May 30, 2014
A 24-week regimen of sofosbuvir plus ribavirin cured 93% of people with HCV genotype 4, another hard-to-treat subtype of HCV, although treatment for only 12 weeks was not as effective, according to a poster presented at the 49th International Liver Congress (EASL 2014).
The study followed 60 Egyptian patients, all of whom completed treatment, which was generally safe and well tolerated. The participants were randomized to receive 400 mg of once-daily sofosbuvir plus 1,000-1,200 mg of ribavirin for either 12 or 24 weeks.
- SVR12 rates were 68% in the 12-week treatment arm and 93% in the 24-week arm.
- Among treatment-naive participants, the 12- and 24-week SVR12 rates were 70% and 100%, respectively.
- Among treatment-experienced patients, SVR12 rates were 59% and 87%, respectively.
Sofosbuvir was approved by the FDA last December, although Gilead, the drug's manufacturer, continues to receive backlash for the regimen's high price tag of $1,000 a pill.
In April, the European Association for the Study of the Liver (EASL) issued new guidelines for the treatment of HCV in Europe, recommending the newest direct-acting antivirals, with a "mix-and-match" approach to get the most effective regimens.
The guidelines make recommendations for all HCV genotypes, and include all direct-acting antivirals that are expected to be licensed in Europe during 2014, including the HCV protease inhibitor simeprevir and the NS5A inhibitor daclatasvir. Simeprevir is likely to receive marketing approval in May 2014 and daclatasvir in September 2014. Sofosbuvir was already approved in January 2014.
HIVandHepatitis.com also writes:
The guidelines move beyond U.S. recommendations issued in January, which incorporated a small number of off-label uses not included in the FDA licenses for sofosbuvir (Sovaldi) and simeprevir (Olysio). The new EASL guidelines also include daclatasvir, a NS5A inhibitor that is likely to receive approval in Europe later this year.
The complete guidelines can be found at the EASL website.
Warren Tong is the research editor for TheBody.com and TheBodyPRO.com.
Follow Warren on Twitter: @WarrenAtTheBody.
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