Dataset Information

Projected Impact of Concurrently Available Long-Acting Injectable and Daily-Oral Human Immunodeficiency Virus Preexposure Prophylaxis: A Mathematical Model.

ABSTRACT:

Background

Long-acting injectable (LAI) human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) is reportedly efficacious, although full trial results have not been published. We used a dynamic network model of HIV transmission among men who have sex with men to assess the population impact of LAI-PrEP when available concurrently with daily-oral (DO) PrEP.

Methods

The reference model represents the current HIV epidemiology and DO-PrEP coverage (15% among those with behavioral indications for PrEP) among men who have sex with men in the southeastern United States. Primary analyses investigated varied PrEP uptake and proportion selecting LAI-PrEP. Secondary analyses evaluated uncertainty in pharmacokinetic efficacy and LAI-PrEP persistence relative to DO-PrEP.

Results

Compared with the reference scenario, if 50% chose LAI-PrEP, 4.3% (95% simulation interval, -7.3% to 14.5%) of infections would be averted over 10 years. The impact of LAI-PrEP is slightly greater than that of the DO-PrEP-only regimen, based on assumptions of higher adherence and partial protection after discontinuation. If the total PrEP initiation rate doubled, 17.1% (95% simulation interval, 6.7%-26.4%) of infections would be averted. The highest population-level impact occurred when LAI-PrEP uptake and persistence improved.

Conclusions

If LAI-PrEP replaces DO-PrEP, its availability will modestly improve the population impact. LAI-PrEP will make a more substantial impact if its availability drives higher total PrEP coverage, or if persistence is greater for LAI-PrEP.

SUBMITTER: Maloney KM

PROVIDER: S-EPMC7781468 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Projected Impact of Concurrently Available Long-Acting Injectable and Daily-Oral Human Immunodeficiency Virus Preexposure Prophylaxis: A Mathematical Model.

Maloney Kevin M KM Le Guillou Adrien A Driggers Robert A RA Sarkar Supriya S Anderson Emeli J EJ Malik Amyn A AA Jenness Samuel M SM

The Journal of infectious diseases 20210101 1

<h4>Background</h4>Long-acting injectable (LAI) human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) is reportedly efficacious, although full trial results have not been published. We used a dynamic network model of HIV transmission among men who have sex with men to assess the population impact of LAI-PrEP when available concurrently with daily-oral (DO) PrEP.<h4>Methods</h4>The reference model represents the current HIV epidemiology and DO-PrEP coverage (15% among those with behav ...[more]

PMID: 32882043

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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.

Project description:BackgroundLong-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) has proven efficacious in randomized controlled trials. Further research is critical to evaluate its effectiveness in real-world settings and identify effective implementation approaches, especially among young sexual and gender minorities (SGMs).ObjectiveImPrEP CAB Brasil is an implementation study aiming to generate critical evidence on the feasibility, acceptability, and effectiveness of incorporating CAB-LA into the existing public health oral PrEP services in 6 Brazilian cities. It will also evaluate a mobile health (mHealth) education and decision support tool, digital injection appointment reminders, and the facilitators of and barriers to integrating CAB-LA into the existing services.MethodsThis type-2 hybrid implementation-effectiveness study includes formative work, qualitative assessments, and clinical steps 1 to 4. For formative work, we will use participatory design methods to develop an initial CAB-LA implementation package and process mapping at each site to facilitate optimal client flow. SGMs aged 18 to 30 years arriving at a study clinic interested in PrEP (naive) will be invited for step 1. Individuals who tested HIV negative will receive mHealth intervention and standard of care (SOC) counseling or SOC for PrEP choice (oral or CAB-LA). Participants interested in CAB-LA will be invited for step 2, and those with undetectable HIV viral load will receive same-day CAB-LA injection and will be randomized to receive digital appointment reminders or SOC. Clinical appointments and CAB-LA injection are scheduled after 1 month and every 2 months thereafter (25-month follow-up). Participants will be invited to a 1-year follow-up to step 3 if they decide to change to oral PrEP or discontinue CAB-LA and to step 4 if diagnosed with HIV during the study. Outcomes of interest include PrEP acceptability, choice, effectiveness, implementation, and feasibility. HIV incidence in the CAB-LA cohort (n=1200) will be compared with that in a similar oral PrEP cohort from the public health system. The effectiveness of the mHealth and digital interventions will be assessed using interrupted time series analysis and logistic mixed models, respectively.ResultsDuring the third and fourth quarters of 2022, we obtained regulatory approvals; programmed data entry and management systems; trained sites; and performed community consultancy and formative work. Study enrollment is programmed for the second quarter of 2023.ConclusionsImPrEP CAB Brasil is the first study to evaluate CAB-LA PrEP implementation in Latin America, one of the regions where PrEP scale-up is most needed. This study will be fundamental to designing programmatic strategies for implementing and scaling up feasible, equitable, cost-effective, sustainable, and comprehensive alternatives for PrEP programs. It will also contribute to maximizing the impact of a public health approach to reducing HIV incidence among SGMs in Brazil and other countries in the Global South.Trial registrationClinicaltrials.gov NCT05515770; https://clinicaltrials.gov/ct2/show/NCT05515770.International registered report identifier (irrid)PRR1-10.2196/44961.

Project description:BackgroundLong-acting (LA) injectable preexposure prophylaxis (PrEP) and on-demand PrEP may improve overall PrEP uptake among men who have sex with men (MSM), but little is understood about the PrEP option preferences of MSM in practical scenarios where they may choose between various PrEP options.ObjectiveThis study aims to examine the preferences for starting various PrEP options among a US nationwide online convenience sample of MSM from September 2021 to February 2022.MethodsParticipants reporting no prior HIV diagnosis were provided brief descriptions of each PrEP option and were asked, "If [PrEP option] were available from your local doctor and you could access it for free, would you go to your doctor in the next month to start [PrEP option]?" Those who said "yes" to multiple options were asked to rank them in order of preference. MSM currently taking daily oral (DO) PrEP were asked whether they would switch to on-demand or LA PrEP options. Log binomial models were created to examine the association between willingness to start or switch to on-demand and LA PrEP with various sociodemographic and behavioral factors.ResultsIn the analytic sample (N=7760), among the participants who did not use any PrEP in the past 12 months (n=5108, 66%), 54% (n=2445) reported willingness to start at least 1 PrEP option and 41% (n=1845) of participants showed interest in starting multiple PrEP options. Overall, the highest willingness was reported for on-demand PrEP (n=2235, 44%), followed by DO PrEP (n=2174, 43%) and LA PrEP (n=1482, 29%). LA PrEP was ranked first among those interested in multiple options. Characteristics associated with ranking LA PrEP as a first option to start PrEP versus DO or on-demand PrEP were region of residence (residing in the West vs Northeast), report of sexually transmitted infection diagnosis in the past year, report of illicit drug use other than marijuana in the past year, and prior awareness of LA PrEP. Among current DO PrEP users (n=2379, 31%), 58% (n=1386) were willing to switch to on-demand or LA PrEP, and LA PrEP was ranked first among participants who were open to switching to both options. Willingness to switch to LA PrEP was higher among those who used illicit drugs other than marijuana in the past year, who heard of LA PrEP prior to the survey, and those who took 15 or less doses of oral PrEP in the last 30 days.ConclusionsLA PrEP was the highest-ranked option among most MSM who were willing to try multiple options or switch from DO PrEP. These findings highlight that LA PrEP might fill coverage gaps among MSM who use illicit drugs, have had a recent sexually transmitted infection diagnosis, and have less than optimal DO PrEP adherence.

Project description:ObjectiveTo understand perspectives on and preferences for preexposure prophylaxis (PrEP) for pregnant individuals who are at risk for human immunodeficiency virus (HIV) infection.MethodsIn this qualitative study, we purposively sampled and conducted in-depth interviews with pregnant participants at risk of HIV infection (indicated by a recent sexually transmitted infection [STI]) from a U.S. urban obstetrics clinic. Interview questions focused on perceived HIV risk, knowledge and perceptions of PrEP, and preferences for different PrEP formulations. We coded data using deductive and inductive codes, created matrices to explore patterns in findings, and wrote memos to interpret emergent themes.ResultsTwenty patients were enrolled. Median age of the participants was 24 years (interquartile range 19-26 years), 95.0% were African American, 65.0% were high school graduates, and 70.0% had unplanned pregnancies. Participants had low knowledge of PrEP and most saw themselves at low to no risk of HIV acquisition, despite their recent STI. Further, participants' low HIV risk perception and medication safety concerns reduced PrEP acceptability. Moreover, very few had discussed PrEP with their obstetrician-gynecologists (ob-gyns) during antenatal care, which further affected perceived acceptability. However, participants who did discuss PrEP with their ob-gyns had favorable perceptions of it. These participants indicated that they would choose a formulation based on individual preferences, which were largely shaped by perceived ease of use, acceptability, and prior experience with other medication regimens.ConclusionObstetrician-gynecologists may play an important role in increasing pregnant individuals' knowledge of and access to PrEP during pregnancy among those who are at risk of HIV acquisition. To maximize uptake and adherence during this time, PrEP formulations should be tailored to individual preferences. Prevention of HIV during this critical life transition is important not only for the long-term health and well-being of pregnant individuals and their infants, but to the plan to end the HIV epidemic in the United States by 2030.

Dataset Information

Projected Impact of Concurrently Available Long-Acting Injectable and Daily-Oral Human Immunodeficiency Virus Preexposure Prophylaxis: A Mathematical Model.

Background

Methods

Results

Conclusions

Publications

Projected Impact of Concurrently Available Long-Acting Injectable and Daily-Oral Human Immunodeficiency Virus Preexposure Prophylaxis: A Mathematical Model.

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