Karin Neukam1,2, Luis E Morano-Amado3, Antonio Rivero-Juárez4, María Mancebo1,2, Rafael Granados5, Francisco Téllez6, Antonio Collado7, María J Ríos8, Ignacio de Los Santos-Gil9, Sergio Reus-Bañuls10, Francisco Vera-Méndez11, Paloma Geijo-Martínez12, Marta Montero-Alonso13, Marta Suárez-Santamaría14, Juan A Pineda1. 1. a Unit of Infectious Diseases and Microbiology , Hospital Universitario de Valme , Seville , Spain. 2. b Instituto de Biomedicina de Sevilla (IBiS) , Seville , Spain. 3. c Unit of Infectious Pathology , Hospital Universitario Alvaro Cunqueiro , Vigo , Spain. 4. d Unit of Infectious Diseases , Hospital Universitario Reina Sofía, Maimónides Institute of Biomedical Investigation(IMIBIC), University of Cordoba , Cordoba , Spain. 5. e Unit of Infectious Diseases , Hospital Universitario de Gran Canaria Dr Negrín , Las Palmas de Gran Canaria , Spain. 6. f Unit of Infectious Diseases , Hospital La Línea, AGS Campo de Gibraltar , La Linea de la Concepcion , Spain. 7. g Infectious Diseases Unit , Hospital Universitario Torrecárdenas , Almeria , Spain. 8. h Unit of Infectious Diseases , Hospital Virgen Macarena , Seville , Spain. 9. i Infectious Diseases Unit , Hospital Universitario La Princesa , Madrid , Spain. 10. j Unit of Infectious Diseases , Hospital General Universitario de Alicante , Alicante , Spain. 11. k Section of Infectious Medicine/Service of Internal Medicine , Hospital General Universitario Santa Lucía , Cartagena , Spain. 12. l Unit of Infectious Diseases , Hospital Virgen de la Luz , Cuenca , Spain. 13. m Unit of Infectious Diseases , Hospital Universitario y Politécnico La Fe , Valencia , Spain. 14. n Fundación Biomédica del Complejo Hospitalario Universitario de Vigo (CHUVI) , Vigo , Spain.
Abstract
OBJECTIVE: HIV/HCV-coinfected patients and hepatitis C virus (HCV) monoinfected subjects are thought to respond equally to direct-acting antiviral (DAA)-based therapy despite the lack of data derived from clinical trials. This study is aimed to evaluate the impact of HIV coinfection on the response to DAA-based treatment against HCV infection in the clinical practice. PATIENTS AND METHODS: In a prospective multicohort study, patients who initiated DAA-based therapy at the Infectious Disease Units of 33 hospitals throughout Spain were included. The primary efficacy outcome variables were the achievement of sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12). RESULTS: A total of 908 individuals had reached the SVR12 evaluation time-point, 426 (46.9%) were HIV/HCV-coinfected, and 472 (52%) received interferon (IFN)-free therapy. In an intention-to-treat analysis, SVR12 rates in subjects with and without HIV-coinfection were 55.3% (94/170 patients) versus 67.3% (179/266 subjects; p = 0.012) for IFN-based treatment and 86.3% (221/256 subjects) versus 94.9% (205/216 patients, p = 0.002) for IFN-free regimens. Relapse after end-of-treatment response to IFN-free therapy was observed in 3/208 (1.4%) HCV-monoinfected subjects and 10/231 (4.4%) HIV/HCV-coinfected individuals (p = 0.075). In a multivariate analysis adjusted for age, sex, transmission route, body-mass index, HCV genotype, and cirrhosis, the absence of HIV-coinfection (adjusted odds ratio: 3.367; 95% confidence interval: 1.15-9.854; p = 0.027) was independently associated with SVR12 to IFN-free therapy. CONCLUSIONS: HIV-coinfection is associated with worse response to DAA-based therapy against HCV infection. In patients receiving IFN-free therapy, this fact seems to be mainly driven by a higher rate of relapses among HIV-coinfected subjects.
OBJECTIVE:HIV/HCV-coinfectedpatients and hepatitis C virus (HCV) monoinfected subjects are thought to respond equally to direct-acting antiviral (DAA)-based therapy despite the lack of data derived from clinical trials. This study is aimed to evaluate the impact of HIV coinfection on the response to DAA-based treatment against HCV infection in the clinical practice. PATIENTS AND METHODS: In a prospective multicohort study, patients who initiated DAA-based therapy at the Infectious Disease Units of 33 hospitals throughout Spain were included. The primary efficacy outcome variables were the achievement of sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12). RESULTS: A total of 908 individuals had reached the SVR12 evaluation time-point, 426 (46.9%) were HIV/HCV-coinfected, and 472 (52%) received interferon (IFN)-free therapy. In an intention-to-treat analysis, SVR12 rates in subjects with and without HIV-coinfection were 55.3% (94/170 patients) versus 67.3% (179/266 subjects; p = 0.012) for IFN-based treatment and 86.3% (221/256 subjects) versus 94.9% (205/216 patients, p = 0.002) for IFN-free regimens. Relapse after end-of-treatment response to IFN-free therapy was observed in 3/208 (1.4%) HCV-monoinfected subjects and 10/231 (4.4%) HIV/HCV-coinfected individuals (p = 0.075). In a multivariate analysis adjusted for age, sex, transmission route, body-mass index, HCV genotype, and cirrhosis, the absence of HIV-coinfection (adjusted odds ratio: 3.367; 95% confidence interval: 1.15-9.854; p = 0.027) was independently associated with SVR12 to IFN-free therapy. CONCLUSIONS:HIV-coinfection is associated with worse response to DAA-based therapy against HCV infection. In patients receiving IFN-free therapy, this fact seems to be mainly driven by a higher rate of relapses among HIV-coinfected subjects.
Entities:
Keywords:
Direct-acting antivirals; HIV coinfection; Hepatitis C virus; Interferon-free regimens; Relapse; Sustained virologic response; Treatment
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