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Starting HIV treatment at first clinic visit improves outcomes in African study
Liz Highleyman, 2016-02-24 11:10:00
A programme to accelerate the process of HIV
diagnosis, preparation and starting antiretroviral therapy (ART) in South
Africa led to a higher proportion of people initiating treatment and better
health outcomes, according to results from the RapIT trial presented at the Conference on Retroviruses and Opportunistic Infections
(CROI 2016) taking place this week in Boston, USA.
Recent findings from the START and Temprano trials have shown that starting HIV treatment early,
while the CD4 cell remains above 500 cells/mm3, reduces the
occurrence of AIDS-related events, serious non-AIDS-related illness and death. Recognising
this, the World Health Organization now
recommends that everyone diagnosed with HIV should start treatment.
Yet despite these new guidelines, most people with HIV
in South Africa start treatment too late. One reason for not promptly initiating
ART is that the process is long and cumbersome, explained Sydney Rosen of
Boston University School of Public Health.
In a typical scenario, a person would take an HIV
test, give a blood sample for CD4 cell measurement and complete a tuberculosis
(TB) screen during their first visit. On their second visit, they would obtain
CD4 and TB results and start TB treatment if needed. The third, fourth and
fifth visits would be devoted to counselling and education about the importance
of adherence. Finally, on the sixth visit, the person would undergo a physical
examination and receive antiretrovirals.
requires time, money and motivation on the patient’s part and many do not make
it through the process,” Rosen said. This complex process is a legacy of
expensive, scarce and toxic drugs used in the past and the belief that people
need time, counselling and education to become ready for lifelong therapy, she
suggested, stating “we made them come back essentially to demonstrate their
worthiness for treatment.”
As a result, in 2012-2013 more than half of people
with HIV in South Africa started therapy after their CD4 count had fallen below
200 cells/mm3, and 25 to 40% of those determined to be eligible for
treatment did not start within six months.
randomised, controlled trial was designed to assess the outcomes of same-day
treatment initiation. The RapIT protocol condenses all the steps of the
testing, counselling and medication dispensing process, making it faster and
easier for people to start ART. The aim was to have all steps completed during
a single clinic visit, ideally on the same day a person tests HIV positive.
At last year's
International AIDS Society conference, researchers reported findings from San Francisco's RAPID programme, which found that offering ART on the same day as HIV
diagnosis led to a high rate of treatment uptake and more rapid viral load
suppression. The RapIT trial aimed to show whether a similar accelerated
process would work in a comparatively resource-limited setting.
2013 and September 2014, RapIT enrolled 463 people at two sites in
Johannesburg, one a primary health clinic and the other a hospital-based HIV
clinic. More than half were women – though pregnant women were excluded – and
the median age was approximately 35 years. About 40% had tested positive for
HIV the same day while the rest had been recently diagnosed and were providing
a blood sample for CD4 testing or receiving their first CD4 results.
who were deemed eligible for ART were randomly assigned to follow either the
rapid procedure (n = 187) or the standard multi-visit procedure (n = 190). Most
were started on a standard first-line ART regimen unless this was
contraindicated. Drug resistance testing was not done before dispensing
therapy, following the standard of care in South Africa.
In the rapid
arm, 97% of participants initiated ART within 90 days of enrolment, compared
with 72% in the standard procedure arm. Only five people in the rapid arm did
not start treatment, and four of these were lost during the TB workup. More
than 70% in the rapid arm started ART the same day, and the median time between
study enrolment and dispensing of antiretrovirals was 2.4 hours.
participants who started ART within 90 days, 64% in the rapid arm and 51% in
the standard arm remained on treatment and reached an undetectable viral load by
10 months. The rapid procedure increased ART initiation by 36% and viral
suppression by 26%.
remaining participants, 34% in the rapid arm and 21% in the standard arm started
ART but did not achieve viral suppression. Seventeen per cent and 8%,
respectively, initiated but did not stay on treatment – higher in the rapid arm
because more people in the standard arm never started in the first place. Thus,
most loss to care happened before
starting treatment in the standard arm but after ART initiation in the rapid
factors that influenced outcomes, about equal numbers of participants in the
rapid and standard arms stayed on treatment and achieved viral suppression in
the hospital clinic (63 vs 61%), but at the primary health clinic the rapid arm
did considerably better (64 vs 43%), suggesting the latter had more room for
improvement, Rosen suggested.
outcomes in the rapid versus standard arm were evident for women under age 35
(60 vs 47%) and especially for men under 35 (71 vs 38%), though the difference
was not significant for older women or men.
procedure was both acceptable to patients and feasible to implement, Rosen
said, and a cost-effectiveness is underway.
demonstrated that it is possible to initiate nearly all eligible patients on
ART (and 3/4 on the same day) and
improve overall health outcomes,” the researchers concluded. “[The] largest
effect [was] seen in younger people and primary health clinics.”
While loss to
follow-up after ART initiation was higher in the rapid arm, this was “not
enough to offset the benefits,” they said, adding that adherence support after
starting ART remains a priority.