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:
Treatment eligibility determined by HIV-antibody test alone.
A single national regimen for all women (tenofovir/3TC + efavirenz).
A single 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 transmission.
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 outcome indicators.
The findings are from two main cohorts:
ANC cohort analysis that addresses completed pregnancies by month of registration at the ANC.
ART cohort analysis defined by the quarter in which the patient starts ART.
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 Option B+.
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 pregnancy.
Continue to monitor and support PMTCT coverage and retention on ART, including reasons for lack of uptake and loss to follow-up.
Examine family and community influences on the sustained high ART initiation during the breastfeeding period.
Document maternal and infant outcomes.
Document 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 pregnancy.
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 partner.
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.
Tippett Barr B et al. Uptake and retention in Malawi’s Option B+ PMTCT program: lifelong ART for all HIV+ pregnant or lactating women. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, abstract 82, 2013.