Women should be offered the choice to avoid treatment with
tenofovir and emtricitabine during pregnancy owing to a higher risk of
stillbirth and early infant death associated with these drugs, according
to recommendations in the British Medical
However, this runs contrary to guidelines from several
organisations, including the British HIV Association (BHIVA) and the World
Health Organization. BHIVA has issued a statement,
explaining why it disagrees with the BMJ’s
Current BHIVA guidelines recommend HIV treatment for everyone
living with HIV, including pregnant women. Women who are already taking HIV
treatment when they become pregnant should continue with the drugs they are
already taking. Pregnant women starting HIV treatment can usually follow the
same BHIVA guidelines as for other people – these guidelines recommend
tenofovir and emtricitabine as a first choice, to be taken along with a third
drug. Tenofovir and emtricitabine are included in the combination pills Truvada, Atripla, Eviplera and Stribild.
All of the different sets of recommendations have been put
together by expert clinicians, who have looked at thorough reviews of the available
scientific evidence, taking into account all the relevant studies that were
available at the time. But different experts can sometimes have different
interpretations of the same evidence.
They can also have different priorities. One important feature
BMJ’s review was that they took
particular note of women’s values and preferences regarding HIV treatment during
pregnancy. This suggested that it was very important to women to avoid
stillbirth and early infant death. Avoiding HIV transmission was very important
to women, but so was their babies being healthy in other ways. Their
recommendations took into account all of these concerns.
While the BMJ
reviewers looked at several studies, one was particularly influential. This was
called PROMISE and was conducted in six African countries and in India. It
included a comparison of pregnant women with HIV taking either:
- Tenofovir/emtricitabine and lopinavir/ritonavir,
Zidovudine/lamivudine and lopinavir/ritonavir.
Both drug regimens were equally effective in preventing HIV
from being passed on to the infant. Problems including premature birth,
stillbirth and infant death within a week of birth were not common, but did
occur at a higher rate in women taking the tenofovir/emtricitabine regimen.
This is the reason why the authors in the BMJ recommend that women should be
offered the choice to avoid tenofovir and emtricitabine. They suggest
zidovudine and lamivudine as an alternative. These are older drugs, also known
as AZT and 3TC, which are often provided together in a single pill.
doctors at BHIVA take a different view. They
say that the PROMISE findings are less relevant to the UK because all these
participants took lopinavir/ritonavir, drugs which are no longer recommended in
BHIVA guidelines. An interaction between lopinavir/ritonavir and tenofovir
might make problems more likely.
Further, BHIVA notes that the PROMISE findings relate to
pregnant women taking HIV treatment for the first time. In contrast, most women
living with HIV in the UK are already taking treatment when they get pregnant.
BHIVA also points to several reviews and observational
studies showing that tenofovir and emtricitabine are safe in pregnancy. This
very large study from Botswana, which found that tenofovir/emtricitabine
was safer than zidovudine/lamivudine, and that the highest risk of adverse
outcomes was in women taking lopinavir/ritonavir.
All this information is complex and can be confusing. One
thing that both sets of experts – those at the BMJ and those at BHIVA – agree on is that doctors must take the
time to talk with their patients and to fully involve them in treatment
decisions. Women should be informed of all the potential benefits and harms of
treatment options, they say.
information in NAM’s booklet ‘HIV &
women’. NAM's online tool ‘HIV & pregnancy’ can give you personalised information about