Updated guidance from the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases provides new recommendations regarding the optimal use of antiviral agents for hepatitis C following approval by the US Food and Drug Administration (FDA) of sofosbuvir/velpatasvir (Epclusa®, Gilead).1
The FDA recently approved Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single-tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.
Epclusa is also the first-single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without ribavirin. Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin for patients with decompensated cirrhosis (Child-Pugh B or C).
The FDA approval was based on results from several clinical trials. Of the 1035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2, and ASTRAL-3 clinical trials, 1015 achieved high rates of sustained virologic response.2
The updated guidance integrates recent trial data for other combinations of direct-acting antiviral agents and provides guidance in those patients who have impaired kidney function, have undergone liver transplantation, or have HIV co-infection.
“We believe that the updated recommendations will help caregivers with regimen choice not only in common treatment scenarios, but will also importantly provide guidance in cases where randomized trial data or specific FDA labeling may be lacking,” Raymond Chung, MD, co-chair of the guidance panel, said in a prepared statement.3
The update also offers guidance regarding the prudent use of HCV resistance testing. Important information is also provided regarding the monitoring of patients with cirrhosis who are undergoing therapy with direct acting antiviral agents .
“The latest updates to HCVguidelines.org bring a trusted document up to date with the latest therapeutic options. The guidance now offers more than one front-line regimen for each viral genotype and updates recommendations for patients of high complexity. Most treating clinicians will find workable treatment options for the majority of their patients,” Hugo Vargas, MD, guidance panel co-chair, added in the statement.
- AASLD, IDSA. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. 2016.
- Field JJ, Jacobson IM, Hezode C, et al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med. 2016;doi: 10.1056/NEJMoa1512610.
- HCV guidance website updated to reflect latest drug developments [press release]. Arlington VA; Infectious Diseases Society of America. July 19, 2016.