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A TREATMENT AS PREVENTION TRIAL TO ELIMINATE HCV IN HIV+ MSM: THE SWISS HCVREE TRIAL
Dominique L. Braun1, Benjamin H. Hampel1, Huyen Nguyen1, Markus Flepp2, Marcel Stoeckle3, Charles Béguelin4, Patrick Schmid5, Julie Delaloye6, Mathieu Rougemont7, Enos Bernasconi8, Dunja Nicca3, Roger Kouyos1, Jürg Böni1, Huldrych F. Günthard1, Jan S. Fehr1
1University of Zurich, Zurich, Switzerland,2Centre for Infectious Diseases, Zurich, Switzerland,3University of Basel, Basel, Switzerland,4University of Bern, Bern, Switzerland,5St. Gallen Cantonal Hospital, St Gallen, Switzerland,6Lausanne University Hospital, Lausanne, Switzerland,7University Hospitals of Geneva, Geneva, Switzerland,8Ospedale Regionale di Lugano, Lugano, Switzerland
Incidence of sexually transmitted hepatitis C virus (HCV) infections among HIV+ men who have sex with men (MSM) is rising worldwide. The Swiss HCVree Trial (ClinicalTrials.gov NCT02785666) aimed to test the feasibility of a HCV elimination approach among HIV+ MSM participating in the Swiss HIV Cohort Study (SHCS).
During phase A (10/1/2015-5/31/2016) we systematically tested all MSM in the SHCS by HCV-RNA PCR. During phase B (6/1/2016-2/28/2017) HCV treatment with the DAA grazoprevir/elbasvir ± ribavirin was offered to all MSM with GT 1 or 4 with the goal to reduce the pool of potential transmitters. Individuals with GT 2 or 3 and individuals not eligible for phase B were treated externally with standard of care DAAs. MSM reporting unprotected sex with occasional partners were asked for participation in a behavioral intervention program during phase B to reduce sexual risk behavior to prevent re-infection. During phase C (3/1/-11/30/2017), we re-tested all MSM in the SHCS by HCV-RNA PCR.
During phase A we screened 3'722 out of 4'257 active MSM from the SHCS database (87%) and identified 177 (4.8%) with a replicating HCV infection. Of these 177 infections 31 (18%) were incident (Figure 1A). During phase B we treated 122 out of these 177 replicating infections (69%) within the Swiss HCVree Trial and achieved a SVR12 of 99%. 39 infections (22%) were treated externally using standard of care DAAs (SVR 12 100%). Re-screening of 3'723 MSM during phase C identified 28 infections (0.8%), of them 16 were incident. The remaining 12 infections were chronic infections not treated during phase A. Of the 28 infections identified during phase C, 22 patients (79%) started DAA before end of period C. Overall, we identified and treated 183 out of 206 replicating infections (89%) during phase A and C within and outside the Swiss HCVree Trial (Figure 1B). Of 68 MSM eligible for the behavioral intervention program, 51 (75%) agreed to participate and 46 (68%) completed the program.
A systematic, population based HCV RNA screening approach among HIV+ MSM from the SHCS identified a high number of potential HCV spreaders. Treatment initiation in 89% of individuals with replicating HCV reduced incident HCV infections by 50% during the study. A systematic population based screening followed by prompt treatment of identified infections combined with a strong behavioral intervention can serve as a model to reach WHO elimination targets by 2030 in HIV/HCV co-infected MSM.