HIV Treatment as Prevention: Issues in Economic Evaluation
TL;DR: Economic evaluations of antiretroviral therapy in currently existing programs and in HIV treatment as prevention (TasP) programs should use cost functions that capture cost dependence on a number of factors, such as scale and scope of delivery.
Abstract: Meyer-Rath and Over assert in another article in the July 2012 PLoS Medicine Collection, “Investigating the Impact of Treatment on New HIV Infections”, that economic evaluations of antiretroviral therapy (ART) in currently existing programs and in HIV treatment as prevention (TasP) programs should use cost functions that capture cost dependence on a number of factors, such as scale and scope of delivery, health states, ART regimens, health workers' experience, patients' time on treatment, and the distribution of delivery across public and private sectors. We argue that for particular evaluation purposes (e.g., to establish the social value of TasP) and from particular perspectives (e.g., national health policy makers) less detailed cost functions may be sufficient. We then extend the discussion of economic evaluation of TasP, describing why ART outcomes and costs assessed in currently existing programs are unlikely to be generalizable to TasP programs for several fundamental reasons. First, to achieve frequent, widespread HIV testing and high uptake of ART immediately following an HIV diagnosis, TasP programs will require components that are not present in current ART programs and whose costs are not included in current estimates. Second, the early initiation of ART under TasP will change not only patients' disease courses and treatment experiences—which can affect behaviors that determine clinical treatment success, such as ART adherence and retention—but also quality of life and economic outcomes for HIV-infected individuals. Third, the preventive effects of TasP are likely to alter the composition of the HIV-infected population over time, changing its biological and behavioral characteristics and leading to different costs and outcomes for ART.
Citations
More filters
TL;DR: Ongoing research and normative deliberation is required in order to successfully and ethically scale-up TasP within the continuum of HIV care models.
Abstract: Background: Despite the evidence showing the promise of HIV treatment as prevention (TasP) in reducing HIV incidence, a variety of ethical questions surrounding the implementation and “scaling up” of TasP have been articulated by a variety of stakeholders including scientists, community activists and government officials. Given the high profile and potential promise of TasP in combatting the global HIV epidemic, an explicit and transparent research priority-setting process is critical to inform ongoing ethical discussions pertaining to TasP. Methods: We drew on the Arksey and O’Malley framework for conducting scoping review studies as well as systematic approaches to identifying empirical and theoretical gaps within ethical discussions pertaining to population-level intervention implementation and scale up. We searched the health science database PubMed to identify relevant peer-reviewed articles on ethical and implementation issues pertaining to TasP. We included English language articles that were published after 2009 (i.e., after the emergence of causal evidence within this field) by using search terms related to TasP. Given the tendency for much of the criticism and support of TasP to occur outside the peer-reviewed literature, we also included grey literature in order to provide a more exhaustive representation of how the ethical discussions pertaining to TasP have and are currently taking place. To identify the grey literature, we systematically searched a set of search engines, databases, and related webpages for keywords pertaining to TasP. Results: Three dominant themes emerged in our analysis with respect to the ethical questions pertaining to TasP implementation and scale-up: (a) balancing individual- and population-level interests; (b) power relations within clinical practice and competing resource demands within health care systems; (c) effectiveness considerations and socio-structural contexts of HIV treatment experiences within broader implementation contexts. Conclusion: Ongoing research and normative deliberation is required in order to successfully and ethically scale-up TasP within the continuum of HIV care models. Based on the results of this scoping review, we identify several ethical and implementation dimensions that hold promise for informing the process of scaling up TasP and that could benefit from new research.
17 citations
Cites background from "HIV Treatment as Prevention: Issues..."
...For example, some have suggested that TasP burdens individuals with chronic disease management at an early stage of their disease progression, thereby altering their capacity for economic productivity as well as their overall quality of life [22]....
[...]
...Moreover, the unknown issues pertaining to the long-term preventative effects of TasP have been said to be so significant that predicting the associated costs and benefits is not yet possible [22]....
[...]
TL;DR: It is demonstrated that anogenital warts occur in almost one-third of the male population infected with HIV and factors associated with a higher risk of being diagnosed with anogenITAL warts were irregular cART use and co-infection with HSV, other variables could not be associated.
Abstract: Background: Infection with human papilloma virus (HPV) is the most common sexually transmitted disease in the world. Among the 630 million new cases of HPV that occur each year, 30 million develop anogenital warts. Although subclinical infection with HPV is the most common cause, genital warts are also associated with immunosuppression caused by HIV. In view of the high prevalence of HPV/HIV co-infection particularly among men who have sex with men, the objectives of this study were to determine the prevalence of anogenital warts in men with HIV/AIDS and to identify associated factors. Methods: A cross-sectional study was conducted on 159 men with HIV/AIDS consecutively selected at a referral service in Botucatu, Sao Paulo, Brazil, in which the association between sociodemographic, behavioral and clinical variables and the presence of anogenital warts was evaluated. After hierarchical analysis of the data, variables presenting a p value ≤ 0.2 were entered into an unconditional multivariate logistic regression model. Results: Forty-nine (31%) of the HIV-positive patients had anogenital warts. The mean age was 44.6 ± 9.6 years. The main factors associated with the presence of anogenital warts were irregular antiretroviral treatment and genital herpes(HSV). Conclusion: The present study demonstrate that anogenital warts occur in almost one-third of the male population infected with HIV and factors associated with a higher risk of being diagnosed with anogenital warts were irregular cART use and co-infection with HSV, other variables could not be associated.
15 citations
Cites background from "HIV Treatment as Prevention: Issues..."
...[25], the incorrect use of cART can reduce immunity reflected in a decline of CD4+ T lymphocytes, thus facilitating the occurrence of other STDs....
[...]
TL;DR: This cluster-RCT would have provided insights into the health effects, motivational qualities, and cost-effectiveness of mHealth interventions for PLHIV in public sector settings.
Abstract: Background: Adherence to prevention, care, and treatment recommendations among people living with HIV (PLHIV) is a critical challenge Yet good clinical outcomes depend on consistent, high adherence to antiretroviral therapy (ART) regimens Mobile phones offer a promising means to improve patient adherence and health outcomes However, limited information exists on the impact that mobile phones for health (mHealth) programs have on ART adherence or the behavior change processes through which such interventions may improve patient health, particularly among ongoing clients enrolled in large public sector HIV service delivery programs and key populations such as men who have sex with men (MSM) and female sex workers (FSW) Objective: Our aim is to evaluate an mHealth intervention where text message reminders are used as supportive tools for health providers and as motivators and reminders for ART clients to adhere to treatment and remain linked to care in Ghana Using an implementation science framework, we seek to: (1) evaluate mHealth intervention effects on patient adherence and health outcomes, (2) examine the delivery of the mHealth intervention for improving HIV care and treatment, and (3) assess the cost-effectiveness of the mHealth intervention Methods: The 36-month study will use a facility cluster randomized controlled design (intervention vs standard of care) for evaluating the impact of mHealth on HIV care and treatment Specifically, we will look at ART adherence, HIV viral load, retention in care, and condom use at 6 and 12-month follow-up In addition, participant adoption and satisfaction with the program will be measured This robust methodology will be complemented by qualitative interviews to obtain feedback on the motivational qualities of the program and benefits and challenges of delivery, especially for key populations Cost-effectiveness will be assessed using incremental cost-effectiveness ratios, with health effects expressed in terms of viral load suppression and costs of resources used for the intervention Results: This study and protocol was fully funded, but it was terminated prior to review from ethics boards and study implementation Conclusions: This cluster-RCT would have provided insights into the health effects, motivational qualities, and cost-effectiveness of mHealth interventions for PLHIV in public sector settings We are seeking funding from alternate sources to implement the trial
15 citations
Cites background from "HIV Treatment as Prevention: Issues..."
...Due to favorable findings from mobile phones for health (mHealth) interventions, limited proven adherence and treatment support interventions [3,16,17], and the need for a combination of interventions to address the complexities of adherence, mHealth programs are rapidly being scaled up globally [18,19]....
[...]
TL;DR: Evidence is presented regarding the effect of ART on the incidence of HIV and TB, benefits and risks associated with embracing TasP, and the need for multicomponent prevention strategies and for further research to generate empiric data on theeffect of TasP on HIV andTB at a population level.
Abstract: The demonstration of the efficacy of antiretroviral therapy (ART) for HIV prevention in heterosexual HIV serodiscordant couples has resulted in the call for widespread implementation of "Treatment as Prevention" (TasP) to confront the challenge of continued transmission of HIV. In addition, evidence of the possible effect of use of ART on decreasing the incidence of tuberculosis (TB) in persons living with HIV has also contributed further enthusiasm. Mathematical modeling studies evaluating the potential impact of TasP on the trajectory of the HIV and TB epidemics have inspired discussions about a possible future without AIDS. We present the evidence regarding the effect of ART on the incidence of HIV and TB, benefits and risks associated with embracing TasP, and the need for multicomponent prevention strategies and for further research to generate empiric data on the effect of TasP on HIV and TB at a population level.
13 citations
TL;DR: In this article, the authors examine the production of new modes of calculation, calibration and measurement of bodies at work in the timber plantations of northern KwaZulu-Natal, South Africa.
Abstract: The article examines the production of new modes of calculation, calibration and measurement of bodies at work in the timber plantations of northern KwaZulu-Natal, South Africa — modes that echo older, diverse technologies of self and health while producing new ways of talking about the body and its social context. I describe two sets of substances that augment wellbeing for those who work the plantations, one in the form of a nutrition intervention and the other a class of popular curatives that operate in the registers of traditional medicine, vitamin supplement, and herbal tonic. I track the concepts and techniques of measurement, calibration and intervention in this locale in order to understand how they employ and generate ideas about culture, history, and wellbeing to produce new populations available for labour — as timber plantation labourers and as compliant HIV surveillance subjects.
12 citations
References
More filters
University of North Carolina at Chapel Hill1, Fred Hutchinson Cancer Research Center2, FHI 3603, University of Zimbabwe4, Johns Hopkins University5, Oswaldo Cruz Foundation6, Chiang Mai University7, Fenway Health8, Harvard University9, Kenya Medical Research Institute10, University of the Witwatersrand11, University of California, San Francisco12, University of Nebraska Medical Center13, National Institutes of Health14, University of California, Los Angeles15, University of Washington16
TL;DR: In this article, Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples.
Abstract: Background Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. Methods In nine countries, we...
5,871 citations
TL;DR: These Guidelines were developed by the Panel* on Clinical Practices for Treatment of HIV Infection convened by the Department of Health and Human Services and the Henry J. Kaiser Family Foundation.
Abstract: SUMMARY The availability of an increasing number of antiretroviral agents and the rapid evolution of new information has introduced extraordinary complexity into the treatment of HIV-infected persons. In 1996, the Department of Health and Human Services and the Henry J. Kaiser Family Foundation convened the Panel on Clinical Practices for the Treatment of HIV to develop guidelines for the clinical management of HIV-infected adults and adolescents. This report recommends that care should be supervised by an expert, and makes recommendations for laboratory monitoring including plasma HIV RNA, CD4 cell counts and HIV drug resistance testing. The report also provides guidelines for antiretroviral therapy, including when to start treatment, what drugs to initiate, when to change therapy, and therapeutic options when changing therapy. Special considerations are provided for adolescents and pregnant women. As with treatment of other chronic conditions, therapeutic decisions require a mutual understanding between the patient and the health care provider regarding the benefits and risks of treatment. Antiretroviral regimens are complex, have major side effects, pose difficulty with adherence, and carry serious potential consequences from the development of viral resistance due to non-adherence to the drug regimen or suboptimal levels of antiretroviral agents. Patient education and involvement in therapeutic
4,321 citations
TL;DR: The exciting evidence generated by this paper – that antiretroviral treatment of HIV-1 infection definitively reduces the risk of onward transmission of the virus by 96% – was rightly dubbed Science magazine's ‘Breakthrough of the Year’ in 2011.
Abstract: MS Cohen, YQ Chen, M McCauley N Engl J Med 2011 365:493–505.
The exciting evidence generated by this paper – that antiretroviral treatment of HIV-1 infection definitively reduces the risk of onward transmission of the virus by 96% – was rightly dubbed Science magazine's ‘Breakthrough of the Year’ in 2011.1 ,2
It has long been known that the probability of sexual transmission of HIV is strongly correlated with concentrations of HIV in blood and genital fluids.3 ,4 Effective antiretroviral therapy (ART) produces prolonged and sustained suppression of HIV replication in these compartments, reducing the amount of free virus.5 ,6 Thus, there has long been a …
4,259 citations
"HIV Treatment as Prevention: Issues..." refers result in this paper
...The results from the HTPN 052 trial reported in August 2011 demonstrated under the controlled conditions of a well-conducted clinical trial that early antiretroviral therapy (ART) can be highly effective in preventing transmission of HIV in stable heterosexual HIV-discordant couples [1]....
[...]
TL;DR: A theoretical strategy of universal voluntary HIV testing and immediate treatment with ART, combined with present prevention approaches, could have a major effect on severe generalised HIV/AIDS epidemics.
1,948 citations
"HIV Treatment as Prevention: Issues..." refers background in this paper
...Of course, the specific components required for successful TasP will depend on the particular TasP intervention strategy—universal population-wide HIV testing and treatment will use different approaches, and incur different costs, than TasP strategies targeted at people at high risk of HIV transmission, such as HIV-infected individuals in HIV-discordant couples [2,13,20]....
[...]
...[13] assert based on their modeling results, the economic case for TasP would likely be robust to large increases in the cost estimates....
[...]
...[13], it may not alter the overall conclusion that TasP is a socially worthwhile intervention....
[...]
...[13] ‘‘for scale and a plausible pattern of distribution of patients into clinics’’ [8]....
[...]
TL;DR: In this article, the authors compared the predictions of several mathematical models simulating the same ART intervention programmes to determine the extent to which models agree about the epidemiological impact of expanded ART.
Abstract: Background: Many mathematical models have investigated the impact of expanding access to antiretroviral therapy (ART) on new HIV infections. Comparing results and conclusions across models is challenging because models have addressed slightly different questions and have reported different outcome metrics. This study compares the predictions of several mathematical models simulating the same ART intervention programmes to determine the extent to which models agree about the epidemiological impact of expanded ART. Methods and Findings: Twelve independent mathematical models evaluated a set of standardised ART intervention scenarios in South Africa and reported a common set of outputs. Intervention scenarios systematically varied the CD4 count threshold for treatment eligibility, access to treatment, and programme retention. For a scenario in which 80% of HIV-infected individuals start treatment on average 1 y after their CD4 count drops below 350 cells/ml and 85% remain on treatment after 3 y, the models projected that HIV incidence would be 35% to 54% lower 8 y after the introduction of ART, compared to a counterfactual scenario in which there is no ART. More variation existed in the estimated long-term (38 y) reductions in incidence. The impact of optimistic interventions including immediate ART initiation varied widely across models, maintaining substantial uncertainty about the theoretical prospect for elimination of HIV from the population using ART alone over the next four decades. The number of person-years of ART per infection averted over 8 y ranged between 5.8 and 18.7. Considering the actual scale-up of ART in South Africa, seven models estimated that current HIV incidence is 17% to 32% lower than it would have been in the absence of ART. Differences between model assumptions about CD4 decline and HIV transmissibility over the course of infection explained only a modest amount of the variation in model results. Conclusions: Mathematical models evaluating the impact of ART vary substantially in structure, complexity, and parameter choices, but all suggest that ART, at high levels of access and with high adherence, has the potential to substantially reduce new HIV infections. There was broad agreement regarding the short-term epidemiologic impact of ambitious treatment scale-up, but more variation in longer term projections and in the efficiency with which treatment can reduce new infections. Differences between model predictions could not be explained by differences in model structure or parameterization that were hypothesized to affect intervention impact. Please see later in the article for the Editors’ Summary.
361 citations
Additional excerpts
...A few mathematical modeling studies have predicted the cost-effectiveness of TasP, using cost estimates derived from currently existing ART programs [4–7]....
[...]