Link-to-Care Approach Shows Promise for HCV Elimination

A prospective hepatitis C virus (HCV) elimination program for hemodialysis patients highlighted the viability of a “treatment as prevention” approach, demonstrating the impact of microelimination on reinfection and new infections.

Using decentralized screening followed by timely link-to-treat strategies in a cohort of more than 2000 patients with end-stage renal disease (ESRD) on maintenance hemodialysis, the program effectively reduced the HCV-viremic rate from 7.7% to 0.6%, saw primary infection rates as low as 0.01%, and prevented reinfection among HCV-cured patients.¹

“ESRD patients with HCV infection are associated with higher risks of cardiovascular disease and hospitalization, worse quality of life and greater mortality,” wrote investigators.¹ “Therefore, there is an urgent need to adopt HCV microelimination among HD patients at both the individual and population levels.”

Globally, an estimated 58 million people have chronic HCV infection, with about 1.5 million new infections occurring per year. The World Health Organization’s (WHO) global hepatitis strategy aims to reduce new hepatitis infections by 90% and deaths by 65% by 2030. Although direct-acting antivirals (DAAs) ​​can cure more than 95% of HCV infections, HCV screening and access to treatment pose significant barriers to its eradication, especially among vulnerable patient populations such as those on hemodialysis.²

To assess the concept of “treatment as prevention,” Chung-Feng Huang, MD, MS, PhD, director of the hepatobiliary division in the department of internal medicine at Kaohsiung Medical University in Taiwan, and a team of investigators launched a pair of screening programs across 22 hemodialysis centers in Taiwan to connect HCV-viremic patients with DAA treatment and assess the effect on the prevalence of HCV viremia and the incidence of HCV infections/reinfections.¹

Participants were enrolled in the present study from the Formosan Coalition for the Study of Liver Disease in Chronic Kidney Disease (FORMOSA-LIKE) group, a collaborative alliance of hepatologists and nephrologists in southern Taiwan consisting of more than 2000 ESRD patients with maintenance hemodialysis in 22 units.¹

Investigators conducted the first universal surveillance in January 2019, testing all hemodialysis patients for anti-HCV antibodies and further testing patients with anti-HCV seropositivity for HCV virology. HCV-viremic patients received onsite treatment by an outreach treatment team or were linked to local DAA treatment.¹

The second surveillance was conducted in December 2021, including both patients who participated in the first surveillance, the longitudinal cohort, and those who were enrolled only in the second surveillance, the new cohort.¹

Investigators defined HCV primary infection as anti-HCV seropositivity in the second surveillance that seroconverted from anti-HCV-seronegative subjects in the first surveillance. HCV reinfection was defined as HCV RNA reappearance in the second surveillance for anti-HCV-seropositive/HCV RNA-negative subjects, either due to treatment-induced sustained virological response or spontaneous clearance.¹

The primary objective was to address HCV seroprevalence before and after the link-to-care program. The secondary objective was to assess the incidence of new HCV infections after link-to-care in the ESRD population per the requirements of the WHO.¹

A total of 2336 patients were enrolled in the first surveillance. The mean age was 64.7 years and females accounted for 47.4% (n = 1108) of the cohort. Hypertension (62.5%), diabetes (49.7%), cardiovascular disease (37.9%), and dyslipidemia (29.5%) were among the most common comorbidities. The seroprevalences of anti-HCV and HBsAg were 13.7% (n = 320) and 11.5% (n = 268), respectively.¹

Of the 320 anti-HCV-seropositive patients, 181 (56.6%) were HCV RNA-positive. Of these patients, 152 (84.0%) were linked to DAA treatment and 140 (92.1%) achieved SVR12.¹

After excluding 155 patients who refused the second surveillance or had no data available, 1733 patients in the initial cohort participated in the second surveillance. An additional 620 patients were enrolled in the FORMOSA-LIKE group and participated in the second surveillance, increasing the total patient population to 2353. Investigators pointed out the rates of anti-HCV (9.8% vs 13.7%; P = .01) and HCV RNA (1.3% vs 7.7%; P < .001) in the new cohort were significantly lower than those in the initial cohort.¹

Among the combined longitudinal and new cohort, the seropositive rate of anti-HCV and HCV RNA viremic rates were 12.4% and 0.6%, respectively, during the second surveillance. Of the 1733 patients in the longitudinal cohort, 5 anti-HCV-seronegative patients became anti-HCV-seropositive in the second surveillance, a 0.01% annual incidence of HCV primary infection. Of the 119 SVR patients and the 102 anti-HCV-seropositive but HCV RNA-negative patients, none had HCV RNA reappearance in the second surveillance, and there was no HCV reinfection.¹

“The link-to-care program provided a thorough demonstration of HCV microelimination in the HD population in terms of reducing the HCV prevalence and incidence at the population level. Long-term benefits of HCV eradication in improving hepatic and extrahepatic outcomes on an individual basis are anticipated in vulnerable populations,” investigators concluded.¹

References:

1. Huang CF, Dai CY, Wang CW, et al. Therapy as prevention toward HCV elimination in maintenance hemodialysis: a multi-center, prospective cohort study. Clin Kidney J. 2023;16(12):2429-2436. Published 2023 Jun 14. doi:10.1093/ckj/sfad138
2. World Health Organization. Elimination of hepatitis by 2030. Hepatitis. Accessed December 13, 2023. https://www.who.int/health-topics/hepatitis/elimination-of-hepatitis-by-2030