New Horizons Advancing Pediatric HIV Care Collaborative
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 and the updated 2015 WHO consolidated treatment guidelines recommending treatment for all HIV-infected individuals, including children, regardless of CD4 count or clinical stage, programs are expected to scale-up efforts to significantly increase the number of HIV-infected children and adolescents 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 also 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 Collaborative
In response to these issues, Janssen, the Pharmaceutical Companies of Johnson & Johnson, Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), and Partnership for Supply Chain Management System (SCMS), have partnered to implement New Horizons Advancing Pediatric HIV Care Collaborative. This multi-sector partnership aims to improve and scale-up pediatric HIV/AIDS treatment through increased awareness and research, health systems strengthening, and improved access to HIV/AIDS medicines. Since its inception, additional partnerships with organizations such as CIPHER-IAS, The Relevance Network Ltd, and Right to Care have been developed.
The overall New Horizons Collaborative facilitates several directly funded platforms for reaching its objectives. One of the initial programs, a darunavir (DRV), etravirine (ETV) donation program, was launched in 2014 to address the need for increased access to pediatric medicines for children and adolescents with treatment-experienced HIV.
New Horizons Collaborative, 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, as designated by the participating countries’ ministries of health. 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. Darunavir (DRV) in combination with ritonavir (RTV) may be used for either second- or third-line after failure on lopinavir (LPV)/RTV and/or multiple protease inhibitor resistance mutations. The New Horizons Collaborative does not endorse the use of DRV/RTV as second- or third-line therapy for patients previously on nucleoside/non-nucleoside regimens only.
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 (see below). EGPAF will also provide technical support for the program and facilitate sharing best practices across participating countries.
PFSCM and Imperial Health Sciences will work together to manage the logistics of drug donation, including forecasting support, receipt of product, warehousing, and distribution of drugs to appropriate countries. 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
- There is a demonstrated need for third-line ARVS for children and adolescents in the applicant country
- The applicant country has national guidelines for third-line pediatric HIV treatment
- The applicant country has the laboratory, facility infrastructure, and resources (including viral load monitoring and genotyping) needed to support the provision and management of third-line treatment for children and adolescents
- The applicant country has the necessary clinical expertise to identify children experiencing HIV treatment failure and manage children and adolescents on third-line treatment
- Other ARVs necessary to create an active regimen with darunavir and/or etravirine, such as raltegravir and an optimized backbone (based on patient’s ART history), are available in the applicant country
- Standalone ritonavir (i.e., ritonavir not coformulated with other drugs such as lopinavir) for boosting darunavir, is available in the applicant country
- 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)
National programs unsure of their eligibility are encouraged to review the Expression of Interest Application Form (below) and submit questions to email@example.com.
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 early 2017. Please refer back to this website periodically for further details on the next opportunity, or contact firstname.lastname@example.org with questions.