EASL 2014: Abstract O63. EFFICACY AND SAFETY OF THE ALL-ORAL REGIMEN, MK-5172/MK-8742 +/- RBV FOR 12 WEEKS IN GT1 HCV/HIV CO-INFECTED PATIENTS: THE C-WORTHY STUDY
M. Sulkowski1, J. Mallolas2, S. Pol3, M. Bourliere4, J. Gerstoft5, O. Shibolet6, R. Nahass7, E. DeJesus8, M. Shaughnessy9, P. Hwang9, J. Wahl9, M.N. Robertson9, B. Haber9
1Johns Hopkins University School of Medicine, Baltimore, MD, United States, 2Hospital Clínic, Barcelona, Spain, 3Université Paris Descartes, APHP, Unité d'Hépatologie, Hôpital Cochin, INSERM U 1016 Institut Cochin, Paris, 4Service d'Hépato-Gastroentérologie, Hôpital Saint-Joseph, Marseille, France, 5Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark, 6Department of Gastroenterology, Liver Unit, Tel Aviv Medical Center, Tel Aviv, Israel, 7ID Care, Hillsborough, NJ, 8Orlando Immunology Center, Orlando, FL, 9Merck, Whitehouse Station, NJ, United States
Background and aims: To assess the efficacy and safety of a 12 week regimen of MK-5172 (a hepatitis C virus [HCV] NS3/4A protease inhibitor) and MK-8742 (a HCV NS5A inhibitor) +/- ribavirin (RBV) in patients with genotype (GT)1 HCV and HIV co-infection. This is the first report of the treatment of co-infected patients with this all-oral, once-daily, highly potent regimen.
Results: 40 patients were enrolled (83% male, 20% African American, and 78 % GT1a). Mean baseline HCV-RNA was 6.2 log10 IU/mL. All patients that have reached treatment week 4 (n = 22) had HCV-RNA < 25 IU/mL at treatment week 4, regardless of ribavirin therapy (Table 1). The most common adverse events were: fatigue 10% (4/40); headache 5% (2/40); back pain 5% (2/40) and asthenia 5% (2/40). No patient discontinued due to either an adverse event or study medication intolerance. Enrollment is on-going; end of treatment response and follow-up week 4 data will be presented.
Conclusions: Patients with HCV GT1 infection and HIV co-infection achieved rapid viral suppression during the first 4 weeks of therapy with MK-5172 and MK-8742, regardless of ribavirin therapy.