IFN-free DAA Regimens Found Safe and Effective for Elderly Patients
BOSTON, MA—Interferon (IFN)-free direct-acting antiviral agent (DAA) regimens are “as safe and effective” for elderly patients with hepatitis C virus (HCV)-related cirrhosis or severe fibrosis as they are for younger patients, according to research presented at The Liver Meeting® 2016.
“The lifetime utility of HCV eradication in the elder in terms of reduction of events and overall survival needs evaluation in long-term observational cohorts,” however, cautioned senior study author Vincenza Calvaruso, MD, PhD, of the University of Palermo, in Palermo, Italy.
In Italy, IFN-free regimens are prescribed for severe fibrosis or cirrhosis, resulting in an older DAA-administered population with more comorbidities and polypharmacy issues. The evidence base is relatively sparse, however. Phase 3 DAA clinical trials have included few elderly patients with chronic HCV or cirrhosis, Dr. Calvaruso noted.
The study team therefore sought to evaluate the safety and efficacy of DAA regimens in elderly patients, using the regional database RESIST-HCV, which contains data for all HCV cases at Sicilian liver centers.
During 2015-2016, a total of 9,154 patients were registered in RESIST-HCV (Rete Sicilia Selezione Terapia - HCV). Of these, “5,480 (54%) met the AIFA criteria for treatment and 4,881 (48%) started DAA IFN-free regimens,” and 2,045 (41.5%) of these were aged 70 years or older, Dr. Calvaruso reported.
Compared to 2,836 younger patients (age <70 years), the cohort had significantly higher prevalences of patients with comorbidities. These included eradicated HCC (3.5% vs. 1.8%, P<0.001), diabetes (32.4% vs. 24.9%, <0.001), arterial hypertension (54.8% vs. 29.8%, P <0.001), heart disease (6.5% vs. 2.7%, P <0.001), and stage 3 kidney disease (4.0% vs. 2.5%, P=0.003), Dr. Calvaruso reported.
Co-medications were also more frequent among the elderly patients (81.8% vs. 67.8%, P<0.001).
“HIV co-infection (0.09% vs. 5.3%, P<0.001) and a previous orthotopic liver transplantation (OLT; 4.2% vs. 7.2%, P=0.058) were less frequent in the elderly,” Dr. Calvaruso noted. “At the end of October 2016, a total of 3,733 (76.5%) completed treatment and 2,066 patients (42.3%) concluded 12 weeks of follow-up and were evaluable for SVR."
For the intent-to-treat population, the rate of end treatment response (ETR) was 90.2% in the elderly cohort vs. 93.5% in younger patients (P=0.02). Sustained virological response (SVR) rates were 86.9% vs. 88.9%, respectively (P=0.1)
Twenty-three patients died during treatment, 7 of which were due to liver failure. The authors noted more elderly patients withdrew from treatment compared to younger patients (8.4% vs. 5.3%; P=0.005).
Members of the research team disclosed speaking and teaching grants from BMS, Gilead, Roche, Merck, Janssen, Bayer, MSD, and research support from AbbVie.