Views Mixed on Prison Screening for Hepatitis C

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By Llewellyn Hinkes-Jones

Dec. 21 — The U.S. Preventive Services Task Force won't be recommending general screening of the prison population for hepatitis C, but might make a targeted recommendation when evidence becomes available, the panel told Bloomberg BNA.

The statement comes after a recent study published in the Annals of Internal Medicine concluded that screening of the prison population would greatly reduce hepatitis C transmission for the general population. The study found that screening would be cost-effective overall even though prison health care spending would increase by 12.4 percent as a result, totaling $1.15 billion nationwide.

Two of the authors of the study indicated conflicts of interest with Gilead sciences, Inc., which manufactures recent antiviral treatments for hepatitis C, such as Sovaldi and Harvoni.

The effectiveness of general screening in the study centered on a 90 percent cure rate offered by new antiviral medications. Dr. Raymond Chung, director of Hepatology and Liver Center, Massachusetts General Hospital and previous councilor-at-large for the American Association for the Study of Liver Diseases, believes that the new antiviral treatments absolutely constitute a cure for hepatitis C.

“They provide sustained anti-HCV over indefinite periods of time, inflammation of fibrosis on liver biopsies has improved, and liver failure and liver cancer are remarkably reduced,” he told Bloomberg BNA.

But agreement on the benefits of general screening isn't universal. Dr. Steven Woloshin, professor of Medicine and of Community & Family Medicine at The Dartmouth Institute, told Bloomberg BNA he isn't supportive of general screening since the long-term benefits of screening are unknown, overdiagnosis is a major issue and there are ethical issues related to screening populations that don't qualify for treatment. According to Woloshin, there are concerns about “telling people they are sick but not being able to help them.”

Dr. Ronald Koretz, emeritus professor of clinical medicine at the David Geffen-UCLA School of Medicine, believes that the clinical utility of recent treatments for hepatitis C haven't been proven and can't be used to justify screening of a general population. Koretz also contends that few patients with chronic hepatitis C develop end-stage liver disease to justify widespread treatment and the potential side effects.

Even though the FDA allows Gilead to advertise treatments that lead to sustained virological response (SVR) as a “cure,” according to Koretz, no randomized, controlled clinical trial has been completed that proves it. Major clinical studies supporting the efficacy of these treatments haven't been randomized and lack proper control groups. While SVR has been correlated with better outcomes for patients, some treatments intended to improve SVR have shown little difference in clinical utility and some patients with SVR still develop end-stage liver disease.

“[The connection between SVR and improved outcomes] can only be answered by a randomized trial comparing treatment to no treatment with the patients being followed long enough for end-stage disease to develop,” Koretz said.

Price Is Key Issue

Access to hepatitis C treatments in prison is a contentious issue because of the high cost of treatment. Newer hepatitis C treatments from Gilead can cost upwards of $90,000 per person per year, or $1,000 a pill. Over the last two decades there have been dozens of lawsuits brought by prisoners seeking access to expensive treatments not provided by the state. Certain prison systems, like the Colorado Department of Corrections, include additional criteria for treatment, like length of prison stay and screening for alcohol and drug abuse, to ensure a full treatment cycle and avoid the chance of reinfection. In a lawsuit brought against the Kentucky Department of Corrections in 2001 over older and much cheaper treatments, the state claimed that screening and treating the entire state prison population would double the state prison system's entire medical budget.

A recent report by the Senate Finance Committee on Gilead's pricing of its hepatitis C drugs found that the company didn't determine prices based on the costs of developing the drug, but instead “set a price as high as it thought acceptable before significant access restrictions would be imposed” (See previous story, 12/02/15).

In the report, Washington state's Medicaid director believed that if the state treated all Medicaid clients with hepatitis C, it would cost the state “three times the current total pharmacy budget.” Even without treating all patients, the state will spend more than $242 million in 2016 alone.

To contact the reporter on this story: Llewellyn Hinkes-Jones in Washington at ljones@bna.com

To contact the editor responsible for this story: Heather Rothman at hrothman@bna.com