Dataset Information

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

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.

SUBMITTER: Gupta A

PROVIDER: S-EPMC5063297 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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

Gupta Aastha A Juneja Sandeep S Vitoria Marco M Habiyambere Vincent V Nguimfack Boniface Dongmo BD Doherty Meg M Low-Beer Daniel D

PloS one 20161013 10

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 peopl ...[more]

PMID: 27736953

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Project description:Adolescents and youth living with HIV have poorer antiretroviral treatment (ART) adherence and viral suppression outcomes than all other age groups. Effective interventions promoting adherence are urgently needed. We reviewed and synthesized recent literature on interventions to improve ART adherence among this vulnerable population. We focus on studies conducted in low- and middle-income countries (LMIC) where the adolescent and youth HIV burden is greatest. Articles published between September 2015 and January 2019 were identified through PubMed. Inclusion criteria were: [1] included participants ages 10-24 years; [2] assessed the efficacy of an intervention to improve ART adherence; [3] reported an ART adherence measurement or viral load; [4] conducted in a LMIC. Articles were reviewed for study population characteristics, intervention type, study design, outcomes measured, and intervention effect. Strength of each study's evidence was evaluated according to an adapted World Health Organization GRADE system. Articles meeting all inclusion criteria except being conducted in an LMIC were reviewed for results and potential transportability to a LMIC setting. Of 108 articles identified, 7 met criteria for inclusion. Three evaluated patient-level interventions and four evaluated health services interventions. Of the patient-level interventions, two were experimental designs and one was a retrospective cohort study. None of these interventions improved ART adherence or viral suppression. Of the four health services interventions, two targeted stable patients and reduced the amount of time spent in the clinic or grouped patients together for bi-monthly meetings, and two targeted patients newly diagnosed with HIV or not yet deemed clinically stable and augmented clinical care with home-based case-management. The two studies targeting stable patients used retrospective cohort designs and found that adolescents and youth were less likely to maintain viral suppression than children or adults. The two studies targeting patients not yet deemed clinically stable included one experimental and one retrospective cohort design and showed improved ART adherence and viral suppression outcomes. ART adherence and viral suppression outcomes remain a major challenge among adolescents and youth. Intensive home-based case management models of care hold promise for improving outcomes in this population and warrant further research.

Project description:AimDiabetes is a growing burden especially in low and middle income countries (LMICs). Inadequate access to diabetes care is of particular concern and selection of appropriate diabetes medicines on national essential medicines lists (NEMLs) is a first step in achieving adequate access. This selection was studied among LMICs and influences of various factors associated with selection decisions were assessed.MethodsCountries were studied if they employed NEMLs for reimbursement or procurement purposes. Presence and number of essential diabetes medicines from different classes, both insulins and oral blood glucose lowering medicines, were surveyed and calculated. Data were also analyzed by country income level, geographic region, year of last update of the NEML and purpose of NEML employment. The effect of prevalence and burden of disease on the number of essential diabetes medicines was also studied. Non parametric tests and univariate linear regression analysis were used.ResultsNearly all countries (n?=?32) had chosen fast (97%) and intermediate acting insulin (93%), glibenclamide and metformin (100% both) as essential medicines. The median number of essential diabetes medicines was 6, equally divided between insulins and oral medicines. 20% of the countries had selected insulin analogues as essential medicines. Among all the studied factors, an increase in burden of diabetes and wealth of countries were associated with selection of higher numbers of essential diabetes medicines (p?=?0.02 in both cases).ConclusionsNearly all the studied LMICs had included the minimum required medicines for diabetes management in their NEMLs. Selection can still be improved (e.g. exclusion of insulin analogues and replacement of glibenclamide by gliclazide). Nevertheless, the known suboptimal and inconsistent availability of essential diabetes medicines in LMICs cannot be explained by inadequate selection of essential medicines. Countries should therefore be encouraged to give precedence to implementation of NEMLs to make essential diabetes medicines more accessible.

Project description:BackgroundAntiretroviral therapy (ART) management is challenging for individuals in resource-limited settings presenting for third-line treatment because of complex resistance patterns, partly due to reduced access to viral load monitoring. We aimed to evaluate use of newer antiretroviral drugs and contemporary management approaches, including population-based sequencing, to select appropriate antiretrovirals, plasma viral load monitoring, and interventions to improve adherence in individuals presenting with second-line viral failure.MethodsA5288 was a phase 4, third-line ART strategy study done at 19 urban sites in ten countries that enrolled adult participants with confirmed plasma HIV-1 RNA (viral load) of 1000 copies per mL or more after more than 24 weeks of protease inhibitor-based second-line ART. The primary objective was to use antiretrovirals (raltegravir, etravirine, and ritonavir-boosted darunavir) and diagnostic monitoring technologies, including viral load, genotyping, and adherence support to achieve viral load suppression (defined as ≤200 copies per mL) in 65% or more of participants. ART history and real-time drug resistance genotypes were used to assign participants to one of four cohorts: cohort A (no lopinavir resistance) stayed on second-line ART and cohorts B (B1, best available nucleoside reverse transcriptase inhibitors [NRTIs] plus ritonavir-boosted darunavir plus raltegravir; B2, ritonavir-boosted darunavir plus raltegravir plus etravirine; B3, ritonavir-boosted darunavir, raltegravir, and either tenofovir plus emtricitabine or tenofovir plus lamivudine), C (ritonavir-boosted darunavir plus raltegravir plus tenofovir-emtricitabine or tenofovir plus lamivudine), and D (best available NRTIs plus ritonavir-boosted darunavir plus raltegravir) were defined by increasing levels of resistance and received appropriate regimens, including new antiretrovirals. Participants in Cohort B without detectable hepatitis B surface antigen were assigned by blocked randomisation to cohorts B1 and B2, and those with detectable hepatitis B surface antigen were assigned to cohort B3. The trial is registered with ClinicalTrials.gov, number NCT01641367.FindingsFrom Jan 10, 2013, to Sept 10, 2015, 545 participants were enrolled. 287 (53%) were assigned to cohort A, 74 (14%) to B1, 72 (13%) to B2, eight (1%) to B3, 70 (13%) to C, and 34 (6%) to D. Overall, 349 (64%, 95% CI 60-68) participants achieved viral suppression at week 48, with proportions varying from 125 (44%) of 287 in cohort A to 65 (88%) of 74 in cohort B1, 63 (88%) of 72 in B2, eight (100%) of eight in B3, 63 (90%) of 70 in C, and 25 (74%) of 34 in D. Participants in cohort A remained on their second-line protease inhibitor, and had the most participants with grade 3 or higher adverse events (147 [51%]).InterpretationTargeted real-time genotyping to select third-line ART can appropriately allocate more costly antiretrovirals to those with greater levels of HIV drug resistance.FundingNational Institutes of Health.

Project description:ObjectivePrior studies have reported inequitable global access to essential medicines for cardiovascular disease (CVD) prevention, especially statins. Here we examine recent trends and disparities in statin utilisation at the income group, regional and country levels.DesignEcological study. Pharmaceutical sales data were used to examine statin utilisation in high-income counties (HICs) and low/middle-income countries (LMICs) from 2015 to 2020. Population estimates were obtained from the Global Burden of Disease. Fixed-effects panel regression analysis was used to examine associations between statin utilisation and country-level factors.SettingGlobal, including 41 HICs and 50 LMICs.ParticipantsPopulation older than 40 years of age.Primary and secondary outcome measuresStatin utilisation was measured using defined daily doses (DDDs) per 1000 population ≥40 years per day (TPD).ResultsGlobally, statin utilisation increased 24.7% from 54.7 DDDs/TPD in 2015 to 68.3 DDDs/TPD in 2020. However, regional and income group disparities persisted during this period. In 2020, statin utilisation was more than six times higher in HICs than LMICs (192.4 vs 28.4 DDDs/TPD, p<0.01). Substantial disparities were also observed between LMICs, ranging from 3.1 DDDs/TPD in West African nations to 225.0 DDDs/TPD in Lebanon in 2020. While statin utilisation increased in most LMICs between 2015 and 2020, several experienced declines in utilisation, most notably Venezuela (-85.1%, from 92.3 to 14.0 DDDs/TPD). In LMICs, every $100 increase in per capita health spending was associated with a 17% increase in statin utilisation, while every 10% increase in out-of-pocket health spending was associated with a 11% decline (both p<0.05).ConclusionsDespite global increases in statin utilisation, there are substantial regional and country-level disparities between HICs and LMICs. To address global CVD disparities, policymakers should promote increased and equitable access to statins in LMICs.

Project description:BackgroundPrimary health care (PHC) is a driving force for advancing towards universal health coverage (UHC). PHC-oriented health systems bring enormous benefits but require substantial financial investments. Here, we aim to present measures for PHC investments and project the associated resource needs.MethodsThis modelling study analysed data from 67 low-income and middle-income countries (LMICs). Recognising the variation in PHC services among countries, we propose three measures for PHC, with different scope for included interventions and system strengthening. Measure 1 is centred on public health interventions and outpatient care; measure 2 adds general inpatient care; and measure 3 further adds cross-sectoral activities. Cost components included in each measure were based on the Declaration of Astana, informed by work delineating PHC within health accounts, and finalised through an expert and country validation meeting. We extracted the subset of PHC costs for each measure from WHO's Sustainable Development Goal (SDG) price tag for the 67 LMICs, and projected the associated health impact. Estimates of financial resource need, health workforce, and outpatient visits are presented as PHC investment guide posts for LMICs.FindingsAn estimated additional US$200-328 billion per year is required for the various measures of PHC from 2020 to 2030. For measure 1, an additional $32 is needed per capita across the countries. Needs are greatest in low-income countries where PHC spending per capita needs to increase from $25 to $65. Overall health workforces would need to increase from 5·6 workers per 1000 population to 6·7 per 1000 population, delivering an average of 5·9 outpatient visits per capita per year. Increasing coverage of PHC interventions would avert an estimated 60·1 million deaths and increase average life expectancy by 3·7 years. By 2030, these incremental PHC costs would be about 3·3% of projected gross domestic product (GDP; median 1·7%, range 0·1-20·2). In a business-as-usual financing scenario, 25 of 67 countries will have funding gaps in 2030. If funding for PHC was increased by 1-2% of GDP across all countries, as few as 16 countries would see a funding gap by 2030.InterpretationThe resources required to strengthen PHC vary across countries, depending on demographic trends, disease burden, and health system capacity. The proposed PHC investment guide posts advance discussions around the budgetary implications of strengthening PHC, including relevant system investment needs and achievable health outcomes. Preliminary findings suggest that low-income and lower-middle-income countries would need to at least double current spending on PHC to strengthen their systems and universally provide essential PHC services. Investing in PHC will bring substantial health benefits and build human capital. At country level, PHC interventions need to be explicitly identified, and plans should be made for how to most appropriately reorient the health system towards PHC as a key lever towards achieving UHC and the health-related SDGs.FundingThe Bill & Melinda Gates Foundation.

Project description:The incidence and mortality of cardiovascular diseases (CVDs) in low and middle income countries (LMICs) have been increasing, while access to CVDs medicines is suboptimal. We assessed selection of essential medicines for the prevention and treatment of CVDs on national essential medicines lists (NEMLs) of LMICs and potential determinants for selection.Only operational NEMLs were considered eligible for this study. A selection of medicines listed under "cardiovascular medicines" or "blood products and plasma substitutes" in the NEMLs were included if they were present on international guidelines for the prevention and treatment of CVDs (hyperlipidemia, hypertension, platelet inhibition, ischemic stroke, stable ischemic heart disease, acute coronary syndromes, heart failure, atrial fibrillation, peripheral arterial disease and acute limb ischemia). The number and diversity of essential medicines selected for CVDs were studied. Moreover, determinants of selection of essential medicines for CVDs at a national level were explored. Data analysis was done using univariate linear regression and non-parametric tests.All medicine groups listed by the international guidelines were selected by the majority of the 34 countries studied with the exception of adenosine diphosphate receptor inhibitors which appeared on less than half of the NEMLs studied (41% of countries). The total number of essential medicines for the prevention and treatment of cardiovascular diseases (median 24 (range 16-50)) differed significantly across income levels (median range: 19.5-25, p?=?0.014) and across regions (median range: 20-32, p?=?0.049). When recommendations of the international guidelines were considered, over 75% of the NEMLs contained essential medicines for the majority of CVDs.The main medicine classes for the management of CVDs were represented on NEMLs. Consequently, for the majority of CVDs, evidence-based guideline-recommended treatment is possible as far as selection of essential medicines is concerned. Selection will therefore not be the limiting step in access to medicines for cardiovascular diseases.

Dataset Information

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

Publications

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

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