5PSQ-040 Real-life direct-acting antivirals effectiveness comparative study in HIV-hepatitis C virus coinfected patients

European Journal of Hospital Pharmacy-Science and Practice(2019)

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摘要
Background Chronic hepatitis C (CHC) treatment has dramatically changed with the introduction of direct-acting antivirals (DAAs) for hepatitis C virus (HCV)-infected patients. Available data from clinical trials reveal the effectiveness and safety of DAA, both in mono- or HIV-coinfected patients, with virologic response rates between 92%–98%. Purpose To compare the real-life effectiveness of DAAs therapy in HCV-monoinfected or HIV-coinfected patients. Material and methods Prospective study in patients with CHC who initiated treatment for 8–24 weeks, between 1 April 2015 and 1 January 2018. Exclusion criteria: patients from penitentiary centres and paediatric patients. Main variable: sustained virological response 12 weeks’ post-treatment (SVR12). Covariates: gender, age, HIV coinfection, previous treatment, hepatic transplantation, cirrhosis, fibrosis, viral genotype, baseline viral load and antiviral treatment. Statistical method: descriptive analysis comparing patients with SVR and patients with relapse. Statistical significance was calculated with the Fisher exact test and the Mann–Whitney U test. This study was authorised by the Health System Investigation Committee. Results One-thousand three-hundred and thirteen patients were included. One-thousand one-hundred and forty-one monoinfected, 172 HIV-coinfected: 73% males; 49.2 years mean age; 66.2% genotype 1; 23.8% cirrhotics (F4), 20.1% F3 fibrosis grade, 34.3% F2. 2.3% with hepatocellular carcinoma; 22.6% HCV-treatment-experienced; 31.6% null-responders and 23.7% recidivists to previous treatments; 90.9% with estimated glomerular filtration rate ≥60 mL/min; 58.8% treated with ledispasvir/sofosbuvir±ribavirin, 19.2% with sofosbuvir/daclatasvir±ribavirin and 7.0% with sofosbuvir/velpatasvir; and 79.1% treatment length for 12 weeks, 15.1% for 24 weeks and 5.2% for 8 weeks. There were no clinical or statistical critical basal differences related with DDAs’ effectiveness in genotype, fibrosis grade or treatment experience between mono- or HIV-coinfected patients (p>0.05). Effectiveness results: HIV-coinfected vs monocoinfected patients: 0.6% vs 1.3% recidivists (p=0.66); 0.6% vs 0.3% null-responders (p=0.97); and 93.6% vs 96.6% SVR12 (p=0.091). Conclusion DAAs against HCV are highly effective in HIV-coinfected patients, with response rates very similar to those observed in clinical trials. Also, no effectiveness differences were observed compared with HCV-monoinfected patients, even in this studied population with a high presence of advanced fibrosis grade. So, HIV-coinfection cannot constitute a barrier to accessibility to chronic hepatitis C interferon-free treatments for HCV/HIV-coinfected patients. References and/or acknowledgements Milazzo L, et al. Direct-acting antivirals in hepatitis C virus (HCV)-infected and HCV/HIV-coinfected patients: real-life safety and efficacy. HIV Med 2017;18:284–91. No conflict of interest.
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antivirals effectiveness,virus,real-life,direct-acting,hiv-hepatitis
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