Tuesday, 23 April 2019 at 12:00 am
The objective of this call for proposals is to speed the development of existing medicines, into long-acting products, for treatment and prevention of diseases including HIV and its coinfections/comorbidities, tuberculosis (TB) and malaria.
Safe and efficacious medicines are available for the prevention and treatment of major diseases, but their effectiveness can be compromised by poor treatment completion. Lack of adherence can worsen clinical outcomes, leading to increased mortality, persistent transmission and increased drug resistance in the case of antimicrobials and antivirals. Analyses of treatment and prevention of HIV, malaria, and TB within public health programs show wide disparities in rates of completion, especially among specific populations and regions.[1],[2],[3],[4],[5]
Currently, most medicines in use require daily intake of oral tablets. Reasons for limited levels of adherence include: pill burden; duration of treatment (e.g., antiretrovirals (ART), maintenance phase for treatment of drug susceptible TB); stigma (e.g., treatment of TB, prophylaxis or treatment of HIV); discontinuation in access to health care for key populations (e.g. hepatitis C (HCV) treatment in people who inject drugs); and supply and programmatic issues. In addition, treatment interruptions are frequent in asymptomatic people (e.g., TB or malaria prophylaxis, HIV pre-exposure prophylaxis (PrEP) or ART).
Long-acting products have revolutionized other fields, such as schizophrenia and contraception, and could dramatically change the response to other major diseases affecting LMICs.
While not yet approved, long-acting products at various stages of development have been identified through wide-ranging consultations[6] and landscaping[7],[8],[9] that hold promise to dramatically transform the management of HIV and its co-infections/comorbidities, TB, or malaria, among other disease areas.
However, in the absence of intervention, an extensive time-lag for these new technologies to be available in LMICs can be expected. Therefore, Unitaid aims to support interventions that can accelerate development of game-changing long-acting solutions for global health impact.
________________
[1]. Bezabhe WM et al. Adherence to antiretroviral therapy and virologic failure. Medicine. 2016 Apr; 95(15): e3361.
[2]. Shargie EB et al. Determinants of treatment adherence among smear-positive pulmonary tuberculosis patients in Southern Ethiopia. PLoS Med 2007; 4(2): e37
[3]. Sandgren et al. Initiation and completion rates for latent tuberculosis infection treatment: A systematic review. BMC Infectious Diseases 2016 16:204
[4]. Bruxvoort K et al. How patients take malaria treatment: A systematic review of the literature on adherence to antimalarial drugs. 2014 PLoS ONE 9(1): e84555.
[5]. Siddiqui MR et al. Adherence to Artemisinin Combination Therapy for the treatment of uncomplicated malaria in the Democratic Republic of the Congo. F1000Res. 2015; 4: 51.
[6] Unitaid Technical Consultation Meeting: Bringing innovation to the frontline for impact—long-acting solutions to prevent and treat major infectious diseases, 1-2 November 2018, Geneva.
[7] Medicines Patent Pool and Unitaid intellectual Property Report on Long-Acting Technologies, https://medicinespatentpool.org/uploads/2018/12/MPP-Unitaid_Intellectual-property-report-on-long-acting-technologies.pdf .
[8] Marmora L et al. Long-acting technologies for infectious diseases in LMICs. Lancet (2018) 392(10158):1610-1611.
[9] Unitaid Compendium of Technical and Market Information: Bringing innovation to the front line for impact—long-acting technologies for the prevention and treatment of major infectious diseases, November 2018. [PDF, 12 MB]
Under this call, Unitaid is soliciting proposals to support development of long-acting products of medicines to treat and/or prevent diseases affecting LMICs, notably HIV, HIV coinfections/comorbidities, TB, and malaria, with broader consideration for management of antimicrobial resistance (AMR). Proposals should include the following elements:
AND
Proposals submitted should clearly demonstrate the fit with the objectives set out above, the expected impact and value for money, as well as, the complementarity to similar projects in this area.
Applicants are encouraged to consider products that can be introduced in the market within three to five years (i.e. products that could be eligible for purchase by major funders and countries as relevant and supply capacity created to address demand sufficiently by the end of this timeframe).
Topics which are out of scope for this Call include: a) proposals seeking the development of long-acting products including new chemical entities (NCEs), or new indications for approved drugs, that require full clinical development prior to submission to regulatory approval; b) proposals aiming to implement and/or deliver products at scale.
Proposals that include more than one product, leveraging investments across product-categories, and collaborative partnerships including industry are welcomed. Proposed project governance should consider the integration of a scientific advisory board.
If you intend to submit a proposal, please complete and send the [intention to submit (ISP) form PDF, 70 KB] to proposalsUnitaid@who.int by 04 March 2019.
The closing date for receipt of full proposals is 23 April 2019, at 12:00 noon Geneva (Switzerland) time. Applications received past the indicated deadline will not be considered.
