Providing treatment for hepatitis C in the primary care
setting significantly improves the uptake of treatment and cure rates in people
who inject drugs, a randomised study conducted in Australia and New Zealand has
found.
The study findings are published in the journal Clinical Infectious
Diseases.
The Prime study compared the uptake and outcomes of
treatment in people who inject drugs who were randomised to receive hepatitis C
care either in a primary healthcare setting or in a hospital-based clinic.
At the time the Prime study began in 2015, provision of
direct-acting antiviral treatment through general practitioners was largely
untested. Prescription of direct-acting antivirals by general practitioners was
authorised in Australia in 2016 as part of the country’s effort to eliminate
hepatitis C. Earlier this year the French national health authority recommended
that anyone without complications such as cirrhosis or diabetes should receive
hepatitis C treatment at primary care level. But few other countries have relaxed
restrictions on who can prescribe direct-acting antivirals, limiting capacity
to treat hepatitis C.
Treatment in the primary care setting, by doctors familiar
with the healthcare needs of people who inject drugs, may encourage the uptake
of hepatitis C treatment.
The study randomised 136 participants at 13 sites in
Australia and New Zealand. The study excluded people with cirrhosis as Australian
guidelines recommended that people with hepatitis C and cirrhosis should be
treated by a liver specialist in a hospital-based clinic.
Study participants were predominantly male and approximately
70% were unemployed. Forty-nine per cent had injected drugs in the past six
months and approximately 85% were being prescribed opioid substitution therapy
at the time of study screening.
The original study protocol restricted recruitment to people
with genotype 1 infection and all participants were treated with parataprevir/ritonavir,
dasabuvir and ombitasvir, with the addition of ribavirin for genotype 1a.
Recruitment was expanded to genotype 3 after the Australian national treatment
programme excluded the use of ribavirin, to enhance study recruitment. Participants
with genotype 3 infection received sofosbuvir/daclatasvir. All treatment regimens
lasted 12 weeks.
The primary study outcome was non-inferiority of sustained
virologic response 12 weeks after the completion of treatment (SVR12, cure) in
the primary care arm compared to a historical cure rate of 85%. The study also
measured uptake of treatment, and retention in care in comparison to the hospital
care arm.
Of the participants randomised to primary care, 48 were
eligible for study treatment (13 were excluded due to fibrosis, drug-drug
interactions, and 9 did not complete liver fibrosis assessment). Forty-three of
45 people eligible for treatment began treatment and 28 achieved SVR12. Ten
people who started treatment were lost to follow-up and two stopped treatment
due to adverse events.
In the hospital-based care group, 29 of 66 participants were
eligible for treatment (13 were ineligible due to fibrosis or drug-drug
interaction and 24 did not complete fibrosis assessment). Sixteen of 18 who
began treatment achieved SVR12.
No treatment failures occurred in either study arm.
Intent-to-treat analysis showed that participants in primary
care were significantly more likely to start treatment (75% vs 34%, p < 0.001,
relative risk 2.48, 95% CI 1.54-3.95) and had a significantly higher cure rate
(49% vs 30%, relative risk 1.63, 95% CI 1.0-2.65, p = 0.043).
The study authors say their study participants reflect the
real-world population of people in need of treatment – not linked to specialist
hepatology clinics, current or recent injectors and highly likely to be
receiving opioid substitution therapy. Providing on-site assessment of live
fibrosis in primary care is key to engaging this population in treatment.
“To attain the World Health Organization hepatitis C elimination target of an 80%
decrease in incident hepatitis C, it is critical to increase treatment uptake
in people who inject drugs (PWID) […] Providing treatment in primary care is an essential component of
engaging PWID in hepatitis C treatment,” the study authors conclude.