Recently, the Malawi Ministry of Health Department of HIV and AIDS implemented an innovative policy for women living with HIV in Malawi: all HIV infected pregnant or breastfeeding women are started on lifelong antiretroviral treatment (ART), regardless of their clinical stage or CD4 count. This program, Malawi’s “Option B+” for prevention of mother-to-child transmission of HIV (PMTCT) marks the first true implementation of a “test and treat” program, and is set to become a game changer for global policy for HIV prevention and treatment. The program caught the attention of health leaders worldwide and has opened up important discussion on the most viable treatment and prevention options for women living with HIV and their children in resource-limited settings. Now, more formal recognition of the program from the World Health Organization is opening up furthering discussion on the merits of Option B+. I-TECH’s Dr. Andreas Jahn and Dr. Zengani Chirwa work with the Department of HIV and AIDS. Together with Dr. Frank Chimbwandira, the head of the Department, they are part of the dedicated team that articulated the benefits of the program, guided its adoption, and are closely monitoring its effects.
Standard Preventive Care for Mothers and Children
In Malawi, without intervention, about 15% of babies born to women living with HIV are infected at birth, and an additional 15% acquire the virus from their mothers through breast-feeding. Until now, prevention of mother-to-child transmission of HIV (PMTCT) programs in many resource-limited settings have focused on providing pregnant women with preventive (prophylactic) antiretroviral (ARV) treatment regimens. A woman will be given ARVs during labor, throughout pregnancy and breast-feeding, or both. Often, this is combined with efforts to reduce the length of time she breast-feeds her child.
When she has finished breast-feeding, her doctor will decide whether to remove her from treatment or start her on lifelong ARVs for the sake of her own health. This decision is based on the results of a blood test during her pregnancy to test her CD4 cell count. These policies were developed by the World Health Organization (WHO), a trusted standard for care.
A New Approach: Option B+
In July 2011, however, a striking Viewpoint essay appeared in The Lancet. In the piece, a group of prominent physicians and scholars, including I-TECH’s Dr. Andreas Jahn and Dr. Zengani Chirwa, and Dr. Frank Chimbwandira, the Head of the HIV and AIDS Department within the Malawi Ministry of Health, put forth a strong argument for a different policy, one that was firmly rooted in the realities of scaling up public health programs in resource-limited settings. They announced that this new policy, which fell outside of current WHO guidelines, would be implemented by the Ministry in cooperation with global funders and local partners.
The team suggested that initiating lifetime treatment for pregnant women living with HIV regardless of their CD4 count or clinical stage—continuing to provide them with ART even after birth and breast-feeding—would go much farther to support the health of Malawian women and children. The latest WHO guidelines outlined two different PMTCT prophylactic regimens, “Option A,” using a single ARV drug, and “Option B,” using a combination of three ARVs equivalent to the regimens used for ART. The team therefore called their alternative approach “Option B+.”
Dr. Jahn elaborates: “Based on a decade of experience and high quality monitoring data from the HIV programs in Malawi, [the team] concluded that complicated protocols and reliance on CD4 counts had effectively created an insurmountable obstacle for the majority of women trying to access PMTCT interventions, resulting in low uptake and high losses along the cascade of follow-up.” The team noted that the underlying challenges with staffing, logistics, and quality of CD4 counts were likely a similar concern in many limited-resource settings. They also suggested that in countries like Malawi, where the time between pregnancies is relatively short for many women, taking them on and off treatment for each of their pregnancies had the potential to create a variety of health risks.
Lifetime treatment, they argued, is not very risky for the health of women, is practical, and is likely to confer wide-reaching health benefits, including reduced HIV transmission to sexual partners (because ART dramatically lessens the amount of virus in body fluids), and improving mothers’ health at the start of new pregnancies.
The approach boldly expanded beyond existing global guidelines. And it caught the attention of policy leaders and physicians around the world, many of whom were trying to scale up PMTCT programs but often grappling with weak program data and similar issues around CD4 count testing.
In July 2011, the Malawi Ministry of Health started implementing Option B+ in Malawi, formally defined as “universal life-long ART for all HIV infected pregnant and breastfeeding women regardless of clinical or immunological stage” as part of a new set of national HIV treatment guidelines. Notably, Option B+ had also led to the effective integration of the ART and PMTCT programs in Malawi, with significant gains in efficiency for program coordination, trainings, logistics, and supply chain management.
The researchers proceeded based on sound scientific practice and with the approval of many participating stakeholders, but the program was still courageous. Not only did Option B+ challenge accepted guidelines, but it was a costly, large-scale program designed for, but also challenged by, implementation in a resource-limited setting. The team had already determined that the risk of not putting a woman on ART made it ethically untenable to run a pilot or trial of the study. Still, all HIV testing and treatment programs (like all medical programs) have profound ethical implications.
The team felt that the program was better aligned, intuitively and scientifically, to the Malawian public health context and the lived experience of Malawian women. They implemented rigorous monitoring and evaluation to monitor progress. Within the first year, data has begun to show that, despite some setbacks, implementation of Option B+, together with the new guidelines, has had an unprecedented effect on ART access in Malawi (figure 1).
What Now? Global Discussion
Policy leaders worldwide, many of whom are also considering Option B+ for use in their countries, have been watching the Malawi experience with keen interest. This April, Option B+ received an official nod from the World Health Organization as part of a wider programmatic update on PMTCT treatment options. In the document, Programmatic Update: Use of Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants,  the WHO suggested that the method demonstrates some clear benefits, and that although these benefits “need to be evaluated in programme settings, and systems and support requirements need careful consideration” countries may “start assessing their situation and experience to make optimal programmatic choices” including Option B+.
This is welcome news to Dr. Jahn and the team at the Malawi Ministry of Health, and represents a green light for international partners who had anxiously awaited WHO approval in order to continue their support for Malawi’s bold initiative.
According to Dr. Jahn, “Malawi’s move to Option B+ is a remarkable example of public health action guided by sound program data and rational evaluation of the experience of women and health care workers in the local context, acknowledging the fact that program impact critically depends on the last mile of implementation in the real world.”
Read more about I-TECH’s work in Malawi.
 The expertise and contributions of Malawi HIV Fellows Jonas Nyasuli, IT Fellow; Gerald Zomba and Joseph Njala, Care and Treatment Fellows; and Lyson Tenthani, M&E Fellow, are also integral to this effort.
 Schouten E, Jahn A, Midiani D, Makombe SD, Mnthambala A, Chirwa Z, Harries AD, van Oosterhout JJ, Meguid T, Ben-Smith A, Zachariah R, Lynen L, Zolfo M, Van Damme W, Gilks CF, Atun R, Shawa M, Chimbwandira F. Prevention of mother-to-child transmission of HIV and the health-related Millennium Development Goals: time for a public health approach. Lancet. 2011; 378: 282–84.
 Government of Malawi, Malawi Ministry of Health. Quarterly HIV Programme Report. Quarter 4. Lilongwe (Malawi): Malawi Ministry of Health; 2011.
 World Health Organization. Programmatic Update: Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants. Geneva: World Health Organization; April 2012.