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.

 

No Silver Bullet: HIV & AIDS Challenges and Solutions

Dr Nelly Mugo, AIDS 2012

XIX International AIDS Conference (AIDS 2012) Washington, DC. Dr. Nelly Mugo, Kenya © IAS/Steve Shapiro -Commercialimage.net

Tuesday’s (July 24) session at the XIX International AIDS Conference kicked off with a plenary session on HIV & AIDS “Challenges and Solutions”.

The first three presenters, Javier Martinez-Picado (Spain) from the AIDS Research Institute IrsiCaixa and ICREA; Dr. Nelly Mugo (Kenya) of the University of Nairobi and Kenyatta National Hospital; and Dr. Bernhard Schwartländer, (Switzerland) the Director for Evidence, Innovation and Policy at UNAIDS, each spoke about the possibilities for ending AIDS. Dr. Howard Koh, Assistant Secretary for Health for the US Department of Health and Human Services described US efforts to end AIDS.

A cure or eradication is necessary

Dr. Martinez-Picado launched the session with a list of reminders why a cure or eradication is necessary: (1) The HIV virus is suppressed with antiretroviral therapy (ART), and (2) the vast majority of patients who adhere to treatment will live long, healthy lives. However, (3) mortality and morbidity from chronic diseases such as heart disease and cancer is still higher in populations of HIV-positive patients in treatment than in the general population. In addition, (4) stigma and discrimination against people living with HIV continues to plague nearly every community. And (5) the cost of treatment is projected at $22 billion per year for universal access. For all of these reasons, a cure or eradication is preferable to lifelong treatment.

This cure or eradication will require, “a prolonged period of research,” said Martinez-Picado. But he urged the audience not to let that deter our efforts. He presented a series of scientific studies that are showing varying signs of promise for progress toward a cure. Though none of them is a silver bullet, it is clear that progress is being made in HIV science.

Science, Not the Only Answer

Science isn’t the only answer — though an important one — Dr. Nelly Mugo reminded us in her presentation. According to Dr. Mugo, 44 percent of new HIV infections in Kenya are among married or cohabitating couples, and 50 percent of HIV-positive couples are serodiscordant. Often a couple’s desire for children will overshadow their fear of transmitting the virus to their partner, thus preexposure prophylaxis and treatment as prevention are important strategies for keeping partners of people living with HIV free of the disease.

However, adherence to treatment and linking patients with care after testing are still major problems — not only in Kenya, but worldwide. The solution to these problems is not more advances in science, but rather community-based efforts to make sure both HIV-positive clients and their partners understand the necessity of accessing treatment and adhering to it for life. After all, treatment as prevention cannot work if treatment is not accessed.

Another $7 Billion

Neither science, nor social programming is free. And without increased funding, the number of new HIV infections per year will stagnate, said Dr. Bernhard Schwartländer. Though he believes we must “learn how to do more with what we have,” Dr. Schwartländer also urged countries to take ownership of their health and increase domestic funding for health, including HIV services. Though he believes another $7 billion is needed by 2015 in order to halve the rate of new HIV infections, he says that if low- and middle-income countries continue to fund health services at the same rate they are currently funding them, the gap will be closed as these nations emerge from low-income to middle- and high-income status over the next decade.

“None of this will be achieved without a strong activist voice,” Dr. Schwartländer reminded the crowd, and urged us to challenge our governments to rise to the challenge. “The world overall is getting richer,” he said, “We have to make it fairer.”

Dr. Howard Koh presented achievements made during the first two years of implementation of the United States’ HIV and AIDS strategy. He praised the FDA’s recent approval of Truvada for pre-exposure prophylaxis and the provisions the Affordable Care Act will make for HIV care — including ending insurance companies’ ability to cap lifetime care limits and preexisting condition exclusions. The US plans to decrease the number of new infections within our borders by 25 percent by 2015 through cutting-edge research on vaccines and microbicides and increasing the number of people who know their status through innovative programs, such as free HIV testing at the department of motor vehicles.

It is clear from this session that we will not end AIDS tomorrow. But with the vision of our leaders, the voices of our activists, and the hard work of those on the front lines living and working with people living with HIV a future free of HIV is within our reach.

Mary Burket is communications manager in MSH’s Center for Health Services.