MOAB0105LB - Oral Abstract Session
All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotypes 1, 2, 3 and 4 infection in patients co-infected with HIV (PHOTON-2)
Presented by Jean-Michel Molina (France).
J.-M. Molina1, C. Orkin2, D.M. Iser3, F.X. Zamora4, M. Nelson5, C. Stephan6, B. Massetto7, A. Gaggar7, L. Ni7, E. Svarovskaia7, D. Brainard7, G.M. Subramanian7, J.G. McHutchison7, M. Puoti8, J.K. Rockstroh9
1University of Paris Diderot, Paris 7 and Department of Infectious Diseases, Saint-Louis Hospital, Paris, France, 2Barts Health NHS Trust, London, United Kingdom, 3Infectious Diseases Unit, Alfred Hospital, Melbourne, Australia, 4HIV Unit, Internal Medicine Service, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain, 5Chelsea and Westminster Hospital, St. Stephens Centre, London, United Kingdom, 6Infectious Diseases Unit at Medical Department, Hospital of the Johann Wolfgang Goethe-University, Frankfurt, Germany, 7Gilead Sciences, Inc., Foster City, United States, 8Division of Infectious Diseases, AO Ospedale Niguarda Ca' Granda, Milan, Italy, 9Department of General Internal Medicine I, University Hospital of Bonn, Bonn, Germany
Background: HIV/HCV co-infected patients require effective interferon-free HCV therapy that is tolerable and easy to administer in combination with antiretroviral therapy (ART). This study evaluated the safety and efficacy of the oral HCV NS5B inhibitor sofosbuvir with ribavirin in patients coinfected with HIV and HCV genotypes (GT) 1-4.
Methods: 274 patients infected with HIV and HCV GT1-4, including those with compensated cirrhosis, were enrolled to receive sofosbuvir 400 mg QD and weight-based ribavirin 1000-1200 mg/day; GT 1, 3, 4 treatment-naïve and GT 2, 3 treatment-experienced patients received 24 weeks of therapy and GT 2 treatment-naïve 12 weeks. The primary efficacy endpoint was sustained virologic response 12 weeks after treatment (SVR12); safety assessments also included HIV RNA and CD4 cell levels.
Results: Baseline characteristics and SVR12 rates are shown in the table. 20% of patients were cirrhotic, 81% were male, 97% were receiving ART. Median CD4 was >500 cell/µL in all groups. SVR12 rates ranged from 83% to 91% across GT1-4. Of 38 patients not achieving SVR12, 31 patients relapsed, 1 had breakthrough and 6 were lost to follow-up or withdrew consent. HCV resistance testing is ongoing. Treatment discontinuations from sofosbuvir due to adverse events (AEs) were observed in 5/274 (2%) of patients and grade 3/4 AEs were reported in 15/274 (6%). No change in CD4% was observed through SVR12. Four patients had an HIV-RNA rebound that did not require ARV modification.
Conclusions: HCV GT 1-4 treatment naïve and experienced HIV coinfected patients achieved high rates of SVR12 with 12 or 24 weeks of an interferon-free, oral regimen of sofosbuvir + ribavirin. Sofosbuvir + ribavirin treatment was well-tolerated and safely coadministered with multiple ART regimens.
| ||GT1 TN|
|IL28B CC genotype, %||43||63||53||29||50||51|
|Log10 HCV RNA (IU/mL), mean (SD)||6.3 (0.7)||6.7 (0.7)||6.3 (0.7)||5.9 (0.9)||6.4 (0.6)||6.3 (0.8)|
|Week 4 HCV RNA <25 IU/mL, (%)||97||100||98||100||100||96|
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