PhD student Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, United States
Background: Hepatitis C virus (HCV) is the leading cause of hepatocellular carcinoma (HCC) in the United States. HCV treatment has greatly improved with the introduction of direct-acting antivirals (DAA), which have a high therapeutic efficacy (≥95% cure rate). A single center study showed DAAs were associated with decreased risk of mortality among patients with HCV-related HCC. However, findings were limited due to lack of generalizability.
Objectives: To assess the effects of DAAs on mortality among Medicare beneficiaries with HCV-induced HCC.
Methods: We conducted a retrospective cohort study using 2014-2019 Surveillance, Epidemiology, and End Results (SEER) linked Medicare data. Patients aged ≥ 18 years with diagnosed HCC and HCV were included. Early-stage HCC was defined as tumor size < 5cm, diagnosed in localized stage, and receipt of curative treatment (e.g., liver transplant, resection, and ablation). Patients were required to initiate DAAs after their first HCC diagnosis (DAA group) or not (non-DAA group). For the DAA group, the first DAA prescription date was assigned as the index date. Using a prescription-time distribution approach, a hypothetical index date was assigned to the non-DAA group based on the distribution between HCC diagnosis and the index date in the DAA group. Follow-up continued until the occurrence of death or disenrollment or the end of the study period (December 31, 2019), whichever occurred first. After inverse probability treatment weighting (IPTW), multivariable Cox proportional hazards model were used to compare mortality between the DAA and non-DAA groups.
Results: A total of 1523 patients with HCV-induced HCC were identified including 78 in the DAA group and 1445 in the non-DAA group (mean age: 67.0 ± 8.3 years; 76.7% male, and 72.0% white). 80.8% of patients in the DAA and 41.5% in the non-DAA groups had early-stage HCC. The crude incidence rates of mortality were 0.36 and 0.67 deaths per 100 person-years in the DAA and non-DAA groups, respectively. After IPTW adjustment, the Cox regression models showed the DAA group was associated with decreased risk of death (adjusted hazard ratio, 0.62; 95% CI: 0.26, 1.47) compared with the non-DAA group, although it was not statistically significant.
Conclusions: Our finding suggests that there was no survival benefit of DAAs among patients with HCV-induced HCC. Future studies investigating the long-term effects of DAAs on mortality among this population are needed.
