Retrospective-Prospective Study of Safety and Efficacy of Sofosbuvir based Direct Acting Antivirals in HIV/HCV Coinfected Participants with Decompensated Liver Disease Pre or Post Liver Transplant.

Direct acting antiviral (DAA) therapy has transformed the management of human Immunodeficiency virus (HIV) and hepatitis C (HCV) coinfected patients with advanced liver disease. STOP-Coinfection was a multi-center prospective and retrospective, open-label study using sofosbuvir-based DAA therapy to treat HIV/HCV coinfected participants pre- or post-liver transplant (LT). Sixty-eight participants with end stage liver disease (Child-Turcotte-Pugh score ≥7 and Model for End-Stage Liver Disease score 6-29) were enrolled, 26 had hepatocellular carcinoma. Forty-two participants were treated pre-LT and 26 post-LT. All participants completed therapy without need for dose reduction or transfusion; 8 required 2 or more courses of therapy. Ninety-three% achieved a sustained virologic response and DAA therapy was well tolerated. Despite HCV cure, 12 end-stage liver disease participants required subsequent LT, 7 for decompensated liver disease. Thirteen participants died, 10 with decompensated liver disease pre-LT and 3 post-LT. Overall, transplant free survival was 42.8% at 4 years and post-LT survival was 87.9% at 5 years. We conclude that sofosbuvir-based DAA therapy is safe and highly effective in HCV-HIV patients with decompensated liver disease and post-LT, with post-LT survival rates comparable to other indications. This removes one of the last barriers to liver transplantation in this challenging cohort of recipients.