Associated Costs Are a Barrier to HIV Preexposure Prophylaxis Access in the United States.
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SUBMITTER: Srikanth K
PROVIDER: S-EPMC9137017 | biostudies-literature | 2022 Jun
REPOSITORIES: biostudies-literature
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Associated Costs Are a Barrier to HIV Preexposure Prophylaxis Access in the United States.
Srikanth Karishma K Killelea Amy A Strumpf Andrew A Corbin-Gutierrez Edwin E Horn Tim T McManus Kathleen A KA
American journal of public health 20220414 6
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Project description:ObjectiveThe 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.DesignWe 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.SettingU.S. healthcare sector perspective.ParticipantsSerodiscordant couples in the U.S. was composed of an HIV-infected male and HIV-uninfected female seeking conception.InterventionEconomic 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.ResultscART 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.ConclusionFrom a U.S. healthcare sector perspective, when the male partner was not reliably suppressed, PrEP became economically attractive, and in some cases, cost-saving.
| S-EPMC6805137 | biostudies-literature
Project description:BackgroundThe total population health benefits and costs of HIV preexposure prophylaxis (PrEP) for people who inject drugs (PWID) in the United States are unclear.ObjectiveTo evaluate the cost-effectiveness and optimal delivery conditions of PrEP for PWID.DesignEmpirically calibrated dynamic compartmental model.Data sourcesPublished literature and expert opinion.Target populationAdult U.S. PWID.Time horizon20 years and lifetime.InterventionPrEP alone, PrEP with frequent screening (PrEP+screen), and PrEP+screen with enhanced provision of antiretroviral therapy (ART) for individuals who become infected (PrEP+screen+ART). All scenarios are considered at 25% coverage.Outcome measuresInfections averted, deaths averted, change in HIV prevalence, discounted costs (in 2015 U.S. dollars), discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.Results of base-case analysisPrEP+screen+ART dominates other strategies, averting 26 700 infections and reducing HIV prevalence among PWID by 14% compared with the status quo. Achieving these benefits costs $253 000 per QALY gained. At current drug prices, total expenditures for PrEP+screen+ART could be as high as $44 billion over 20 years.Results of sensitivity analysisCost-effectiveness of the intervention is linear in the annual cost of PrEP and is dependent on PrEP drug adherence, individual transmission risks, and community HIV prevalence.LimitationData on risk stratification and achievable PrEP efficacy levels for U.S. PWID are limited.ConclusionPrEP with frequent screening and prompt treatment for those who become infected can reduce HIV burden among PWID and provide health benefits for the entire U.S. population, but, at current drug prices, it remains an expensive intervention both in absolute terms and in cost per QALY gained.Primary funding sourceNational Institute on Drug Abuse.
| S-EPMC5118181 | biostudies-literature
Project description:The potential for human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) to reduce the racial disparities in HIV incidence in the United States might be limited by racial gaps in PrEP care. We used a network-based mathematical model of HIV transmission for younger black and white men who have sex with men (BMSM and WMSM) in the Atlanta, Georgia, area to evaluate how race-stratified transitions through the PrEP care continuum from initiation to adherence and retention could affect HIV incidence overall and disparities in incidence between races, using current empirical estimates of BMSM continuum parameters. Relative to a no-PrEP scenario, implementing PrEP according to observed BMSM parameters was projected to yield a 23% decline in HIV incidence (hazard ratio = 0.77) among BMSM at year 10. The racial disparity in incidence in this observed scenario was 4.95 per 100 person-years at risk (PYAR), a 19% decline from the 6.08 per 100 PYAR disparity in the no-PrEP scenario. If BMSM parameters were increased to WMSM values, incidence would decline by 47% (hazard ratio = 0.53), with an associated disparity of 3.30 per 100 PYAR (a 46% decline in the disparity). PrEP could simultaneously lower HIV incidence overall and reduce racial disparities despite current gaps in PrEP care. Interventions addressing these gaps will be needed to substantially decrease disparities.
| S-EPMC6438815 | biostudies-literature
Project description:ObjectiveTo evaluate if community-level HIV PrEP coverage is correlated with individual sexual behaviors.DesignWe used demographic, behavioral, and sexual network data from ARTnet, a 2017-2019 study of United States MSM.MethodsMultivariable regression models with a Bayesian modeling framework were used to estimate associations between area-level PrEP coverage and seven sexual behavior outcomes [number of total, main, and casual male partners (network degree); count of one-time partnerships; consistent condom use in one-time partnerships; and frequency of casual partnership anal sex (total and condomless)], controlling for individual PrEP use.ResultsPrEP coverage ranged from 10.3% (Philadelphia) to 38.9% (San Francisco). Total degree was highest in Miami (1.35) and lowest in Denver (0.78), while the count of one-time partners was highest in San Francisco (11.7/year) and lowest in Detroit (1.5/year). Adjusting for individual PrEP use and demographics, community PrEP coverage correlated with total degree [adjusted incidence rate ratio (aIRR) = 1.73; 95% credible interval (CrI), 0.92-3.44], casual degree (aIRR = 2.05; 95% CrI, 0.90-5.07), and count of one-time partnerships (aIRR = 1.90; 95% CrI, 0.46-8.54). Without adjustment for individual PrEP use, these associations strengthened. There were weaker or no associations with consistent condom use in one-time partnerships (aIRR = 1.68; 95% CrI, 0.86-3.35), main degree (aIRR = 1.21; 95% CrI, 0.48-3.20), and frequency of casual partnership condomless anal sex (aIRR = 0.23; 95% CrI, 0.01-3.60).ConclusionMost correlations between community PrEP coverage and sexual behavior were explained by individual PrEP use. However, some residual associations remained after controlling for individual PrEP use, suggesting that PrEP coverage may partially drive community-level differences in sexual behaviors.
| S-EPMC9617766 | biostudies-literature
Project description:BackgroundThe HIV Prevention Trials Network (HPTN) 083 trial demonstrated the superiority of long-acting injectable cabotegravir (CAB-LA) compared with oral emtricitabine-tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP).ObjectiveTo identify the maximum price premium (that is, greatest possible price differential) that society should be willing to accept for the additional benefits of CAB-LA over tenofovir-based PrEP among men who have sex with men and transgender women (MSM/TGW) in the United States.DesignSimulation, cost-effectiveness analysis.Data sourcesTrial and published data, including estimated HIV incidence (5.32, 1.33, and 0.26 per 100 person-years for off PrEP, generic F/TDF and branded emtricitabine-tenofovir alafenamide (F/TAF), and CAB-LA, respectively); 28% 6-year PrEP retention. Annual base-case drug costs: $360 and $16 800 for generic F/TDF and branded F/TAF. Fewer side effects with branded F/TAF versus generic F/TDF were assumed.Target population476 700 MSM/TGW at very high risk for HIV (VHR).Time horizon10 years.PerspectiveHealth care system.InterventionCAB-LA versus generic F/TDF or branded F/TAF for HIV PrEP.Outcome measuresPrimary transmissions, quality-adjusted life-years (QALYs), costs (2020 U.S. dollars), incremental cost-effectiveness ratios (ICERs; U.S. dollars per QALY), maximum price premium for CAB-LA versus tenofovir-based PrEP.Results of base-case analysisCompared with generic F/TDF (or branded F/TAF), CAB-LA increased life expectancy by 28 000 QALYs (26 000 QALYs) among those at VHR. Branded F/TAF cost more per QALY gained than generic F/TDF compared with no PrEP. At 10 years, CAB-LA could achieve an ICER of at most $100 000 per QALY compared with generic F/TDF at a maximum price premium of $3700 per year over generic F/TDF (CAB-LA price <$4100 per year).Results of sensitivity analysisIn a PrEP-eligible population at high risk for HIV, rather than at VHR (n = 1 906 800; off PrEP incidence: 1.54 per 100 person-years), CAB-LA could achieve an ICER of at most $100 000 per QALY versus generic F/TDF at a maximum price premium of $1100 per year over generic F/TDF (CAB-LA price <$1500 per year).LimitationUncertain clinical and economic benefits of averting future transmissions.ConclusionEffective oral PrEP limits the additional price society should be willing to pay for CAB-LA.Primary funding sourceFHI 360; Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institute of Allergy and Infectious Diseases; National Heart, Lung, and Blood Institute; National Institute on Drug Abuse; the Reich HIV Scholar Award; and the Steve and Deborah Gorlin MGH Research Scholars Award.
| S-EPMC9087297 | biostudies-literature
Project description: Not available
| S-EPMC9833205 | biostudies-literature
Project description:BackgroundHIV preexposure prophylaxis (PrEP) using daily oral tenofovir-disoproxil-fumarate/emtricitabine (TDF/FTC) is effective for preventing HIV acquisition, but concerns remain about its potential kidney toxicity. This study examined kidney function in individuals using PrEP in real-world clinical settings.SettingDemonstration project in 2 sexually transmitted infection clinics and a community health center.MethodsWe evaluated kidney function among men who have sex with men and transgender women taking tenofovir-disoproxil-fumarate/emtricitabine PrEP for up to 48 weeks. Serum creatinine and urine dipstick for protein were obtained at 12-week intervals. Kidney function was estimated using creatinine clearance (CrCl) (Cockcroft-Gault) and estimated glomerular filtration rate (eGFR) (CKD-EPI).ResultsFrom October 2012 to January 2014, we enrolled 557 participants (median age 33). Mean creatinine increased from baseline to week 12 by 0.03 mg/dL (4.6%) (P < 0.0001); mean CrCl decreased by 4.8 mL/min (3.0%) (P < 0.0001). These changes remained stable through week 48 (P = 0.81, P = 0.71 respectively). There were 75/478 (15.7%) participants who developed worsening proteinuria at week 12 compared with baseline (P < 0.0001), and this percent remained stable through week 48 (P = 0.73). Twenty-five participants (5.1%) developed new-onset eGFR <70 mL/min/1.73 m; independent predictors of this outcome were age ≥40 years (OR 3.79, 95% CI: 1.43 to 10.03) and baseline eGFR <90 mL/min/1.73 m (OR 9.59, 3.69-24.94).ConclusionsIn a demonstration setting, daily tenofovir-disoproxil-fumarate/emtricitabine PrEP leads to reduced CrCl and eGFR; however, these eGFR changes are based on very small changes in serum creatinine and seem to be nonprogressive after the first 12 weeks. Future studies are needed to understand the prognostic significance of these small changes.
| S-EPMC5762266 | biostudies-literature
Project description:OBJECTIVES:To review the main factors influencing the costs of nondaily oral preexposure prophylaxis (PrEP) with tenofovir (±emtricitabine). To estimate the cost reductions possible with nondaily PrEP compared with daily PrEP for different populations (MSM and heterosexual populations). DESIGN:Systematic review and data triangulation. METHODS:We estimated the required number of tablets/person/week for dosing regimens used in the HPTN 067/ADAPT (daily/time-driven/event-driven) and IPERGAY (on-demand) trials for different patterns of sexual intercourse. Using trial data, and behavioural and cost data obtained through systematic literature reviews, we estimated cost savings resulting from tablet reductions for nondaily versus daily oral PrEP, assuming 100% adherence. RESULTS:Among different populations being prioritized for PrEP, the median reported number of days of sexual activity varied between 0 and 2 days/week (0-1.5 days/week for MSM, 1-2 days/week for heterosexual populations). With 100% adherence and two or fewer sex-days/week, HPTN 067/ADAPT nondaily regimens reduced the number of tablets/week by more than 40% compared with daily PrEP. PrEP program costs were reduced the most in settings with high drug costs, for example, by 66-69% with event-driven PrEP for French/US populations reporting on average one sex-day/week. CONCLUSION:Nondaily oral PrEP could lower costs substantially (>50%) compared with daily PrEP, particularly in high-income countries. Adherence and efficacy data are needed to determine cost-effectiveness.
| S-EPMC5854532 | biostudies-literature
Project description: Not available
| S-EPMC11772257 | biostudies-literature
Project description:HIV-testing algorithms for preexposure prophylaxis (PrEP) should be optimized to minimize the risk of drug resistance, the time off PrEP required to evaluate false-positive screening results, and costs and to expedite the start of therapy for those confirmed to be infected. HIV rapid tests (RTs) for anti-HIV antibodies provide results in less than 1 h and can be conducted by nonlicensed staff at the point of care. In many regions, Western blot (WB) testing is required to confirm reactive RT results. WB testing, however, causes delays in diagnosis and adds expense. The iPrEx study evaluated the safety and efficacy of daily oral emtricitabine-tenofovir disoproxil fumarate among HIV-seronegative men and transgender women who have sex with men: HIV infection was assessed with two RTs plus WB confirmation, followed by HIV-1 plasma viral load testing. During the iPrEx study, there were 51,260 HIV status evaluations among 2,499 volunteers using RTs: 142 (0.28%) had concordant positive results (100% were eventually confirmed) and 19 (0.04%) had discordant results among 14 participants; 11 were eventually determined to be HIV infected. A streamlined approach using only one RT to screen and a second RT to confirm (without WB) would have had nearly the same accuracy. Discrepant RT results are best evaluated with nucleic acid testing, which would also increase sensitivity.
| S-EPMC4290918 | biostudies-literature