by Gregory Dober
In 2013, the FDA approved two new life-saving hepatitis C (HCV) drugs known as simeprevir (brand named Olysio) and sofosbuvir (brand named Sovaldi). The drugs, a new class of medication called direct-acting antivirals (DAAs), were proven to be over 90% effective in clinical trials. Additionally, they reduced the course of treatment for hepatitis C from approximately 24-48 weeks to 12 weeks without the harsh side effects of previous medications like interferon. [See: PLN, July 2014, p.20].
Since 2013, eight DAA drugs have been approved and marketed by five different pharmaceutical companies. Despite the creation of more drugs and competition, treatment costs remain high and many state Departments of Corrections have resisted providing DAA treatment to prisoners with HCV.
In February 2018, California prisoners filed a class-action suit in federal district court against the state’s prison healthcare service, corrections officials and several other defendants, alleging violations of the Eighth Amendment and the Americans with Disabilities Act. See: Bayse v. California Department of Corrections and Rehabilitation, U.S.D.C. (E.D. Cal.), Case No. 2:18-cv-00278-MCE-DB.
The plaintiffs claim that despite the availability of the new drugs and a finding by the Centers for Disease Control that such drugs are the standard of medical care for HCV, the defendants have improperly denied prisoners’ requests to receive DAA treatment. The plaintiffs list a myriad of reasons for the denials, including being told they are not sick enough, not being in or near “end stage” liver failure or death, and that the drugs are too expensive. In a twist of irony, one prisoner was denied HCV treatment because his “disease is too advanced.”
The complaint states that prison officials have a vetting policy for treatment that uses the AST to Platelet Ratio Index (APRI) score. If the ratio is greater than 2 over several months, a prisoner will be considered for treatment. However, the plaintiffs note that one-half of people with cirrhosis will present a ratio below two; further, they allege that the ratio score can be influenced by other factors, such as other liver enzymes and day-to-day fluctuations. Therefore, the APRI score should not be solely relied upon to determine who receives HCV treatment using the new drugs. As HCV is already causing liver damage in prisoners who have an APRI score below two, they argue the failure to provide the DAA drugs is a violation of the Eighth Amendment and constitutes deliberate indifference to prisoners’ serious medical needs.
In addition to California, prisoners in other states have filed lawsuits to be treated with DAAs. In 2015, Minnesota prisoners filed a class-action complaint against state corrections officials for access to the new HCV treatment protocol. See: Ligons v. MN Department of Corrections, U.S.D.C. (D. Minn.), Case No. 0:15-cv-02210-PJS-BRT [PLN, Aug. 2015, p.22].
At a July 2017 hearing, the state’s Assistant Attorney General argued that HCV could take decades before the disease progresses into a “serious medical condition.” She therefore claimed that denying DAAs to prisoners not suffering from advanced stages of HCV did not amount to “deliberate indifference.”
“If I get infected today,” she told the judge, “I could go years without any sort of medical impact to my health.” However, the judge, critical of her argument, responded: “You could, but you wouldn’t. You, like anybody in this courtroom, would go to your doctor and get the drugs so that you didn’t even risk it....”
In January 2018, the Idaho Department of Correction received an additional budget allocation of $3 million for the treatment of prisoners with severe liver disease. The budget increase may have been attributed to a decades-old class-action suit filed by prisoners seeking better health care. See: Balla v. Idaho State Board of Corrections, U.S.D.C. (D. Idaho), Case No. CV-81-1165-S-BLW. [PLN, Nov. 2016, p.44].
A number of other states face litigation over their failure to provide DAA drugs to prisoners infected with HCV – including Tennessee, Florida, Colorado, Missouri and Pennsylvania – while others are considering the cost of supplying such treatment.
In Oklahoma, state officials reported that over 2,700 prisoners have HCV, though according to an article by Oklahoma Watch, only five prisoners have received the new drugs since July 1, 2017. The Department of Corrections is reportedly seeking $79.4 million in funding for fiscal year 2019 to provide DAA treatment to all HCV-positive prisoners. In comparison, the DOC’s budget for the drugs in fiscal year 2018 was just $86,408. The state legislature would have to approve the budget request.
“Prisons and jails are ground zero,” noted Michael Ninburg, executive director of the Hepatitis Education Project. “By treating [prisoners] now and curing them now, not only are we preventing an early death, we are also preventing transmission to other community members when the prisoner gets out,” he added.
Sources: www.oklahomawatch.org, www.triblive.com, www.npr.org, www.allianceforpatientaccess.org, www.usnews.com, www.courthousenews.com
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Related legal cases
Balla v. Idaho State Board of Corrections
|Cite||U.S.D.C. (D. Idaho), Case No. CV-81-1165-S-BLW|
Ligons v. MN Department of Corrections
|Cite||U.S.D.C. (D. Minn.), Case No. 0:15-cv-02210-PJS-BRT|