HCV mono-infected and HIV/HCV co-infected individuals treated with direct-acting antivirals: to what extent do they differ?

• Main Authors: Giuseppe Bruno, Annalisa Saracino, Luigia Scudeller, Claudia Fabrizio, Raffaele Dell’Acqua, Eugenio Milano, Michele Milella, Nicoletta Ladisa, Laura Monno, Gioacchino Angarano
• Format: Article
• Language: English
• Published: Elsevier 2017-09-01
• Series: International Journal of Infectious Diseases
• Subjects: Direct-acting antivirals; DAAs; SVR; Safety; HIV/HCV co-infection; Real world
• Online Access: http://www.sciencedirect.com/science/article/pii/S1201971217301790

Background: Direct-acting antiviral (DAA)-based treatment of hepatitis C virus (HCV) has been associated with high sustained virological response (SVR) rates and good tolerability in randomized clinical trials. This study was performed to assess the safety and effectiveness of DAAs in both HCV mono-infected and HIV/HCV co-infected patients. Methods: All consecutive HCV-infected patients, including HIV/HCV co-infected patients, receiving DAA-based treatment from February 2015 to September 2016 at the study clinic were included. Clinical, virological, and biochemical data were retrieved. The primary end-point was the SVR12 (HCV RNA undetectable 12 weeks after the end of treatment) is commonly used worldwide. The secondary end-point was the safety profile of DAAs during the treatment period. Results: A total of 382 patients were included; 62 were HIV/HCV co-infected. Cirrhosis was found in 256 patients (67.4%). SVR12 was achieved in 365/382 (95.5%) individuals (58/62 HIV/HCV co-infected, 93.5%) in the intention-to-treat (ITT) analysis. A platelet count <90 × 109/l (odds ratio (OR) 4.12, 95% confidence interval (CI) 1.5–11.3, p = 0.006), HCV genotype 3 infection (OR 5.49, 95% CI 1.9–15.7, p = 0.002), liver stiffness >20 kPa (OR 3.05, 95% CI 1.03–8.96, p = 0.04), and Model for End-Stage Liver Disease (MELD) score >10 (OR 5.27, 95% CI 1.16–23.8, p = 0.03) were associated with lower SVR rates. On multivariate analysis, only genotype 3 infection remained a negative predictor of SVR (OR 21.6, 95% CI 3.81–123, p = 0.001). Treatment discontinuation was observed in 10 subjects. Severe adverse events (SAEs) occurred in 17 patients (4.5%). Conclusions: High SVR12 rates were observed in both HCV mono-infected and HIV/HCV co-infected individuals. Overall, DAA-based treatment was safe and there were no differences in terms of SAEs and treatment discontinuation between the two groups.