LT Yeo is a pharmacist at the U.S. Penitentiary Canaan in Waymart, Pennsylvania; CDR Johnson is a nurse practitioner and CAPT Heng is a dentist, both at the Federal Correctional Institution in Danbury, Connecticut; all are Commissioned Corps Officers serving in the U.S. Public Health Service.
Author disclosures The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.
Cost of HCV Treatment
The U.S. has the highest health care costs in the world—consuming 17% of the nation’s gross domestic product. 27,28 Health care costs also have been steadily increasing in U.S. prisons because of the expanding and aging incarcerated population. The Eighth Amendment provides inmates with the constitutional right to health care. The BOP’s overall expense of pharmaceuticals for HCV treatment has soared in recent years. It was kept below $2 million in fiscal years 2010 and 2011 but more than doubled the next 2 years, to more than $4 million in 2012 and 2013, and increased in 2014 to about $6 million. Hepititis C treatment accounted for 3% of the BOP pharmaceutical budget in 2011 and 7% in 2014. 29 Increased HCV pharmaceutical expenses were attributable to the introduction of DAAs. Even so, the majority of inmates with chronic HCV infection remained untreated.
Compared with DAA PIs, sofosbuvir is a game changer. Its all-oral, INF-free regimen makes treatment of chronic HCV infection more effective and safer. However, its cost is prohibitive, even in rich countries: A 12-week course costs $84,000, and Harvoni (ledispasvir/ sofosbuvir) costs $94,000. 30,31 A generic version of sofosbuvir is not expected until 2025. 32 Many studies have been conducted on the cost-effectiveness of these newer DAAs, but the picture is unclear, as the results were sensitive to drug price, drug efficacy (SVR rates vary with genotype and patient profile), quality of life after successful treatment, and the willingness-to-pay threshold. 30 Ironically, treatment cost could be the primary barrier to HCV eradication.
At USP Canaan, 137 inmates with chronic HCV infection potentially could have benefited from treatment. A majority (91 inmates) were infected with HCV genotype 1; of the other 46 inmates, 12 had genotype 2, 18 had genotype 3, 2 had genotype 4, and 14 lacked genotyping. The all-oral, INF-free regimen obviates the need for weekly injection, and treatment duration is shorter. The AASLD/IDSA treatment guidelines recommend all-oral, INF-free treatment regimens for all patients with genotype 1. Typically, treatment lasts 12 or 24 weeks, depending on presence or absence of liver cirrhosis, among other considerations. 16
Because of the high cost of treating all inmates with chronic HCV infection, the large number of inmates who are asymptomatic, and the potential decrease in medication costs after the introduction of generic versions, inmates are being prioritized for treatment based primarily on staging (presence or absence of liver disease). The rationale for using staging for prioritization is that patients with chronic HCV infection and no or minimal fibrosis at presentation seem to progress slowly, and treatment possibly can be delayed or withheld; whereas patients with significant fibrosis (septal or bridging fibrosis) progress almost invariably to cirrhosis over a 10- to 20-year period, so antiviral treatment becomes urgent. 33
APRI: Biomarker for Liver Fibrosis
A liver biopsy is the gold standard for the diagnosis of liver fibrosis. Although generally safe, it is costly. It is also subject to sampling error and examiner discrepancy, which lead to incorrect staging of fibrosis in 20% of patients. 5,33 Alternatively, various biologic markers can be used to diagnose liver disease. The aspartate aminotransferase (AST) platelet ratio index (APRI) is a simple and useful index based on readily available laboratory results: AST level and platelet count. APRI correlated significantly with fibrosis stage in patients with chronic HCV infection. 33