New Horizons Advancing Pediatric HIV Care
Diagnosing HIV infection and initiating treatment are critical steps toward addressing gaps in antiretroviral therapy (ART) coverage between adult and pediatric patients, and are highly prioritized in the fight to eradicate HIV. With the release of the 2014 UNAIDS 90-90-90 treatment target, programs are expected to scale-up efforts to significantly increase the number of HIV-infected children and adolescents identified and initiated on ART. However, as the number of individuals on first-line ART grows, greater awareness and increased programmatic focus will also be necessary to reach the third “90” of the 2014 UNAIDS target – 90% of all people receiving ART will have viral suppression by 2020. The issues of adherence, retention in care, and advanced (second- and third-line) treatment for children and adolescents living with HIV must be prioritized 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. The absence of systematic data on viral load and treatment failure among children on ART likely leads to underestimates of the need for pediatric second- and third-line treatment. With the rapid scale-up of first-line, demand for these drugs is expected to increase 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 Care, an initiative to improve and scale-up pediatric HIV/AIDS treatment through increased awareness and research, health systems strengthening, and improved access to HIV/AIDS medicines. Other external partners and experts will be invited to join thereby maximizing the impact and reach of this initiative.
As a first step under the New Horizons initiative, a Donation Program was launched in 2014 to increase access to pediatric HIV medicines for children experiencing ART failure.
New Horizons Donation Program
Janssen is donating its HIV medicines PREZISTA® (darunavir) and/or INTELENCE® (etravirine) to eligible national HIV/AIDS programs (see below) for use in children and adolescents up to 19 years of age. Upon turning 19 years, patients are to be transitioned into the participating countries’ HIV/AIDS treatment programs for adults. 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.
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 also be responsible for monitoring and evaluation of the Donation Program. SCMS will provide logistical support for the donated medicines, including warehousing, and onward distribution of drugs to the appropriate treatment sites within the country programs. Please reference Logistic Procedures, Roles and Responsibilities for more information on the supply chain management processes.
Who May Apply
Expressions of Interest may be submitted by Ministries of Health, or a designee, from countries in sub-Saharan Africa or those countries considered to be least developed as defined by the United Nations. Individuals and non-governmental organizations not designated by a national Ministry of Health may not submit independent applications.
In order to participate in the Donation Program, countries must meet and verify the following eligibility criteria:
- Applicant country is located in sub-Saharan Africa or else considered to be a Least Developed Country as defined by the United Nations
- Medicine donation is legal in the applicant country
- Official regulatory processes exist in-country to direct the acceptance of donated medicines
- Adult third-line HIV treatment is currently part of the national HIV program (or will be in place within 6 months of the applicant country’s acceptance into the Donation Program)
- Other ARVs, including ritonavir, needed to create an active regimen with darunavir and/or etravirine, are available in the applicant country
- Darunavir is approved for use in children in the applicant country
- Etravirine is approved for use in children in the applicant country
- There is a demonstrated need for third line ARVS for children and adolescents in the applicant country
- The applicant country has the necessary clinical expertise to identify children experiencing HIV treatment failure and manage children on third-line treatment
- The applicant country has national guidelines for second- and third-line pediatric HIV treatment
National programs unsure of their eligibility are encouraged to review the Expression of Interest Application Form (below) and submit questions to firstname.lastname@example.org.
Expression of Interest
The submission period for the Expression of Interest by countries will open on February 13, 2015 and close on April 10, 2015. An independent, third-party Review Committee of international experts in pediatric HIV will review all applications to determine countries’ eligibility to participate in the Donation Program. An announcement on country selections will be made in May, 2015.
To submit an Expression of Interest, please download the following forms:
Completed applications and all supporting documents should be submitted to email@example.com no later than April 10, 2015.
Pour une version en français sélectionnez:
- Formulaire de Demande pour la Déclaration d'Intérêt
- Procédures, Rôles et Responsabilités Logistiqueses
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 above), and recommend countries who meet the eligibility criteria for participation. The Review Committee will also provide feedback to countries determined not yet eligible and suggest actions to meet eligibility criteria in the future. The names of the 2015 Review Committee members will be made public by April, 2015.
Frequently Asked Questions
Pour une version en français sélectionnez, Foire Aux Questions.