Article ; Online: Efficacy and safety of direct antiviral agents in a cohort of cirrhotic HCV/HIV-coinfected patients.
The Journal of antimicrobial chemotherapy
2017 Volume 72, Issue 10, Page(s) 2850–2856
Abstract: 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 ... ...
| Abstract | 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. |
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| MeSH term(s) | Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Benzimidazoles/administration & dosage ; Benzimidazoles/adverse effects ; Benzimidazoles/therapeutic use ; Cohort Studies ; Coinfection/drug therapy ; Coinfection/virology ; Drug Therapy, Combination/adverse effects ; Female ; Fluorenes/administration & dosage ; Fluorenes/adverse effects ; Fluorenes/therapeutic use ; Genotype ; HIV/drug effects ; HIV Infections/complications ; HIV Infections/drug therapy ; HIV Infections/epidemiology ; Hepacivirus/drug effects ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/drug therapy ; Hepatitis C, Chronic/epidemiology ; Humans ; Liver Cirrhosis/complications ; Male ; Middle Aged ; Prospective Studies ; RNA, Viral/drug effects ; Ribavirin/administration & dosage ; Ribavirin/adverse effects ; Ribavirin/therapeutic use ; Simeprevir/administration & dosage ; Simeprevir/adverse effects ; Simeprevir/therapeutic use ; Spain/epidemiology ; Sustained Virologic Response ; Treatment Outcome ; Uridine Monophosphate/administration & dosage ; Uridine Monophosphate/adverse effects ; Uridine Monophosphate/analogs & derivatives ; Uridine Monophosphate/therapeutic use |
| Chemical Substances | Antiviral Agents ; Benzimidazoles ; Fluorenes ; RNA, Viral ; ledipasvir, sofosbuvir drug combination ; Ribavirin (49717AWG6K) ; Simeprevir (9WS5RD66HZ) ; Uridine Monophosphate (E2OU15WN0N) |
| Language | English |
| Publishing date | 2017-10-31 |
| Publishing country | England |
| Document type | Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 191709-2 |
| ISSN | 1460-2091 ; 0305-7453 |
| ISSN (online) | 1460-2091 |
| ISSN | 0305-7453 |
| DOI | 10.1093/jac/dkx223 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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