Responding to HIV Treatment Failure in Children

Background

Treatment of children with HIV remains a critical public health concern and is often neglected in resource-limited settings. Today, more than three million children are living with HIV – 91 percent of them in sub-Saharan Africa. Yet, only one-third of children in low- and middle-income countries in need of HIV medicines, or antiretrovirals (ARVs), are receiving them today.

Diagnosing HIV infection in children and initiating treatment are critical first steps in addressing this public health issue – and are currently the focus of many in the international community. Yet children on first-line regimens for HIV treatment face continued challenges. Clinical experience in the United States and Europe has shown that even with the best treatment, adherence, and medical care, children living with HIV will eventually need second- and third-line HIV treatments. Today, a small but growing number of children and adolescents are already experiencing HIV treatment failure in resource-limited settings. 

Program Overview and Partners

Janssen, the Pharmaceutical Companies of Johnson & Johnson, Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), Supply Chain Management System (SCMS), and MAP International will collaborate on a first-of-its-kind initiative to improve access to pediatric HIV medicines for children experiencing HIV treatment failure in sub-Saharan Africa.

Janssen will donate its HIV medicines PREZISTA® (darunavir) and/or INTELENCE® (etravirine)  to national HIV programs in eligible countries in sub-Saharan Africa for use in children and adolescents up to 19 years of age. Upon turning 19 years, patients would be transitioned into the country’s HIV treatment program for adults or other programs designated by the national HIV program. The donation would be made 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 eligible countries are not required to accept both PREZISTA® (darunavir) and INTELENCE® (etravirine) to qualify for participation in this program. 

EGPAF will support the program application process, including convening an independent, third-party Review Committee for country selection based on a predetermined set of criteria. EGPAF also will provide targeted technical support for the program and opportunities for 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 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.

Ministries of Health (MOHs) from countries in sub-Saharan Africa are invited to submit a formal Expression of Interest to participate in this donation program.

The donation is intended to be a 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.

Review Committee Members

EGPAF has convened a group of five 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:

Expression of Interest

The submission period for the Expression of Interest by countries will run from January 15, 2014 until February 14, 2014. An independent, third-party review committee of international experts in pediatric HIV will review all applications to determine country eligibility to receive the medicine donation. An announcement on country selections will be made in March 2014. If you have any questions in the meantime, please see these frequently asked questions or contact us for additional information: treatmentdonation@pedaids.org.

Who May Apply

Applications to the program may be submitted by Ministries of Health or a designee. Individuals and undesignated non-governmental organizations may not submit independent applications.

Eligibility Criteria

In order to participate in the donation program, countries must meet and verify the following eligibility criteria:

  1. Medicine donation is legal and an official regulatory process exists in country to accept donated medicines
  2. Adult third-line HIV treatment is currently part of the national HIV program (or will be in place within six months of Country’s acceptance into donation program)
  3. Country has national guidelines for second-line and/or third-line pediatric HIV treatment that recognize that access to darunavir and/or etravirine may be necessary
  4. Country has necessary clinical expertise, to identify and manage children experiencing HIV treatment failure
  5. Access to other ARVs, including ritonavir, needed to create an active regimen with PREZISTA® and/or INTELENCE® exists in the country
  6. Country is in sub-Saharan Africa

Whilst not an absolute determinant of eligibility, access to and provision of genotyping for children experiencing second-line HIV treatment failure is strongly recommended.

To Submit an Expression of Interest

Please download and complete the Expression of Interest Application Form. Completed applications and all supporting documents should be submitted to treatmentdonation@pedaids.org no later than February 14th, 2014

Please e-mail treatmentdonation@pedaids.org with any questions.

Frequently Asked Questions

For more information, please see this list of frequently asked questions.