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Changing Treatment Landscape of Hepatitis C Virus Infection Among Penitentiary Inmates

Resource constraints and sound clinical judgment provide the rationale for step-by-step screening, monitoring, and treatment prioritization for inmates infected with the hepatitis C virus.
Federal Practitioner. 2016 April;33(3)s:
April 25, 2016|Federal Practitioner
LT Yvon Yeo, PharmD, USPHS;CDR Rosemary Johnson, MSN, APRN, ANP-BC, USPHS;CAPT Christine Heng, DDS, MPH, USPHS
Author and Disclosure Information

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.

Changing Landscape of HCV Treatment

Treatments for chronic HCV infection have never been more promising. There is the prospect of a cure with the new DAAs. These new medications are active against HCV and interfere with viral enzymes and other proteins essential for viral replication. Until recently, the mainstay of treatment for chronic HCV infection was pegINF/RBV. However, INF-based dual therapies were associated with high rates of adverse effects (AEs) and treatment discontinuation. In 2011, release of the protease inhibitors (PIs) boceprevir and telaprevir improved sustained virologic response (SVR) rates for treatment-naïve patients with genotype 1 from about 50% (pegINF/RBV dual therapies) to 70% to 75% (PI in combination with pegINF/RBV triple therapies). However, first-generation DAAs were INF-based, and their dosing was cumbersome.15,17-19

Starting with the 2013 approval of simeprevir (second-wave PI) and sofosbuvir (polymerase inhibitor), most patients’ SVR rates improved to 75% to 90%.20,21 Sustained virologic response rates were boosted to > 95% after the 2014 approval of Harvoni, coformulated ledispasvir (replication complex inhibitor) and sofosbuvir, and Viekira Pak, a combination of ombitasvir (replication complex inhibitor), paritaprevir (PI), and ritonavir (inhibitor of CYP3A4 enzyme) co-packaged with dasabuvir (polymerase inhibitor).22-24 In 2015, daclatasvir (replication complex inhibitor) was approved, followed in 2016 by Zepatier, coformulated elbasvir (replication complex inhibitor) and grazoprevir (PI). Harvoni has simplified the treatment regimen to 1 pill a day and shortened the duration of treatment to as few as 8 weeks for some
patients.25

The option of an all-oral, INF-free treatment regimen and the prospect of freedom from the HCV could not come at a more opportune time, given the aging of baby boomers with chronic HCV infection and the high rates of HCV and HIV infections contracted in the 1970s and 1980s. An estimated one-third of those infected is expected to develop cirrhosis within 20 years.26

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

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