HCV mono-infected and HIV/HCV co-infected individuals treated with direct-acting antivirals: to what extent do they differ?. (September 2017)

• Record Type: Journal Article
• Authors: Bruno, Giuseppe; Saracino, Annalisa; Scudeller, Luigia; Fabrizio, Claudia; Dell'Acqua, Raffaele; Milano, Eugenio; Milella, Michele; Ladisa, Nicoletta; Monno, Laura; Angarano, Gioacchino
• Is Part Of: International journal of infectious diseases. Volume 62(2017:Sep.)
• Page Start: 64
• Page End: 71
• Publication Date: 2017-09
• Subjects: Direct-acting antivirals -- DAAs -- SVR -- Safety -- HIV/HCV co-infection -- Real world; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2017.07.001
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: This study was performed to assess the safety and efficacy of direct-acting antivirals (DAAs) in a real-life setting in both hepatitis C virus (HCV) mono-infected and HIV/HCV co-infected patients. A sustained virological response (SVR12; undetectability lasting for 12 consecutive weeks after the cessation of treatment) was achieved in 365/382 (95.5%) individuals (58/62 HIV/HCV co-infected, 93.5%). HCV genotype 3 infection was a negative predictor of SVR12. DAA-based treatment was effective and safe in both HCV and HIV/HCV co-infected patients. Abstract: 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 × 10 9 /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.