Combination of Gilead Sciences' Sovaldi, Bristol-Myers Squibb's daclatasvir effective against hepatitis C: study

Study data published Thursday in the NEJM revealed that the all-oral combination of Gilead Sciences' Sovaldi (sofosbuvir) and Bristol-Myers Squibb's daclatasvir was associated with high rates of sustained virologic response (SVR) among patients infected with hepatitis C virus (HCV) genotypes 1, 2 and 3. The researchers additionally observed that the combination was effective in patients who failed to respond to previous treatment with hepatitis C protease inhibitors plus peginterferon and ribavirin.

In the study, 88 treatment-naïve patients infected with HCV genotype 1, 2 or 3 received Sovaldi and daclatasvir with or without ribavirin for 24 weeks. In addition, 123 HCV genotype 1-infected patients, including 41 patients who failed to respond to triple therapy consisting of a hepatitis C protease inhibitor, peginterferon and ribavirin, were randomised to receive Sovaldi and daclatasvir with or without ribavirin for 12 or 24 weeks.

The researchers found that 98 percent of treatment-naïve HCV genotype 1-infected patients and 98 percent of previously-treated patients infected with HCV genotype 1 displayed an SVR after 12 weeks of treatment, including SVR rates of 98 percent and 100 percent among patients infected with HCV genotypes 1a and 1b, respectively. Moreover, an SVR rate at 12 weeks of 92 percent was noted for patients with genotype 2 infection, while 89 percent of patients with genotype 3 infection displayed an SVR at 12 weeks. The researchers added that an SVR was observed in 94 percent of patients who received ribavirin, versus 98 percent for those in the ribavirin-free arms.

"This research paves the way for safe, tolerable and effective treatment options for the vast majority of those infected with hepatitis C," said study author Mark Sulkowski, adding that the safety profile of the combination of Sovaldi and daclatasvir compares favourably to that of interferon-containing regimens.

Sovaldi, a nucleotide analogue, was cleared by the FDA in December last year for the treatment of patients infected with HCV genotypes 1, 2, 3 or 4, as part of a combination antiviral regimen involving ribavirin and in certain cases peginterferon alfa (for related analysis, see ViewPoints: Gilead Sciences' Sovaldi hits the ground running). Earlier in January, the European Medicines Agency validated Bristol-Myers Squibb's filing for the use of daclatasvir for the treatment of adults with chronic HCV with compensated liver disease, including genotypes 1, 2, 3, and 4. A regulatory filing for the NS5A complex inhibitor has also been submitted in Japan.

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