Rapid hepatitis C treatment leads to high cure rate in young people who inject drugs

A simplified, same-day treatment model led to a higher cure rate compared with usual care for young people who inject drugs, according to research presented last week at the virtual IDWeek meeting. However, less than two-thirds were cured – well below rates seen in other studies of easier-to-treat groups.

Direct-acting antiviral therapy for hepatitis C virus (HCV) is highly effective, producing sustained virological response (SVR) rates upwards of 90% in clinical trials. But outcomes may not be as good in the real world because some people do not start or complete treatment.

Young people who inject drugs have a high incidence of HCV infection but lower rates of treatment initiation compared with their older peers, presenter Professor Benjamin Eckhardt of New York University School of Medicine noted as background. Therefore, simplified care models are needed to engage, treat and cure this population. Previous research has shown good outcomes for simplified treatment with minimal monitoring.

HCV-Seek Test & Rapid Treatment (HCV-ST&RT) was a randomised trial comparing rapid treatment versus usual care for young injection drug users age 18 to 29 years. Antibody screening took place as part of the Staying Safe study, focused on HCV prevention for this population.  

Eligible participants tested positive for HCV antibodies, had not previously received treatment for hepatitis C and had injected drugs within the past 30 days. Among the 47 eligible participants, 38 consented to enrol and were randomly assigned to either the rapid-treatment or usual-care arm.

Those in the rapid-treatment group received a same-day medical evaluation, a confirmatory HCV RNA test and baseline lab tests and were given a seven-day starter pack of sofosbuvir/velpatasvir (Epclusa). They were scheduled for further visits on day 7 for side effects monitoring and to receive another 21-day supply of pills; on day 28 for lab work and to receive their final 56-day pill supply (for a total of 12 weeks of therapy); and at 12 weeks post-treatment for follow-up testing.

Those in the usual-care group also received a confirmatory HCV test, but if they tested positive, they were referred to local providers to manage their care and treatment.

About three-quarters of the enrolled participants were men, 55% were White, 34% were Hispanic, 3% were Black and the average age was 26 years. Just over a third had been homeless and 13% had been incarcerated within the past 90 days. Although more than half had received medication-assisted treatment for opioid use (methadone or buprenorphine) within the past 90 days, they reported injecting drugs a median of 17 of the past 30 days.

Four people in the rapid-treatment group and nine in the usual-care group tested negative for HCV RNA, indicating that they likely naturally cleared the virus; they were not treated or included in the analysis. For the remainder – 14 in the rapid-treatment arm and 11 in the usual-care arm – the researchers assessed how many achieved SVR, or continued undetectable HCV RNA at 12 weeks after completion of treatment, over the course of a year.

Looking at the continuum of care, all 14 participants in the rapid-treatment group had an initial visit with an HCV provider and completed baseline lab work. All but one (92.9%) started treatment. The median time to treatment initiation was five days after enrolment, though one person started at 12 weeks post-enrolment due to incarceration. Twelve (85.7%) completed treatment and nine (64.3%) achieved SVR.

Limiting the analysis to the 13 who started treatment, nine (69.2%) achieved SVR, one (7.7%) experienced treatment failure – meaning they still had detectable HCV – and three (23.1%) had unknown outcomes. Of these, one was incarcerated. The other two had undetectable viral load while on treatment and were known to have finished therapy, but they did not undergo follow-up SVR testing; they may have been cured, but the researchers had no way to confirm this.

In contrast, just five of the 11 participants (45.5%) in the usual-care group had an initial visit and baseline lab work. Of these, three (27.3%) started treatment. Only one person completed treatment and was cured, for an SVR rate of 9.1%. Looking just at the three people who started treatment, one (33.3%) achieved SVR and two (66.7%) experienced treatment failure.

Among young people who inject drugs who tested positive for HCV RNA, "significantly higher rates of cure were achieved using the Rapid Treatment model with same day, low-threshold, simplified HCV care compared to facilitated referral," the researchers concluded.

"Meeting young [people who inject drugs] where they’re at, and initiating HCV treatment ‘in the moment’ without the need for repeat visits (minimal monitoring), appears to be a promising strategy for treating this hard to reach population," they suggested.