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
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 Prof. 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.
- sustained virological response (SVR)
Undetectable hepatitis C RNA after treatment has come to an end. Usually SVR refers to RNA remaining undetectable for 24 weeks (six months) after ending treatment and is considered to be a cure. SVR4 and SVR12 refer to RNA remaining undetectable for 4 and 12 weeks respectively.
HCV-Seek Test & Rapid
Treatment (HCV-ST&RT) was a randomized 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 sustained virological response,
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
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
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.