Rapid treatment model improves HCV care in injection drug users

A simplified, rapid treatment model for hepatitis C virus improved cure rates and the cascade of care among young people who inject drugs, according to a recent study.

“Over the prior decade, a growing proportion of untreated HCV infection is in younger people, specifically young people who inject drugs (PWID), and young PWID seek and engage in HCV treatment at low rates,” Benjamin Eckhardt, MD, MS, assistant professor at NYU School of Medicine, said during a presentation at The Liver Meeting Digital Experience. “There is a growing body of research to support simplified hepatitis treatment strategies with fewer baseline laboratory tests, pan-genotypic direct-acting antiviral therapy and less on-treatment monitoring.”

To evaluate outcomes of such an approach in PWID, Eckhardt and colleagues conducted the HCV-Seek, Test and Rapid Treatment (ST&RT) study — an open-label, randomized, controlled pilot study conducted at the Lower East Side Harm Reduction Center in New York City.

They recruited young, active PWID aged 18 to 29 years who injected drugs in the last 30 days and were HCV-antibody positive and treatment-naïve. Enrollment occurred from October 2018 to March 2020, with 1-year follow-up continuing through March 2021. The primary endpoint was the percentage of patients achieving sustained virologic response at 12 weeks after treatment within 12 months of enrollment, with secondary endpoints looking at treatment cascade numbers.

A simplified strategy

For the ST&RT study, participants underwent HCV RNA testing and were then randomly assigned to usual care or rapid treatment. In the usual care arm, participants received baseline HCV RNA test results within 2 to 7 days via in-person or telephone conversations. Those who were antibody-positive were then referred to an on-site care coordinator and, through the NYC Department of Health-funded Check Hep C Patient Navigation Program, were linked to community-based HCV providers and went through the typical cascade of care before initiation of therapy. In the rapid treatment arm, participants underwent additional lab tests and a medical evaluation in addition to HCV RNA testing at day 0. They were sent home with a 7-day starter pack of Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) and those confirmed HCV RNA-positive were advised to initiate treatment via telephone or in-person 2 to 7 days later.

In terms of follow-up, participants in the rapid treatment arm returned at day 7 to receive the remainder of their first month of medication, at day 28 for on-treatment monitoring labs and to receive the remainder of their 12 weeks of therapy and again at 12 weeks after treatment to test for cure. Eckhardt noted, however, that the researchers intentionally had “a very flexible, individualized” treatment plan.

Increased cure rates

The researchers recruited 39 young, active PWID, of whom 19 were randomly assigned rapid treatment and 20 assigned usual care. Of those, 14 in the rapid treatment arm and nine in the usual care arm were HCV RNA-positive. The majority of patients were young, with a mean age of approximately 26 years, and male. A large percentage were very active in their injection drug use, with most injecting drugs more than half of the days in the last 30 days.

Notably, Eckhardt said, a significant proportion had been previously diagnosed with HCV and approximately one-quarter had previously sought HCV care. All study participants, however, were treatment naïve.

After treatment, nine of 14 participants in the rapid treatment arm achieved SVR at 12 weeks after treatment compared with one participant in the usual care arm (P < .01). Among those who did not achieve cure in the rapid treatment arm, two participants had continued viremia, including one with confirmed treatment failure and one who opted not to initiate therapy, and three participants had missing follow-up viral load testing, including one who was incarcerated for longer than 1 year within 7 days of initiation of therapy and two who were lost to follow-up after treatment during the first wave of the COVID-19 pandemic. Among those who did not achieve cure in the usual care arm, two had confirmed treatment failure and eight never initiated therapy.

Results also showed that the cascade of care was significantly better in the rapid treatment arm vs. the usual care arm.

“The goal of this study was to combine the first three, and ideally the first four, steps of this cascade into a single visit,” Eckhardt said. “Compared with the rapid treatment arm, you can see a significant drop-off in engagement and subsequent treatment initiation and cure rate in the usual care arm, all of which are statistically significant.”

Additionally, Eckhardt noted that the researchers were able to treat and cure patients more quickly in the rapid treatment arm than in the usual care arm. For example, the median time to treatment initiation in the 13 participants in the rapid treatment arm who started sofosbuvir/velpatasvir was only 5 days from enrollment and 1 day from confirmation of HCV RNA.

Promise of rapid treatment

Eckhardt acknowledged several of the study’s limitations, including the fact that it was a single-site study with a small sample size. Additionally, the researchers noted that this type of strategy is limited to treatment-naïve participants. They also lacked real-time HCV RNA confirmation, which hampered their goal of initiating treatment on the same day as enrollment.

Nevertheless, the rapid treatment strategy proved beneficial for treatment of HCV in this particular patient population.

“By simplifying and consolidating the initial visit and providing HCV DAA starter packs, treatment initiation occurred within 7 days in 12 out of 14 rapid treatment participants and often on the same day as HCV RNA confirmation,” Eckhardt said. “Meeting young people, and specifically young PWID, where they’re at and initiating HCV treatment in the moment without the need for repeated visits, or minimal monitoring in this case, appears to be a promising strategy for treating this hard-to-reach population.”