For hepatitis C virus (HCV) patients who inject drugs, HCV care at a needle-exchange program led to higher cure rates than usual care with patient navigators, a randomized trial found.
In an intent-to-treat analysis involving 165 such patients at a New York harm reduction center, 67% of those who received HCV care at the center (accessible care) had sustained virological response within 12 months, as compared to 23% of those who were referred to local clinicians through a patient navigation program (P<0.001), reported Benjamin Eckhardt, MD, of NYU School of Medicine in New York City, and colleagues.
As described in JAMA Internal Medicine, a significantly greater number of patients in the group receiving accessible care — where “study staff attempted to maintain a friendly, informal, and nonjudgmental atmosphere to reduce the stigma associated with health care” — advanced along each step of the HCV care cascade versus the usual care group, respectively:
- Referred to an HCV clinician: 93% vs 45%
- Attended an initial HCV clinical visit: 87% vs 37%
- Completed baseline lab tests: 87% vs 31%
- Started treatment: 78% vs 27%
“When provided with HCV treatment that was tailored to their needs, people who inject drugs successfully engaged in treatment, and two-thirds achieved an HCV cure,” wrote Eckhardt and coauthors.
“With the introduction of direct-acting antiviral (DAA) therapy, considerable progress has been made in reducing the health effects of HCV,” the authors noted. “These new therapies have removed the most difficult aspects of prior interferon-based HCV therapy, including the need for injections, adverse effects, long duration of treatment, and adherence burden.”
In their study, they found that for participants who started on therapy, cure rates were 85.9% in the accessible care group (55 of 64 patients) versus 86.3% in the usual care group (19 of 22 patients).
“Once patients initiated treatment, cure rates were the same in both groups, indicating that the major benefit of the accessible care program was facilitating treatment, not adherence to treatment,” stated Asha Choudhury, MD, MPH, of the University of California San Francisco, and Mitchell Katz, MD, of NYC Health and Hospitals in New York City, writing in an accompanying editorial.
“It is not surprising that the accessible care arm achieved a higher rate of viral eradication, as it created a patient-focused experience,” Choudhury and Katz added. “The success of the accessible care arm raises two dueling questions: Is this model replicable across the U.S.? And, conversely, why isn’t all medical care offered in friendly, nonjudgmental settings with the intention of meeting patient goals?”
From July 2017 to March 2020, Eckhardt and colleagues enrolled 165 adults with RNA-positive HCV at the Lower East Side Harm Reduction Center in New York City and randomized them 1:1 to the accessible care program or usual care. For inclusion, participants needed to have both used injection drugs and tested positive for HCV in the 90 days prior to enrollment, and have used injection drugs for at least a year prior.
Patients in the accessible care group were provided with an on-site HCV treatment team consisting of a physician and care coordinator. They were given evaluations, phlebotomy testing, and follow-up care. Usual care patients were connected with a separate on-site HCV patient navigator and were provided similar education and social support, but referred to care at surrounding treatment programs.
Follow-up occurred every 3 months. Participants in both groups were compensated $40 for each PCR test and $50 to $70 for each quarterly research visit attended. A similar number of patients were lost to follow-up: 12% in the accessible care group and 17% in the usual care group.
Overall, more than three-fourths of participants were men, the average age was 42 years, 59% were Hispanic, and 57% were homeless. Close to two-thirds of participants were on methadone (64%), a little less than half regularly used heroin, and about a quarter used cocaine regularly. The Most common DAAs prescribed were glecaprevir/pibrentasvir (Mavyret; 72%) and sofosbuvir/velpatasvir (Epclusa; 13%).
No significant differences between groups were seen for demographics, prior HCV treatment, or homeless status. The accessible group had fewer incarcerations within the last 90 days (2% vs 12%).
Beyond those cured through DAAs, six participants in the study cleared their HCV infection without treatment. Additionally, four patients in the accessible care group became reinfected.
The authors acknowledged several limitations to the data, including the lack of generalizability to areas with less harm reduction services.
Source : https://www.medpagetoday.com/gastroenterology/hepatitis/97643
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