open to eligible people ages 18 years and up
People who are recently infected with HCV have a great chance of being cured of the infection when they are treated with a combination of two drugs within the first 6 months of being infected. This study is being done to see if a combination of two new drugs in one pill can replace the old drugs to provide a safer, more effective, and better tolerated treatment for new HCV infection. The names of the new drugs are ledipasvir (LDV) and sofosbuvir (SOF), and they will replace pegylated-interferon alfa (PEG-IFN, a drug given as a weekly injection under the skin). The fixed-dose combination of LDV and SOF (LDV/SOF) has been approved by the Food and Drug Administration (FDA). This study started with participants in Group 1 receiving SOF in combination with RBV, a drug also approved by the FDA, for 12 weeks. There were a total of 17 participants in Group 1 and all completed treatment. All participants were monitored for safety and viral response while on treatment. After completing treatment, all participants were evaluated for a treatment response after the end of treatment. If the treatment response in Group 1 was high enough, the study design allowed for the possibility to decrease the length of therapy for Group 2 to 8 weeks, using the same treatment. However, this did not occur. Combined with the fact that a new and more effective treatment for chronic HCV has been approved since the study started, Group 2 will now receive 8 weeks of LDV/SOF instead of 12 or 8 weeks of SOF with RBV.
San Francisco, California and other locations