People who had a simplified monitoring schedule of hepatitis
C viral load tests at the beginning of treatment and 12 weeks after completing
treatment were just as likely to be cured as people who underwent more
intensive monitoring during treatment, a randomised Australian study has shown.
People who were randomised to simplified monitoring visited the clinic twice, for blood tests and to collect medication at the start of treatment, and again 12 weeks after completing treatment to check that they had been cured. They received follow-up calls from a nurse while taking treatment to check that they were having no problems taking medication.
The findings indicate that delivering treatment outside
traditional healthcare settings, with a minimum of monitoring, will probably
not affect the likelihood of curing hepatitis C.
The results of the study, SMART-C, were presented on
Saturday at The International Liver Congress by Professor Greg Dore of the
Kirby Institute, University of New South Wales, Australia.
The study was designed to test whether minimal monitoring
compromised the efficacy of treatment. Standard monitoring requires people to
undergo viral load tests at baseline, 4 weeks after starting treatment, at the
end of treatment (8 or 12 weeks depending on the treatment course) and 12 weeks
after completing treatment.
The number of clinic visits and blood tests involved in
standard treatment have drawbacks for both healthcare providers and patients. For patients,
clinic visits may be time-consuming, costly and difficult to fit into their
schedule, especially for people on low incomes or who live far away from a treatment
For healthcare providers, especially those treating many
patients, clinic visits for routine tests consume resources that might be
better applied to diagnosis, management of patients with symptoms or initiating
new patients on treatment. This problem is especially pronounced in healthcare
settings where the number of people needing treatment is high or where
healthcare resources are limited.
Also, it’s unclear if testing during treatment and at the
end of treatment provides any useful information. As HCV RNA tests cost up to
$50 each, it is essential to know if all tests are necessary.
The SMART-C study was designed to investigate these
questions. The study randomised 380 people with hepatitis C starting an 8-week
course of glecaprevir/pibrentasvir (Maviret)
to minimal monitoring (before treatment and 12 weeks after completing
treatment) or standard monitoring (before treatment, at weeks 4 and 8 during
treatment, and 12 weeks after completing treatment). Participants were
randomised to minimal monitoring in a 2:1 ratio.
People randomised to the minimal monitoring arm received a
phone call from a study nurse at weeks 4 and 8 during treatment to check if any
problems had arisen in taking medication, or if any potential side-effects had
The study excluded people with cirrhosis, people who had
injected drugs in the previous six months and people judged likely to require
extra adherence support during treatment.
The study population was 60% male, 48% had genotype 1
infection and 32% had genotype 3 infection. Ten per cent were taking opioid substitution
By intent-to-treat analysis (counting everyone randomised),
91% in the minimal monitoring arm and 94% in the standard monitoring arm
achieved a sustained virologic response (SVR12). The virologic failure rate was
the same in both arms (2%). The rate of loss to follow-up was also similar (5%
in the simplified arm and 4% in the standard arm).
Per protocol analysis (everyone who completed treatment)
showed no significant difference in outcome (97% in the minimal arm and 98% in
the standard arm).
There was no significant difference in adherence to
treatment; 98% of the standard monitoring group and 96% of the simplified
monitoring group took at least 90% of the prescribed medication.
study has indicated that a simplified monitoring strategy for ’easy-to-manage’ individuals
initiated on GLE/PIB is feasible and associated with similar virological
outcomes to those of individuals monitored more intensively,” said Principal
Investigator, Prof Greg Dore.
“Simplified monitoring of new-generation DAAs [direct-acting antivirals]
such as GLE/PIB could enhance the rapid scale-up of treatment, which will help
to achieve the WHO’s [World Health Organization's] goal of eliminating chronic HCV infection as a major
public health threat by 2030”.
“A less intensive monitoring schedule
for those patients who do not need it, will allow more time to be dedicated to
patients who do require treatment adherence support,” he said.