As obstacles to hepatitis C treatment uptake were removed, rates of hepatitis-related liver disease in marginalized groups plummeted, according to a new study in Baltimore, Maryland published in Annals of Internal Medicine.
A community-based cohort study that follows current and former people who inject drugs (PWID) with hepatitis C documented drastic reductions in liver disease and death as effective oral antivirals became more readily accessible there between 2015 and 2019.
The researchers concluded that hepatitis C elimination targets are achievable. But, they warned, uptake is uneven, and more needs to be done to facilitate treatment.
“[The study] gives us a real-world perspective on what’s happening on the ground, in terms of people getting treated,” said first author Javier Cepeda, PhD, MPH, an assistant professor at the Johns Hopkins Bloomberg School of Public Health, in an interview with Medscape Medical News. “Changing policy, reducing barriers, getting them access to treatment really does have this really important public health benefit.”
“It’s compelling to see these improved outcomes amongst a cohort of people who inject drugs with baseline hep C,” said Maria Corcorran, MD, MPH, to Medscape. Corcorran, an acting assistant professor for the Department of Medicine at the University of Washington, was not involved with the study. “It’s just further evidence that we need to really be linking people to care and getting people treated and cured.”
The World Health Organization has called for the disease’s global elimination by 2030. Cure rates top 95%. But, there are so many new cases and so many barriers to detection and treatment that how to develop and roll out a public health response is the most important question in the field, wrote study co-author David L. Thomas, MD, MPH, in a 2019 review article in The New England Journal of Medicine.
“Folks who inject drugs…do well on hep C treatment and have similar rates of sustained virologic response or cure,” said Corcorran, who runs a low-barrier clinic for people experiencing homelessness.
But, she added, “there are barriers that are still put up to treatment in terms of who can treat and what insurance is going to cover.”
A Look at a Vulnerable Population
The authors studied adults enrolled in ALIVE (AIDS Linked to the Intravenous Experience), a cohort study that has recruited current and former PWID in the Baltimore area since 1988.
Participants visit the clinic twice a year for health-related interviews and blood testing, including HIV serology, hepatitis C virus (HCV) antibody and RNA testing, and liver function tests. They are counseled about HCV testing and treatment but do not receive treatment through the study.
Beginning in 2006, researchers added liver stiffness measures (LSMs), a noninvasive measure conducted with transient elastography.
From 2006 to 2019, the authors followed 1323 ALIVE participants with chronic HCV infection. The primary outcome was LSMs.
Less Liver Disease, Fewer Deaths
At baseline, participants’ median age was 49 years; 82% of participants were Black individuals, 71% percent were male, and two thirds were HIV-negative.
Three percent reported receiving hepatitis C treatment in 2014, which increased to 39% in 2019.
Among 10,350 LSMs, 15% showed cirrhosis at baseline in 2006. In 2015, that rose to 19%, but by 2019, it had fallen to 8%.
By definition, 100% had detectable HCV RNA at baseline. In 2015, 91% still did. By 2019, that rate had fallen to 48%.
Undetectable HCV RNA correlated with lower log LSM in adjusted models (P < .001). It also correlated strongly with lower odds of liver cirrhosis, with an adjusted odds ratio of 0.28 (95% CI, 0.17-0.45; P < .001). In addition, it correlated with lower risk for all-cause mortality, with an adjusted hazard ratio of 0.54 (95% CI, 0.38-0.77; P < .001).
Limitations include the fact that, although transient elastography is considered the most valid way to detect cirrhosis in people with hepatitis C, liver stiffness has not been validated as a measure of fibrosis among people with a sustained virologic response.
In addition, ALIVE participants are older and more likely to be African American individuals compared with the general population of PWID in Baltimore, wrote co-author Shruti H. Mehta, PhD, a professor of epidemiology at Hopkins, in an email exchange with Medscape. That could affect generalizability.
Treatment Is Crucial
The first direct-acting antiviral (DAA) for hepatitis C was approved in 2011 and an oral fixed-dose combination antiviral was approved in 2014, ushering in treatments with cure rates far exceeding those with interferon-based therapy.
But until recently, Medicaid patients in Maryland seeking DAA therapy for hepatitis C required prior authorization, with initial restrictions related to disease stage, substance use, and provider type, according to Mehta.
Gradually, those restrictions were lifted, Mehta added, and all were eliminated by 2019.
Cepeda urges clinicians to treat patients infected with hepatitis C immediately.
“There are really important implications on both reducing liver disease progression and all-cause mortality,” he said.
“Hep C is just one part of a whole constellation of healthcare delivery [and] of treating all of the other potential problems that might need to be addressed — especially with people who inject drugs,” Cepeda added. “Getting them into care is really, really important.”
The study was funded by the National Institutes of Health. Cepeda and Corcorran report no relevant financial relationships. Mehta reports receiving payments or honoraria and travel support from Gilead Sciences, the makers of the oral hepatitis C medication ledipasvir/sofosbuvir (Harvoni), as well as equipment, materials, drugs, medical writing, gifts, or other services from Abbott, which sells hepatitis C diagnostics. Thomas reports ties to Excision Bio and to Merck DSMB.
Ann Intern Med. Published online July 11, 2022. Full text
Jenny Blair, MD, is a journalist, writer, and editor in Vermont.