In patients aged 70 years or older with hepatitis C virus (HCV) genotype 1b compensated cirrhosis, treatment with paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) plus ribavirin is as effective, safe, and well tolerated as in younger patients, according to a recent study published in Medicine.
Compared with younger individuals, older people are more likely to be infected with HCV and have advanced liver disease.1 Yet the use of interferon-based treatment for chronic HCV infection has been limited in these patients due to their poor response and low tolerability of these regimens.
Direct-acting antiviral (DAA) regimens have been shown to be safe and very effective in this population, but many trials of oral DAA combination treatments included few elderly patients with compensated cirrhosis.
To assess the real-world efficacy and safety of PrOD plus ribavirin in patients aged 70 years and older, Anca Trifan, MD, Institute of Gastroenterology and Hepatology, St. Spiridon Hospital, Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania, and colleagues conducted this study.
“Fortunately, interferon-free HCV therapy with DAAs is highly effective and safe, allowing treatment for elderly patients in whom several studies reported similar sustained virologic response (SVR) rates as those obtained in younger patients,” the authors noted.
They included 1,008 patients with HCV genotype 1b compensated cirrhosis who were prospectively treated with PrOD plus ribavirin for 12 weeks, and excluded those with decompensated liver cirrhosis, severe chronic kidney disease, documented malignant neoplastic disease, active alcohol consumption, and HIV co-infection.
Dr. Trifan et al recorded SVR at 12 weeks after treatment (SVR12), adverse events (AEs), comorbidities, discontinuation, and death rates. In addition, they assessed the efficacy and safety of treatment in 117 patients aged 70 years or older (mean age: 73.3 years; 58.9% female; 31.6% treatment experienced), and compared the results with efficacy and safety in subjects aged less than 70 years.
A full 60.6% of patients 70 years or older had comorbidities, compared with only 39.8% of those less than 70 years (P < 0.001), and the most common in elderly patients were cardiovascular diseases, including hypertension, ischemic heart disease, and atrial fibrillation.
Upon intention-to-treat and per-protocol analyses, the SVR12 rates were 97.4% and 100%, respectively, in those 70 years or older compared with 97.8% and 99.6% in those less than 70 years, for no significant differences. Researchers also found no significant differences in the incidence of AEs (37.6% vs 34.6%, respectively; P=0.51) or severe AEs (3.4% vs 2.6%). The most common AEs in both groups included asthenia, pruritus, insomnia, and headache. Most were mild and manageable, and none led to treatment discontinuation.
Finally, only one death occurred in the group aged 70 years or older compared with six in the younger group (0.9% vs 0.8%), for another nonsignificant difference.
“Our study was carried out in a real-life setting on a homogeneous elderly population (older than 70 years of age) with HCV-genotype 1b compensated cirrhosis only, which is what makes it uniquely interesting among many others of its kind. There are but few published studies regarding efficacy of PrOD ± ribavirin in patients with HCV genotype 1 compensated cirrhosis in real-life setting,” wrote Dr. Trifan and colleagues.
“In conclusion, our results demonstrate that a 12-week regimen of PrOD + ribavirin is highly effective, safe, and well-tolerated treatment for patients aged 70 years or older with HCV-genotype 1b compensated cirrhosis, adding new evidence that advanced age should not be a barrier anymore in treating this growing subgroup of HCV patients,” they concluded.
- Thabut D, Le Calvez S, Thibault V, et al. Hepatitis C in 6,865 patients 65 yr or older: a severe and neglected curable disease? Am J Gastroenterol 2006;101:1260–1267.