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Cost-effectiveness of preexposure prophylaxis for HIV prevention for conception in the United States.

ABSTRACT: OBJECTIVE:The aim of this study was to investigate the value of coformulated Tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) for preexposure prophylaxis (PrEP) for conception in the U.S. and to identify scenarios in which 'Undetectable?=?Untransmittable' (U?=?U) may not be adequate, and rather, PrEP or assisted reproduction would improve outcomes. DESIGN:We developed a Markov cohort simulation model to estimate the incremental benefits and cost-effectiveness of PrEP compared with alternative safer conception strategies, including combination antiretroviral therapy (cART) alone for the HIV-infected partner and assisted reproductive technologies. We modelled various scenarios in which HIV RNA suppression in the male partner was less than perfect. SETTING:U.S. healthcare sector perspective. PARTICIPANTS:Serodiscordant couples in the U.S. was composed of an HIV-infected male and HIV-uninfected female seeking conception. INTERVENTION:Economic analysis. MAIN OUTCOME MEASURE(S):Cumulative risks of HIV transmission to women and babies, maternal life expectancy, discounted quality-adjusted life years (QALY), discounted lifetime medical costs and incremental cost-effectiveness ratios. RESULTS:cART with condomless intercourse limited to ovulation was the preferred HIV prevention strategy among women seeking to conceive with an HIV-infected partner who is HIV-suppressed. PrEP was not cost-effective for women who had partners who were virologically suppressed. When the probability of male partner HIV suppression was low and we assumed generic pricing of PrEP, PrEP was cost-effective, and sometimes even cost-saving compared with cART alone. CONCLUSION:From a U.S. healthcare sector perspective, when the male partner was not reliably suppressed, PrEP became economically attractive, and in some cases, cost-saving.

SUBMITTER: Leech AA

PROVIDER: S-EPMC6805137 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Cost-effectiveness of preexposure prophylaxis for HIV prevention for conception in the United States.

Leech Ashley A AA Burgess James F JF Sullivan Meg M Kuohung Wendy W Horný Michal M Drainoni Mari-Lynn ML Christiansen Cindy L CL Linas Benjamin P BP

AIDS (London, England) 20181101 18

<h4>Objective</h4>The aim of this study was to investigate the value of coformulated Tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) for preexposure prophylaxis (PrEP) for conception in the U.S. and to identify scenarios in which 'Undetectable = Untransmittable' (U = U) may not be adequate, and rather, PrEP or assisted reproduction would improve outcomes.<h4>Design</h4>We developed a Markov cohort simulation model to estimate the incremental benefits and cost-effectiveness of PrEP comp ...[more]

PMID: 30234602

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Project description:A recent randomized, controlled trial showed that daily oral preexposure chemoprophylaxis (PrEP) was effective for HIV prevention in men who have sex with men (MSM). The Centers for Disease Control and Prevention recently provided interim guidance for PrEP in MSM at high risk for HIV. Previous studies did not reach a consistent estimate of its cost-effectiveness.To estimate the effectiveness and cost-effectiveness of PrEP in MSM in the United States.Dynamic model of HIV transmission and progression combined with a detailed economic analysis.Published literature.MSM aged 13 to 64 years in the United States.Lifetime.Societal.PrEP was evaluated in both the general MSM population and in high-risk MSM and was assumed to reduce infection risk by 44% on the basis of clinical trial results.New HIV infections, discounted quality-adjusted life-years (QALYs) and costs, and incremental cost-effectiveness ratios.Initiating PrEP in 20% of MSM in the United States would reduce new HIV infections by an estimated 13% and result in a gain of 550,166 QALYs over 20 years at a cost of $172,091 per QALY gained. Initiating PrEP in a larger proportion of MSM would prevent more infections but at an increasing cost per QALY gained (up to $216,480 if all MSM receive PrEP). Preexposure chemoprophylaxis in only high-risk MSM can improve cost-effectiveness. For MSM with an average of 5 partners per year, PrEP costs approximately $50,000 per QALY gained. Providing PrEP to all high-risk MSM for 20 years would cost $75 billion more in health care-related costs than the status quo and $600,000 per HIV infection prevented, compared with incremental costs of $95 billion and $2 million per infection prevented for 20% coverage of all MSM.PrEP in the general MSM population would cost less than $100,000 per QALY gained if the daily cost of antiretroviral drugs for PrEP was less than $15 or if PrEP efficacy was greater than 75%.When examining PrEP in high-risk MSM, the investigators did not model a mix of low- and high-risk MSM because of lack of data on mixing patterns.PrEP in the general MSM population could prevent a substantial number of HIV infections, but it is expensive. Use in high-risk MSM compares favorably with other interventions that are considered cost-effective but could result in annual PrEP expenditures of more than $4 billion.National Institute on Drug Abuse, Department of Veterans Affairs, and National Institute of Allergy and Infectious Diseases.

Project description:Preexposure prophylaxis (PrEP) with antiretroviral medication has been proven effective in reducing the risk for acquiring human immunodeficiency virus (HIV). The fixed-dose combination tablet of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) was approved by the U.S. Food and Drug Administration (FDA) for use as PrEP for adults in 2012. Since then, recognition has been increasing that adolescents at risk for acquiring HIV can benefit from PrEP. In 2018, FDA approved revised labeling for TDF/FTC that expanded the indication for PrEP to include adolescents weighing at least 77 lb (35 kg) who are at risk for acquiring HIV. In 2019, FDA approved the combination product tenofovir alafenamide (TAF)/FTC as PrEP for adolescents and adults weighing at least 77 lb (35 kg), excluding those at risk for acquiring HIV through receptive vaginal sex. This exclusion is due to the lack of clinical data regarding the efficacy of TAF/FTC in cisgender women.Clinical providers who evaluate adolescents for PrEP use must consider certain topics that are unique to the adolescent population. Important considerations related to adolescents include PrEP safety data, legal issues about consent for clinical care and confidentiality, the therapeutic partnership with adolescents and their parents or guardians, the approach to the adolescent patient's clinical visit, and medication initiation, adherence, and persistence during adolescence. Overall, data support the safety of PrEP for adolescents. PrEP providers should be familiar with the statutes and regulations about the provision of health care to minors in their states. Providers should partner with the adolescent patient for PrEP decisions, recognizing the adolescent's autonomy to the extent allowable by law and including parents in the conversation about PrEP when it is safe and reasonable to do so. A comprehensive approach to adolescent health is recommended, including considering PrEP as one possible component of providing medical care to adolescents who inject drugs or engage in sexual behaviors that place them at risk for acquiring HIV. PrEP adherence declined over time in the studies evaluating PrEP among adolescents, a trend that also has been observed among adult patients. Clinicians should implement strategies to address medication adherence as a routine part of prescribing PrEP; more frequent clinical follow-up is one possible approach.PrEP is an effective HIV prevention tool for protecting adolescents at risk for HIV acquisition. For providers, unique considerations that are part of providing PrEP to adolescents include the possible need for more frequent, supportive interactions to promote medication adherence. Recommendations for PrEP medical management and additional resources for providers are available in the U.S. Public Health Service clinical practice guideline Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Update and the clinical providers' supplement Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Update: Clinical Providers' Supplement (https://www.cdc.gov/hiv/clinicians/prevention/prep.html).

Dataset Information

Cost-effectiveness of preexposure prophylaxis for HIV prevention for conception in the United States.

Publications

Cost-effectiveness of preexposure prophylaxis for HIV prevention for conception in the United States.

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