Efficacy and safety of direct antiviral agents in a cohort of cirrhotic HCV/HIV-coinfected patients
Por:
Navarro, J, Laguno, M, Vilchez, HH, Guardiola, JM, Carrion, JA, Force, L, Cairo, M, Cifuentes, C, Vilaro, J, Cucurull, J, Marco, A, Roget, M, Erice, E, Crespo, M
Publicada:
1 oct 2017
Resumen:
Background: 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.
Methods: 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.
Results: 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).
Conclusions: 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.
Filiaciones:
Navarro, J:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Barcelona, Spain
Hosp Valle De Hebron, Inst Recerca, Barcelona, Spain
Laguno, M:
Hosp Clin Barcelona, Barcelona, Spain
Vilchez, HH:
Hosp Univ Son Espases, Palma De Mallorca, Spain
Guardiola, JM:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Carrion, JA:
Univ Autonoma Barcelona, Hosp del Mar, Inst Hosp del Mar Invest Med IMIM, Barcelona, Spain
Force, L:
Hosp Mataro, Mataro, Spain
Cairo, M:
Hosp Univ Mutua Terrassa, Terrassa, Spain
Cifuentes, C:
Hosp Son Llatzer, Palma De Mallorca, Spain
Vilaro, J:
Hosp Univ Vic, Vic, Spain
Cucurull, J:
Hosp Figueres, Figueres, Spain
Marco, A:
Inst Catala Salut, Programa Penitenciari, Barcelona, Spain
Roget, M:
Consorci Sanitari Terrassa, Terrassa, Spain
Erice, E:
Fundacio Privada Hosp Mollet, Mollet Del Valles, Spain
Crespo, M:
Complexo Hosp Univ Vigo, IIS Galicia Sur, Vigo, Spain
Bronze
|