New Horizons Advancing Pediatric HIV Care Collaborative

Background

Diagnosing HIV infection and initiating patients on treatment as early as possible are critical steps in the fight to eradicate HIV and vital to addressing the gap in antiretroviral therapy (ART) coverage between adult and pediatric patients. With the release of the 2014 UNAIDS 90-90-90 treatment targets and the updated 2016 WHO consolidated treatment guidelines recommending treatment for all HIV-infected individuals, including children, regardless of CD4 count or clinical stage (otherwise known as “test and treat”), programs are expected to significantly scale-up the number of 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 reach the third “90” of the 2014 UNAIDS target: 90% of all people receiving ART will have viral suppression by 2020. Adherence, retention in care, and treatment failure 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 limited availability 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 ART, 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, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), and Partnership for Supply Chain Management (PFSCM), have partnered to implement New Horizons Advancing Pediatric HIV Care Collaborative. This multi-sector partnership aims to improve and scale-up pediatric HIV and AIDS treatment through increased awareness and research, health systems strengthening, and improved access to HIV and 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, DRV, TMC114) and/or INTELENCE® (etravirine, ETR, TMC125), (including child-friendly formulations) to national HIV/AIDS programs for use in children and adolescents up to 19 years of age. Upon turning age 19, participating countries are responsible for transitioning patients to adult HIV and AIDS treatment programs. All donations are free of charge to participating countries. 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 supports the expression of interest process, including convening an independent review committee for assessment of country readiness and capacity building needs). 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 applications 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 independently.

Expression of Interest Process

The expression of interest period for the New Horizons Advancing Pediatric HIV Care donation program will accept applications on a quarterly basis with the following deadlines: 21 February 2018, 21 May 2018, 21 August 2018, and 21 November 2018.

Following submission of materials for review, an expert review committee convened by EGPAF will assess and document the readiness of countries to manage donated product (i.e., DRV and/or ETR) based on the materials submitted. Countries will be notified of the Committee’s decision within 4-6 weeks of receiving a submission.

Readiness to Manage Donated Product

  • Countries determined to be ready to manage donated product will be connected to Janssen and PFSCM for next steps related to donation regulation, forecasting, and procurement. Countries may also be asked to sign a letter of mutual intent acknowledging the roles and responsibilities of participating parties.
  • Countries determined not ready for management of donated product at the time of submission of their expression of interest application are welcome to address recommendations made by the review committee and resubmit materials for review prior to the following quarter or after.

Capacity Building and Health Systems Strengthening

Recommendations for capacity building and health systems strengthening will be provided to all national HIV and AIDS programs which submit an expression of interest. Areas of potential collaboration with the New Horizons Collaborative on capacity building and technical assistance will be highlighted and next steps for this collaboration will be detailed.

To Submit an Expression of Interest

Please download and complete the following forms. Note that additional materials requested for submission are detailed within the expression of interest application form and must be included as part of a complete packet of materials. Note that incomplete submissions may not be considered and/or returned to the submitting entity for completion prior to review.

Completed materials for review (including ALL requested supporting materials as detailed in the expression of interest form) should be submitted to newhorizons@pedaids.org, no later than 21 February 2018, 21 May 2018, 21 August 2018, or 21 November 2018. Please include the submitting country name in the subject line of the email as the submitting individuals name, title, and representing office.

Frequently Asked Questions

For more information, please see this list of Frequently Asked Questions or contact newhorizons@pedaids.org.