Cost-effectiveness of Sofosbuvir plus Ledipasvir Antiviral Treatment for Elderly Patients with Chronic Hepatitis C Genotype 1

A relevant proportion of patients affected by Chronic Hepatitis C (CHC) is older than 65 years. In the interferon era, comorbidities and a higher susceptibility to interferon/ribavirin adverse events have limited treatment in these patients. Recent approval of interferon-free regimens, with high efficacy and limited toxicity, provide unprecedented chances for these patients to be treated. However, the cost-effectiveness of all-oral Direct-Acting Antivirals (DAAs) has not been addressed in the elderly population. We have performed a cost-effectiveness analysis taking into account the severity of liver disease, the age of the patient and the geriatric (frailty) status. METHODS: A semi-Markov model of CHC natural history was built. The study focuses on CHC Genotype 1 patients older than 65 years, stratified according to liver fibrosis (METAVIR F3 and F4), age (65 to 90 years old) and frailty phenotype defined by Fried’s (not frail, pre-frail and frail) for a total of 30 cohorts simulated. Treatment with sofosbuvir plus ledipasvir (SOF/LDV) versus no treatment was assessed for each cohort. The model estimated costs, Life Years and Quality-Adjusted Life Years (QALY) using a lifetime time horizon and the Health System perspective. Results are presented as incremental cost-effectiveness ratios (ICERs) per QALY gained. Cost-effectiveness was defined as an ICER under the willingness-to-pay threshold of 40,000 € per QALY gained. RESULTS: At each fibrosis score, ICER increased with age and frailty index. Among patients with F3 fibrosis, ICER ranged from €5,530/QALY in not-frail 65 years old and €149,355 in frail 85 years old patients. Among F4 patients ICER ranged from €6,552/QALY in not frail 65 years old and €85,559 in frail 85 years old patients. In F3 and F4 cohorts ICER was below €40,000/QALY up to age 84 and 87 years in non-frail pts, up to age 80 and 83 years in pre-frail patients, and up to age 76 and 80 in frail patients, respectively. Adopting an alternative scenario with a 20% discount of SOF/LDV treatment, cost-effectiveness increases accordingly. CONCLUSION: This analysis shows that, assuming that efficacy and safety of SOF/LDV are not age-dependent, SOF/LDV treatment is cost-effective in most CHC patients older than 65 years, although a careful assessment of the patient status is mandatory. Furthermore, under conditions of restricted budget, it should be considered that ICER varies considerably between two non-frail F4 patients, one at age 65 and the other at 85 years (between 8,000 and 33,000 EUR/QALY, respectively). This cost-effectiveness analysis should promote a prospective study to verify efficacy and side effects in elderly HCV patients