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J Infect. 2019 Jul;79(1):30-35. doi: 10.1016/j.jinf.2019.05.005. Epub 2019 May 14.

Higher relapse rate among HIV/HCV-coinfected patients receiving sofosbuvir/ledipasvir for 8 vs 12 weeks.

Author information

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.

KEYWORDS:

8 week treatment; HCV genotype 1; HIV-coinfection; Ledipasvir; Real-word; Sofosbuvir

PMID:
31100364
DOI:
10.1016/j.jinf.2019.05.005

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