Gilead Sciences Inc.'s wonder drug Sovaldi has faced criticism due to its prohibitive cost. In March this year, some members of the congress raised concern that the price of the hepatitis C drug is inaccessible to poor patients.
The Foster-city-based biotech company, however, does not appear to run out of reasons that could justify Sovaldi's high cost, which runs from $94,500 for a 12-week treatment to $189,000 for a 24-week treatment of hepatitis C virus (HCV). In a phase III clinical trial, the result of which was published in the Journal of the American Medical Association on July 23, scientists revealed that the drug Sovaldi also helps cure hepatitis C in patients infected with the human immunodeficiency virus, or HIV.
Treatment of hepatitis C in HIV patients poses problems because of the HCV drug's interaction with antiretroviral treatments. Older hepatitis C therapies that include interferon do not go well with HIV drugs and are associated with more anemia, depression and fatigue, which may have contributed as to why many HIV patients die due to complications from hepatitis C. Research suggest that HCV-related complications are the leading cause of deaths in patients with HIV.
For the study, Mark Sulkowski, from the Viral Hepatitis Center at the Johns Hopkins University in Baltimore, Maryland, and colleagues involved 223 patients who were both infected with HIV and the hepatitis C virus to assess the rate of HIV eradication and adverse events associated with treatment using sofosbuvir, e.g. Sovaldi, combined with ribavirin.
The researchers reported that of the subjects who did not receive prior treatment for hepatitis C virus, the combination treatment of sofosbuvir and ribavirin resulted in 76 percent of those with HCV genotype 1 to achieve sustained virologic response, or SVR, which is considered as a cure of hepatitis C virus. The SVR rate was 88 percent of the 26 patients with genotype 2 and 67 percent of the 42 HIV patients with genotype 3.
Of the patients who were treated for their HCV previously, 92 percent of the 24 with genotype 2 and 94 percent of the 16 patients with genotype 3 attained SVR. Seven patients or 3 percent of the participants, however, did not continue with their treatment because of adverse events that included insomnia, headache, nausea and fatigue.
"In this open-label, nonrandomized, uncontrolled study, patients with HIV who were coinfected with HCV genotype 1, 2, or 3 who received the oral, interferon-free combination of sofosbuvir and ribavirin for 12 or 24 weeks had high rates of SVR," Sulkowski and colleagues concluded.