Eighteen months after implementation of 'Option B+' in Malawi – ART for life for all HIV-infected,
pregnant or breastfeeding women regardless of CD4 count or disease stage – the
number of HIV-infected pregnant women on ART increased dramatically (763%),
with retention rates at twelve months (78%) comparable to that in other adults (81%), researchers
reported at the 20th Conference on Retroviruses and Opportunistic
Infections (CROI 2013) last week in Atlanta.
The rapid increase in the
number of sites integrating ART into antenatal care (ANC) settings from 350 to
over 650 has resulted in close to a 50% increase in coverage of HIV-infected
pregnant women receiving ARVs of any kind.
Perhaps the most striking
finding during the first 18 months of Option B+ implementation is the high proportion of women
who only began ART during the breastfeeding period. In the last six months
(June to December 2012) one-in-four women (25%) started Option B+ during the
breastfeeding period. This was an unexpected finding, a client-initiated
phenomenon that happened once information about the programme became public. Although
the 25% rate is an improvement from the 41% starting ART during the breastfeeding period in the first nine months
of implementation, it is still high and of concern.
The researchers plan to look at how the family and community influence this outcome. There is a critical need for women identified as HIV
positive, for their own health and their infant’s, to get the support and
counselling needed to start ART early and not to wait until after delivery.
The 2010 World Health
Organization (WHO) guidelines for prevention of mother-to-child transmission (PMTCT)
required a CD4 count to determine when to start ART.
However, the Malawi Ministry
of Health decided a lack of resources – limited access to CD4 count testing and
a severe shortage of healthcare workers (one doctor and 26 nurses for every
100,000 people) and other structural barriers – would make this unfeasible in
Malawi. Rapid scale-up of services across the PMTCT cascade would
be hindered, making virtual elimination of MTCT difficult to achieve. (See this 2010
news story on planning for Option B+ and this 2012 update on the situation in Malawi.)
With assistance from the
President’s Emergency Plan for AIDS Relief (PEPFAR), the government chose to
streamline the process by expanding an ART public health approach – implementing 'test
and treat' for all HIV-infected pregnant and breastfeeding women to receive lifelong ART.
Option B+ is a simplified
public health approach to preventing vertical HIV transmission while protecting
the health of women. It emphasises:
eligibility determined by HIV-antibody test alone.
national regimen for all women (tenofovir/3TC + efavirenz).
message for all people taking antiretroviral treatment: ART is for life.
Option B+ protects future
pregnancies as well as keeping mothers healthy and reducing the risk of sexual
Beginning in July 2011, implementation
of Option B+ required complete decentralisation with integration of ART into
all ANC settings. Following revision of Malawi's national guidelines, over 4000
health care workers were trained over a period of three months.
While Uganda, Rwanda and
Haiti have adopted similar approaches and Zambia, Tanzania and Kenya are in the
planning stages, implementation of Option B+ has not been without controversy nor
embraced by all countries in sub-Saharan Africa, notably South Africa (see this 2013 letter to The Lancet).
A robust monitoring and
evaluation framework is the backbone of the programme. Routine ANC and ART
programme data are collected during quarterly supervision visits and are
validated by comprehensive review of primary patient records.
An independent data quality
audit commissioned by the Global Fund in 2011 showed 99.2% data accuracy of ART
The findings are from two
Between July and December 2012,
the total number of women receiving ART during pregnancy increased to 20,687 (from
13,910) in the six-month period (January to June 2011) before implementation of
In addition to achieving the seven-fold
increase in women starting ART, the use of single-dose nevirapine and combination
prophylaxis has now been eliminated.
In March 2012, 100% of pregnant
women were prescribed ART, compared to just 17% (2398) in the six months before
implementation of Option B+.
While retention in care among HIV-infected
pregnant or breastfeeding women was comparable to other adults, the death rate among
those lost to follow-up was considerably less: 4% (112) compared to 31% (4573)
in other adults.
The researchers concluded
that Option B+ has rapidly increased access to efficacious ART for HIV-infected
pregnant women in Malawi with promising initial uptake and retention results. The
following recommendations were made:
Address the continuing need to reduce the number of women who do not start ART during
to monitor and support PMTCT coverage and retention on ART, including reasons
for lack of uptake and loss to follow-up.
family and community influences on the sustained high ART initiation during the
maternal and infant outcomes.
the public health impact of Option B+.
Responding to questions from
the audience Beth Tippett Barr, who
presented the data on behalf of the Malawi Ministry of Health, said that the
delayed presentation for ART by breastfeeding women was probably explained by
the time which women took to process an HIV-positive diagnosis during
While not an official policy,
a system is now in place for women not starting ART on the same day to come
back in seven days for a second counselling session, accompanied by a treatment
Surveillance of birth defects
will be implemented. A birth defects registry will be established; in two to
three years time women on efavirenz (see last week’s report from a French
study) may become pregnant again.
There is approximately 50%
coverage for early infant diagnosis, with plans to continue scale-up, but staff
shortages are slowing plans for more extensive infant HIV testing.