ABSTRACT FINAL ID: 1972
TITLE: Maximizing access to HCV treatment with direct-acting antiviral agents for uninsured patients in the United States.
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BACKGROUND: Direct-acting antiviral agents (DAAs) revolutionized treatment of hepatitis C virus (HCV) infection; nevertheless, high cost remains a critical barrier to access these highly effective therapies, particularly for uninsured patients. We sought to evaluate the effectiveness of assigning a dedicated member of the liver team to help uninsured patients navigate patient-assistance programs (PAP) of pharmaceutical companies and obtain antiviral therapy.
METHODS: This was a retrospective study using the HCV treatment database at a tertiary referral center. Patients were enrolled in the county hospital healthcare discount program, which provides access to clinical visits, laboratory and imaging testing at discounted prices. This program does not cover any cost associated with antiviral therapy. Data for all uninsured patients prescribed antiviral therapy with DAAs were analyzed.
RESULTS: Ninety four uninsured patients with chronic HCV infection were prescribed antiviral therapy with DAAs from January 2014 to May 2016. Choice of DAA regimens was at the discretion of the treating physician and according to HCV genotype, presence of hepatic decompensation and or renal dysfunction. All prescriptions for DAAs along with supporting information were submitted to PAP of individual pharmaceutical companies by a single dedicated member of the liver team. Antiviral therapy with DAAs was obtained for 94 (100%) of uninsured patients: sofosbuvir/ledipasvir 52%, sofosbuvir/ribavirin 19%, simeprevir/sofosbuvir 17%, paritaprevir/ritonavir/ombitasvir/dasabuvir 8%, sofosbuvir/daclatasvir 3%, and elbasvir/grazoprevir 1%. Minor issues with the initial PAP applications were encountered in 34% of cases but were readily resolved with help from the dedicated member of the liver team. The main clarifications requested were with regards to proof of income (17%) and proof of address (12%). The median time from submission of the applications to approval of DAAs was 7 days (range 0 to 379 days). Sustained virological response was achieved in 99% of patients; one patient had to change antiviral regimen during treatment due to a severe adverse event but achieved SVR and only one patient did not achieve SVR as she passed away with acute on chronic liver failure during treatment.
CONCLUSION: access to DAAs for uninsured patients with HCV infection can be achieved through dedicated personnel to help patients and their families navigate applications for PAP of various pharmaceutical companies. This type of methods to overcome inaccessibility to DAAs for uninsured patients should be widely used, as SVR is associated with improvements in major patient-related outcomes.