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Cure Rate 99% With Grazoprevir/Elbasvir
in HCV/HIV-Infected MSM in Switzerland
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16th European AIDS Conference, October 25-27, 2017. Milan
Mark Mascolini
Twelve or 16 weeks of once-daily grazoprevir/elbasvir (Zepatier) with or without ribavirin cured HCV infection in 121 of 122 HIV-positive men who have sex with men (MSM) in the Swiss HIV Cohort Study (SHCS) [1]. Researchers used baseline HCV resistance testing to guide regimen selection.
From 1998 through 2010, HCV incidence rose 18-fold among MSM in the SHCS, while falling in injection drug users [2]. Working toward a goal of eliminating HCV among SHCS MSM, researchers planned the HCVree study--a phase 3 open-label trial of a test, treat, counsel, and cure strategy [3].
HCVree participants with genotype 1a and with pretreatment resistance got Zepatier plus weight-based ribavirin for 16 weeks, as did genotype 4 patients already treated with PegIFN/ribavirin. Genotype 1a or 1b patients with PegIFN/ribavirin or protease inhibitor experience got Zepatier plus ribavirin for 12 weeks. Everyone else got Zepatier alone for 12 weeks. Trial participants reporting condom-free sex were asked to take part in a behavioral intervention program.
Among 4257 MSM in the SHCS database, 3722 (87%) got screened for HCV for the HCVree trial, and 177 screened men (4.8%) had replicating HCV. In this group, 122 men fulfilled trial inclusion criteria and agreed to participate. Enrollees had a median age of 46.7, 88% were Caucasian and the others Asian (5%), Latino (4%), or black (3%). Median time since HCV diagnosis stood at 36 months, 62% had genotype 1a without resistance, 5% had genotype 1a with resistance, 7% had genotype 1b, 23% had genotype 4 and no treatment experience, and 3% had genotype 4 with treatment experience. All but 1 man were taking antiretroviral therapy.
Of the 68 men reporting condomless sex, 51 (75%) agreed to behavioral intervention. Among 122 treated men, 121 (99.2%) had sustained virologic response 12 weeks after treatment ended (SVR12), indicating HCV clearance. The man who did not achieve SVR12 had on-treatment failure with genotype 4, despite good adherence and no pretreatment mutations. Two mutations affecting susceptibility to ombitasvir emerged in a week-24 sample.
Nine serious adverse events developed during the study, none judged related to study drugs. No one quit treatment because of an adverse events. Possible drug-related adverse events included fatigue in 6%, diarrhea in 5%, nausea/vomiting in 3%, and pruritus in 3%.
The SHCS team stressed that HCV screening identified a "substantial number" of potential HCV transmitters among these HIV-positive MSM. They concluded that once-daily Zepatier is effective and has an excellent safety profile in HIV-coinfected MSM.
References
1. Braun DL, Hampel B, Kouyos R, et al. High SVR 12 rates with grazoprevir/elbasvir +/- ribavirin for 12-16 weeks guided by genotypic resistance testing among HIV/HCV coinfected MSM in the Swiss HCVree trial. 16th European AIDS Conference. October 25-27, 2017. Milan. Abstract PS9/4.
2. Wandeler G, Gsponer T, Bregenzer A, et al. Hepatitis C virus infections in the Swiss HIV Cohort Study: a rapidly evolving epidemic. Clin Infect Dis. 2012;55:1408-1416.
3. ClinicalTrials.gov. Swiss HCVree Trial (HCVree). ClinicalTrials.gov identifier NCT02785666. https://clinicaltrials.gov/ct2/show/NCT02785666
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