Evolución temporal de la terapia antirretroviral (2017-2021): análisis de la modificación del tratamiento y su impacto económico / Temporal evolution of antiretroviral therapy (2017-2021): analysis of treatment change and its economic impact

Objetivos. Analizar las modificaciones de la terapia antirre troviral (TAR) y su impacto económico en la práctica clínica diaria. Material y métodos. Estudio observacional, retrospectivo de los pacientes que iniciaron TAR entre 01/2017-12/2021 (se guimiento hasta 12/2022). Variables recogidas: TAR, duración, motivo del cambio y costes del tratamiento. Resultados. 280 pacientes iniciaron TAR. La mediana de durabilidad de la 1ª línea fue: 19,9 meses en 2017 (IC95% 13,9-25,9), 12,2 meses en 2018 (IC95% 4,7-19,7), 27,4 meses en 2019 (IC95% 6,8-48,1) y no se alcanzó la mediana para los años 2020 y 2021 (p p<0,001). De un total de 541 líneas prescri tas, la triple terapia con inhibidores de la proteasa se modificó en el 63,8% (81/127), seguido de los inhibidores de la integrasa 52,1% (159/305), mientras que, la terapia dual (DTG/3TC) solo en el 8,3% (7/84). De un total de 261 modificaciones, la simpli ficación/optimización 47,5% (124/261) fue el principal motivo, seguido de efectos adversos 21,8% (57/261), siendo el 2017 el único año donde ambos motivos se encontraban al mismo nivel. El impacto económico de los cambios supusieron una re ducción del coste medio de 34,0€ [-391,4 a +431,4] al mes/ paciente. El año 2019 es el único año donde estos cambios se asociaron con un incremento del coste adicional medio (23,4€ [-358,3 a +431,4]). Conclusiones. Dejando atrás el fracaso virológico, la sim plificación a regímenes de un solo comprimido y de mayor tolerancia han marcado la nueva la era TAR. Con un impacto económico que, a pesar del punto de inflexión del 2019, refleja una reducción progresiva de costes mantenida en el tiempo (AU)

Objectives. To analyze the modifications of antiretrovi ral therapy (ART) and their economic impact on daily clinical practice. Material and methods. Observational, retrospective study of patients who started ART between 01/2017-12/2021 (follow-up until 12/2022). Variables collected: prescribed ART, duration, the reason for the change, and treatment costs. Results. A total of 280 patients initiated ART therapy. The median durability of 1st line was: 19.9 months in 2017 (95%CI 13.9-25.9), 12.2 months in 2018 (95%CI 4.7-19.7), 27.4 months in 2019 (95%CI 6.8-48.1) and the median was not reached for the years 2020 and 2021 (p<0.001). Triple therapy with protease inhibitors was changed in 63.8% (81/127) of cases, followed by integrase inhibitors 52.1% (159/305), while dual therapy (DTG/3TC) only in 8.3% (7/84). The main cause of dis continuation was simplification/optimization 47.5% (124/261), followed by adverse effects 21.8% (57/261), with 2017 being the only year where simplification/optimization was at the same level as adverse effects. The economic impact of ART changes resulted in an average cost reduction of 34.0€ [-391.4 to +431.4] per month per patient. The year 2019 stands out as the only year where these changes were associated with an increase in mean additional cost (23.4€ [-358.3 to +431.4]). Conclusions. Optimization/simplification accounts for almost half of the reasons for TAR change, with an econom ic impact that, despite the inflection point of 2019, each year manages to exceed the previous one, achieving a progressive cost reduction maintained over time (AU)

Economic and modeling evidence for tuberculosis preventive therapy among people living with HIV: A systematic review and meta-analysis.

BACKGROUND: Human immunodeficiency virus (HIV) is the strongest known risk factor for tuberculosis (TB) through its impairment of T-cell immunity. Tuberculosis preventive treatment (TPT) is recommended for people living with HIV (PLHIV) by the World Health Organization, as it significantly reduces the risk of developing TB disease. We conducted a systematic review and meta-analysis of modeling studies to summarize projected costs, risks, benefits, and impacts of TPT use among PLHIV on TB-related outcomes. METHODS AND FINDINGS: We searched MEDLINE, Embase, and Web of Science from inception until December 31, 2020. Two reviewers independently screened titles, abstracts, and full texts; extracted data; and assessed quality. Extracted data were summarized using descriptive analysis. We performed quantile regression and random effects meta-analysis to describe trends in cost, effectiveness, and cost-effectiveness outcomes across studies and identified key determinants of these outcomes. Our search identified 6,615 titles; 61 full texts were included in the final review. Of the 61 included studies, 31 reported both cost and effectiveness outcomes. A total of 41 were set in low- and middle-income countries (LMICs), while 12 were set in high-income countries (HICs); 2 were set in both. Most studies considered isoniazid (INH)-based regimens 6 to 2 months long (n = 45), or longer than 12 months (n = 11). Model parameters and assumptions varied widely between studies. Despite this, all studies found that providing TPT to PLHIV was predicted to be effective at averting TB disease. No TPT regimen was substantially more effective at averting TB disease than any other. The cost of providing TPT and subsequent downstream costs (e.g. post-TPT health systems costs) were estimated to be less than $1,500 (2020 USD) per person in 85% of studies that reported cost outcomes (n = 36), regardless of study setting. All cost-effectiveness analyses concluded that providing TPT to PLHIV was potentially cost-effective compared to not providing TPT. In quantitative analyses, country income classification, consideration of antiretroviral therapy (ART) use, and TPT regimen use significantly impacted cost-effectiveness. Studies evaluating TPT in HICs suggested that TPT may be more effective at preventing TB disease than studies evaluating TPT in LMICs; pooled incremental net monetary benefit, given a willingness-to-pay threshold of country-level per capita gross domestic product (GDP), was $271 in LMICs (95% confidence interval [CI] -$81 to $622, p = 0.12) and was $2,568 in HICs (-$32,115 to $37,251, p = 0.52). Similarly, TPT appeared to be more effective at averting TB disease in HICs; pooled percent reduction in active TB incidence was 20% (13% to 27%, p < 0.001) in LMICs and 37% (-34% to 100%, p = 0.13) in HICs. Key limitations of this review included the heterogeneity of input parameters and assumptions from included studies, which limited pooling of effect estimates, inconsistent reporting of model parameters, which limited sample sizes of quantitative analyses, and database bias toward English publications. CONCLUSIONS: The body of literature related to modeling TPT among PLHIV is large and heterogeneous, making comparisons across studies difficult. Despite this variability, all studies in all settings concluded that providing TPT to PLHIV is potentially effective and cost-effective for preventing TB disease.

Cost and cost-effectiveness of a universal HIV testing and treatment intervention in Zambia and South Africa: evidence and projections from the HPTN 071 (PopART) trial.

BACKGROUND: The HPTN 071 (PopART) trial showed that a combination HIV prevention package including universal HIV testing and treatment (UTT) reduced population-level incidence of HIV compared with standard care. However, evidence is scarce on the costs and cost-effectiveness of such an intervention. METHODS: Using an individual-based model, we simulated the PopART intervention and standard care with antiretroviral therapy (ART) provided according to national guidelines for the 21 trial communities in Zambia and South Africa (for all individuals aged >14 years), with model parameters and primary cost data collected during the PopART trial and from published sources. Two intervention scenarios were modelled: annual rounds of PopART from 2014 to 2030 (PopART 2014-30; as the UNAIDS Fast-Track target year) and three rounds of PopART throughout the trial intervention period (PopART 2014-17). For each country, we calculated incremental cost-effectiveness ratios (ICERs) as the cost per disability-adjusted life-year (DALY) and cost per HIV infection averted. Cost-effectiveness acceptability curves were used to indicate the probability of PopART being cost-effective compared with standard care at different thresholds of cost per DALY averted. We also assessed budget impact by projecting undiscounted costs of the intervention compared with standard care up to 2030. FINDINGS: During 2014-17, the mean cost per person per year of delivering home-based HIV counselling and testing, linkage to care, promotion of ART adherence, and voluntary medical male circumcision via community HIV care providers for the simulated population was US$6·53 (SD 0·29) in Zambia and US$7·93 (0·16) in South Africa. In the PopART 2014-30 scenario, median ICERs for PopART delivered annually until 2030 were $2111 (95% credible interval [CrI] 1827-2462) per HIV infection averted in Zambia and $3248 (2472-3963) per HIV infection averted in South Africa; and $593 (95% CrI 526-674) per DALY averted in Zambia and $645 (538-757) per DALY averted in South Africa. In the PopART 2014-17 scenario, PopART averted one infection at a cost of $1318 (1098-1591) in Zambia and $2236 (1601-2916) in South Africa, and averted one DALY at $258 (225-298) in Zambia and $326 (266-391) in South Africa, when outcomes were projected until 2030. The intervention had almost 100% probability of being cost-effective at thresholds greater than $700 per DALY averted in Zambia, and greater than $800 per DALY averted in South Africa, in the PopART 2014-30 scenario. Incremental programme costs for annual rounds until 2030 were $46·12 million (for a mean of 341 323 people) in Zambia and $30·24 million (for a mean of 165 852 people) in South Africa. INTERPRETATION: Combination prevention with universal home-based testing can be delivered at low annual cost per person but accumulates to a considerable amount when scaled for a growing population. Combination prevention including UTT is cost-effective at thresholds greater than $800 per DALY averted and can be an efficient strategy to reduce HIV incidence in high-prevalence settings. FUNDING: US National Institutes of Health, President's Emergency Plan for AIDS Relief, International Initiative for Impact Evaluation, Bill & Melinda Gates Foundation.

Development of a Mathematical Model to Estimate the Cost-Effectiveness of HRSA's Ryan White HIV/AIDS Program.

BACKGROUND: The Health Resources and Services Administration's Ryan White HIV/AIDS Program provides services to more than half of all people diagnosed with HIV in the United States. We present and validate a mathematical model that can be used to estimate the long-term public health and cost impact of the federal program. METHODS: We developed a stochastic, agent-based model that reflects the current HIV epidemic in the United States. The model simulates everyone's progression along the HIV care continuum, using 2 network-based mechanisms for HIV transmission: injection drug use and sexual contact. To test the validity of the model, we calculated HIV incidence, mortality, life expectancy, and lifetime care costs and compared the results with external benchmarks. RESULTS: The estimated HIV incidence rate for men who have sex with men (502 per 100,000 person years), mortality rate of all people diagnosed with HIV (1663 per 100,000 person years), average life expectancy for individuals with low CD4 counts not on antiretroviral therapy (1.52-3.78 years), and lifetime costs ($362,385) all met our validity criterion of within 15% of external benchmarks. CONCLUSIONS: The model represents a complex HIV care delivery system rather than a single intervention, which required developing solutions to several challenges, such as calculating need for and receipt of multiple services and estimating their impact on care retention and viral suppression. Our strategies to address these methodological challenges produced a valid model for assessing the cost-effectiveness of the Ryan White HIV/AIDS Program.

COVID-19 pandemic and antiretrovirals (ARV) availability in Nigeria: recommendations to prevent shortages.

HIV/AIDS is an infectious disease that has claimed the lives of millions of people worldwide. Currently, there is no vaccine that has been developed in a bid to fight this deadly infection, however, antiretrovirals (ARVs), which are drugs used in the treatment of HIV infection are routinely prescribed to infected persons. They act via several mechanisms of action to reduce the severity of infection and rate of infectivity of the virus by decreasing the viral load while increasing CD4 counts. COVID-19 pandemic has resulted in unprecedented events affecting almost all areas of humans' life including availability of medicines and other consumables. This paper analyses the availability of ARVs during COVID-19 era and offered recommendations to be adopted in order to prevent shortages.

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2020 Recommendations of the International Antiviral Society-USA Panel.

Importance: Data on the use of antiretroviral drugs, including new drugs and formulations, for the treatment and prevention of HIV infection continue to guide optimal practices. Objective: To evaluate new data and incorporate them into current recommendations for initiating HIV therapy, monitoring individuals starting on therapy, changing regimens, preventing HIV infection for those at risk, and special considerations for older people with HIV. Evidence Review: New evidence was collected since the previous International Antiviral (formerly AIDS) Society-USA recommendations in 2018, including data published or presented at peer-reviewed scientific conferences through August 22, 2020. A volunteer panel of 15 experts in HIV research and patient care considered these data and updated previous recommendations. Findings: From 5316 citations about antiretroviral drugs identified, 549 were included to form the evidence basis for these recommendations. Antiretroviral therapy is recommended as soon as possible for all individuals with HIV who have detectable viremia. Most patients can start with a 3-drug regimen or now a 2-drug regimen, which includes an integrase strand transfer inhibitor. Effective options are available for patients who may be pregnant, those who have specific clinical conditions, such as kidney, liver, or cardiovascular disease, those who have opportunistic diseases, or those who have health care access issues. Recommended for the first time, a long-acting antiretroviral regimen injected once every 4 weeks for treatment or every 8 weeks pending approval by regulatory bodies and availability. For individuals at risk for HIV, preexposure prophylaxis with an oral regimen is recommended or, pending approval by regulatory bodies and availability, with a long-acting injection given every 8 weeks. Monitoring before and during therapy for effectiveness and safety is recommended. Switching therapy for virological failure is relatively rare at this time, and the recommendations for switching therapies for convenience and for other reasons are included. With the survival benefits provided by therapy, recommendations are made for older individuals with HIV. The current coronavirus disease 2019 pandemic poses particular challenges for HIV research, care, and efforts to end the HIV epidemic. Conclusion and Relevance: Advances in HIV prevention and management with antiretroviral drugs continue to improve clinical care and outcomes among individuals at risk for and with HIV.

Provider- and patient-level costs associated with providing antiretroviral therapy during the postpartum phase to women living with HIV in South Africa: A cost comparison of three postpartum models of care.

OBJECTIVE: To compare the unit and total costs of three models of ART care for mother-infant pairs during the postpartum phase from provider and patient's perspectives: (i) local standard of care with women in general ART services and infants at well-baby clinics; (ii) women and infants continue to receive care through an integrated maternal and child care approach during the postpartum breastfeeding period; and (iii) referral of women directly to community adherence clubs with their infants receiving care at well-baby clinics. METHODS: Capital and recurrent cost data (relating to buildings, furniture, equipment, personnel, overheads, maintenance, medication, diagnostic tests and immunisations) were collected from a provider's perspective at six sites in Cape Town, South Africa. Patient time, collected via time-and-motion observation and questionnaires, was used to estimate patient perspective costs and is comprised of lost productivity time, time spent travelling and the direct cost of travelling. RESULTS: The cost of postpartum ART visits under models I, II and III was US $13, US $10 and US $7 per visit for a mother-infant pair, respectively, in 2018 US$. The annual costs for the mother-infant pair utilising the average visit frequencies (a mean of 4.5, 6.9 and 6.7 visits postpartum for models I, II and III, respectively) including costs for infant immunisations, visits, medication and diagnostic tests for both mothers and infants were: I - US $222, II - US $335 and III - US $249. Sensitivity analysis to assess the impact of visit frequency on visit cost showed that Model I annual costs would be most costly if visit frequency was equalised. CONCLUSION: This comparative analysis of three models of care provides novel data on unit costs and insight into the costs to provide ART and care to mother-infant pairs during the delicate postpartum phase. These costs may be used to help make decisions around integrated services models and differentiated service delivery for postpartum WLH and their children.

OBJECTIF: Comparer le coût et unitaire et total de trois modèles de soins ART pour les paires mère-enfant pendant la phase post-partum selon les perspectives du fournisseur et du patient: (I) - normes locales des soins avec les femmes dans les services généraux de l'ART et les nourrissons dans les cliniques de bien-être pour bébés; (II) - les femmes et les nourrissons continuent de recevoir des soins via une approche intégrée de soins maternels et infantiles pendant la période d'allaitement post-partum; et (III) - orientation des femmes directement vers les clubs d'adhésion communautaires, leurs nourrissons recevant des soins dans les cliniques de bien-être pour bébés pour bébés. MÉTHODES: Les données sur les coûts d'investissement et les coûts récurrents (relatifs aux bâtiments, au mobilier, à l'équipement, au personnel, aux frais généraux, à l'entretien, aux médicaments, aux tests de diagnostic et aux vaccinations) ont été recueillies selon le point de vue du prestataire sur six sites à Cape Town, en Afrique du Sud. Le temps du patient, recueilli via l'observation du temps et des mouvements et des questionnaires, a été utilisé pour estimer les coûts selon le point de vue du patient, et comprend le temps de productivité perdu, le temps passé en déplacement et le coût direct du déplacement. RÉSULTATS: Le coût des visites ART post-partum dans les modèles I, II et III était respectivement de 13 USD, 10 USD et 7 USD par visite pour une paire mère-enfant en USD de 2018. Les coûts annuels pour la paire mère-enfant en utilisant la fréquence moyenne des visites (une moyenne de 4,5 ; 6,9 et 6,7 visites post-partum pour les modèles I, II et III respectivement), y compris les coûts des vaccinations infantiles, des visites, des médicaments et des tests diagnostiques pour les mères et les nourrissons étaient: I - 222 USD, II - 335 USD et III - 249 USD. L'analyse de sensibilité pour évaluer l'impact de la fréquence des visites sur le coût des visites a montré que les coûts annuels du modèle I seraient les plus élevés si la fréquence des visites était égalisée. CONCLUSIONS: Cette analyse comparative de trois modèles de soins fournit de nouvelles données sur les coûts unitaires et un aperçu des coûts de fourniture de l'ART et de soins aux paires mère-enfant pendant la phase délicate du post-partum. Ces coûts peuvent être utilisés pour aider à la prise des décisions concernant les modèles de services intégrés et la prestation de services différenciés pour les femmes en période de post-partum et leurs enfants.

Achieving HIV targets by 2030: the possibility of using debt relief funds for sustainable HIV treatment in sub-Saharan Africa.

This paper assesses the possibility of using debt relief funds to sustain HIV treatment in sub-Saharan Africa, suppress transmission, and reach global goals to quell the epidemic by 2030. The cost of providing antiretroviral treatment is a huge burden on African countries. Concerns for Africa's capacity to keep pace with global advances are well founded. By analysing levels of 'debt distress', health expenditure per capita, and HIV antiretroviral therapy requirements in sub-Saharan African countries, the need for innovative finance with international cooperation emerges clearly. In addition to the HIV epidemic, African countries may become more vulnerable to disasters and other public health diseases such as malaria, tuberculosis, Ebola and COVID-19, especially without alternatives to current means of financing. Relief from debt service payments could release funds for sub-Saharan African countries to support universal HIV antiretroviral treatment with sustainable results.

Opportunities for improved HIV prevention and treatment through budget optimization in Eswatini.

INTRODUCTION: Eswatini achieved a 44% decrease in new HIV infections from 2014 to 2019 through substantial scale-up of testing and treatment. However, it still has one of the highest rates of HIV incidence in the world, with 14 infections per 1,000 adults 15-49 years estimated for 2017. The Government of Eswatini has called for an 85% reduction in new infections by 2023 over 2017 levels. To make further progress towards this target and to achieve maximum health gains, this study aims to model optimized investments of available HIV resources. METHODS: The Optima HIV model was applied to estimate the impact of efficiency strategies to accelerate prevention of HIV infections and HIV-related deaths. We estimated the number of infections and deaths that could be prevented by optimizing HIV investments. We optimize across HIV programs, then across service delivery modalities for voluntary medical male circumcision (VMMC), HIV testing, and antiretroviral refill, as well as switching to a lower cost antiretroviral regimen. FINDINGS: Under an optimized budget, prioritising HIV testing for the general population followed by key preventative interventions may result in approximately 1,000 more new infections (2% more) being averted by 2023. More infections could be averted with further optimization between service delivery modalities across the HIV cascade. Scaling-up index and self-testing could lead to 100,000 more people getting tested for HIV (25% more tests) with the same budget. By prioritizing Fast-Track, community-based, and facility-based antiretroviral refill options, an estimated 30,000 more people could receive treatment, 17% more than baseline or US$5.5 million could be saved, 4% of the total budget. Finally, switching non-pregnant HIV-positive adults to a Dolutegravir-based antiretroviral therapy regimen and concentrating delivery of VMMC to existing fixed facilities over mobile clinics, US$4.5 million (7% of total budget) and US$6.6 million (10% of total budget) could be saved, respectively. SIGNIFICANCE: With a relatively short five-year timeframe, even under a substantially increased and optimized budget, Eswatini is unlikely to reach their ambitious national prevention target by 2023. However, by optimizing investment of the same budget towards highly cost-effective VMMC, testing, and treatment modalities, further reductions in HIV incidence and cost savings could be realized.

Costs and Cost Drivers of Providing Option B+ Services to Mother-Baby Pairs for PMTCT of HIV in Health Centre IV Facilities in Jinja District, Uganda.

BACKGROUND: In 2013, the World Health Organization (WHO) revised the 2012 guidelines on use of antiretroviral drugs (ARVs) for the prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV). The new guidelines recommended lifelong antiretroviral therapy (ART) for all HIV-positive pregnant and breastfeeding women irrespective of CD4 count or clinical stage (also referred to as Option B+). Uganda started implementing Option B+ in 2012 basing on the 2012 WHO guidelines. Despite the impressive benefits of the Option B+ strategy, implementation challenges, including cost burden and mother-baby pairs lost to follow-up, threatened its overall effectiveness. The researchers were unable to identify any studies conducted to assess costs and cost drivers associated with provision of Option B+ services to mother-baby pairs in HIV care in Uganda. Therefore, this study determined costs and cost drivers of providing Option B+ services to mother-baby pairs over a two-year period (2014-2015) in selected health facilities in Jinja district, Uganda. METHODS: The estimated costs of providing Option B+ to mother-baby pairs derived from the provider perspective were evaluated at four health centres (HC) in Jinja district. A retrospective, ingredient-based costing approach was used to collect data for 2014 as base year using a standardized cost data capture tool. All costs were valued in United States dollars (USD) using the 2014 midyear exchange rate. Costs incurred in the second year (2015) were obtained by inflating the 2014 costs by the ratio of 2015 and 2014 USA Gross Domestic Product (GDP) implicit price deflator. RESULTS: The average total cost of Option B+ services per HC was 66,512.7 (range: 32,168.2-102,831.1) USD over the 2-year period. The average unit cost of Option B+ services per mother-baby pair was USD 441.9 (range: 422.5-502.6). ART for mothers was the biggest driver of total mean costs (percent contribution: 62.6%; range: 56.0%-65.5%) followed by facility personnel (percent contribution: 8.2%; range: 7.7%-11.6%), and facility-level monitoring and quality improvement (percent contribution: 6.0%; range: 3.2%-12.3%). Conclusions and Recommendations. ART for mothers was the major cost driver. Efforts to lower the cost of ART for PMTCT would make delivery of Option B+ affordable and sustainable.

Treatment as insurance: HIV antiretroviral therapy offers financial risk protection in Malawi.

Many countries have expanded insurance programmes in an effort to achieve universal health coverage (UHC). We assess a complementary path toward financial risk protection: increased access to technologies that improve health and reduce the risk of large health expenditures. Malawi has provided free HIV treatment since 2004 with significant US Government support. We investigate the impact of treatment access on medical spending, capacity to pay and catastrophic health expenditures at the population level, exploiting the phased rollout of HIV treatment in a difference-in-differences design. We find that increased access to HIV treatment generated a 10% decline in medical spending for urban households, a 7% increase in capacity to pay for rural households and a 3-percentage point decrease in the likelihood of catastrophic health expenditure among urban households. These risk protection benefits are comparable to that found from broad-based insurance coverage in other contexts. Our findings show that targeted treatment programmes that provide free care for high burden causes of death can provide substantial financial risk protection against catastrophic health expenditure, while moving developing nations toward UHC.

Assessment of out-of-pocket and catastrophic expenses incurred by patients with Human Immunodeficiency Virus (HIV) in availing free antiretroviral therapy services in India.

OBJECTIVES: With the free availability of antiretroviral therapy in India, one expects that the out-of-pocket (OOP) expenditure would reduce and would not be a significant financial burden. However, the cost of seeking care is also dependent on accessibility of services, as well as other non-medical and indirect expenses. This study aims to analyze the OOP expenditure in availing antiretroviral therapy (ART) services and determine the prevalence and pattern of catastrophic and impoverishing health expenditure. The study also discusses the policy implications of these findings in the light of growing commitment toward universal health coverage. STUDY DESIGN: This was a cross-sectional study. METHODS: A total of 434 patients receiving antiretroviral treatment were interviewed. OOP expenses included a measure of direct medical expenditure, non-medical expenditure, and indirect expenditure incurred in availing ART services. A threshold level of 40% of 'capacity to pay' was taken as catastrophic expenditure. Based on previous research, different demographic, socio-economic, and clinical factors were selected as independent variables to determine their association with catastrophic expenditure. Logistic regression was conducted to study the association between independent and dependent variables keeping the level of significance at <0.05. RESULTS: The mean OOP expenditure among patients with human immunodeficiency virus (HIV) taking ART was Rs. 238.8 ± 193.7. Majority of these expenses were incurred on non-medical expenditure (58.1%), while indirect expenditure accounted for 29.7%. The direct health expenditure was the lowest (12.2%) type of expenditure in the total OOP expenditure. OOP spending was catastrophic in 8.1% (35/434) of households in our study. Patients belonging to nuclear family (odds ratio [OR] = 2.99; 95% confidence interval [CI] = 1.19-7.58), who are unemployed (OR = 2.56; 95% CI = 1.18-5.54), of lower socio-economic classes (OR = 8.46; 95% CI = 1.93-37.02), those who traveled more than 50 km for getting drugs (OR = 2.80; 95% CI = 1.26-6.23), and those having CD4 cell count lower than 200 (OR = 3.11; 95% CI = 1.32-7.32) were found to be independently and significantly associated with catastrophic OOP health expenditure among patients with HIV. CONCLUSIONS: A high direct and indirect expenditure was observed among patients with HIV seeking treatment in North India leading to catastrophic expenditure in a significant number of households. A service-level integration of HIV care at subdistrict levels within the Universal health coverage (UHC) framework could reduce catastrophic expenditure.

Cost-Effectiveness of antiretroviral therapy: A systematic review.

BACKGROUND: The mobilization of resources to prevent and treat human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) is unparalleled in the history of public health. The uptake of antiretroviral therapy (ART) has been rapid and unprecedented and made possible by the availability of funding - external and domestic. To justify continuous funding of ART in resource-scarce settings, a spate of cost-effectiveness studies has been undertaken in a number of countries. This paper is based on a systematic review of global studies on cost-effectiveness analysis of ART. OBJECTIVES: The major objective was to review the existing literature on cost-effectiveness of ART to determine whether ART has been cost-effective (CE) in different settings. METHODS: We searched PubMed and Google Scholar for articles published between 2008 and 2017. We included studies that measured costs as well as effectiveness of HIV treatment - specifically ART - using incremental cost-effectiveness ratio as one of the outcomes. RESULTS: We identified 15 studies that met the search criteria for inclusion in the systematic review. The review confirms that ART programs have been CE across different settings, contexts, and strategies. CONCLUSION: The review would be useful for countries that are straining to raise funds for the health sector, generally, and for AIDS prevention and control program, specifically. This would also be beneficial for carrying out similar studies, if necessary, and as an advocacy tool for garnering additional funding.

A Descriptive Study of HIV Patients Highly Adherent to Antiretroviral.

HIV medication adherence is a topic of major public health concern in the United States. Adherent patients may be less likely to experience treatment failure, AIDS presentations and extreme medical costs. We evaluate a cohort of highly adherent Medicare beneficiaries to establish if the out of pocket costs of HIV medications are an inherent barrier to adherence. We analyzed a 100% sample of Medicare Part-D prescription medications. The drug and out ofpocket costs for HIV and non-HIV medications of highly adherent cohort were extracted and analyzed. The average gross drug cost per beneficiary was $34,029for HIV medications and $11,439for non-HIV medications. Average out of pocket costs per beneficiary was $454for HIV medications and $129 for non-HIV medications. Out of pocket costs do not reasonably appear to be a barrier to adherence for Part-D beneficiaries.

Comparative analyses of published cost effectiveness models highlight critical considerations which are useful to inform development of new models.

Background: Comparative analyses of published cost effectiveness models provide useful insights into critical issues to inform the development of new cost effectiveness models in the same disease area.Objective: The purpose of this study was to describe a comparative analysis of cost-effectiveness models and highlight the importance of such work in informing development of new models. This research uses genotypic antiretroviral resistance testing after first line treatment failure for Human Immunodeficiency Virus (HIV) as an example.Method: A literature search was performed, and published cost effectiveness models were selected according to predetermined eligibility criteria. A comprehensive comparative analysis was undertaken for all aspects of the models.Results: Five published models were compared, and several critical issues were identified for consideration when developing a new model. These include the comparator, time horizon and scope of the model. In addition, the composite effect of drug resistance prevalence, antiretroviral therapy efficacy, test performance and the proportion of patients switching to second-line ART potentially have a measurable effect on model results. When considering CD4 count and viral load, dichotomizing patients according to higher cost and lower quality of life (AIDS) versus lower cost and higher quality of life (non-AIDS) status will potentially capture differences between resistance testing and other strategies, which could be confirmed by cross-validation/convergent validation. A quality adjusted life year is an essential outcome which should be explicitly explored in probabilistic sensitivity analysis, where possible.Conclusions: Using an example of GART for HIV, this study demonstrates comparative analysis of previously published cost effectiveness models yields critical information which can be used to inform the structure and specifications of new models.