Intervention improves HCV testing, but not treatment


Tafirayi Marukutira, PhD, MPH, MBChB

Credit: Burnett Institute

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Informing primary care physicians and proactive follow-up with better case management may help improve hepatitis C (HCV) RNA testing rates, according to findings from the CONNECT study.

A study of HCV RNA testing and treatment examining standard of care compared to an intervention showed that despite increased HCV RNA testing and a trend toward improved engagement, treatment remained unaffected.1

“People living with hepatitis C should be actively involved in care,” the investigators wrote, “through strategies that ensure health care providers are available to discuss treatment with patients, prescribe DAAs, or refer patients to care.” Be able to connect with.”1

Globally, the World Health Organization (WHO) estimates that 58 million people have chronic HCV, with approximately 1.5 million new infections each year. Although direct acting antivirals (DAAs) can cure more than 95% of people with hepatitis C infection, access to diagnosis and treatment remains low. Of the 58 million people living with HCV infection globally in 2019, an estimated 21% (15.2 million) knew their diagnosis and approximately 9.4 million were treated with a DAA.2

To assess the potential of HCV surveillance data to increase adherence to treatment, Tafirayi Marukutira, PhD, MPH, MBChB, senior research officer at the Burnet Institute in Australia, and a team of investigators conducted a 2-arm, non-blind, cluster Randomized trial. , Controlled trials comparing active follow-up and advanced case management to standard of care. Study participants were primary care physicians who ordered HCV antibody testing, prompting a new or repeat notification by the testing laboratory to the Tasmanian Department of Health.1

Primary care physicians, correctional services, sexual health, or family planning services, and specialists, trainees, or nurse practitioners located outside Tasmania were excluded. Overall, the investigators enrolled 171 primary care physicians with a total of 226 associated HCV case notifications.1

For participants in the standard of care arm, health surveillance department officials sent a surveillance letter and advanced surveillance data collection form to the notified primary care practitioner. In addition to standard of care, participants in the intervention arm received advanced case management support by a Department of Health hepatitis specialist based on HCV RNA status, primary care practitioner need, and familiarity with DAA prescribing.1

Using consecutive HCV notifications, investigators randomized them 1:1 to primary care physicians within 3 weeks of their first notification during the 12-month study period. In total, 86 primary care physicians were randomized to the standard of care arm and 85 were randomized to the intervention arm. During the observation period, primary care physicians in the intervention and standard of care arms were associated with 111 and 115 HCV case notifications, respectively. After obtaining physicians’ consent, 102 notifications in the standard of care arm and 103 notifications in the intervention arm were eligible for analysis.1

The primary outcome of interest was the proportion of notified patients with chronic HCV RNA who initiated treatment within 12 weeks of notification. Secondary outcomes included the proportion of patients diagnosed with HCV with documented RNA or with unknown test results and the proportion of patients diagnosed with antibody positive HCV RNA.1

Study arms were compared using proportions with the patient as the unit of analysis. The investigators sought to explore factors that predicted treatment initiation, including patients’ age, sex, previous HCV treatment experience and potential routes of transmission, and primary care physicians’ experience with HCV care or treatment, and opioid substitution treatment prescribing status. Univariate logistic regression modeling was used.1

The investigators observed a higher rate of HCV RNA testing in the intervention arm, with 92 (89%) patients tested compared with 80 (78%) in the standard of care arm.P = .03). Of these patients, 34 in the intervention group and 33 in the standard of care group had RNA detected and were eligible for the primary and secondary outcome analyzes (P = .56). Of the 11 patients who did not undergo RNA testing in the intervention arm, 6 (55%) were lost to follow-up and 9 (75%) were referred to a specialist, while 11 (50%) and 7 (58%) were referred to a specialist. Sent to. In the standard of care branch.1

The investigators found an 8-point difference in treatment between the intervention and standard of care arms over the 12-week period after notification (41% vs. 33%); P = .74) and a 17-point difference between the arms by the end of the observation period (65% vs. 48%); P = .18). The median time to DAA initiation was similar between the intervention and standard of care study arms (47 days vs. 39 days); P = .23).1

Within the groups, 13 patients in the intervention group and 12 patients in the standard of care group had previously been treated for HCV and had HCV RNA testing. RNA was detected in 3 (23%) of 13 patients in the intervention arm, 2 of whom were withdrawn. Of the 12 RNA tested patients in the standard of care arm, RNA was detected in 5 (42%) and 3 had retreated.1

The investigators reported that the most common reason for not initiating DAA treatment was specialist referral through the attending primary care physician. Of the 12 patients eligible for treatment in the intervention arm, 5 (25%) were referred to a specialist compared with 10 (45%) in the standard of care arm. In a univariate logistic regression of factors associated with treatment initiation, men were more likely to initiate than women (odds ratio, 3.40; 95% CI, 1.0–11.1; P = .04). The investigators reported that no other significant covariates were associated with DAA uptake.1

The investigators concluded, “In light of the higher treatment rates in the intervention arm, active follow-up of information may significantly impact treatment in jurisdictions with historically low treatment access.”1 “In Australian or similar contexts, adapting this intervention to currently underserved underserved areas, using longer treatment start windows, or intervening directly with patients rather than their doctor, could optimize health department HCV treatment support.” “There remain unanswered research questions about how we can make these efforts.”

Reference:

  1. Marukutira T, Barter R, Moore KP, et al. Connecting patients with hepatitis C to treatment (the CONNECT study): a randomized controlled trial of active case management by a health department to support primary care physicians. [published online ahead of print, 2023 Sep 13], Int J Drug Policy, 2023;121:104184. doi:10.1016/j.drugpo.2023.104184
  2. World Health Organization. Hepatitis C. Newsroom. July 18, 2023. Accessed September 20, 2023. https://www.who.int/news-room/fact-Sheets/detail/hepatitis-c

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