Abstract
With anti-retroviral treatment (ART) scale-up set to continue over the next few years it is of key importance that manufacturers and planners in low- and middle-income countries (LMICs) hardest hit by the HIV/AIDS pandemic are able to anticipate and respond to future changes to treatment regimens, generics pipeline and demand, in order to secure continued access to all ARV medicines required. We did a forecast analysis, using secondary WHO and UNAIDS data sources, to estimate the number of people living with HIV (PLHIV) and the market share and demand for a range of new and existing ARV drugs in LMICs up to 2025. UNAIDS estimates 24.7 million person-years of ART in 2020 and 28.5 million person-years of ART in 2025 (24.3 million on first-line treatment, 3.5 million on second-line treatment, and 0.6 million on third-line treatment). Our analysis showed that TAF and DTG will be major players in the ART regimen by 2025, with 8 million and 15 million patients using these ARVs respectively. However, as safety and efficacy of dolutegravir (DTG) and tenofovir alafenamide (TAF) during pregnancy and among TB/HIV co-infected patients using rifampicin is still under debate, and ART scale-up is predicted to increase considerably, there also remains a clear need for continuous supplies of existing ARVs including TDF and EFV, which 16 million and 10 million patients—respectively—are predicted to be using in 2025. It will be important to ensure that the existing capacities of generics manufacturers, which are geared towards ARVs of higher doses (such as TDF 300mg and EFV 600mg), will not be adversely impacted due to the introduction of lower dose ARVs such as TAF 25mg and DTG 50mg. With increased access to viral load testing, more patients would be using protease inhibitors containing regimens in second-line, with 1 million patients on LPV/r and 2.3 million on ATV/r by 2025. However, it will remain important to continue monitoring the evolution of ARV market in LMICs to guarantee the availability of these medicines.
Highlights
The number of people on antiretroviral therapy (ART) in low- and middle-income countries (LMICs) continues to grow, with the number of people receiving ART reaching 17 million by end 2015 [1]
95% of people taking ART are residing in LMICs [2]. 36.9 million people globally need ART but almost half of them are not yet accessing it, leaving treatment coverage still well below the 90% target proposed by UNAIDS in 2014 [3]
Despite the gap in ART coverage and constraints in international donor funding UNAIDS has stated that the resources to support the fight against AIDS will continue to increase and ART scaleup will likely continue, at least over the few years [3,4]
Summary
The number of people on antiretroviral therapy (ART) in low- and middle-income countries (LMICs) continues to grow, with the number of people receiving ART reaching 17 million by end 2015 [1]. 36.9 million people globally need ART but almost half of them are not yet accessing it, leaving treatment coverage still well below the 90% target proposed by UNAIDS in 2014 [3]. Demand for ART globally is not levelling off, and it will remain crucially important that manufacturers, global policy planners and procurement agents anticipate future changes to treatment regimens, demand, and the generics pipeline, in order to secure continued access to all antiretroviral (ARV) medicines needed. Gilead Sciences obtained approval from the US Food and Drug Administration (USFDA) for a novel and less toxic prodrug of tenofovir called TAF in combination with emtricitabine (FTC) in April 2016 [7]. Generic manufacturers have already been granted patent licences for these novel drugs and are already exploring and developing fixed-dose combinations (FDCs) involving TAF and DTG. There are multiple novel ARV drugs in Phase III of clinical development including new class of drugs that, if successfully developed, could benefit both the patients and funders
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