DAA Treatment for Patients with HCV Show Promise

Intravenous, or injection, drug use is still a leading risk factor for Hepatitis C Virus (HCV) transmission world-wide, with an estimated 60% of all new infections linked to persons who inject drugs (PWID), according to a 2013 article from the Journal of Infectious Diseases.

A new retrospective study from researchers at the Yale University School of Medicine — with help from the APT Foundation for Substance Abuse, Drug, Alcohol and Mental Health in New Haven, CT — has determined that treatment of PWID patients with HCV with direct acting antivirals in outpatient programs provides highly successful outcomes leading to sustained-viral-response (SVR).

Jenna L. Butner, MD, DABAM, with the Yale University School of Medicine, reports that PWID with HCV face difficulties in accessing treatment in health settings due to negative stigmas in health settings where their drug-use status excludes them from treatment, and are limited in treatment opportunities in rehabilitation centers serving them.

Butner states that guidelines from several associations including the National Institute of Health (NIH) originally “excluded PWID from being considered for HCV therapy, citing concerns about adherence, side effects from standard therapy” and potential for HCV re-infection.

Although guidelines currently recommend treatment for “all patients with chronic HCV infection,” there are ongoing concerns about providing access for PWID and HCV due to their status as a “high-risk and vulnerable group.”

In order to test the efficacy of treating PWID and HCV with oral direct acting antivirals (DAA) onsite in an outpatient treatment program, Butler and colleagues worked with patients at the APT Foundation center.

PWID patients with HCV were offered HCV education, counseling, and screening before undergoing treatment with DAAs. Butler states that the APT Foundation coordinated biweekly care visits and provided oversight for the program. Patients in the program were administered DAAs in 2-week allotments concurrent to their participation in the substance use treatment programs at the OTP.

Data were collected on the first 75 program participants (80% of whom had HCV genotype 1) to provide background information, determine HCV genotype, assess comorbidities, monitor viral load, guide regimens, and determine treatment adherence. Treatment outcomes were monitored to assess virological response to the DAA regimen.

At the end of the DAA treatment regimen, 98% of those patients who completed treatment and follow-up achieved SVR, and 85% patients who entered treatment (regardless of completion or follow up) achieved SVR. Butler reported that 10 patients were lost to follow up, and one patient developed virologic relapse of HCV in the context of ongoing drug use.

HCV treatment adherence was measured at 99% among patients in the program, and 13% of treatment patients successfully completed treatment while incarcerated and under Department of Corrections medical staff direction.

Butler and colleagues believe that their study, although limited in size, provides remarkable evidence demonstrating that treatment of these at-risk, and oftentimes excluded, PWID patients with DAAs during their rehabilitation programs is an unmitigated success.

“The DAAs in combination with on-site HCV treatment delivery in an OTP provide an integrated approach to the care and education of patients,” Butler wrote. Rather than excluding treatment for this at-risk group, Butler believed priority should be given to PWID with HCV as their treatment is crucial to “positively impact the HCV epidemic.”

The group recommended further research on the benefits of DAA-based therapies on PWID patients with HCV.

The article, "Onsite Treatment of HCV Infection with Direct Acting Antivirals Within an Opioid Treatment Program" appeared in the Journal of Substance Abuse Treatment in April 2017.

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