Anaïs Corma-Gómez1, Juan Macías2, Dolores Merino Muñoz3, Francisco Téllez4, Rafael Granados5, Luis E Morano6, Ignacio De Los Santos Gil7, Francisco J Vera-Méndez8, Antonio Collado9, Rosario Palacios10, Juan A Pineda1. 1. Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain. 2. Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain. Electronic address: juan.macias.sanchez@gmail.com. 3. Unit of Infectious Diseases, Hospitales Juan Ramón Jiménez e Infanta Elena, Huelva, Spain. 4. Unit of Infectious Diseases and Microbiology, Hospital Universitario de Puerto Real, Cádiz, Spain; Instituto de Investigación e Innovación en Ciencias Biomédicas de la provincia de Cádiz (INiBICA), Cádiz, Spain. 5. Unit of Infectious Diseases, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain. 6. Unit of Infectious Pathology, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain. 7. Unit of Internal Medicine and Infectious Diseases, Hospital La Princesa, Madrid, Spain. 8. Section of Infectious Medicine/Service of Internal Medicine, Hospital General Universitario Santa Lucía, Cartagena, Spain. 9. Infectious Diseases Unit, Hospital Universitario Torrecárdenas, Almeria, Spain. 10. Unit of Infectious Diseases and Microbiology, Hospital Virgen de la Victoria, Málaga, Spain.
Abstract
OBJECTIVES: To compare the efficacy of sofosbuvir/ledipasvir (SOF/LDV) for 8 weeks (SL8) versus a 12-week course of SOF/LDV (SL12) among HIV/HCV-coinfected patients in clinical practice. In addition we compared sustained virological response (SVR) rates achieved with SL8 in HCV-monoinfected and HIV/HCV-coinfected patients in a real life setting. METHODS: HCV-infected patients were retrospectively selected from the HEPAVIR-DAA and GEHEP-MONO real-life prospective cohorts if they fulfilled the following criteria: 1) Infected with genotype 1; 2) Treatment with SL8 or SL12; 3) Treatment naïve prior to receiving SL8 or SL12; 4) Absence of cirrhosis; 5) Baseline HCV RNA<6 × 106 IU/mL; 6) Reached the scheduled time-point for SVR (SVR12) assessment. SVR12 and relapse rates of HCV-monoinfected and HIV/HCV-coinfected patients were compared on an intention to treat basis. The responses with SL8 and SL12 were also compared. RESULTS: In the SL8 group, 107 (51%) HCV-monoinfected and 102 (49%) HIV/HCV-coinfected patients were included. One hundred and sixty-four (43%) HCV-monoinfected subjects and 220 (57%) HIV/HCV-coinfected patients received SL12. SVR12 rates for HIV/HCV-coinfected patients treated with SL8 vs SL12 were SVR12 92.2% vs. 97.3% (p = 0.044) and the respective relapse rates were 4.9% vs. 0.5% (p = 0.013). SVR12 rates for SL8 among HCV-monoinfected and HIV/HCV-coinfected patients were: 96.3% vs. 92.2% (p = 0.243), respectively. The corresponding relapse rates were 0.9% vs. 4.9% (p = 0.112). CONCLUSION: HIV/HCV-coinfected patients reach high rates of SVR12 with SL8, although lower than with SL12, mainly due to a higher probability of relapse. SVR12 rates with SL8 are numerically lower and the proportion of relapses higher in HIV/HCVcoinfected patients than in HCV-monoinfected subjects.
OBJECTIVES: To compare the efficacy of sofosbuvir/ledipasvir (SOF/LDV) for 8 weeks (SL8) versus a 12-week course of SOF/LDV (SL12) among HIV/HCV-coinfectedpatients in clinical practice. In addition we compared sustained virological response (SVR) rates achieved with SL8 in HCV-monoinfected and HIV/HCV-coinfectedpatients in a real life setting. METHODS:HCV-infectedpatients were retrospectively selected from the HEPAVIR-DAA and GEHEP-MONO real-life prospective cohorts if they fulfilled the following criteria: 1) Infected with genotype 1; 2) Treatment with SL8 or SL12; 3) Treatment naïve prior to receiving SL8 or SL12; 4) Absence of cirrhosis; 5) Baseline HCV RNA<6 × 106 IU/mL; 6) Reached the scheduled time-point for SVR (SVR12) assessment. SVR12 and relapse rates of HCV-monoinfected and HIV/HCV-coinfectedpatients were compared on an intention to treat basis. The responses with SL8 and SL12 were also compared. RESULTS: In the SL8 group, 107 (51%) HCV-monoinfected and 102 (49%) HIV/HCV-coinfectedpatients were included. One hundred and sixty-four (43%) HCV-monoinfected subjects and 220 (57%) HIV/HCV-coinfectedpatients received SL12. SVR12 rates for HIV/HCV-coinfectedpatients treated with SL8 vs SL12 were SVR12 92.2% vs. 97.3% (p = 0.044) and the respective relapse rates were 4.9% vs. 0.5% (p = 0.013). SVR12 rates for SL8 among HCV-monoinfected and HIV/HCV-coinfectedpatients were: 96.3% vs. 92.2% (p = 0.243), respectively. The corresponding relapse rates were 0.9% vs. 4.9% (p = 0.112). CONCLUSION:HIV/HCV-coinfectedpatients reach high rates of SVR12 with SL8, although lower than with SL12, mainly due to a higher probability of relapse. SVR12 rates with SL8 are numerically lower and the proportion of relapses higher in HIV/HCVcoinfectedpatients than in HCV-monoinfected subjects.