Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain

Abstract

AimWe describe the effectiveness and safety of the interferon-free regimen ombitasvir/paritaprevir/ritonavir plus dasabuvir with or without ribavirin (OBV/PTV/r ± DSV ± RBV) in a nationwide representative sample of the hepatitis C virus (HCV) monoinfected and human immunodeficiency virus-1/hepatitis C virus (HIV/HCV) coinfected population in Spain.Material and methodsData were collected from patients infected with HCV genotypes 1 or 4, with or without HIV-1 coinfection, treated with OBV/PTV/r ± DSV ± RBV at 61 Spanish sites within the initial implementation year of the first government-driven “National HCV plan.” Effectiveness was assessed by sustained virologic response at post-treatment week 12 (SVR12) and compared between monoinfected and coinfected patients using a non-inferiority margin of 5% and a 90% confidence interval (CI). Sociodemographic and clinical characteristics or patients and adverse events (AEs) were also recorded.ResultsOverall, 2,408 patients were included in the intention-to-treat analysis: 386 (16%) were patients with HIV/HCV. Patient selection reflected the real distribution of patients treated in each participating region in Spain. From the total population, 96.6% (95% CI, 95.8–97.3%) achieved SVR12. Noninferiority of SVR12 in coinfected patients was met, with a difference between monoinfected and coinfected patients of −2.2% (90% CI, −4.5% - 0.2%). Only genotype 4 was associated with non-response to OBV/PTV/r ± DSV ± RBV treatment (p<0.001) in the multivariate analysis. Overall, 286 patients (11.9%) presented AEs potentially related to OBV/PTV/r ± DSV, whereas 347 (29.0%) presented AEs potentially related to ribavirin and 61 (5.1%) interrupted ribavirin.ConclusionsOur results confirm that OBV/PTV/r ± DSV ± RBV is effective and generally well tolerated in a representative sample of the HCV monoinfected and HCV/HIV coinfected population in Spain within the experience of a national strategic plan to tackle HCV.

Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co‐infection: systematic review and network meta‐analysis

“…From a total of 2360 citations identified through the search strategy, 33 studies with 7 combinations of all‐oral DAAs were included for the analyses of efficacy. A total of 7877 HIV/HCV co‐infected patients from 16 countries were involved, including 4128 HCV genotype 1 patients, 92 genotype 2 patients, 648 genotype 3 patients, and 541 genotype 4 patients 14–46 . Overall, 7250 patients achieved SVR.…”

Treatment outcomes in hepatitis C virus genotype 1a infected patients with and without baseline NS5A resistance‐associated substitutions

“…Real‐world data on the efficacy of different DAA regimens in DAA‐naïve HCV genotype 1a infected patients are mainly available from studies that have not performed a systematic RAS testing at baseline 13‐20 . Our study analysed a large German real‐world cohort of genotype 1a‐infected patients, for whom treatment with EBR/GZR was intended and thus baseline resistance analysis was requested in the resistance laboratory in Frankfurt.…”