Darunavir in patients who failed on fos-amprenavir: efficacy at week 48 (original) (raw)
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Journal of acquired immune deficiency syndromes (1999), 2017
Efficacious, well-tolerated direct antiviral agents have drastically changed the prognosis of hepatitis C virus (HCV) disease, but real-world data for oral treatments are limited in key populations such as human immunodeficiency virus (HIV)/HCV co-infection with advanced liver disease. Daclatasvir (DCV) efficacy and safety was assessed in the French "Autorisation Temporaire d'Utilisation" (ATU) program providing DCV ahead of market authorization to patients with advanced HCV disease without other treatment options. This was a sub-analysis of HIV/HCV co-infected ATU patients treated with DCV plus sofosbuvir (SOF). Recommended duration was 24 weeks; addition of ribavirin (RBV) and/or shorter treatment was at physician's discretion. Primary efficacy analysis was sustained virologic response at post-treatment week 12 (SVR12; modified intention-to-treat). Safety was assessed by spontaneous adverse event reporting. The efficacy population (N=407) was mostly cirrhotic (72...
JAIDS Journal of Acquired Immune Deficiency Syndromes, 2021
Objectives: To investigate the effectiveness, safety and reasons for premature discontinuation of directacting 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.