MedicalResearch.com Interview with:
Dr. Michael P. Curry, MD
Medical Director for Liver Transplantation
Harvard Medical Faculty Physicians
Beth Israel Deaconess Medical Center
Medical Research: What is the background for this study? What are the main findings
Dr. Curry: As the population that is infected with the hepatitis C virus (HCV) ages, the number of patients with decompensated cirrhosis is expected to increase. For many years, the only treatment option for these patients was liver transplantation. Recently, however, clinical trials of newly approved direct-acting antiviral agents (DAAs) have shown that it is possible to treat HCV infection safely and effectively in patients with decompensated cirrhosis. We conducted this Phase 3, open-label trial to assess the efficacy and safety of a fixed dose combination of sofosbuvir/velpatasvir with or without ribavirin for 12 weeks or sofosbuvir/velpatasvir for 24 weeks in patients infected with hepatitis C virus genotypes 1 through 6 and with decompensated cirrhosis. We found that treatment with sofosbuvir/velpatasvir resulted in high rates of sustained virologic response (SVR) and early improvements in hepatic function in this patient population. SVR rates were 83 percent in patients who received sofosbuvir/velpatasvir for 12 weeks, 94 percent among those who received sofosbuvir/velpatasvir plus ribavirin, and 86 percent among those who received sofosbuvir/velpatasvir for 24 weeks.
Medical Research: What should clinicians and patients take away from your report?
Dr. Curry: These study results are in line with those of other recent trials of DAA regimens, showing high SVR rates that are comparable to SVR rates achieved in patients with earlier-stage disease. Clinicians should give consideration to utilize DAA regimens in selected patients with decompensated cirrhosis caused by HCV infection as these regimens have demonstrated high SVR rates and early improvements in liver function across multiple clinical trials.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Curry: Future research is needed to determine if early improvements in liver function in patients with decompensated cirrhosis translate into long-term clinical benefits. Additionally, future trials are required to assess this regimen in patients with more severe degrees of liver decompensation.
Michael P. Curry, M.D., Jacqueline G. O’Leary, M.D., M.P.H., Natalie Bzowej, M.D., Andrew J. Muir, M.D., Kevin M. Korenblat, M.D., Jonathan M. Fenkel, M.D., K. Rajender Reddy, M.D., Eric Lawitz, M.D., Steven L. Flamm, M.D., Thomas Schiano, M.D., Lewis Teperman, M.D., Robert Fontana, M.D., Eugene Schiff, M.D., Michael Fried, M.D., Brian Doehle, Ph.D., Di An, Ph.D., John McNally, Ph.D., Anu Osinusi, M.D., Diana M. Brainard, M.D., John G. McHutchison, M.D., Robert S. Brown, Jr., M.D., M.P.H., and Michael Charlton, M.D. for the ASTRAL-4 Investigators
Dr. Michael P. Curry, MD (2015). New HCV Treatment Improves Hepatitis C Cirrhosis