MSH Supports Growing International Acceptance of Option B+, Encourages Country Adoption, Further Research

Drs Scott Kellerman (left) and Erik Schouten at "Prevention of Vertical Transmission and Beyond: How to Identify, Enroll and Retain Children in Treatment Programmes in Resource-Limited Settings?" a satellite session at XIX International AIDS Conference on Sunday, July 22, 2012. (Photo credit: S. Holtz/MSH)

Drs Scott Kellerman (left) and Erik Schouten at “Prevention of Vertical Transmission and Beyond: How to Identify, Enroll and Retain Children in Treatment Programmes in Resource-Limited Settings,” a satellite session at XIX International AIDS Conference on Sunday, July 22, 2012. (Photo credit: S. Holtz/MSH)

Cross-posted on MSH.org

July 31, 2012 – As the international community gathered for the XIX International AIDS Conference last week, HIV & AIDS experts and key organizations voiced their support for a new approach to preventing mother-to-child transmission of HIV: Option B+.

Option B+ calls for antiretroviral therapy (ART) for life for all HIV-positive pregnant women, regardless of CD4 levels.

The government of Malawi, with the support of MSH, adapted the World Health Organization (WHO) guidelines on preventing mother-to-child transmission, to the needs of Malawi. Current WHO guidelines (2010) distinguish between treatment and prevention (known as “prophylaxis”) and rely on accurate CD4 counts to determine ARV regimens.

Unable to quickly and accurately ensure results from CD4 counts on HIV-positive women, and struggling to adjust treatment regimens given the high fertility rates and frequent pregnancies, Malawi elected to combine ART with PMTCT in a new approach they dubbed Option B which offers lifelong treatment to all HIV-positive pregnant women, regardless of their CD4 levels. The Malawi Ministry of Health devised this approach with support of MSH’s Basic Support for Institutionalizing Child Survival (BASICS) program, funded by USAID.

Dr. Erik Schouten of MSH and colleagues described the bold, new approach in a Lancet article in July, 2011. Option B+ puts women and children first, and, as Schouten and colleagues argue, will likely be cost-effective for countries, like Malawi, in the long-term.

In April, 2012, the World Health Organization (WHO) released a programmatic update on “Use of ARVs for Treating Pregnant Women and Preventing HIV Infection in Infants” (PDF). In the executive summary, the WHO said:

Now a new, third option (Option B+) proposes further evolution—not only providing the same triple ARV drugs to all HIV-infected pregnant women beginning in the antenatal clinic setting but also continuing this therapy for all of these women for life. Important advantages of Option B+ include: further simplification of regimen and service delivery and harmonization with ART programmes, protection against mother-to-child transmission in future pregnancies, a continuing prevention benefit against sexual transmission to serodiscordant partners, and avoiding stopping and starting of ARV drugs. While these benefits need to be evaluated in programme settings, and systems and support requirements need careful consideration, this is an appropriate time for countries to start assessing their situation and experience to make optimal programmatic choices.

Since July, 2011, MSH has helped trained a cadre of 3,366 health workers in Malawi. Within the first year of implementation in Malawi, the number of HIV-positive pregnant women starting ARV treatment has increased six-fold from 1,200 per quarter prior to implementation, to 7,200 in the quarter ending in June 2012. MSH is currently working on a cost-benefit analysis, and is studying the efficacy and challenges of option B+ scale up for preventing vertical transmission in Malawi.

Now others are following Malawi’s lead, particularly in light of Ambassador Eric Goosby’s and UNAIDS’ Michel Sidibe’s call for eliminating pediatric HIV by 2015 (PDF). Earlier this year, Uganda announced its intention to adopt Option B+; UNICEF began a thorough review of the approach; and other countries have expressed a strong interest in moving toward including Option B+ in their strategies for decreasing vertical HIV transmission.

Throughout the XIX International AIDS Conference, researchers and global health leaders touted the benefits of Option B+, and discussed the potential for combining ART and PMTCT in other countries. At a satellite session on Sunday, July 22, leaders from UNICEF, the International AIDS Society (IAS) and MSH discussed Option B+ for preventing vertical transmission. Dr Chewe Luo, Senior Programme Advisor at UNICEF, discussed the topic in depth during her plenary speech on July 25. And in the closing words of the conference, two rapporteurs gave a hat-tip to Option B+, displaying early data from Malawi, provided by Dr Erik Schouten of MSH.

“Option B+ is a game-changer and one of the most exciting developments in decreasing vertical transmission and pediatric HIV in recent years. In short, it calls for treating the mother, preventing vertical transmission to the child, and continuing to treat the mother. It offers the promise of much reduced vertical transmission rates while simultaneously decreasing maternal morbidity and mortality from HIV,” says Dr. Scott Kellerman, MSH’s global technical lead on HIV & AIDS.

MSH is thrilled that the global momentum toward Option B+ is building. Option B+ may not be right for every country or every situation, but in Malawi – and likely in many more countries – Option B+ will prove efficacious and cost-effective in not only protecting babies, but also in treating HIV-positive women. MSH is proud to have been a part of the inception of this idea and looks forward to working with our broad network of HIV & AIDS programs throughout sub-Saharan Africa and the world, using our technical capacity and research ability to investigate the operational issues that need to be addressed and understood for optimal implementation and scale-up of this approach.

Learn more about Option B+:
For additional information or to arrange for a press interview, please contact Barbara Ayotte, Director of Strategic Communications, at 617.852.6011 or bayotte@msh.org.

 

Scientists & Rock Stars: The Dream Team at AIDS 2012

XIX International AIDS Conference (AIDS 2012) Washington D.C. Plenary Session Secretary of State Hillary Rodham Clinton, Phil Wilson, President and CEO of the Black AIDS Institute, Sheila Tlou, Director, UNAIDS Regional Support Team for Eastern and Southern Africa, Anthony S. Fauci, M.D.. NIAID Director and Michel Sidibe, Executive Director of UNAIDS © IAS/Steve Shapiro - Commercialimage.net

XIX International AIDS Conference (AIDS 2012) Washington D.C. Plenary Session Secretary of State Hillary Rodham Clinton, Phil Wilson, President and CEO of the Black AIDS Institute, Sheila Tlou, Director, UNAIDS Regional Support Team for Eastern and Southern Africa, Anthony S. Fauci, M.D.. NIAID Director and Michel Sidibe, Executive Director of UNAIDS © IAS/Steve Shapiro – Commercialimage.net

Science was at the forefront of the opening event of the XIX International AIDS Conference on day two, but the “dream team” and a rock star also made an appearance, in a rousing plenary session attended by more than a thousand members of the global public health community in Washington, DC.

In an opening presentation entitled, “Ending the HIV/AIDS Pandemic: From Scientific Advance to Public Health Implementation,” Dr Anthony Fauci of the National Institute of Allergy and Infectious Diseases (NIAID) captured more than 30 years of the epidemic’s history in less than 20 minutes, from what he called the “dark years” of the 1980’s to the present day “new dawn of therapeutics.” Recapping the increasing evidence behind biomedical approaches from prevention of mother-to-child transmission, voluntary male medical circumcision, and treatment as prevention, Dr Fauci underscored the fact that those working in the field of HIV today must “marry the biological with the behavioral.” He closed his remarks by saying how proud he was, after attending 18 previous AIDS conferences, to be able to say, “We do have the scientific basis to implement!”

Fauci was followed by Phil Wilson, founder and executive director of the Los Angeles-based Black AIDS Institute, who also applauded the tools and knowledge available today, after 31 years of living with this epidemic. Wilson’s mood grew more sober, however, as he highlighted the dismal reality for black American men who have sex with men: at age 25, their odds are one in four that they will contract the virus; by age 40, 59.3% are infected. Wilson enumerated five steps to end the epidemic, starting with fully implementing the Affordable Care Act and ending with a plea to AIDS organizations to “re-tool” themselves – noting that community based organizations are central to the fight against the epidemic but are not in a position to deliver health services or implement the important, effective biomedical interventions that exist today.

UNAIDS Executive Director Michel Sidibé took the stage briefly, reminding the audience that he had called upon them on the conference’s opening day to “dream big dreams” and think of the opportunity that exists today to end this epidemic. He referred to his own dream team – mentioning President Obama, US Secretary of Health and Human Services Kathleen Sebelius, and US Global AIDS Coordinator Eric Goosby — and then called to the podium the woman that the New York Times referred to a few weeks ago as the “rock star diplomat,” US Secretary of State Hillary Clinton.

As chanting activists tried to drown out her voice, Secretary Clinton opened her remarks with the words, “What would an AIDS conference be without a little protesting?” and moved on, talking about how AIDS is no longer the death sentence that it once was, and highlighting the possibility that we are moving toward an AIDS-free generation.

Clinton spoke enthusiastically about the role that the US government has played in the global fight against HIV, lauding the creation of the Presidents Emergency Plan for AIDS Relief (PEPFAR), as well as the work of the US Centers for Disease Control  and Prevention (CDC) and the US Agency for International Development (USAID).

Acknowledging that all the work “only matters if in the end we are saving more lives,” Clinton reiterated the US government’s commitment to the effort to fight AIDS, announcing an $80 million investment to help pregnant women in developing countries receive treatment and prevention services; $15 million in scientific research aimed at specific interventions for key at-risk populations; a $20 million challenge fund to support country-led efforts to target key populations; and a $2 million investment to reinforce civil society organizations’ efforts for those most at-risk.

More than 20,000 health workers, people living with HIV/AIDS, development specialists, and community activists are attending the AIDS conference, which concludes this Friday. For more on MSH’s presence at the event, visit MSH at AIDS 2012.

Elizabeth Walsh is director of communications in MSH’s Center for Leadership & Management.