High cure rates with grazoprevir-elbasvir with or without ribavirin guided by genotypic resistance testing among human immunodeficiency virus/hepatitis C virus–coinfected men who have sex with men. Clinical Infectious Diseases
Braun, Hampel et al. aimed to investigate the efficacy and safety of grazoprevir-elbasvir guided by baseline resistance- associated substitutions (RASs) in the Swiss HCVree Trial. Individuals with replicating HCV genotype 1 or 4 infection were eligible for grazoprevir-elbasvir treatment. Genotype 1a-infected individuals with baseline RASs and genotype 4–infected individuals with prior failure of HCV treatment received 16 weeks of grazoprevir-elbasvir combined with ribavirin. All other individuals received 12 weeks of grazoprevir-elbasvir alone. Patients reporting unprotected sex with occasional partners were offered a HCV risk reduction-oriented behavioral intervention.
A total of 122 individuals (3.3%) were eligible for study treatment with grazoprevir-elbasvir. Six of 76 patients infected with genotype 1a (7.3%) harbored baseline RASs. Sustained virological response after 12 weeks of follow-up was achieved in 121 patients (99%), including all with genotype 1a infection. Overall, 8 serious adverse events occurred, none of which was related to the study drug. Seventy-five percent of eligible MSM participated in the risk-counseling program.
In conclusion, the study confirmed the high efficacy and excellent safety and tolerability of treatment with once-daily grazoprevir-elbasvir for 12 or 16 weeks, with or without ribavirin. A patient-individualized treatment approach based on the presence of baseline RASs in genotype 1a-infected patients was feasible and resulted in 100% SVR12 rates among those harboring RASs. Although the effectiveness of this approach for preventing reinfection is currently unclear and was not explicitly assessed in the current study, models suggest that sustained reductions in high-risk behavior in the MSM population could rapidly curb the epidemic.