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Efficacy and safety of direct antiviral agents in a cohort of cirrhotic HCV/HIV-coinfected patients

2017; Oxford University Press; Volume: 72; Issue: 10 Linguagem: Inglês

10.1093/jac/dkx223

1460-2091

Jordi Navarro, Montserrat Laguno, Helem Vílchez, José M. Guardiola, J.A. Carrión, Luís Force, Mireia Cairó, Carmen Luna, Josep Vilaró, Josep Cucurull, Andrés Marco, Mercè Roget, Eva Erice, Manuel Crespo, Manuel Crespo, Mercè Roget, Jordí Ortiz, Carla Aparicio, Montserrat Laguno, Josep Mallolas, Maria Martínez Rebollar, Josep Cucurull, J.A. Carrión, Marc Puigvehí, Luís Force, Pilar Barrufet, Glòria Sempere, Eva Erice, Josep M. Guardiola, Mireia Cairó, Helem Vílchez, Carmen Luna, Jordi Navarro, Mercè Pérez‐Riba, Josep Vilaró, Andrés Marco, C Sarriera, Imma Valls,

Hepatitis B Virus Studies

New direct-acting antiviral agents (DAAs) have shown great efficacy and tolerability in clinical trials and real-life cohorts. However, data are scarce regarding efficacy and safety in cirrhotic HCV/HIV-coinfected patients. A multicentre prospective analysis was performed in 13 Spanish hospitals, including all cirrhotic HCV/HIV-coinfected patients starting DAA combinations from January to December 2015. Sustained virological response 12 weeks after treatment (SVR12) was analysed. Withdrawal due to toxicity and/or hepatic decompensation and change in liver stiffness measurement (LSM) after HCV treatment were evaluated. Patients (n = 170) were mostly male (n = 125; 74.3%) with the following HCV genotype (Gt) distribution: Gt-1a, 68 (40%); Gt-1b, 21 (12.4%); Gt-4, 47 (27.6%); and Gt-3, 26 (15.3%). Baseline median LSM was 20.6 kPa (IQR 16.1–33.7) and log10 HCV-RNA 6.1 IU/mL (IQR 5.7–6.5). Most patients had a Child–Pugh class A score (n = 127; 74.7%) and 28 (16.5%) had prior hepatic decompensation. There were 89 (52.4%) pretreated patients with 40.4% (n = 36) of null responders. Preferred regimens were as follows: sofosbuvir/ledipasvir + ribavirin, 43 (25.3%) patients; sofosbuvir + simeprevir + ribavirin, 34 (20%); sofosbuvir/ledipasvir, 26 (15.3%) and sofosbuvir + daclatasvir + ribavirin, 25 (14.7%). Overall SVR12 was 92.9% (158/170), without differences between genotypes. Pretreated patients had lower SVR12 rates compared with naive (88.8% versus 97.5%; P = 0.026). Treatment failures were as follows: 7 (4.1%) relapses; 2 (1.2%) lost to follow-up; 1 (0.6%) toxicity-related discontinuation; 1 (0.6%) hepatic decompensation; and 1 (0.6%) viral breakthrough. On-treatment hepatic decompensation was recorded in four (2.4%) patients (encephalopathy and ascites, two each). Paired LSM in 33 patients showed a decrease of 5.6 kPa (95% CI 1.8–9.2; P = 0.004). In our cohort of cirrhotic HCV/HIV-coinfected patients, DAAs were highly safe and efficacious. Viral eradication was associated with a significant decrease in liver stiffness.