Oral Drug Combo Shows Promise for Hep C Cure

An experimental oral drug combination therapy proved safe and highly effective in curing even the toughest cases of hepatitis C—showing promise for future injection-free treatment of the hepatitis C virus (HCV). The study results appear in the January 16 issue of The New England Journal of Medicine. Researchers at Johns Hopkins Medical Center conducted the study, which included 211 men and women with HCV genotypes 1, 2, and 3 who had been treated at 18 medical centers throughout the US and Puerto Rico. They administered a daily combination of 60mg of daclatasvir and 400mg of sofosbuvir, with or without ribavirin. These highly potent, direct-acting antiviral (DAA) drugs target the virus directly. “This study includes one of several experimental regimens that will offer most HCV-infected patients the opportunity to cure their HCV infection without the injection of interferon alfa, which has been a mainstay of treatment since the early 1990s,” says lead study author Mark Sulkowski, MD, medical director of the Johns Hopkins Center for Viral Hepatitis in Baltimore. “The regimen used in this study was also important because it demonstrated the potential to treat without ribavirin, another one of the mainstays of HCV treatment.” Of the 126 previously untreated patients with genotype 1, the most common strain in the US, 98% were considered cured. Another 41 study participants with genotype 1 had been previously treated with standard triple therapy and yet their infections remained. Of these patients, 98% showed no detectable virus in their blood 3 months after treatment with the new experimental drug combo. The combination showed similar efficacy in the other genotypes as well. Three months after treatment, 92% of the 26 patients with genotype 2 infection and 89% of the 18 patients with genotype 3 infection showed no detectable signs of the virus in their blood. “This approach is truly transformative, leading to safer, more effective treatment for the majority of patients,” Sulkowski says. He explains that simpler regimens like this one should make it easier to cure patients with HCV, preventing the development of liver cancer and liver failure. The new pill combo therapy had mild side effects, including fatigue, headache, and nausea. This is quite favorable compared to peginterferon, which is tied to severe side effects, and ribavirin, which is known to cause anemia. In December, the FDA approved sofosbuvir in combination with peginterferon and ribavirin to treat genotype 1 HCV and in combination with ribavirin alone for genotypes 2 and 3. Daclatasvir has not yet received FDA approval. “We anticipate that by the end of 2014 or early 2015 that this highly active, oral DAA combination will be approved for the treatment of hepatitis C in the United States,” Sulkowski says. The study was funded by Bristol-Myers Squibb and Pharmasset (Gilead). —Colleen Mullarkey Reference Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21.