Combo HCV Tx Efficacy Comparable in Elderly, Non-Elderly
SAN FRANCISCO, CA—At The Liver Meeting® 2015, researchers reported that the efficacy of dual oral therapy with asunaprevir + daclatasvir was comparable between elderly and non-elderly patients with chronic hepatitis C, including compensated cirrhosis.
"This dual oral therapy rapidly reduced ALT, GGTP and α-fetoprotein even in elderly adults," reported Takashi Honda, MD, PhD, and colleagues from Nagoya University Graduate School of Medicine, Nagoya, Japan.
The efficacy of asunaprevir, a NS3 protease inhibitor, and daclatasvir, a NS5A replication complex inhibitor, for elderly patients with HCV genotype 1b has not been fully "clarified," Dr. Honda and colleagues explained. They therefore evaluated the early response and efficacy of dual oral therapy in this population.
In the study, 483 consecutive patients with chronic HCV genotype 1b, including those with compensated cirrhosis, were given dual oral asunaprevir (100mg twice daily) + daclatasvir (60mg once daily) therapy for 24 weeks, between September 2014 and March 2015, the team reported. Patients were categorized as either elderly (age ≥70 years; n=278) and non-elderly (<70 years; n=205). Using univariate and multivariate analyses, the researchers compared clinical characteristics, rapid virological response (RVR), and sustained virological response at post-treatment Week 4 (SVR4) between the two study arms, and compared baseline and Week 4 biochemical response and α-fetoprotein.
Efficacy did not vary significantly by patient age, with non-elderly and elderly-group per-protocol SVR4 rates of 96.3 and 96.0, and RVR rates of 96.3 and 95.5. Discontinuation rates were 8.3 and 11.2, respectively, a numerical difference that did not reach statistical significance.
In multivariate analysis, SVR4 was associated only with GGT and RVR overall (odds ratios [ORs] 0.991 and 0.060, respectively; P=0.006 and P<0.0001), and among elderly patients (OR 0.988, 0.034; P=0.048 and P<0.0001, respectively), Dr. Honda reported.
From baseline to Week 4, both elderly and non-elderly patients had experienced statistically significant declines in HCV-RNA, ALT, GGTP, and α-fetoprotein (all Ps<0.0001), Dr. Honda reported.