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Study looks at use of PrEP during pregnancy and breastfeeding
Liz Highleyman, 2016-09-01 07:10:00
Women in San Francisco and the New York
City frequently chose to use Truvada
for pre-exposure prophylaxis (PrEP) when it was offered as an additional tool
for preventing HIV infection during the pre-conception period, pregnancy and
breastfeeding, according to study findings presented at the 21st International AIDS Conference
(AIDS 2016) last month in
Durban, South Africa and published in the July 19 online edition of the American
Journal of Obstetrics and Gynecology.
Transmission of HIV to the negative partner is a
concern when serodiscordant heterosexual couples wish to conceive. Some couples
opt for assisted reproductive technology such as 'sperm washing' (separating
individual sperm from semen) and artificial insemination, but these are
expensive and not widely available.
Given the development of highly effective
antiretroviral therapy (ART) that maintains viral suppression -- and the
growing recognition that people on treatment with undetectable viral load do not
transmit HIV through sex
-- treatment-as-prevention may be enough to protect the
HIV-negative partner when trying to conceive naturally. But adding PrEP offers
an extra measure of protection, for example if the positive partner misses
medication doses or experiences viral 'blips' for other reasons. If the woman
is HIV-negative, protecting her from infection also protects the baby, as
recent infection is associated with high viral load that makes mother-to-child
HIV transmission more likely.
(tenofovir/emtricitabine) was approved for HIV prevention based on findings
from clinical trials, including the iPrEx
study of mostly gay and bisexual men and the Partners PrEP study of serodiscordant
heterosexual couples, showing that PrEP reduces the risk of HIV infection by
90% or more if used consistently.
To date there have been
no randomized controlled studies of Truvada
or tenofovir PrEP for pregnant women or those trying to conceive; these are
unlikely in the future for ethical and logistical reasons. In PrEP clinical
trials women generally stopped the drugs if they became pregnant, and there are
no published reports of PrEP use after seven
weeks gestation or during lactation.
disoproxil fumarate and emtricitabine have been used by thousands of
HIV-positive pregnant women over many years as part of antiretroviral
treatment. Observational studies and data from the Antiretroviral
Pregnancy Registry do
not show increased likelihood of birth defects or adverse pregnancy outcomes.
These drugs are regarded as generally safe and well tolerated for both mothers
and foetuses, though there is some evidence that infants
born to women who take tenofovir during pregnancy may be smaller
and have reduced bone density. The Microbicide
Trials Network's ongoing EMBRACE study (MTN-016)
hopes to shed further light on the safety of PrEP during pregnancy.
Dominika Seidman of the University of
California at San Francisco, Shannon Weber of HIVE (who presented the findings at AIDS 2016) and
colleagues aimed to characterise use of Truvada
for PrEP and to identify gaps in HIV prevention services for women at risk of
HIV before conception and during pregnancy and breastfeeding.
Pregnancy is an important opportunity to
assess women for HIV risk. Many women who do not otherwise receive regular
medical care do seek care when they become pregnant, and many may remain at on-going
risk for HIV infection after giving birth.
The researchers performed a
retrospective chart review of 27 women considered to be at 'substantial risk'
for HIV infection who received care at two centres -- the University of
California at San Francisco and Montefiore Medical Center in the Bronx, New
York City -- between 2010 and 2015. If eligible they were referred to specialty
clinics for women living with or at risk of HIV that started offering PrEP in
were identified by clinicians, health educators and health departments. The
median time from identification as being at 'substantial risk' to consultation
was 30 days, and two women were lost to follow-up before consultation.
two-thirds (18 women) were identified when they were already pregnant, at a
median of five months gestation; none had received counselling about safer
conception to reduce HIV risk. About a third (eight women) were identified
pre-conception and one was identified during the post-partum period.
median age was 27 years; 12 were Latina, five were black, four were white, two
were Asian and four were of other races/ethnicities. Just over half had unstable
housing, 22% had on-going intimate partner violence, 22% were active substance
users and 44% had a history of mental health issues.
but one of the women had HIV-positive partners and the remaining woman had a
male partner who had sex with men. Among the HIV-positive partners 19 (73%)
were on ART and 11 (42%) had documented viral suppression; of the remainder, ten
(39%) had known detectable virus and five (19%) had unknown viral loads.
majority of women were assessed for post-exposure prophylaxis (PEP), but nearly
a third were not asked about their recent HIV exposures. Of those assessed, seven
were deemed eligible and four of them were offered PEP, but only two started
the 24 women who were offered daily Truvada
PrEP, 16 (67%) chose to use it. Among the rest, two-thirds chose to use
condoms, over half relied on their partner's treatment-as-prevention and a
fifth relied on abstinence. The likelihood of accepting PrEP was similar before
conception and during pregnancy.
median length of time on PrEP was 30 weeks. Half the women reported some
challenges in maintaining good adherence, with a third each citing side
effects, social stressors and difficulty taking daily pills. The researchers
did not identify any PrEP-related pregnancy complications. There was only one
HIV seroconversion, in a woman not taking PrEP.
the women on PrEP chose to breastfeed, as did half of those not taking PrEP.
Among the women who were in care at the time of delivery, half did not attend a
post-partum follow-up visit, so their long-term outcomes are unknown.
their conference poster the researchers described three "missed
- A woman came to the emergency department after an assault when she was 27 weeks
pregnant. She said her partner was living with HIV and not on ART. However, she
was not offered PEP or PrEP and was lost to follow-up.
- A second woman was diagnosed with syphilis at 32
weeks into pregnancy. She had multiple partners (some of whom were HIV-positive),
was homeless, engaged in sex work and used methamphetamine. She was treated for
syphilis and had multiple prenatal care visits, but was never offered PEP or
PrEP and was also lost to follow-up.
- A third woman was identified as
being at high risk for HIV infection, with an HIV-positive partner, but was not
referred for PrEP due to pregnancy complications including foetal anomalies.
She remained in care and was HIV-negative at the time of delivery; her infant
died after birth. She was lost to follow-up for awhile but returned to care at
10 months post-partum and was diagnosed with HIV.
at two United States centres frequently chose to use pre-exposure prophylaxis
for HIV prevention when it was offered preconception and during pregnancy and
lactation," the study authors concluded.
"Further research and education are
needed to close critical gaps in screening for women who are at risk of HIV for
pre- and post-exposure prophylaxis eligibility and gaps in care linkage before
and during pregnancy and lactation," they added. "Post-partum women
are particularly vulnerable to loss-to-follow-up and miss opportunities for
safe and effective HIV prevention."