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Projected Uptake of New Antiretroviral (ARV) Medicines in Adults in Low- and Middle-Income Countries: A Forecast Analysis 2015-2025

机译:中低收入国家成年人的新抗逆转录病毒药物的预计摄入量:2015-2025年预测分析

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摘要

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.
机译:随着抗逆转录病毒治疗(ART)规模的扩大将在未来几年内继续进行,至关重要的是,受艾滋病毒/艾滋病大流行打击最严重的中低收入国家(LMIC)的制造商和计划者必须能够预测并应对治疗方案,仿制药销售和需求的未来变化,以确保持续获得所需的所有抗逆转录病毒药物。我们使用世卫组织和联合国艾滋病规划署的二手数据来源进行了预测分析,以估计到2025年中低收入国家中艾滋病毒携带者的数量以及对一系列新药和现有抗逆转录病毒药物的市场份额和需求。联合国艾滋病规划署估计24.7 2020年抗逆转录病毒治疗将达到100万人年,2025年抗逆转录病毒治疗将达到2850万人年(一线治疗为2430万,二线治疗为350万,三线治疗为60万)。我们的分析表明,到2025年,TAF和DTG将成为抗逆转录病毒疗法的主要参与者,分别有800万和1500万患者使用这些抗逆转录病毒药物。然而,由于在怀孕期间以及在使用利福平的结核病/艾滋病毒合并感染的结核病患者中,多洛格韦(DTG)和替诺福韦阿拉芬酰胺(TAF)的安全性和有效性仍存在争议,并且ART扩大规模预计会大大增加,因此仍然存在明确需要持续供应包括TDF和EFV在内的现有抗逆转录病毒药物,预计到2025年将分别使用1600万和1000万患者。重要的是要确保针对抗逆转录病毒药物的仿制药生产商的现有能力由于引入了较低剂量的ARV(例如TAF 25mg和DTG 50mg),因此不会对较高剂量(例如TDF 300mg和EFV 600mg)产生不利影响。随着获得病毒载量测试的机会增加,更多的患者将使用包含二线方案的蛋白酶抑制剂,到2025年,将有100万患者接受LPV / r,230万接受ATV / r。然而,继续监测肝炎仍然很重要。中低收入国家抗逆转录病毒药物市场的发展,以保证这些药物的可用性。

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