Real life efficacy of ledipasvir/sofosbuvir in hepatitis C genotype 4–infected patients with advanced liver fibrosis and decompensated cirrhosis - 02/06/18
, Ibrahim H. Altraif b, c, Khalid Alswat d, Adnan AlZanbagi e, Mohamed A. Babatin f, Abdallah AlMousa g, Nawaf H Almutairi h, Mohammed S. Aljawad i, Abdullah S. Alghamdi f, Abdulrahman A. Aljumah b, c, Abduljaleel M. Alalwan b, c, Waleed K. Al-Hamoudi d, Abdullah M. Assiri j, Yaser Dahlan a, c, Ashwaq Alsahafi f, Hammad S. Alothmani f, Mohammed S. AlSaleemi g, Waleed A. Mousa h, Ali Albenmousa k, Abdelrahman Awny b, Haziz Albiladi f, Ayman A. Abdo d, Hamdan AlGhamdi b, cSummary |
Limited clinical trial data has shown high efficacy of co-formulated ledipasvir/sofosbuvir (LDV/SOF) in the treatment of hepatitis C virus (HCV) genotype (GT)-4 infected cirrhotic patients. We assessed real-world safety and efficacy of LDV/SOF with or without ribavirin (RBV) in GT4-infected patients with compensated and decompensated cirrhosis.
Patients & Methods |
This observational cohort (n = 213) included GT4 treatment-naïve (59.6%) and -experienced (40.4%) patients with advanced fibrosis (F3, Metavir; n = 30), compensated (F4, n = 135) and decompensated cirrhosis (n = 48) treated for 12 (n = 202) or 24 weeks (n = 11) with LDV/SOF. RBV was dosed by physician discretion between 600–1200 mg daily. Patients with prior DAA failure were excluded from the analysis. The primary efficacy endpoint was sustained virologic response 12 weeks after treatment (SVR12) on an intention-to-treat analysis, and occurrence of serious adverse events (SAEs).
Results |
The mean age of the overall cohort was 59.6 ± 12.1 years and 125 (58.7) were female. Overall, 197 (92.5%) of the patients achieved SVR12, including 93.3% of F3 fibrosis, 93.3% of compensated cirrhotics and 89.6% of the decompensated cirrhotics (P = 0.686). Addition of RBV (68.5%) did not enhance efficacy (91.8% vs. 94.0% without RBV, P = 0.563), including in F3 fibrosis, compensated and decompensated cirrhosis (P > 0.05, for all). There was no difference in SVR12 rates with 24 and 12 weeks therapy (90.9% and 92.6%, respectively; P = 0.586). Treatment failure (n = 16) was mostly related to relapse (n = 11), while on-treatment death (n = 3) and breakthrough (n = 2) comprised a minority. SAEs occurred in 9 (4.2%) patients requiring early treatment discontinuation in 4 (3 on-treatment deaths and 1 pregnancy).
Conclusion |
LDV/SOF therapy yielded high SVR12 rates in both compensated and decompensated cirrhotic GT4 patients. The addition of RBV to this regimen did not improve efficacy. The safety profile of this regimen was comparable with that reported for other HCV genotypes.
Le texte complet de cet article est disponible en PDF.Keywords : Hepatitis C virus, Genotype 4, Treatment, Sofosbuvir, Cirrhosis, Efficacy
Abbreviations : GT, SAE, ALT, AST, BMI, SD, HCV, eGFR, PegIFN, RBV, SVR, DAA, LDV, SOF, HCC, ITT, LT
Plan
| ☆ | Potential conflict of interest: Dr. Sanai advises, is on the speakers' bureau of, and received grants from Bristol-Myers Squibb and AbbVie pharmaceuticals. He is a consultant for and on the speakers' bureau of Merck Sharp Dohme, Gilead Sciences, Roche Pharmaceuticals and Janssen Pharmaceuticals. Drs. AlTraif and Alalwan have received grants from, are on the speakers' bureau of Roche Pharmaceuticals. Drs. Abdo, Babatin, Alghamdi, Aljumah, Altraif advise, and are on the speakers' bureau of Merck Sharpe Dohme, Gilead Sciences and Bristol-Myers Squibb. Other authors have nothing to disclose. |
| ☆☆ | Authors Role: Drs. Sanai, Babatin, Alghamdi, Altraif, Abdo, Albenmousa, Alzanbagi helped in study concept and design; Sanai, Babatin, Al-Hamoudi, Almutairi, Almousa, Dahlan, Mousa, Alghamdi, Aljawad, Aljumah, Alalwan, Albiladi, AlTraif, Alsahafi, Alothmani were responsible for acquisition of data; Babatin, Alghamdi, Sanai analyzed and interpreted data; Sanai drafted the manuscript; All authors contributed to the critical revision of the manuscript for important intellectual content; Sanai, Almousa performed the statistical analysis. |
| ☆☆☆ | Financial support: None. |
Vol 76 - N° 6
P. 536-542 - juin 2018 Retour au numéro
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