Twelve opioid treatment programs (OTPs) in New York State are participating in a $7 million clinical trial integrating treatment of hepatitis C virus (HCV) infection in patients taking methadone. The clinical trial, “Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals,” being carried out at the University at Buffalo (UB), is aimed at showing how telemedicine can be useful in treating these and other patients. The Patient-Centers Outcomes Research Institute (PCORI) provided the funding and the telecommunications technology to the university.
Andrew H. Talal, MD, a professor of medicine at the Jacobs School of Medicine and Biomedical Sciences at UB, is sponsor of the clinical trial and lead author of two earlier related studies. He is also affiliated with UBMD, a group of more than 500 physicians at the University at Buffalo. The Buffalo campus, also known as SUNY, is the largest in the New York State University system.
All OTPs taking part in the clinical trial are members of the Coalition of Medication Assisted Treatment Providers and Advocates (COMPA) of New York State, an organization that also includes office-based opioid treatment (OBOT) providers.
“One-Stop Shopping”
The main takeaway from a preliminary pilot study (see below) is this: if you want patients to take their HCV medication, don’t send them to another location—make the HCV medication available to them at the OTP when they get their medication for opioid use disorder (OUD). The HCV infection can almost always be cured, and the possibility of transmission greatly reduced. It’s a public health and a personal health win.
Telemedicine makes this possible: pretreatment HCV laboratory studies are obtained at the OTP, and direct-acting antiviral medications are co-administered with methadone during observed dosing.
Medication adherence is almost certain to be improved when the patient has a trusting relationship with the health care provider, which is a part of treatment in OTPs. Going to a strange new provider for HCV treatment is not likely to be conducive to trust among these patients.
Among people who use drugs, hepatitis C is transmitted by sharing needles. It can be transmitted sexually, but that happens only rarely; communicable disease experts recommend use of a condom under certain unusual conditions. Once they are in treatment, compliant patients no longer share needles, but the virus can continue to be spread until it has been eradicated. The virus can also continue to damage the liver; cancer and even death can result.
While the technology of telemedicine seems like the main story here, the real story is the personal connection between OTP patients and OTP staff.
Even when patients receive regular treatment—methadone, buprenorphine, or naltrexone, at OTPs—many do not seek treatment for HCV. Yet about half of these patients are likely to be infected. Or, to put it more bluntly, they don’t go to the offsite treatment programs where testing and medications are offered.
It would be much more patient-friendly—and more likely to increase adherence to a treatment that now usually results in a cure in two to three months—if the OTP could treat the hepatitis C, the researchers hypothesized. And that’s exactly what the UB researchers found in their pilot study.
“Our OTPs across New York State answered the call to science for this important research,” said Allegra Schorr, MA, president of COMPA. “We are proud that each OTP chosen for the study is a COMPA member, and we are hopeful that, if proven successful with HCV, telemedicine might be a useful approach to treating other diseases where patients face similar challenges.”
“Management of other common conditions encountered in the OTP patient population could be modeled on our experiences with HCV care delivered in the OTP,” Dr. Talal added. “We commend COMPA on its robust response to our statewide call for OTPs to participate.”
Lawrence S. Brown, Jr., MD, CEO of START Treatment & Recovery Centers (START), Brooklyn, another study participant, stated, “Behavioral, biomedical, and health service research have been part of START’s legacy since its founding in 1969. Our patients and staff view this study as another vehicle in which START is connecting research, the provision of the highest quality of care, and educating the public by sharing our experiences.”
References
Verification Study
Talal AH, Andrews P, Mcleod A, et al. Integrated, co-located, telemedicine-based treatment approaches for hepatitis C virus management in opioid use disorder patients on methadone [Epub ahead of print October 18, 2018]. Clin Infect Dis. 2019;Jul 2;69(2):323-331. doi:10.1093/cid/ciy899.
Clinical Trial
Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals. https://clinicaltrials.gov/ct2/show/NCT02933970
(ClinicalTrials.gov Identifier: NCT02933970).
Pilot Study
Talal AH, McLeod A, Andrews P, et al. Patient reaction to telemedicine for clinical management of hepatitis C virus integrated into an opioid treatment program [Epub ahead of print October 16, 2018]. Telemed J E Health. 2019; Sep;25(9):791-801. doi:10.1089/tmj.2018.0161
For Additional Reading
https://www.mayoclinic.org/diseases-conditions/hepatitis-c/expert-answers/hepatitis-c/faq-20058441
https://www.webmd.com/hepatitis/default.htm
https://clinicaltrials.gov/ct2/show/NCT02933970