung said.

Dr. Welzel did not respond to a request for comments.

The study was supported by several drug companies, including Gilead Sciences, which markets sofosbuvir. Dr. Welzel has received fees from Gilead and other companies.

SOURCE: http://bit.ly/2ahZuGI

Gut 2016.