December
15

CHAI and Unitaid Seek Proposals to Catalyze Optimization of 2nd-line Treatment with DRV/r

Published December 15th, 2017

Request for Proposals (RfP) to Accelerate Affordability of a Darunavir/Ritonavir (DRV/r) Formulation
 

Under the Unitaid-funded project titled ‘Accelerating Patient Access to Optimal Antiretrovirals’ (Optimal ARV Project), CHAI is working to increase the affordability of, and accelerate access to, optimal antiretroviral (ARV) therapies in low- and middle-income countries (LMICs). This project is developing interventions that will:

1) Accelerate time to market for innovative ARV products
2) Generate early demand and rapid uptake through working with country HIV programs in a set of focal countries, including Cambodia, Kenya, Malawi, Nigeria, South Africa, Uganda, Zimbabwe and Francophone West Africa.

Within the first objective, this project includes a subsidy incentive program for products that may require commercialization support in order to accelerate access to priority products at the most affordable level possible, including adult second-line and pediatric ARVs. The first focal product under the incentive program was pediatric dolutegravir, and that RfP was already posted. The second focal product under the incentive program will be a darunavir/ritonavir (DRV/r) 400/50mg fixed-dose combination product, for second-line treatment in adults living with HIV.

Today the standard of care for second-line adult HIV treatment includes lopinavir/ritonavir 200/50mg and atazanavir/ritonavir 300/100mg available at the price of $18.41 per pack and $15 per pack, respectively, with darunavir only available in most LMICs as a very costly third-line treatment. Superior clinical efficacy, a favorable tolerability and toxicity profile, along with a high genetic barrier to resistance makes DRV/r the optimal component of second-line antiretroviral therapy. DRV/r is currently the preferred protease inhibitor (PI) in high-income countries, and despite approval of the originator product by the United States Food and Drug Administration (FDA) over a decade ago, patients in LMICs still lack access to this treatment – representing a serious inequity for most of the people living with HIV. Indeed, in the latest HIV treatment guidelines, WHO indicates that DRV/r was only reserved for special situations and third-line “as it was not available as a heat-stable FDC boosted with low-dose RTV at that time and because of its higher price compared with other options”.[1]

The goal of the project is to rapidly enable the launch of a Stringent Regulatory Authority (SRA) approved DRV/r (400/50) fixed-dose combination (FDC) that is affordably priced so that patients in LMICs will finally have access to this treatment option (two tablets, once-daily). Together with Unitaid, CHAI works on accelerating access to optimal first-line regimens and making DRV/r available for LMICs, will enable countries to adopt a comprehensive package of optimal products for all people living with HIV (PLHIV), with very robust options (DTG, DRV) to prevent resistance spreading both in first- and second-line therapy.

This RfP marks the culmination of global efforts aimed to support the affordability and availability of DRV/r in LMICs. The availability of DRV/r 400/50mg will help to build the DRV/r market, paving the way for future formulations of DRV/r if and when they become available, such as lower dosage forms.

To initiate the adult DRV/r access program, CHAI will undergo a competitive selection process to identify generic manufacturer partner(s). The RfP is open to companies that meet CHAI’s proposed regulatory filing deadlines and pricing targets. The manufacturer(s) will be chosen via a multi-tiered selection process, involving a written proposal and a potential face-to-face 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 January 17, 2018 at 5 pm EST. As listed in the RfP document, CHAI will hold an informational webinar to answer all process-related questions. For more information on how this specific subsidy incentive grant will work for this product, please refer to the RfP document. Companies are encouraged to submit any questions, which CHAI will be collecting and uploading in a Q&A document to be posted on CHAI’s website – for details on this, please refer to the RfP.

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

1] WHO, Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection,  2016, http://apps.who.int/iris/bitstream/10665/208825/1/9789241549684_eng.pdf?ua=1

 

For Download

RfP to accelerate affordability of Adult Darunavir /Ritonovir 400 mg /50mg tablets in a fixed dose combination (PDF)

Informational slides (PDF)

Responses to manufacturers’ questions

 
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

Founded in 2002, by President William J. Clinton and Ira C. Magaziner, the Clinton Health Access Initiative, Inc. (“CHAI”) is a global health organization committed to saving lives, reducing the burden of disease and strengthening integrated health systems in the developing world.