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We aimed to calculate the efficiency of the EmERGE Pathway of Care in five European HIV clinics, developed and implemented for medically stable people living with HIV.Participants were followed up for 1 year before and after implementation of EmERGE, between April 2016 and October 2019. Micro-costing studies were performed in the outpatient services of the clinics. Unit costs for outpatient services were calculated in national currencies and converted to US$ 2018 OECD purchasing parity prices to enable between clinic comparisons in terms of outcomes and costs. Unit costs were linked to the mean use of services for medically stable people living with HIV, before and after implementation of EmERGE. Primary outcome measures were CD4 count and viral load; secondary outcomes were patient activation (PAM13) and quality of life (PROQOL-HIV). Out-of-pocket expenditure data were collected.There were 2251 participants: 87-93% were male, mean age at entry was 41-47 years. Medically stable people living with HIV had outpatient visits in four sites which decreased by 9-31% and costs by 5-33%; visits and costs increased by 8% in one site, which had to revert back to face-to-face visits. Antiretroviral drugs comprised 83-91% of annual costs: the Portuguese site had the highest antiretroviral drug costs in US$ purchasing parity prices. Primary and secondary outcome measures of participants did not change during the study.EmERGE is acceptable and provided cost savings in different socio-economic settings. Antiretroviral drug costs remain the main cost drivers in medically stable people living with HIV. While antiretroviral drug prices in local currencies did not differ that much between countries, conversion to US$ purchasing parity prices revealed antiretroviral drugs were more expensive in the least wealthy countries. This needs to be taken into consideration when countries negotiate drug prices with pharmaceutical vendors. Greater efficiencies can be anticipated by extending the use of the EmERGE Pathway to people with complex HIV infection or other chronic diseases. Extending such use should be systematically monitored, implementation should be evaluated and funding should be provided to monitor and evaluate future changes in service provision.

Background: Increased coverage with antiretroviral therapy for people living with HIV in low- and middle-income countries has increased their life expectancy associated with non-HIV comorbidities and the need for quality-assured and affordable non-communicable diseases drugs . Funders are leaving many middle-income countries that will have to pay and provide quality-assured and affordable HIV and non-HIV drugs, including for non-communicable diseases. Objective: To estimate costs for originator and generic antiretroviral therapy as the number of people living with HIV are projected to increase between 2016 and 2026, and discuss country, regional and global factors associated with increased access to generic drugs. Methods: Based on estimates of annual demand and prices, annual cost estimates were produced for generic and originator antiretroviral drug prices in low- and middle-income countries and projected for 2016–2026. Results: Drug costs varied between US$1.5 billion and US$4.8 billion for generic drugs and US$ 8.2 billion and US$16.5 billion for originator drugs between 2016 and 2026. Discussion: The global HIV response increased access to affordable generic drugs in low- and middle-income countries. Cheaper active pharmaceutical ingredients and market competition were responsible for reduced drug costs. The development and implementation of regulatory changes at country, regional and global levels, covering intellectual property rights and public health, and flexibilities in patent laws enabled prices to be reduced. These changes have not yet been applied in many low- and middle-income countries for HIV, nor for other infectious and non-communicable diseases, that lack the profile and political attention of HIV. Licensing backed up with Trade-Related Aspects of Intellectual Property Rights safeguards should become the norm to provide quality-assured and affordable drugs within competitive generic markets. Conclusion: Does the political will exist among policymakers and other stakeholders to develop and implement these country, regional and global frameworks for non-HIV drugs as they did for antiretroviral drugs?

Background: With advances in antiretroviral therapy, most deaths in people with HIV are now attributable to noncommunicable illnesses, especially cardiovascular disease. We determine the association between HIV and cardiovascular disease, and estimate the national, regional, and global burden of cardiovascular disease attributable to HIV. Methods: We conducted a systematic review across 5 databases from inception to August 2016 for longitudinal studies of cardiovascular disease in HIV infection. A random-effects meta-analysis across 80 studies was used to derive the pooled rate and risk of cardiovascular disease in people living with HIV. We then estimated the temporal changes in the population-attributable fraction and disability-adjusted life-years (DALYs) from HIV-associated cardiovascular disease from 1990 to 2015 at a regional and global level. National cardiovascular DALYs associated with HIV for 2015 were derived for 154 of the 193 United Nations member states. The main outcome measure was the pooled estimate of the rate and risk of cardiovascular disease in people living with HIV and the national, regional, and global estimates of DALYs from cardiovascular disease associated with HIV. Results: In 793 635 people living with HIV and a total follow-up of 3.5 million person-years, the crude rate of cardiovascular disease was 61.8 (95% CI, 45.8–83.4) per 10 000 person-years. In comparison with individuals without HIV, the risk ratio for cardiovascular disease was 2.16 (95% CI, 1.68–2.77). Over the past 26 years, the global population–attributable fraction from cardiovascular disease attributable to HIV increased from 0.36% (95% CI, 0.21%–0.56%) to 0.92% (95% CI, 0.55%–1.41%), and DALYs increased from 0.74 (95% CI, 0.44–1.16) to 2.57 (95% CI, 1.53–3.92) million. There was marked regional variation with most DALYs lost in sub-Saharan Africa (0.87 million, 95% CI, 0.43–1.70) and the Asia Pacific (0.39 million, 95% CI, 0.23–0.62) regions. The highest population-attributable fraction and burden were observed in Swaziland, Botswana, and Lesotho. Conclusions: People living with HIV are twice as likely to develop cardiovascular disease. The global burden of HIV-associated cardiovascular disease has tripled over the past 2 decades and is now responsible for 2.6 million DALYs per annum with the greatest impact in sub-Saharan Africa and the Asia Pacific regions. Clinical Trial Registration: URL: https://www.crd.york.ac.uk/prospero . Unique identifier: CRD42016048257.

BackgroundThe increasing numbers of people living with HIV (PLHIV) who are receiving antiretroviral therapy (ART) have near normal life-expectancy, resulting in more people living with HIV over the age of 50 years (PLHIV50+). Estimates of the number of PLHIV50+ are needed for the development of tailored therapeutic and prevention interventions at country, regional and global level.MethodsThe AIDS Impact Module of the Spectrum software was used to compute the numbers of PLHIV, new infections, and AIDS-related deaths for PLHIV50+ for the years 2000-2016. Projections until 2020 were calculated based on an assumed ART scale-up to 81% coverage by 2020, consistent with the UNAIDS 90-90-90 treatment targets.ResultsGlobally, there were 5.7 million [4.7 million- 6.6 million] PLHIV50+ in 2016. The proportion of PLHIV50+ increased substantially from 8% in 2000 to 16% in 2016 and is expected to increase to 21% by 2020. In 2016, 80% of PLHIV50+ lived in low- and middle-income countries (LMICs), with Eastern and Southern Africa containing the largest number of PLHIV50+. While the proportion of PLHIV50+ was greater in high income countries, LMICs have higher numbers of PLHIV50+ that are expected to continue to increase by 2020.ConclusionsThe number of PLHIV50+ has increased dramatically since 2000 and this is expected to continue by 2020, especially in LMICs. HIV prevention campaigns, testing and treatment programs should also focus on the specific needs of PLHIV50+. Integrated health and social services should be developed to cater for the changing physical, psychological and social needs of PLHIV50+, many of whom will need to use HIV and non-HIV services.

Between 2000 and 2015, the number of people newly infected with HIV in the Caribbean decreased by 76% and HIV-related deaths by 42%. The number of people living with HIV (PLHIV) on anti-retroviral therapy (ART) increased from near zero to 50% (44% to 57%) in 2015. In many Caribbean countries communities of men-who-have-sex-with-other-men (MSM) have higher incidence and prevalence of HIV. They are often stigmatized and subjected to both social and institutional discrimination. This study compared attitudes of the general public obtained through public opinion polls 2013-2014 towards homosexuals and willingness to socialize with them in seven Caribbean countries. Informants were asked if they "hate, tolerate or accept" homosexuals and if they would socialize with them. In St. Vincent 53% indicated they "hate" homosexuals, compared with 12% in Suriname; the converse was observed for those who "accept" homosexuals; 63% of St. Vincent informants would not socialize with homosexuals, compared with 25% in Suriname. Findings for the other 5 countries fell within these ranges. Women were more likely to accept and socialize with homosexuals, as were informants with a tertiary education and "passive" religious believers. These groups are less likely to adhere to a culture of "compulsory heterosexuality" or "hyper-masculinity" dominant among Caribbean men. The homophobic views expressed by these cultures result in stigma and discrimination by members of the "general" public towards MSM. This negatively affects the involvement of MSM in successful national HIV responses. Public messaging, communications campaigns and educational measures need to be employed to change the culture of "compulsory heterosexuality" or "hyper-masculinity" that result in stigma and discrimination of homosexuals to improve early access to services by MSM. Repeat use of well performed opinion polls is one method that can be employed to monitor progress over time in "key" and "general" populations.

With 33 million people living with human immunodeficiency virus (HIV) worldwide and 2.7 million new infections occurring annually, additional HIV prevention and treatment efforts are urgently needed. However, available resources for HIV control are limited and must be used efficiently to minimize the future spread of the epidemic. We develop a model to determine the appropriate resource allocation between expanded HIV prevention and treatment services. We create an epidemic model that incorporates multiple key populations with different transmission modes, as well as production functions that relate investment in prevention and treatment programs to changes in transmission and treatment rates. The goal is to allocate resources to minimize R 0, the reproductive rate of infection. We first develop a single-population model and determine the optimal resource allocation between HIV prevention and treatment. We extend the analysis to multiple independent populations, with resource allocation among interventions and populations. We then include the effects of HIV transmission between key populations. We apply our model to examine HIV epidemic control in two different settings, Uganda and Russia. As part of these applications, we develop a novel approach for estimating empirical HIV program production functions. Our study provides insights into the important question of resource allocation for a country's optimal response to its HIV epidemic and provides a practical approach for decision makers. Better decisions about allocating limited HIV resources can improve response to the epidemic and increase access to HIV prevention and treatment services for millions of people worldwide.

PURPOSE OF REVIEW: Increasing number of people living with HIV (PLHIV) will require expanded access to health services. Countries need robust and contemporary strategic information on the cost of care to monitor and evaluate the effectiveness efficiency equity and acceptability of services. Published HIV cost literature from July 1999 to December 2008 was reviewed. Articles were identified using specific databases and scored based on explicit criteria relating to the services covered utilization data cost data used and quality of the study. RECENT FINDINGS: One hundred and fifteen articles were identified 47% came from North America 29% from Europe 17% from Africa and 8% from Asia; no studies from Latin America could be identified. The mean score across all studies was 33.7 out of a maximum of 64 with a median of 34 and a range of 11-51. Mean score did not change significantly over time (Pearsons R8 = 0.3; P > 0.05). SUMMARY: Great variation was observed in the methods used to estimate cost data across the studies identified including range of services patients covered and outcomes costed. Progress in the quantity and quality of studies published since 1999 has been limited. More consistent costing methods and more comprehensive coverage - both by country and level of care - are needed in order for policymakers and other stakeholders to be able to optimally monitor and evaluate the cost and cost-effectiveness of country services for HIV treatment and care especially as population costs are likely to increase with more PLHIV on antiretroviral therapy.

The objective of this study was to determine the cost and cost-effectiveness of antiretroviral therapy (ART) in Singapore. The use and cost of HIV services was calculated for patients managed at the national HIV referral centre in Singapore between 1996 and 2001 from a hospital perspective. Three groups of patients were compared by Centers for Disease Control and Prevention (CDC) stage of HIV infection: those who had never received ART; those who had received only dual therapy; and those who had only received highly active antiretroviral therapy (HAART). Hospital charges were used to estimate the average hospital inpatient and outpatient care costs. Life years gained (LYG) were calculated for different stages of HIV infection and the incremental costs per LYG were calculated comparing those on dual ART and HAART with those who did not receive ART. Patients on ART progressed less rapidly across all CDC stages. For CDC stage A, the incremental cost per LYG was $17,007 (Singaporean dollar) (interquartile range [IQR] $7963–25,113) and $22,511 (IQR $11,299–33,724) for those on dual therapy and HAART, respectively. The incremental cost per LYG in stage B was $10,868 (IQR $4506–17,239) and $21,094 (IQR $7774–34,431) for patients on dual therapy and HAART, respectively, while the incremental cost per LYG for stage C patients was $9,848 (IQR $5256–14,419) and $16,513 (IQR $8677–24,337) for dual therapy and HAART, respectively. Dual ART therapy and HAART were cost-effective interventions in Singapore. Cost-effectiveness is likely to improve if drug prices continue to decrease.

AIMS: To investigate the existence of national adult antiretroviral therapy (ART) guidelines in 43 World Health Organization (WHO) '3 by 5' focus countries and compare their content with the 2003 WHO ART guidelines. METHODS: Questionnaires covered initiation of ART, selection of first or second-line ART, monitoring treatment response and toxicity and dissemination of national guidelines. Weighted concordance scores were created and country scores correlated with national indicators and WHO recommendations. RESULTS: Thirty-nine (91%) countries returned questionnaires, three of which had no national ART guidelines. Of the 36, 16 (44%) recommended to start ART based on WHO clinical staging criteria and CD4 cell count or T-lymphocyte count, 12 (33%) WHO clinical staging criteria and CD4 cell count, four (11%) only CD4 cell counts. 35 (97%) recommended a standard first-line regimen and 24 (67%) preferred stavudine + lamivudine + nevirapine; 33 (92%) recommended second-line regimens, and 24 (60%) preferred abacavir + didanosine + lopinavir/ritonavir. Thirty-one (94%) recommended CD4 cell count, possibly combined with other indicators, to monitor ART. Concordance scores were higher in countries with lower health expenditure per capita (P = 0.009) and lower GDP per capita (P < 0.03). Median concordance scores for starting ART was 100 [interquartile range (IQR), 67 to 100]; first line therapy, 70 (IQR, 60 to 80); second-line regimens, 45 (IQR, 27 to 55) and for laboratory investigations, 80 (IQR, 80 to 100). CONCLUSIONS: Most countries had developed national ART guidelines as part of a comprehensive national HIV program. Concordance with WHO recommendations was strong on starting first-line ART regimens and routine monitoring but lower for second-line recommendations.

BACKGROUND Treatment protocols and prices of antiretroviral therapy (ART) have changed over time. Yet, limited data exist to evaluate the impact of these changes on patient outcomes and treatment costs in resource-poor settings. METHODS We compared patient-level data on outcomes, utilization, and cost for the first 2 years of ART for a cohort of adult patients initiating ART in 2003-2004 and a cohort initiating ART in 2006-2008 at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections clinic (GHESKIO) in Port-au-Prince, Haiti. Costs were measured from the health center perspective. Multivariate analyses were conducted to account for the potential impact of differences in disease severity at baseline. RESULTS With the exclusion of patients who transferred care, 92% (167/181) of patients in the 2006-2008 cohort and 75% (150/200) in the 2003-2004 cohort were alive and in care at the end of the study period. The mean cost per patient for the 2-year study period was US$723 for the 2006-2008 cohort vs. US$1191 for the 2003-2004 cohort, a cost difference of US$468 (P < 0.0001). The mean cost per patient alive and in care at the end of the 2-year study period was US$744 for the 2006-2008 cohort vs. US$1489 for the 2003-2004 cohort (P < 0.0001). CONCLUSIONS HIV treatment outcomes in Haiti have improved over time while treatment costs declined by over 50% per patient alive and in care at the end of the 2-year study period. The major drivers in the reduction of treatment costs were the lower price of ART, lower costs for laboratory testing, and lower overhead costs.

The number of people living with HIV (PLHIV) continues to increase around the world because of the increasing number on antiretroviral therapy (ART) and their associated increase of life expectancy, in addition to the number of people newly infected with HIV each year. Unless a ‘cure’ can be found for HIV infection, PLHIV can anticipate the need to take antiretroviral drugs (ARVs) for the rest of their lives. Because ARVs are now being used for HIV prevention, as well as for therapeutic purposes, the need for effective, affordable ARVs with few adverse effects will continue to rise. It is important to note that the dramatic growth in treatment coverage of PLHIV seen during the past decade has been primarily due to the increased use of generic ARVs. Thus, there will be a need to scale-up the research and development, production, distribution and access to generic ARVs and ART regimens. However, these processes must occur within national and international regulated free-market economic systems and must deal with increasingly multifaceted patent issues affecting the price while ensuring the quality of the ARVs. National and international regulatory mechanisms will have to evolve, which will affect broader national and international economic and trade issues. Because of the complexity of these issues, the Editors of this Supplement conceived of asking experts in their fields to describe the various steps from relevant research and development, to production of generic ARVs, their delivery to countries and subsequently to PLHIV in low- and middle-income countries. A main objective was to highlight how these steps are interrelated, how the production and delivery of these drugs to PLHIV in resource-limited countries can be made more effective and efficient, and what the lessons are for the production and delivery of a broader set of drugs to people in low- and middle-income countries.

Objective In many high-income countries with low HIV prevalence, significant numbers of persons living with HIV (PLHIV) remain undiagnosed. Identification of PLHIV via HIV testing offers timely access to lifesaving antiretroviral therapy (ART) and decreases HIV transmission. We estimated the effectiveness and cost-effectiveness of HIV testing in the United Kingdom (UK), where 25% of PLHIV are estimated to be undiagnosed. Design We developed a dynamic compartmental model to analyze strategies to expand HIV testing and treatment in the UK, with particular focus on men who have sex with men (MSM), people who inject drugs (PWID), and individuals from HIV-endemic countries. Methods We estimated HIV prevalence, incidence, quality-adjusted life years (QALYs), and health care costs over 10 years, and cost-effectiveness. Results Annual HIV testing of all adults could avert 5% of new infections, even with no behavior change following HIV diagnosis because of earlier ART initiation, or up to 18% if risky behavior is halved. This strategy costs £67,000–£106,000/QALY gained. Providing annual testing only to MSM, PWID, and people from HIV-endemic countries, and one-time testing for all other adults, prevents 4–15% of infections, requires one-fourth as many tests to diagnose each PLHIV, and costs £17,500/QALY gained. Augmenting this program with increased ART access could add 145,000 QALYs to the population over 10 years, at £26,800/QALY gained. Conclusions Annual HIV testing of key populations in the UK is very cost-effective. Additional one-time testing of all other adults could identify the majority of undiagnosed PLHIV. These findings are potentially relevant to other low-prevalence, high-income countries.

This review of published studies on the costs of HIV treatment and care describes some of the recent developments that have influenced these costs in industrialised and industrialising countries, especially within the context of changing drug treatments. Some of the different approaches to estimating the economic impact of HIV infection are briefly presented. The methods used to review the literature are described, particularly the criteria of a scoring system that was specifically developed to systematically screen some of the studies identified. The mean review score for studies dealing with direct hospital costs increased significantly (p = 0.003) over the 3 periods analysed (before 1987, 1987 to 1995, and 1996 and beyond), indicating that the overall 'quality' of studies increased over time. All cost estimates, other than those from non-industrialised regions, were converted to 1996 US dollars using country-specific total health expenditure inflaters and country-specific Gross Domestic Product Purchasing Power Parity converters. A summary of hospital cost estimates over time and by region demonstrated that the costs of treating asymptomatic individuals and people with symptomatic non-AIDS increased over the period, but that the costs of treating individuals with AIDS appears to have stabilised since the late 1980s. As fewer studies could be identified on the costs of community and informal care, indirect productivity costs and population cost estimates, and costs of care for children with HIV infection, all of these studies were reviewed without the use of the scoring system. Finally, the discussion explores the evidence on the global costs of HIV in non-industrialised economies and the affordability of HIV treatment and care. Some suggestions for the direction of future HIV costing studies are also presented. A need remains for good quality cost data. Adequate research effort should be directed to improving the scope and quality of information on costs of HIV service provision around the world.

Few studies have estimated the indirect costs of care for HIV infection in England by stage of infection at a population level.This study estimated annual indirect costs of the HIV epidemic in England in 1997-1998 from both a public-sector and societal perspective.Service costs for HIV-infected individuals were indexed to 1997-1998 English prices. Average annual indirect costs included the costs of statutory, community, and informal services; disability payments; and lost economic productivity by stage of HIV infection. Disability payments were excluded from the societal perspective, whereas the degree of lost economic productivity was varied for the sensitivity analyses. Total average annual indirect costs by stage of HIV infection were calculated, as were population-based costs by stage of HIV infection and overall population costs.Annual indirect costs from the public-sector and societal perspectives, respectively, ranged from pound sterling 3169 (dollars 5252) to pound sterling 3931 (dollars 6515) per person-year for asymptomatic individuals, pound sterling 5302 (dollars 8787) to pound sterling 7929 (dollars 13,140) for patients with symptomatic non-AIDS, and pound sterling 9956 (dollars 16,499) to pound sterling 21,014 (dollars 34,825) for patients with AIDS. Estimated population-based indirect costs from the public-sector perspective varied between pound sterling 109 million (dollars 181 million) and pound sterling 145 million (dollars 241 million) for 1997-1998, respectively, comprising between 58% and 124% of direct treatment costs for triple drug therapy in England during 1997. From the societal perspective, estimated population-based costs varied between pound sterling 84 million (dollars 138 million) and pound sterling 119 million (dollars 198 million) in 1997-1998, comprising between 45% and 102% of direct treatment costs and cost of care, respectively, during 1997.Average indirect costs increase as HIV-infected individuals' illness progresses. Whether one takes a public-sector or societal perspective, indirect costs add a considerable amount to the cost of delivering health care to HIV-infected individuals. Both direct and indirect costs, when obtainable, should be used to assess the economic consequences of HIV infection and treatment interventions.

Community services comprise an important part of a country's HIV response. English language cost and cost-effectiveness studies of HIV community services published between 1986 and 2011 were reviewed but only 74 suitable studies were identified, 66% of which were performed in five countries. Mean study scores by continent varied from 42 to 69% of the maximum score, reflecting variation in topics covered and the quality of coverage: 38% of studies covered key and 11% other vulnerable populations - a country's response is most effective and efficient if these populations are identified given they are key to a successful response. Unit costs were estimated using different costing methods and outcomes. Community services will need to routinely collect and analyze information on their use, cost, outcome and impact using standardized costing methods and outcomes. Cost estimates need to be disaggregated into relevant cost items and stratified by severity and existing comorbidities. Expenditure tracking and costing of services are complementary aspects of the health sector 'resource cycle' that feed into a country's investment framework and the development and implementation of national strategic plans.

The HIV pandemic continues to be one of our greatest contemporary public health threats. Policy makers in many middle- and low-income countries are in the process of scaling up HIV prevention, treatment and care services in the context of a reduction in international HIV funding due to the global economic downturn. In order to scale up services that are sustainable in the long term, policy makers and implementers need to have access to robust and contemporary strategic information, including financial information on expenditure and cost, in order to be able to plan, implement, monitor and evaluate HIV services. A major problem in middle- and low-income countries continues to be a lack of basic information on the use of services, their cost, outcome and impact, while those few costing studies that have been performed were often not done in a standardized fashion. Some researchers handle this by transposing information from one country to another, developing mathematical or statistical models that rest on assumptions or information that may not be applicable, or using top-down costing methods that only provide global financial costs rather than using bottom-up ingredients-based costing. While these methods provide answers in the short term, countries should develop systematic data collection systems to store, transfer and produce robust and contemporary strategic financial information for stakeholders at local, sub-national and national levels. National aggregated information should act as the main source of financial data for international donors, agencies or other organizations involved with the global HIV response. This paper describes the financial information required by policy makers and other stakeholders to enable them to make evidence-informed decisions and reviews the quantity and quality of the financial information available, as indicated by cost studies published between 1981 and 2008. Among the lessons learned from reviewing these studies, a need was identified for providing countries with practical guidance to produce reliable and standardized costing data to monitor performance, as countries want to improve programmes and services, and have to demonstrate an efficient use of resources. Finally, the issues raised in this paper relate to the provision of all areas of healthcare in countries and it is going to be increasingly important to leverage the lessons learned from the HIV experience and use resources more effectively and efficiently to improve health systems in general.

AimInvestigate the cost and effects of a single-pill versus two- or three pill first-line antiretroviral combinations in reducing viral load, increasing CD4 counts, and first-line failure rate associated with respective regimens at 6 and 12 months.MethodsPatients on first-line TDF+3TC+EFV, TDF+FTC+EFV, Truvada®+EFV or Atripla® between 1996-2008 were identified and viral load and CD4 counts measured at baseline, six and twelve months respectively. Factors that independently predicted treatment failure at six and twelve months were derived using multivariate Cox's proportional hazard regression analyses. Use and cost of hospital services were calculated at six and twelve months respectively.ResultsAll regimens reduced viral load to below the limit of detection and CD4 counts increased to similar levels at six and twelve months for all treatment regimens. No statistically significant differences were observed for rate of treatment failure at six and twelve months. People on Atripla® generated lower healthcare costs for non-AIDS patients at £5,340 (£5,254 to £5,426) per patient-semester and £9,821 (£9,719 to £9,924) per patient-year that was £1,344 (95%CI £1,222 to £1,465) less per patient-semester and £1,954 (95%CI £1,801 to £2,107) less per patient-year compared with Truvada®+EFV; healthcare costs for AIDS patients were similar across all regimens.ConclusionThe single pill regimen is as effective as the two- and three-pill regimens of the same drugs, but if started as first-line induction therapy there would be a 20% savings on healthcare costs at six and 17% of costs at twelve months compared with Truvada®+EFV, that generated the next lowest costs.

Define and identify long-term non-progressors (LTNP) and HIV controllers (HIC), and estimate time until disease progression. LTNP are HIV-1(+) patients who maintain stable CD4(+) T-cell counts, with no history of opportunistic infection or antiretroviral therapy (ART). HIC are a subset of LTNP who additionally have undetectable viraemia. These individuals may provide insights for prophylactic and therapeutic development. Records of HIV-1(+) individuals attending Chelsea and Westminster Hospital (1988-2010), were analysed. LTNP were defined as: HIV-1(+) for >7 years; ART-naïve; no history of opportunistic infection and normal, stable CD4(+) T-cell counts. MIXED procedure in SAS using random intercept model identified long-term stable CD4(+) T-cell counts. Survival analysis estimated time since diagnosis until disease progression. Subjects exhibiting long-term stable CD4(+) T-cell counts with history below the normal range (

BACKGROUND\ud \ud The number of people living with HIV (PLHIV) is increasing in the UK. This study estimated the annual population cost of providing HIV services in the UK, 1997-2006 and projected them 2007-2013.\ud \ud METHODS\ud \ud Annual cost of HIV treatment for PLHIV by stage of HIV infection and type of ART was calculated (UK pounds, 2006 prices). Population costs were derived by multiplying the number of PLHIV by their annual cost for 1997-2006 and projected 2007-2013.\ud \ud RESULTS\ud \ud Average annual treatment costs across all stages of HIV infection ranged from £17,034 in 1997 to £18,087 in 2006 for PLHIV on mono-therapy and from £27,649 in 1997 to £32,322 in 2006 for those on quadruple-or-more ART. The number of PLHIV using NHS services rose from 16,075 to 52,083 in 2006 and was projected to increase to 78,370 by 2013. Annual population cost rose from £104 million in 1997 to £483 million in 2006, with a projected annual cost between £721 and £758 million by 2013. When including community care costs, costs increased from £164 million in 1997, to £683 million in 2006 and between £1,019 and £1,065 million in 2013.\ud \ud CONCLUSIONS\ud \ud Increased number of PLHIV using NHS services resulted in rising UK population costs. Population costs are expected to continue to increase, partly due to PLHIV's longer survival on ART and the relative lack of success of HIV preventing programs. Where possible, the cost of HIV treatment and care needs to be reduced without reducing the quality of services, and prevention programs need to become more effective. While high income countries are struggling to meet these increasing costs, middle- and lower-income countries with larger epidemics are likely to find it even more difficult to meet these increasing demands, given that they have fewer resources.

The number of people in the world living with HIV is increasing as HIV-related mortality has declined but the annual number of people newly infected with HIV has not. The international response to contain the HIV pandemic, meanwhile, has grown. Since 2006, an international commitment to scale up prevention, treatment, care and support services in middle and lower-income countries by 2010 has been part of the Universal Access programme, which itself plays an important part in achieving the Millennium Development Goals by 2015. Apart from providing technical support, donor countries and agencies have substantially increased their funding to enable countries to scale up HIV services. Many countries have been developing their HIV monitoring and evaluation systems to generate the strategic information required to track their response and ensure the best use of the new funds. Financial information is an important aspect of the strategic information required for scaling up existing services as well as assessing the effect of new ones. It involves two components: tracking the money available and spent on HIV at all levels, through budget tracking, national health accounts and national AIDS spending assessments, and estimating the cost and efficiency of HIV services. The cost of service provision should be monitored over time, whereas evaluations of the cost-effectiveness of services are required periodically; both should be part of any country's HIV monitoring and evaluation system. This paper provides country examples of the complementary relationship between monitoring the cost of HIV services and evaluating their cost-effectiveness. It also summarizes global initiatives that enable countries to develop their own HIV monitoring and evaluation systems and to generate relevant, robust and up-to-date strategic information.

The aim of this study was to estimate the outcome and cost-effectiveness per life-year-gained (LYG) of first-, second- and third-line non-nucleoside reverse transcriptase inhibitors (NNRTI) versus protease inhibitor (PI) containing highly active antiretroviral therapy regimens. Hospital care costs (2002 US dollars discounted 3.5% per annum) were linked to treatment failure times. Results show that the median time-to-treatment failure for first-line (nucleoside reverse transcriptase inhibitors) 2NRTIs + NNRTI was substantially longer than that for 2NRTIs + PIboosted, 2NRTIs + PI and 2NRTIs + 2PIs, whereas for second- and third-line they were similar. Comparing first-line 2NRTIs + NNRTI with 2NRTIs + PIboosted cost per LYG was US$ 12,375; US$ 12,139 per LYG when compared with 2NRTIs + PI and US$ 2948 per LYG when compared with 2NRTIs + 2PIs. For second-line cost per LYG comparing 2NRTIs + NNRTI with 2NRTIs + PIboosted was US$ 19,501; US$ 18,364 per LYG when compared with 2NRTIs + PI and cost-saving when compared with 2NRTIs + 2PIs. For third-line cost per LYG comparing 2NRTIs + NNRTI with 2NRTIs + PIboosted was US$ 2708; US$ 11,559 per LYG when compared with 2NRTIs + PI and cost-saving when compared with 2NRTIs + 2PIs. In conclusion, first-line 2NRTIs + NNRTI was cost-effective or cost-saving when compared with PI-containing regimens for all lines of therapy. Such information is required by clinicians and managers of HIV services to make appropriate treatment decisions based on clinical and financial grounds, and given the increasing number of people living with HIV, such information will become more important over time.

Providing quality health care requires access to continuous patient data that developing countries often lack. A panel of medical informatics specialists, clinical human immunodeficiency virus (HIV) specialists, and program managers suggests a minimum data set for supporting the management and monitoring of patients with HIV and their care programs in developing countries. The proposed minimum data set consists of data for registration and scheduling, monitoring and improving practice management, and describing clinical encounters and clinical care. Data should be numeric or coded using standard definitions and minimal free text. To enhance accuracy, efficiency, and availability, data should be recorded electronically by those generating them. Data elements must be sufficiently detailed to support clinical algorithms/guidelines and aggregation into broader categories for consumption by higher level users (e.g., national and international health care agencies). The proposed minimum data set will evolve over time as funding increases, care protocols change, and additional tests and treatments become available for HIV-infected patients in developing countries.

Background Little information exists on the impact of highly active antiretroviral therapy (HAART) on health-care provision in South Africa despite increasing scale-up of access to HAART and gradual reduction in HAART prices. Methods and Findings Use and cost of services for 265 HIV-infected adults without AIDS (World Health Organization [WHO] stage 1, 2, or 3) and 27 with AIDS (WHO stage 4) receiving HAART between 1995 and 2000 in Cape Town were compared with HIV-infected controls matched for baseline WHO stage, CD4 count, age, and socioeconomic status, who did not receive antiretroviral therapy (ART; No-ART group). Costs of service provision (January 2004 prices, US$1 = 7.6 Rand) included local unit costs, and two scenarios for HAART prices for WHO recommended first-line regimens: scenario 1 used current South African public-sector ART drug prices of $730 per patient-year (PPY), whereas scenario 2 was based on the anticipated public-sector price for locally manufactured drug of $181 PPY. All analyses are presented in terms of patients without AIDS and patients with AIDS. For patients without AIDS, the mean number of inpatient days PPY was 1.08 (95% confidence interval [CI]: 0.97–1.19) for the HAART group versus 3.73 (95% CI: 3.55–3.97) for the No-ART group, and 8.71 (95% CI: 8.40–9.03) versus 4.35 (95% CI: 4.12–5.61), respectively, for mean number of outpatient visits PPY. Average service provision PPY was $950 for the No-ART group versus $1,342 and $793 PPY for the HAART group for scenario 1 and 2, respectively, whereas the incremental cost per life-year gained (LYG) was $1,622 for scenario 1 and $675 for scenario 2. For patients with AIDS, mean inpatients days PPY was 2.04 (95% CI: 1.63–2.52) for the HAART versus 15.36 (95% CI: 13.97–16.85) for the No-ART group. Mean outpatient visits PPY was 7.62 (95% CI: 6.81–8.49) compared with 6.60 (95% CI: 5.69–7.62) respectively. Average service provision PPY was $3,520 for the No-ART group versus $1,513 and $964 for the HAART group for scenario 1 and 2, respectively, whereas the incremental cost per LYG was cost saving for both scenarios. In a sensitivity analysis based on the lower (25%) and upper (75%) interquartile range survival percentiles, the incremental cost per LYG ranged from $1,557 to $1,772 for the group without AIDS and from cost saving to $111 for patients with AIDS. Conclusion HAART is a cost-effective intervention in South Africa, and cost saving when HAART prices are further reduced. Our estimates, however, were based on direct costs, and as such the actual cost saving might have been underestimated if indirect costs were also included., Healthcare costs for HIV-infected South African adults on HAART compared with costs for HIV-infected controls not on HAART. Authors conclude HAART is cost effective.

To estimate the cost-effectiveness ratio of highly-active antiretroviral therapy (HAART) in Canada.A before-and-after analysis to calculate incremental cost of life year gained (LYG) between 1991 and 1995 (pre-HAART period) and between 1997 and 2001 (HAART period) for non-AIDS and AIDS groups (CDC stage of HIV infection).For two Quebec HIV hospital clinics, mean inpatient (IP) days, outpatient (OP) visits and direct health care costs per patient-year (PPY) were calculated. Cox's proportional hazards models calculated disease progression, stratified by study periods and adjusted for gender, age at cohort entry, sexual orientation, injecting drug use and baseline CD4 cell count.For non-AIDS patients, mean IP days was 1.6 (pre-HAART period) compared with 0.8 PPY (HAART period); mean OP visits increased from 2.8 to 5.5 PPY. Total cost was US$ 4265 (pre-HAART period) and US$ 9445 PPY (HAART period) of which 66 and 84%, respectively were spent on antiretroviral drugs. Median progression time was 6.3 years in the pre-HAART period compared with 12.5 years in HAART period (log rank chi = 270, P0.0001). Incremental cost per LYG between periods was US$ 14 587. For AIDS patients, mean IP days decreased from 13.3 to 4.4 PPY between periods; OP visits increased from 8.3 to 9.2 PPY. Total costs increased from US$ 9099 to US$ 11 754 PPY, while expenditure on antiretroviral drugs increased from 29 to 72% of total cost. Median progression time was 3.8 years in the pre-HAART period, which increased to 13.3 years in the HAART period (log rank chi = 158, P0.0001); incremental cost per LYG between periods was US$ 12 813.HAART appeared a cost-effective intervention in Canada.

Background Few UK studies have systematically investigated which antiretroviral therapy (ART) combinations HIV-infected people are commenced on, when they start and reasons for stopping or changing their regimens. Objective To describe when HIV-infected ART-naive patients started first-, second- or third-line triple ART, classes of drugs prescribed and whether stopping ART was associated with virological, immunological or clinical indicators of treatment failure. Design A multicentre prospective open cohort study, employing the National Prospective Monitoring System on the use, cost and outcome of HIV service provision in UK hospitals-HIV Health-economics Collaboration (NPMS-HHC). Setting Five hundred and eighty-five ART-naive patients seen in one London and two non-London HIV clinics between 1 January 1998 and 31 December 1999. Results Of 4044 HIV-infected individuals seen, 585 (15%) were ART naive. Median time interval (interquartile range, IQR) between HIV diagnosis and starting triple ART was 800 (63–2094) days. Median CD4 count when first diagnosed with HIV infection was 278 (IQR 127–481) cells/µL which dropped to 190 (IQR 86–297) cells/µL when starting triple ART. Of these 585 patients, 162 started second-line and 46 third-line ART during the study period. Of those patients who stopped ART, 51% did not have evidence of virological, immunological or clinical indicators of therapy failure. Conclusions Reasons for the delay between diagnosis of HIV infection and starting ART are varied. The large proportion of individuals who stopped ART for reasons other than virological, immunological or clinical indicators of therapy failure, are most likely due to drug-associated toxicity. Both of these findings need to be elucidated in greater detail through prospective studies.

Treatment of HIV infection has improved markedly in recent years due to the use of combination antiretroviral therapies. However, the cost of these treatments remains a concern for those who fund health services. This article reports the results of an economic evaluation to determine the incremental cost-effectiveness of triple combination nucleoside analogue (NA) therapy compared with dual NA therapy.A Markov model was developed to assess the incremental cost effectiveness of triple therapy treatment versus dual therapy treatment. Clinical data was derived from published clinical trials and large observational cohorts whilst cost data was derived from a prospective database that monitors health care resource use in the UK HIV population.The model predicted that triple NA combination treatment extended life expectancy by an additional 1.2 years compared with dual therapy NA treatment with an incremental cost-effectiveness ratio of 8,419 pounds per life-year saved. The incremental cost per quality-adjusted life-year (QALY) was estimated to be between 10,072-16,168 pounds per QALY gained depending on the assumptions.The results show triple nucleoside analogue therapy to be a cost effective means of delaying HIV progression and extending life expectancy. However, further research into this issue is warranted.

Background: Individual-level data are needed to optimize clinical care and monitor and evaluate HIV services. Confidentiality and security of such data must be safeguarded to avoid stigmatization and discrimination of people living with HIV. We set out to assess the extent that countries scaling up HIV services have developed and implemented guidelines to protect the confidentiality and security of HIV information. Methods: Questionnaires were sent to UNAIDS field staff in 98 middle- and lower-income countries, some reportedly with guidelines (G-countries) and others intending to develop them (NG-countries). Responses were scored, aggregated and weighted to produce standard scores for six categories: information governance, country policies, data collection, data storage, data transfer and data access. Responses were analyzed using regression analyses for associations with national HIV prevalence, gross national income per capita, OECD income, receiving US PEPFAR funding, and being a G- or NG-country. Differences between G- and NG-countries were investigated using non-parametric methods. Results: Higher information governance scores were observed for G-countries compared with NG-countries; no differences were observed between country policies or data collection categories. However, for data storage, data transfer and data access, G-countries had lower scores compared with NG-countries. No significant associations were observed between country score and HIV prevalence, per capita gross national income, OECD economic category, and whether countries had received PEPFAR funding. Conclusions: Few countries, including G-countries, had developed comprehensive guidelines on protecting the confidentiality and security of HIV information. Countries must develop their own guidelines, using established frameworks to guide their efforts, and may require assistance in adapting, adopting and implementing them.