All-oral DAA therapy against HCV in HIV/HCV-coinfected subjects in real-world practice: Madrid-CoRe Findings

Abstract

We evaluated treatment outcomes in a prospective registry of HIV/HCV-coinfected patients treated with interferon-free direct-acting antiviral agent (DAA)–based therapy in hospitals from the region of Madrid between November 2014 and August 2016. We assessed sustained viral response (SVR) at 12 weeks after completion of treatment and used multivariable logistic regression to identify predictors of treatment failure. We evaluated 2,369 patients, of whom 59.5% were non-cirrhotic (Non-C), 33.9% had compensated cirrhosis (Co-C), and 6.6% had decompensated cirrhosis (De-C). The predominant HCV genotypes were 1a (40.9%), 4 (22.4%), 1b (15.1%), and 3 (15.0%). Treatment regimens included sofosbuvir (SOF)/ledipasvir (LDV) (61.9%), SOF plus daclatasvir (DCV) (14.6%), dasabuvir plus ombitasvir/paritaprevir/ritonavir (DSV+OBV/PTV/r) (13.2%), and other regimens (10.3%). Ribavirin was used in 30.6% of patients. Less than 1% of patients discontinued therapy owing to adverse events. The frequency of SVR by intention-to-treat analysis was 92.0% (95% confidence interval [CI]: 90.9-93.1%) overall, 93.8% (95%CI: 92.4-95.0%) for Non-C, 91.0% (95%CI: 88.8-92.9%) for Co-C, and 80.8% (95%CI: 73.7-86.6%) for De-C. The factors associated with treatment failure were male sex (adjusted odds ratio [aOR] 1.75; 95%CI 1.14-2.69), Centers for Diseases Control and Prevention (CDC) category C (aOR 1.65; 95%CI 1.12-2.41), a baseline CD4+ T-cell count <200/mm³ (aOR 2.30; 95%CI 1.35-3.92), an HCV RNA load ≥ 800,000 IU/mL (aOR 1.63; 95%CI 1.14-2.36), Co-C (aOR 1.35; 95%CI 0.96-1.89), De-C (aOR 2.92; 95%CI 1.76-4.87), and the use of SOF plus simeprevir, SOF plus ribavirin, and SMV plus DCV. In conclusion, in this large real-world study, DAA-based therapy was safe and highly effective in coinfected patients. Predictors of failure included gender, HIV-related immunosuppression, HCV RNA load, severity of liver disease, and the use of suboptimal DAA-based regimens. This article is protected by copyright. All rights reserved.

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