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Results of a large randomised trial
support the use of treatment combinations consisting of a protease inhibitor
plus two nucleoside reverse transcriptase inhibitors (NRTIs) as second-line HIV
therapy in resource-limited settings.
The combination achieved good
outcomes for people who had experienced first-line treatment failure.
The roll-out of antiretroviral
therapy in resource-limited settings often relies on standardised combinations
of drugs. There is limited access to viral load monitoring and resistance
testing. This means that it is not possible to individualise therapy as is the
case in better-resourced countries.
Second-line therapy recommended by
the World Health Organization (WHO) for resource-limited settings consists of a
protease inhibitor plus two NRTIs. It is not certain if the benefits of
continuing to use a ‘recycled’ NRTI backbone will outweigh the risk of serious
side-effects or of virological failure. There is some evidence that an
NRTI-free regimen is simpler, cheaper and equally effective.
The EARNEST study was designed to
examine the safety and efficacy of three alternative second-line treatment
strategies:
>The recommended WHO regimen, a
protease inhibitor with an NRTI backbone.
>A protease inhibitor plus the
integrase inhibitor raltegravir (Isentress).
>Protease inhibitor monotherapy
after a twelve-week induction period phase with raltegravir.
Approximately 1300 people with
first-line treatment failure, in five African countries, were recruited to the
study. Routine viral load and resistance testing were unavailable. The study
participants had severe immune suppression – average CD4 cell count at baseline
was just 70 cells/mm3. Participants were followed for 144 weeks.
HIV disease was well controlled
among people in the protease inhibitor/NRTI and protease inhibitor/raltegravir
arms.
Approximately two thirds of
participants taking these combinations also achieved a CD4 cell count above
250, high enough to be protective against most AIDS-defining illnesses. Drug
resistance was rare among people taking these combinations.
Overall, outcomes were poorer for
people taking protease inhibitor monotherapy.
All three combinations were safe and
well tolerated.
The researchers therefore conclude
their study findings strongly support WHO guidelines for second-line therapy,
showing that prescribing previously used NRTIs doesn’t lead to adverse
outcomes.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus.
To learn more about The Friends of
AIDS Foundation, please visit: http://www.friendsofaids.org.
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