Effectiveness and safety of IFN-free DAA HCV therapy in HIV/HCV co-infected persons: Results from a pan-European study.

Objectives To investigate the effectiveness, safety and reasons for premature discontinuation of direct-acting antivirals (DAAs) in a diverse population of HIV/HCV co-infected individuals in Europe. Methods All HIV/HCV co-infected individuals in the EuroSIDA study that started interferon (IFN) free DAA treatment between 1/6/2014 and 1/3/2018 with ≥12 weeks of follow-up after treatment stop were included in this analysis. Sustained virological response (SVR) was defined as a negative HCV-RNA result ≥12 weeks after stopping treatment (SVR12). Logistic regression was used to explore factors associated with SVR12. Results 1042 individuals started IFN-free DAA treatment after 1/6/2014 and were included, 862 (82.2%) had a known response to treatment, 789 (91.5%, 95% CI 89.7-93.4) of which achieved SVR12. There were no differences in SVR12 across regions of Europe (p=0.84). After adjustment, the odds of achieving SVR12 was lower in individuals that received sofosbuvir/simeprevir +/- RBV (aOR 0.21 (95% CI 0.08-0.53) or ombitasvir/paritaprevir/dasabuvir +/- RBV (aOR 0.46 (95% CI 0.22-1.00) compared to sofosbuvir/ledipasvir +/- RBV. 43 (4.6%) individuals had one or more components of their HCV regimen stopped early, most commonly due to toxicity (n=14); of these 14, 11 were treated with ribavirin. Increased bilirubin was the most common grade 3 or 4 laboratory adverse event (n=15.3%) and was related to treatment with atazanavir and ribavirin. Conclusions Our findings from real-world data on HIV/HCV co-infected individuals across Europe show DAA treatment is well tolerated, and that high rates of SVR12 can be achieved in all regions of Europe.