Pediatric HIV

A general view of the panel during the Symposium held at the University of KwaZulu Natal School of Medicine in Durban, South Africa. Credit: UNAIDS/A.Debiky

When doctors from the University of Mississippi medical centre announced on 2 March 2013 that a baby had been ‘functionally cured’ of HIV, the world hailed the news as a historical medical breakthrough.

The baby—famously known as the ‘Mississippi baby’—was born with HIV and treated with aggressive antiretroviral drugs 30 hours after birth. Now, more than two years old, doctors confirm that the baby has not taken any medication since the age of 18 months and tests show no sign of re-active HIV (detectable viral load).

From the time that this extraordinary news was announced scientists and researchers have been busy trying to understand how the ‘Mississippi baby’ case could advance future research in preventing mother-to-child transmission of HIV.

More than 20 scientists, researchers, public health practitioners, donors, government authorities, representatives of non-government organisations and civil society came together for a two-day symposium on 3-4 June under the theme Scientific advances from ‘Mississippi baby’: Implications for public health programmes on mother-to-child transmission of HIV.

“This meeting is about giving people hope,” said UNAIDS Executive Director, Michel Sidibé. “The Mississippi miracle has to become a Durban miracle, a Bamako miracle, a miracle for all children irrespective of where they are born.”

Organised by UNAIDS and the Centre for the AIDS Programme of Research in South Africa (CAPRISA), the symposium focused on 1) whether programmes to stop new HIV infections among children need to be reformulated to promote early identification and treatment of babies at risk of HIV infection and 2) challenges associated with stopping new HIV infections among children and paediatric antiretroviral treatment.

Despite the 24% drop in new HIV infections in children since 2009, some 330 000 children around the globe were born with HIV in 2011. Most children born with HIV (more than 90%) are in sub-Saharan Africa.

Many African countries have made remarkable progress in preventing mother-to-child transmission of HIV by increasing access and integrating HIV prevention, treatment and cares services to mothers and their new-borns. AIDS-related deaths among children in the 22* priority countries of the Global Plan towards the Elimination of New HIV Infections among Children by 2015 and Keeping their Mothers Alive also reduced from 243 000 in 2009 to 203 000 in 2011

However, progress in expanding access of antiretroviral therapy to children has been minimal. The percentage of children living with HIV  eligible for treatment and who were receiving it in 2011 largely falls below 50% in at least 15 of the 22 priority countries—8% in Chad, 19% in Ethiopia and 29% in Malawi.

“Paediatric treatment and care lags behind; there seems to be a disconnect between investments in programmes to stop new HIV infections in children and for children in need of treatment. Even when the infants are identified they are not successfully linked to care,” said Dr Chewe Luo, UNICEF Senior Advisor on AIDS. 

The ‘Mississippi baby’ case was discussed at great length highlighting the need for early infant diagnosis and initiation of treatment. “The relevance of the ‘Mississippi baby’ to the general population remains unclear and more research, including for safe and appropriate neonatal drugs needs to be done before we push for widespread change in policy,” said Dr Hanna Gay, Associate Professor at University of Mississippi, who treated the ‘Mississippi baby’. “But one thing we can be certain of is that early diagnosis and treatment saves lives.”

At the end of the two-day discussions, participants made several recommendations, including the need for early infant diagnosis, better research and improved medicines for children as well as more efficient funding mechanisms to strengthen mother and child AIDS programmes.

“What we do know is that early diagnosis of HIV and early treatment of infants and children does lead to better outcomes – regardless of the issue of a cure. We should be concerned that we are not diagnosing and treating children early enough. In South Africa only 65% of children who are in need to treatment are on treatment,” said Dr Aaron Motsoaledi, Minister of Health of South Africa.

And looks forward to further studies to see if findings can be replicated.

GENEVA, 4 March 2013—The Joint United Nations Programme on HIV/AIDS (UNAIDS) and UNICEF welcome a new case study, which found a baby treated with antiretroviral drugs in the first 30 hours of life and who continued on HIV treatment for 18 months appeared to be functionally cured.

The findings were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, Georgia in the United States of America.

According to researchers the mother who was living with HIV at the time of birth had not received antiretroviral (ARV) medication or prenatal care. Researchers say that the child was born prematurely in July 2010 in the state of Mississippi. Due to the high risk of exposure to HIV, the researchers say the baby was started on a triple therapy regimen of antiretroviral drug 30 hours after birth and before proof of infection could be confirmed. The newborn’s HIV-positive status was subsequently confirmed through a highly sensitive polymerase chain reaction testing which was conducted on several occasions.

The case study stated that the baby was discharged from the hospital after one week and continued ARV treatment until 18 months of age, when for reasons that are unclear the treatment was discontinued. However, when the child was seen by medical professionals about a half a year later, blood samples revealed undetectable HIV levels and no HIV-specific antibodies.

If the findings are confirmed this would be the first well-documented case of an HIV-positive child who appears to have no detectable levels of the virus despite stopping HIV treatment.

“This news gives us great hope that a cure for HIV in children is possible and could bring us one step closer to an AIDS free generation,” said UNAIDS Executive Director Michel Sidibé. “This also underscores the need for research and innovation especially in the area of early diagnostics.”

In 2011, UNAIDS and its partners launched a Global plan for the elimination of new HIV infections among children by 2015 and keeping their mothers alive. Significant progress has been made and continued support and research is needed.

“While we wait for these results to be confirmed with further research, it is potentially great news,” said UNICEF Executive Director, Anthony Lake. “This case also demonstrates what we already know—it is vital to test newborn babies at risk as soon as possible.”

According to data from the World Health Organization and UNICEF only 28% of HIV-exposed babies were tested for HIV within six weeks of birth in 2010. Obstacles to early diagnosis and treatment include the high cost of diagnostics and difficulty of getting timely results and limited access to services and medicines. There were 330 000 children newly infected with HIV in 2011. At the end of 2011, 28% of children under the age of 15 living with HIV were on HIV treatment, compared to 54% of eligible adults.

Now two and a half year’s old, the toddler continues to thrive without antiretroviral therapy and has no identifiable levels of HIV. However, UNAIDS cautions that more studies need to be conducted to understand the outcomes and whether the current findings can be replicated.

ViiV Healthcare signs agreement to help bridge a critical gap in HIV treatment for children

GENEVA, 28 February 2013—The Joint United Nations Programme on HIV/AIDS (UNAIDS) welcomes the new collaboration between the Medicines Patent Pool and ViiV Healthcare to increase access to antiretroviral therapy for children. The new agreement is a significant step forwards in HIV treatment for children as very few antiretroviral drugs are formulated for paediatric use. In 2012 UNAIDS estimated that 72% of children living with HIV who were eligible for treatment did not have access.

Under the collaboration, ViiV will allow the paediatric formulation of the antiretroviral medicine abacavir to be supplied to 118 countries under a license agreement. The 118 countries are home to more than 98% of all children living with HIV. ViiV have also agreed to negotiate further licences that will allow the manufacture of low-cost versions of promising new, better adapted paediatric medicines that ViiV is currently developing. Once approved for safety and quality, the new medicines could also be supplied to the 118 countries.

“The agreement between the Medicines Patent Pool and ViiV promises to narrow a substantial gap in access to HIV treatment and offer new hope for children,” said Michel Sidibé, Executive Director of UNAIDS. “I strongly urge other pharmaceutical companies, especially companies holding antiretroviral therapy patents, to join the Pool and help improve the lives of children and adults living with HIV around the world.”

ViiV has also pledged to work with other stakeholders to develop additional abacavir-based products for children and bring them quickly to market in developing countries. This is an important affirmation of the Medicines Patent Pool’s role in facilitating faster introduction of new, better-adapted and affordable medicines, particularly for developing countries.

The Medicines Patent Pool was founded in 2010 with the support of the innovative financing mechanism UNITAID to increase access to antiretroviral treatment. It works by creating a pool of patents that can be licensed by generic producers, thereby facilitating competition, fostering innovation and driving down prices. The United States National Institutes of Health and Gilead Sciences have previously contributed voluntary licenses to the Medicines Patent Pool.

(Left to Right): Michel Sidibé, UNAIDS Executive Director; President Bill Clinton; Ban Ki-moon, Secretary General of the UN; Goodluck Jonathan, President of Nigeria; Dr Eric Goosby, US Global AIDS Ambassador, Anthony Lake, UNICEF Executive Director, at launch of the Global Plan towards elimination of new HIV infections among children and keeping their mothers alive, at UN Headquarters, NYC, 9 June 2011.
Credit: UNAIDS/B. Hamilton

NEW YORK/GENEVA, 9 June 2011—World leaders gathered in New York for the 2011 United Nations High Level Meeting on AIDS have today launched a Global Plan that will make significant strides towards eliminating new HIV infections among children by 2015 and keeping their mothers alive.

“We believe that by 2015 children everywhere can be born free of HIV and that their mothers can remain healthy,” said Michel Sidibé, Executive Director of UNAIDS. “This new global plan is realistic, it is achievable and it is driven by the most affected countries.”

“Nearly every minute, a child is born with HIV. Working together, we can reverse this tide as we have done in the United States and they are very close to doing in Botswana,” said Ambassador Eric Goosby, the United States Global AIDS Coordinator. “Preventing new HIV infections among children across the globe is truly a smart investment that saves lives and helps to give children a healthy start in life.”

Providing pregnant women living with HIV with antiretroviral prevention and treatment reduces the risk of a child being born with the virus to less than 5%—and keeps their mothers alive to raise them. Neither technical nor scientific barriers stand in the way of responding to this global call to action. The plan notes that what is needed is leadership, shared responsibility and concerted action among donor nations, recipient countries and the private sector to make an AIDS-free generation a reality. 

In answering the Global Plan’s call to action, the United States President's Emergency Plan for AIDS Relief (PEPFAR) announced an additional US$ 75 million to preventing mother-to-child transmission of HIV (PMTCT) efforts. This funding will be on top of the approximately US$ 300 million that PEPFAR already provides annually for PMTCT.

The Bill & Melinda Gates Foundation pledged US$ 40 million, Chevron committed to US$ 20 million and Johnson & Johnson pledged US$ 15 million.

"Investments in preventing mother-to-child transmission are greatly needed and the Bill & Melinda Gates Foundation is committed to ensuring that such initiatives are fully integrated into family planning and maternal, newborn, and child health programmes," said Stefano Bertozzi, Director of HIV and tuberculosis at the Foundation.

“Chevron understands that its sustainability as a business is inextricably linked to the health and well-being of its employees and the communities in which it operates,” stressed Rhonda Zygocki, Executive Vice President, Policy and Planning, for Chevron Corporation. “We are proud to pledge US$ 20 million, joining in this mission to eliminate mother-to-child transmission of HIV.”

“We have a dream that no baby will be born HIV positive and today’s pledge continues the Johnson & Johnson enduring commitment to eliminating mother-to-child transmission of HIV,” said Brian Perkins, Corporate Vice President, Corporate Affairs. “It is another step in fulfilling our commitment to support achievement of the Millennium Development Goals, and reflects our long-standing dedication to improving maternal and child health.”

In 2009, approximately 370 000 children were born with HIV—almost all of them in low- and middle-income countries, mainly in sub-Saharan Africa. Under the Global Plan, the goal would be to work toward reducing this number by 90% by 2015. All 22 of the countries with the highest burden of new HIV infections among children have contributed to the development of the plan and signed up to implement it.

(Left to Right): Babalwa Mbono, Representative of Women Living with HIV; Michel Sidibé, UNAIDS Executive Director; President Bill Clinton at launch of the Global Plan towards elimination of new HIV infections among children and keeping their mothers alive.
Credit: UNAIDS/B. Hamilton

The Global Plan towards the elimination of new HIV Infections among children by 2015 and keeping their mothers alive was developed by a group of more than 30 countries and 50 community groups, non-governmental and international organizations. The group was convened by UNAIDS and PEPFAR.

Babalwa Mbono found out she was HIV positive when she became pregnant. “Helping pregnant women to protect their babies is really important,” she said. “Like all mothers, I would do anything to give my child a healthy start in life—and this prevention should be available to women everywhere.”

"We can only achieve a generation free of HIV and AIDS by focusing our efforts on the mothers and children at greatest risk and in greatest need," urged UNICEF Executive Director Anthony Lake. "The investments we make in preventing maternal-to-child transmission of HIV—and in expanding more women's access to quality care—will yield tremendous returns, not only in the lives of children and families affected by HIV and AIDS, but in improving mothers' and children's health in the poorest countries that bear the greatest burden of the AIDS epidemic."

The plan focuses on a series of specific policy and programmatic measures which countries will take to ensure that all pregnant women living with HIV have access to HIV prevention and treatment services and that new HIV infections among children are eliminated by 2015. The plan also includes efforts to provide treatment to mothers and children living with HIV during breastfeeding and referral to ongoing HIV prevention and treatment programmes thereafter.

The key elements of the Global Plan include ensuring that:

• All women, especially pregnant women, have access to quality life-saving HIV prevention and treatment services—for themselves and their children.
• The rights of women living with HIV are respected and women, families and communities are empowered to fully engage in ensuring their own health and, especially, the health of their children.
• Adequate resources—human and financial—are available from both national and international sources in a timely and predictable manner while acknowledging that success is a shared responsibility.
• HIV, maternal health, newborn and child health and family planning programmes work together, deliver quality results and lead to improved health outcomes.
• Communities, in particular women living with HIV, are enabled and empowered to support women and their families to access the HIV prevention, treatment and care that they need.
• National and global leaders act in concert to support country-driven efforts and are held accountable for delivering results.

The plan also includes a detailed timetable for action at community, national, regional and global levels to ensure rapid progress towards elimination of new HIV infections in children by 2015 and keeping their mothers alive.

About the Global Plan

This Global Plan provides the foundation for country-led movement towards the elimination of new HIV infections among children and keeping their mothers alive. The Global Plan was developed through a consultative process by a high level Global Task Team convened by UNAIDS and co-chaired by UNAIDS Executive Director Michel Sidibé and United States Global AIDS Coordinator Ambassador Eric Goosby. It brought together 30 countries and 50 civil society, private sector, networks of people living with HIV and international organizations to chart a roadmap towards achieving this goal by 2015.

This plan covers all low- and middle-income countries, but focuses on 22 countries ^[1] with the highest estimate of HIV-positive pregnant women. Exceptional global and national efforts are needed in these countries that are home to nearly 90% of pregnant women living with HIV in need of services. Intensified efforts are also needed to support countries with low HIV prevalence and concentrated epidemics to reach out to all women and children at risk of HIV. The Global Plan supports and reinforces the development of costed, country-driven national plans.

UNAIDS

UNAIDS, the Joint United Nations Programme on HIV/AIDS, is an innovative United Nations partnership that leads and inspires the world in achieving universal access to HIV prevention, treatment, care and support. Learn more at unaids.org.

PEPFAR

The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is the U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world. This historic commitment is the largest by any nation to combat a single disease internationally, and PEPFAR investments also help alleviate suffering from other diseases across the global health spectrum. PEPFAR is driven by a shared responsibility among donor and partner nations and others to make smart investments to save lives. Learn more at www.pepfar.gov.

^[1] Angola, Botswana, Burundi, Cameroon, Chad, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Ghana, India, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, South Africa, Uganda, United Republic of Tanzania, Swaziland, Zambia and Zimbabwe.

Preventing mother-to-child transmission of HIV (PMTCT) is one of the key pillars in the worldwide response to the AIDS epidemic and one of the priorities of UNAIDS Secretariat and its Cosponsors. The World Health Organization (WHO) has recently published a strategy paper outlining its commitment to support country-level and global efforts to scale up PMTCT services and to integrate such services into maternal, newborn and child health programmes.

Preventing mothers from dying and babies from becoming infected with HIV is one of UNAIDS’ key priority areas as outlined in its . The new PMTCT strategic vision 2010–2015: preventing mother-to child transmission of HIV to reach the UNGASS and Millennium Development Goals, reflects an important part of WHO’s health sector response to HIV and will contribute directly towards achieving the results of the Outcome Framework.

As a UNAIDS cosponsor which co-leads efforts to prevent mother-to-child HIV transmission within the United Nations, along with cosponsor UNICEF, WHO will use the PMTCT strategic vision to accelerate global support for prevention of mother-to-child HIV transmission.

The strategy paper urges the international community to set new, more ambitious targets that promote progress towards the virtual elimination of paediatric HIV by 2015. It also calls for greater collaboration with partners, such as the Global Fund to fight AIDS, Tuberculosis and Malaria, and the US President’s Emergency Plan for AIDS Relief (PEPFAR).

Significant progress in PMTCT has occurred in recent years and in 2008 around 45% of pregnant women living with HIV in low- and middle-income countries received antiretroviral drugs to prevent mother-to-child transmission of HIV. This is in contrast to only 10% in 2004.

Despite these successes, coverage levels of PMTCT services are still low in a number of resource-limited countries and communities. According to the UNAIDS/WHO AIDS Epidemic Update 2009 an estimated 430,000 children were newly infected with the virus in 2008, more than 90% of them through vertical transmission from their mothers. Without treatment, around half of these children will die before their second birthday.

But mother-to-child transmission is almost entirely preventable where services are accessible, and PMTCT interventions can reduce the risk of infection to less than 5%.

The PMTCT strategic vision can help address this by promoting a comprehensive approach that includes the following four components: primary prevention of HIV infection among women of childbearing age; preventing unintended pregnancies among women living with HIV; preventing transmission from an HIV-positive woman to her infant; and providing appropriate treatment, care and support to mothers living with HIV and their children and families.

The new document highlights a series of needed strategic directions:

• Strengthen commitment and leadership to achieve full coverage of PMTCT services
• Provide technical guidance to optimize HIV services for women and children
• Promote and support integration of HIV interventions within maternal, newborn and child health and reproductive health programmes
• Ensure equitable access for all women, including the most vulnerable
• Support health systems interventions to improve service delivery
• Track programme performance and impact
• Strengthen global, regional and country partnerships and advocate for increased resources.

The publication provides a number of country and regional examples. In Asia, several nations have begun linking HIV services with reproductive, adolescent, maternal, newborn and child health services.

Along the same lines, the elimination of mother-to-child transmission of HIV and congenital syphilis in Latin America and the Caribbean (affecting some 6,000 children and 450, 000 pregnancies each year respectively) has been defined as a top priority by the WHO Regional Office for the Americas and UNICEF. Together with partners, they have recently launched a campaign with the objective to eliminate mother-to-child transmission of HIV by 2015.

The PMTCT strategic vision also shows that interventions needed vary depending on country or regional circumstances. In Eastern Europe, for instance, emphasis is not on general population interventions but on improving PMTCT services for key populations at higher risk such as injecting drug users and their partners.

It is clear that whatever the context, the need to eliminate mother-to-child transmission of HIV is of paramount necessity. The PMTCT strategic vision is designed to be a key tool to strengthen WHO's support to this global effort to save lives and protect the health of the world’s women and children.

18 month old baby in Baragwanath Hospital, Soweto, South Africa
Credit: UNAIDS/L. Gubb

Bacille Calmette-Guérin, or BCG, is one of the most widely given vaccines globally and is safe in people with healthy immune systems. WHO recently published further research on the finding that this standard tuberculosis vaccine has a higher risk of causing death in babies living with HIV.

Given the severity of these risks, WHO recommends not vaccinating babies with HIV and delaying vaccination for those whose HIV status is unknown but who have signs or symptoms consistent with HIV infection.

This recommendation came in 2007 and poses several challenges to weak health systems around the world.

It underscores the need for more widespread testing of HIV in babies and pregnant mothers. Clinical symptoms of HIV infection typically occur after 3 months of age but in some countries babies are routinely vaccinated with BCG at birth.

UNAIDS calls for scaling up access to and use of quality services for the prevention of mother-to-child transmission as well as integrated delivery of services for HIV and tuberculosis.

“A selective BCG vaccination policy in HIV-exposed infants will require high uptake of maternal HIV testing, strengthened prevention of mother-to-child transmission services, and better integration of TB and HIV programmes,” said Dr Catherine Hankins, UNAIDS Chief Scientific Adviser in HIV this Week scientific blog.

The results of a three-year study in South Africa were published in the July edition of the journal Bulletin of the WHO. They confirm earlier research which led WHO in 2007 to change BCG vaccination policy for babies. The WHO Global Advisory Committee on Vaccine Safety and the Strategic Advisory Group of Experts TB and HIV experts then published Revised BCG vaccination guidelines for infants at risk for HIV infection.

“This paper gives better information on the risk of generalized BCG infection in HIV infected children and strongly reinforces the need to find better ways to prevent TB in infants (who are most at risk of dying from TB) and for diagnosing HIV in infants,” said Dr Alasdair Reid, UNAIDS TB Adviser.

A version of this story first appeared at unicef.org

‘Loud and Clear’, the Unite for Children, Unite against AIDS video, shows how early infant diagnosis of HIV can save lives

Many infants across the world are dying needlessly because they are not being tested early enough for HIV and treated if they have the virus. Without treatment, half of all HIV-positive babies will not live long enough to see their second birthday; a third will not see their first.

To help address this situation, the Unite for Children, Unite against AIDS campaign has launched a new video vividly highlighting the importance of early testing and treatment to save the lives of infants who have HIV.

As the video, known as ‘Loud and Clear’, shows infants who are diagnosed and treated early have a far higher chance of survival than those who go untested and untreated. Research demonstrates that if newborns are tested at the age of six weeks and on treatment by 12 weeks there can be a dramatic 75% reduction in infant mortality due to AIDS.

However, according to a report published last year by UNICEF, UNAIDS and WHO, in 2007 only 8% of children born to HIV-positive mothers were tested before they were two months old. Mothers can also help prevent HIV transmission – and protect their own health – by being tested and treated themselves during pregnancy.

Access to care and treatment

Since the launch of the Unite for Children, Unite against AIDS global campaign in 2005, there has been significant progress in scaling up prevention of mother-to-child transmission of HIV – and in the provision of paediatric treatment for babies born with the virus.

In 2007, a third of HIV-positive pregnant women received antiretroviral drugs, or ARVs, to prevent transmission to their children, compared with only 10 per cent in 2004.

Still, far too few pregnant women in the developing world know their HIV status, and too few are tested and treated: both are essential for mother and child. However, most pregnant women who have been diagnosed with HIV do not have access to essential care and treatment, including ARV therapy.

“Mothers should be able to access the tests and drugs necessary to ensure they can protect their babies and themselves,” said UNICEF Senior Advisor on HIV and AIDS, Dr Doreen Mulenga. “Antiretroviral drugs can substantially reduce the risk of a baby getting the HIV virus from his mother.”

Children at risk

Children bear a heavy burden of the virus. UNAIDS and WHO estimates show that in 2007 alone some 370,000 young people under the age of 15 were newly infected, that’s around 1,000 a day; and 270,000 died, the majority under the age of 5. In the same year, fewer than 200,000 young people living with HIV received antiretroviral treatment. Further, those on ARVs often receive it too late for optimal benefits to be gained: recent studies report that the median age at which children begin such treatment is between five and nine years old.

Great strides in Zambia

In Lusaka, the capital of Zambia, the Chelstone Clinic provides vital programmes to treat pregnant women living with HIV and to prevent mother-to-child transmission. The country has made great strides in expanding such programmes, which include HIV testing during pregnancy, ARV regimens for HIV-positive pregnant women, prophylactic antibiotics and ARVs for infants exposed to HIV in utero, and early infant diagnosis and treatment.

Maureen Sakala, who was diagnosed with HIV while pregnant, practices preparing prophylactic antiretroviral medicine for her newborn son, Christopher, held by midwife Grace Kayumba at the Chelstone Clinic in Lusaka, Zambia.
Credit: UNICEF/NYHQ2009-0307/Nesbitt

Christopher was recently born at the clinic. His mother, Maureen Sakala, lives with her mother, siblings and 12 orphaned children – including the children of her brother, who died of AIDS-related illness.

Ms Sakala learned that she was HIV-positive during an antenatal check-up. She participates in the prevention programme at the clinic, where she learned to administer ARVs to Christopher for the first seven days after his birth as a prophylactic measure against HIV infection. His chances of survival are much improved because of Zambia’s success in strengthening maternal, newborn and child health services.

Preventing mothers from dying and babies from becoming infected with HIV has been identified as one of the eight priority areas UNAIDS and its Cosponsors will focus on for the period 2009–2011 under the Joint action for results: UNAIDS outcome framework, 2009 – 2011.

By providing greater access to HIV testing and treatment, partners around the world are working to protect babies like Christopher, and their mothers, from the devastating impact of AIDS.