EXPRESSION OF INTEREST
Pediatric HIV Treatment Donation Program
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% of them
in sub-Saharan Africa. Yet, in 2012, only one-third of children in low- and middle-income countries in
need of antiretrovirals (ARVs) were receiving them. 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 even children already 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, many 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.
One of the reasons why children and adolescents in sub-Saharan Africa that need second and third
line ARVs are not getting them is lack of affordable drugs.
Janssen, the Pharmaceutical Companies of Johnson & Johnson, the Elizabeth Glaser Pediatric AIDS
Foundation (EGPAF), the Supply Chain Management System (SCMS) and MAP International are
collaborating 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 will 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 – see application form below.
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Application Process
Timeline
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January 14 to February 14, 2014 – Submission period for Expression of Interest by countries
February 15 to March 2014 – Review of applications by independent, third-party review
committee of international experts in pediatric HIV to determine country eligibility to receive
the medicine donation
March/April 2014 – Announcement on country selections
Who May Apply
Applications to the program may be submitted by Ministries of Health or their 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 at the time of application:
1. Country is in sub-Saharan Africa
2. Medicine donation is legal and an official regulatory process exists in country to accept
donated medicines
3. 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)
4. 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
and country has a demonstrated need for third line ARVS for children
5. Country has necessary clinical expertise to identify and manage children experiencing
HIV treatment failure and children on third-line treatment
6. Other ARVs, including ritonavir, needed to create an active regimen with darunavir
and/or etravirine are available at proposed clinical sites
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 Expression of Interest:
Please submit your completed Expression of Interest Application Form and supporting documents to
treatmentdonation@pedaids.org between January 14 and February 14, 2014. Expressions of Interest
submitted after February 14th will be held on file and considered in the next application round to
occur later in 2014. Please direct any questions to treatmentdonation@pedaids.org.
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EXPRESSION OF INTEREST APPLICATION FORM
Pediatric HIV Treatment Donation Program
I.
Applicant Contact Information
Country:
Name of Contact:
Organization and Title of Contact:
Department within MOH or MOH-Designated Organization:
Phone:
Mobile Phone:
Email:
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II.
Applicant Country Verification of Meeting Eligibility Criteria
Please complete the table below by indicating Yes or No for each question with an “X” and provide
any clarifying comments as necessary.
Eligibility Criteria
1. Is the applicant country located in sub-Saharan
Africa?
2. Is medicine donation legal in the applicant
country and does an official regulatory process
exist in-country to accept donated medicines?
3. Is adult third-line HIV treatment 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)?
4. Does the applicant country have national
guidelines for second-line and/or third-line
pediatric HIV treatment, which recognize that
access to darunavir and/or etravirine may be
necessary and is there a demonstrated need for
third line ARVS for children?
5. Does the applicant country have necessary
clinical expertise to identify and manage
children experiencing HIV treatment failure and
children on third-line treatment?
6. Are other ARVs, including ritonavir and
raltegravir, (which are needed to create an
active regimen with darunavir and/or etravirine)
available at proposed clinical sites?
7. Is there access to and provision of genotyping
for children experiencing second-line HIV
treatment failure in the applicant country?
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Yes No
Comments
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III.
Applicant Background Information
Please provide the following information for the applicant country and participating facilities (no
more than one paragraph per item).
A. National-level information
1. Relevant country context including population and epidemiological data
2. Summary of current country guidelines for adult and pediatric first-, second-, and
third-line treatment, or if not in place, plans to create guidelines by July 2014
3. Description of need for third line pediatric ART in country
4. Description of regulatory process (and required documentation if available) to accept
donated medicines. In your description, please include responses to the following
questions:
1. Is it a prerequisite that donated medicines must be first approved in your
country (if yes, please indicate estimated approval timeline from submission to
approval).
2. Is it a prerequisite that donated medicines must be submitted for approval
and/or must be submitted within a certain time frame (if yes, please indicate
the terms and timeline).
3. Please indicate any other requirements that may be necessary to donate
medicines that are not approved in your country (note all donated medicines
from Janssen are approved by the US FDA and are WHO pre-qualified).1
5. Number of facilities expected to participate in the drug donation program in 2014
B. Facility-level information: For each participating clinical facility for which information is
available, please provide the following (required for at least one facility).
1. Name of facility
2. Name of contact person at facility
3. Type (public, private, other) and level of facility (primary, secondary, tertiary, other)
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Please note that one formulation is still pending.
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4. Number and types of providers managing ART in children at facility (doctors, nurses,
clinical officers, other)
5. First-, second-, and third-line ART regimen(s) currently used for children at facility
6. Description of facility’s experience with managing third-line ART treatment for children
7. Availability of other ARVs, including ritonavir and raltegravir, to create an active
regimen with darunavir and/or etravirine
8. Description of relevant laboratory capacity including access to viral load testing and
genotyping
9. Description of supply chain and storage capacity for ARVs at facility and how donated
drugs would integrate with existing system
10. Description of how patients reaching 19 years of age would transition treatment to
national or other program for continued ART
11. Number of children ever started on third-line treatment at facility and, if possible,
median duration on third-line treatment
12. Number of children currently on ART at facility, including numbers on first-, second-,
and third-line treatment
IV.
Supporting Documents
Along with the completed Expression of Interest form and background information, please submit the
following documentation associated with the eligibility criteria for reference (electronic versions
only):

Copy of adult and pediatric treatment guidelines for the applicant country

Relevant descriptions of participating facilities (if available)
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