New Horizons Advancing Pediatric HIV Treatment
It is estimated that there are more than 3 million children currently living with HIV worldwide, 91% of whom reside in sub-Saharan Africa. Yet of this 91%, it has been found that treatment-eligible children living with HIV infection are about half as likely as adults to receive antiretroviral therapy (ART).
Diagnosing HIV infection and initiating treatment are critical first steps toward addressing gaps in ART coverage and are highly prioritized in the fight to eradicate HIV infection in children. However, it is also important to prioritize the issues of retention, adherence, and advanced treatment for children living with HIV in order to achieve and maintain viral suppression as well as prevent drug resistance.
Today, a growing number of children and adolescents are experiencing first- and second-line HIV treatment failure in resource-limited settings. However, the absence of systematic data on viral load or treatment failure among children on ART likely leads to underestimates of the need for pediatric HIV/AIDS second- and third-line treatment, and need for these drugs is expected to grow in the coming years.
New Horizons Initiative
Janssen, the Pharmaceutical Companies of Johnson & Johnson, Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), Supply Chain Management System (SCMS), and MAP International have partnered to implement New Horizons Advancing Pediatric HIV Treatment, an initiative to improve and scale-up pediatric HIV/AIDS treatment through increased awareness, research, and improved access to pediatric HIV/AIDS medicines.
As part of the New Horizons initiative, the partnership is implementing a treatment donation program to increase access to pediatric HIV medicines for children experiencing ART failure. This donation program is the first step in a collaborative effort to build awareness, stimulate action, and advance learning around second- and third-line pediatric HIV treatment in sub-Saharan Africa. Other external partners and experts will be invited to join to fully maximize the impact and reach of this initiative.
Treatment Donation Activities
Janssen is donating its HIV medicines PREZISTA® (darunavir) and/or INTELENCE® (etravirine) to eligible national HIV/AIDS programs in sub-Saharan Africa for use in children and adolescents up to 19 years of age. Upon turning 19 years, patients will be transitioned into the countries’ HIV treatment programs for adults or other programs designated by the national HIV program. All donations are free of charge to countries meeting the eligibility criteria including the clinical capacity and willingness to address second- and third-line pediatric HIV treatment. Please note that participating countries are not required to accept both PREZISTA® (darunavir) and INTELENCE® (etravirine) to qualify for this program.
EGPAF is supporting the program application process, including convening an independent, third-party Review Committee for country selection based on a predetermined set of criteria. EGPAF will also provide targeted technical support for the program and facilitate sharing best practices across participating countries.
In February, 2014, ministries of health (MOHs) from countries in sub-Saharan Africa were invited to submit a formal Expression of Interest to take part in this donation program. Following a thorough review process, four countries were determined to be eligible for participation in the treatment donation program: Swaziland, Zambia, Kenya, and South Africa. Additional opportunities to submit Expressions of Interest will be extended in late 2014 or early 2015.
MAP International will manage the donation of pediatric HIV medicines to eligible countries, providing a single conduit between Janssen and country treatment programs. MAP will be responsible for monitoring and evaluation of the donation program. SCMS will provide logistical support for the donated medicines, including receipt into Africa, warehousing, and onward distribution of drugs to the appropriate treatment sites within the country programs.
Review Committee Members
EGPAF has convened a group of highly qualified experts in the field of pediatric HIV care and treatment to serve as members of the Review Committee. The purpose of the Review Committee is to objectively assess each application based on predetermined eligibility criteria (see below), and recommend countries who meet the eligibility criteria for selection. The Review Committee will also provide feedback to countries determined not yet eligible and suggest actions to meet eligibility criteria in the future.
The members of the Review Committee are:
- Shaffiq Essajee, BMBCh
- Leon Levin, MBBCh, FCPaed(SA), DTM&H
- Dorothy Mbori-Ngacha, MBChB, MMed, MPH
- Denis Tindyebwa, MBChB, MMed (Ped)
Expression of Interest
The submission period for Expressions of Interest by national programs is currently closed. Additional opportunities to submit Expressions of Interest will be extended in either late 2014 or early 2015. Please refer back to this website periodically for further details on the next opportunity.
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