Hepatitis C virus (HCV) treatment has been revolutionized by the recent approval of direct acting antiviral (DAA) therapies. These all-oral DAA therapies achieve high levels of HCV cure when taken as directed, but with a cost of $80,000+ for an entire course of treatment, the cure is expensive. So, who deserves the treatment?
While several studies have found DAA to be cost-effective in the long term, it may be cost prohibitive to treat everyone living with HCV in the short term. Thus, payers are developing and applying criteria to determine which individuals are eligible for these DAA. One eligibility criterion that has engendered a tremendous amount of debate is the exclusion of individuals who use drugs or alcohol. As an example, Colorado Medicaid requires six months of abstinence from alcohol and drugs prior to approving DAA treatment and monthly alcohol/drug screens for anyone with a history of alcohol/drug use within the past two years while receiving the treatment.
"There is extreme resistance to treating Hepatitis C in people who use drugs predicated on the assumption that this population will have poor adherence," says Dr. Jennifer Kiser, an associate professor in the SSPPS. Dr. Kiser recently launched a pharmacology and medication adherence trial in HCV-infected persons who use drugs.
Before the introduction of DAAs, drug users treated for Hepatitis C had cure rates similar and in some instances higher than the rates seen in trials that excluded drug users. Thus, "these criteria have no scientific basis," says Kiser, "We want to offer HCV treatment to individuals who use drugs and generate much-needed data on the pharmacokinetics and adherence-efficacy relationships with new DAAs."
According to the CDC, approximately 3-4 million Americans are chronically infected with HCV, which, if left untreated, can produce long-term complications (such as liver damage, failure and cancer) and even death. Though rates of new HCV infections have declined in the United States, HCV has a slow insidious onset. An individual can be infected for decades without knowledge of their illness. Thus infections from prior decades are placing a substantial burden on our healthcare system and without effective treatment, the peak of complications from HCV is expected to occur in 2030. HCV is the leading cause of cirrhosis and liver cancer and the most common reason for liver transplantation in the United States. Approximately 15,000 people die every year from Hepatitis C related liver disease in the US and there is a death per minute worldwide.
"Approximately 50% of all Americans living with Hepatitis C Virus are drug users, yet they are the least likely to receive treatment. They are denied potentially life-saving therapy - which harms their health and promotes the continued spread of this blood-borne disease," says Kiser.
Tracking participants' adherence
Dr. Kiser’s study will use technology and concentrations of the DAA in the body to track study participants' adherence. Half the participants will use emocha’s medication adherence mobile application, miDOT. Participants will use a secure emocha smartphone application to video record themselves taking their medication then study personnel will review the video on clinician web portal and assess adherence. The app also includes a series of automatic reminders and notifications to connect patients with study personnel, helping them stay on track through completion of therapy. Emocha will also be used to coordinate patient appointments and clinic visits. The other half of the study participants will not use miDOT, but will instead use the Wisepill container. Wisepill is a "smart" pillbox that records a signal to a server each time the pill container is opened. Medication taking behavior, as measured by miDOT or Wisepill will be compared to DAA concentrations in the participants’ blood.
The study has three important goals:
- to define and compare DAA (direct acting antivirals) pharmacokinetics in drug users undergoing miDOT vs. Wisepill;
- determine DAA concentrations associated with gradients of adherence; and
- establish the relationship between DAA adherence and HCV cure.
Kiser "hopes the pharmacology and adherence data generated through this study will promote the treatment of those most affect by Hepatitis C."