2020
2020

CHAI and Unitaid seek proposals to catalyze optimization of 2nd-line HIV treatment for children

 

Request for Proposal (RfP) for selection of generic manufacturer for development of pediatric darunavir/ritonavir (DRV/r) fixed dose combination product

The Clinton Health Access Initiative, Inc. (CHAI), with funding from Unitaid, is requesting proposals to accelerate access to the best-in-class second-line treatment for HIV in children aged 3 (>10kg) and older in low- and middle-income countries.

Darunavir/ritonavir (DRV/r) is the World Health Organization recommended alternative second-line treatment for adults, teens, and children living with HIV for whom first-line regimens have failed.

DRV was first approved for adults by the FDA in 2006. Yet over a decade later, a generic pediatric version of the drug is still not available. This means that children who need the most effective, best-in-class boosted protease inhibitor are not able to access it.

In 2019, there were an estimated 1.8 million children living with HIV, and 95,000 children under age 15 died from AIDS. Despite significant progress in scaling up HIV services for children, the treatment gap persists. Children also have consistently lower rates of viral suppression than adults – driven in part by the lack of availability of optimal formulations.

This RfP will accelerate the development and commercialization of a generic, pediatric fixed-dose combination of DRV/r, using appropriate heat-stabilizing technology (such as hot melt extrusion) for ritonavir.

Darunavir is a best-in-class protease inhibitor. Boosted with ritonavir, it is proven to be an effective treatment in HIV patients with multiple drug resistance. A pediatric version of DRV/r as 120/20mg heat-stable tablets is included on the Expression of Interest list for WHO Prequalification.

To initiate the pediatric DRV/r development program, CHAI will undergo a competitive selection process to identify a generic manufacturing partner with proven technology to produce a heat stable darunavir and ritonavir fixed-dose combination product.

The manufacturer will be chosen via a multi-tiered selection process, involving a written proposal and a follow-up meeting. The first step in this process is to submit a proposal in response to this RfP, with all required documents as outlined in the RfP document, by October 16, 2020 at 5 pm EST.  Prior to this deadline, as listed in the RfP document, CHAI will hold an informational webinar to answer all process-related questions.

Understanding the small market size for this product, an incentive is being offered to offset the cost of development and reduce risk to the manufacturer who is selected.

This is the second incentive program to be launched for the development of a pediatric antiretroviral drug under the Unitaid-funded Optimal grant to CHAI. This grant aims to bring optimized HIV drugs to market more quickly than in the past and integrate them into treatment programs in communities that need them most. The first incentive program for the accelerated development and commercialization of a pediatric dolutegravir (DTG) product is currently in progress.

Please contact Carolyn Amole (camole@clintonhealthaccess.org) with any further questions on the program.

For download
RfP for selection of generic manufacturer for development of pediatric DRV/r fixed dose combination product (PDF)
RfP application form (Excel)

 

About Unitaid | Unitaid is an international organization that invests in new ways to prevent, diagnose, and treat HIV/AIDS, hepatitis C, tuberculosis, and malaria more quickly, more affordably, and more effectively. It accelerates access to innovation so that critical health products can reach the people who most need them. Unitaid’s work facilitates large-scale introduction of health products through funding by the Global Fund, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) and by governments. Learn more about the CHAI-Unitaid collaboration here.

About CHAI | The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to saving lives and reducing the burden of disease in low- and middle-income countries, while strengthening the capabilities of governments and the private sector in those countries to create and sustain high-quality health systems that can succeed without our assistance. For more information please see how we work.