Real-world outcomes of ledipasvir/sofosbuvir in treatment-naive patients with hepatitis C

Document Type

Article

Publication Date

5-1-2016

Publication Title

The American journal of managed care

Keywords

Adult, Aged, Aged, 80 and over, Antiviral Agents, Benzimidazoles, Clinical Trials as Topic, Cost-Benefit Analysis, Drug Therapy, Combination, Female, Fluorenes, Hepatitis C, Chronic, Humans, Longitudinal Studies, Male, Middle Aged, Multicenter Studies as Topic, Outcome Assessment (Health Care), Prospective Studies, Registries, Sustained Virologic Response, United States, Uridine Monophosphate, Young Adult

Abstract

OBJECTIVES: Studies of hepatitis C virus (HCV) regimens have documented substantially reduced effectiveness in sustained virologic response (SVR) in the context of real-world clinical practice compared with clinical trials. Real-world and clinical trial SVR and cost-per-SVR data have not been reported for the all-oral, peginterferon-free and ribavirin (RBV)-free ledipasvir/sofosbuvir (LDV/SOF) regimen. Our objective was to compare the rates of SVR achievement and cost per SVR between pooled data from clinical studies of LDV/SOF and from real-world clinical practice.

METHODS: Data were derived from the Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET), a real-world, multicenter, prospective, observational study; and from the TRIO Network, a retrospective database of HCV-treated patients. The 1-year cost per SVR was calculated as the total cost of an SVR ([cost of treatment regimen, adverse events, and monitoring costs] per SVR) during the first year of treatment.

RESULTS: After 12 weeks, the SVR rates obtained in real-world studies ranged from 94% to 98%, comparing favorably with the SVRs achieved in the ION-1 and ION-3 trials (94% and 95%-99% with 8 and 12 weeks of RBV-free therapy, respectively). A single SVR, on average, cost $84,989 among patients enrolled in the ION-3 trial, with higher costs ($101,204) among patients with compensated cirrhosis compared with noncirrhotic patients ($81,668). In the pooled TARGET/TRIO population, the average cost of an SVR was $84,770, with costs of $101,380 and $81,368 in patients with compensated cirrhosis and patients without cirrhosis, respectively.

CONCLUSIONS: Unlike the results obtained with prior HCV regimens, this study suggests that similar SVR rates are achieved with LDV/SOF in clinical trial-based studies and real-world studies. Further, achieving an SVR in real-world clinical practice was not associated with excess costs.

Medical Subject Headings

Adult; Aged; Aged, 80 and over; Antiviral Agents; Benzimidazoles; Clinical Trials as Topic; Cost-Benefit Analysis; Drug Therapy, Combination; Female; Fluorenes; Hepatitis C, Chronic; Humans; Longitudinal Studies; Male; Middle Aged; Multicenter Studies as Topic; Outcome Assessment (Health Care); Prospective Studies; Registries; Sustained Virologic Response; United States; Uridine Monophosphate; Young Adult

PubMed ID

27266950

Volume

22

Issue

6 Spec No.

First Page

205

Last Page

211

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