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 health care 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 health care 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 WHO hepatitis C elimination target of an 80% decrease in incident hepatitis C, it is critical to increase treatment uptake in PWID […] Providing treatment in primary care is an essential component of engaging PWID in hepatitis C treatment,” the study authors conclude.
Wade AJ et al. Outcomes of treatment for hepatitis C in primary care compared to hospital-based care: a randomise trial in people who inject drugs. Clin Infect Dis, advance online publication 22 June 2019, https://doi.org/10.1093/cid/ciz546