BioPIC Adaptable Product Introduction Framework

7 July 2022

This framework is intended to inform stakeholders involved in all stages of product introduction from clinical research to rollout in low- and middle-income countries (LMICs). While the framework focuses on activities to begin in parallel to phase III clinical trials, stakeholders in early product development phases may also want to understand what to expect in terms of downstream product introduction needs. Stakeholders involved in early product development may also consider leveraging some of the activities included to anticipate future needs.

Featured Resources

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Costs and Cost-Effectiveness of Biomedical, Non-Surgical HIV Prevention Interventions: A systematic literature review

This article from PharmacoEconomics synthesizes findings on cost and cost-effectivness of different biomedical HIV prevention options and identifies remaining knowledge gaps to suggest future research priorities.

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Long-acting HIV Pre-exposure Prophylaxis (PrEP) Approaches: Recent advances, emerging technologies, and development challenges

This review from Expert Opinion on Drug Delivery discusses the current state of the long acting PrEP field, recent advances, and emerging technologies, including ARV prodrug modifications and new drug delivery systems. Technological challenges, knowledge gaps, preclinical testing considerations, and future directions important in the context of clinical translation and implementation of long acting HIV…

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HIV Prevention for the Next Decade: Appropriate, person-centred, prioritised, effective, combination prevention

In light of the development of new HIV prevention technologies, this article from PLOS Medicine proposes a new approach to HIV prevention, that emphasises appropriate, person-centred, prioritised, effective, combination HIV prevention within a framework that reduces existing barriers to services and acknowledges heterogeneity, autonomy, and choice.

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Daily Oral PrEP, Event-Driven PrEP, PrEP Ring, and CAB PrEP Template Guidelines

The intent of this document is to provide adaptable guidelines to support the development and adoption of national guidelines that align with World Health Organization (WHO) pre-exposure prophylaxis (PrEP) recommendations and guidance, including those for tenofovir disoproxil fumarate (TDF)-based daily and event-driven oral PrEP, the monthly dapivirine vaginal ring (“PrEP ring” or “the ring”), and…

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Potential of Long-Acting Products to Transform the Treatment and Prevention of Human Immunodeficiency Virus (HIV) in Infants, Children, and Adolescents

This article from Clinical Infectious Diseases examines the potential of injectable PrEP for HIV prevention in infants, children, and adolescents.

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Barriers to Uptake of Long-Acting Antiretroviral Products for Treatment and Prevention of HIV in Low- and Middle-Income Countries

This article from Clinical Infectious Diseases examines potential barriers to scale-up of injectable PrEP in low and middle income countries.

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A Qualitative Exploration of New and Existing HIV PrEP Modalities Among Men Who Have Sex with Men in Philadelphia

This article from Open Forum Infectious Diseases explores the treatment characteristics that may influence the willingness and uptake of long-acting injectable PrEP as opposed to the daily pills among a racially diverse sample of gay and bisexual men who have sex with men in Philadelphia, Pennsylvania, USA.

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Transgender Women in HPTN 083: An evaluation of safety, efficacy, and gender affirming hormonal therapy interactions with long-acting cabotegravir

This poster from AIDS 2022 presents an analysis of results from the HPTN 083 study, looking at the impact of feminizing gender affirming hormones on cabotegravir (CAB) for PrEP pharmacokinetics.

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Relative Cost-effectiveness of Long-acting Injectable Cabotegravir versus Oral Pre-exposure Prophylaxis in South Africa based on the HPTN 083 and HPTN 084 Trials: A modelled economic evaluation and threshold analysis

This article from The Lancet HIV estimates the incremental cost-effectiveness of long-acting injectable cabotegravir (CAB for PrEP) compared with tenofovir disoproxil fumarate and emtricitabine (TDF/FTC oral PrEP) in South Africa, using methods standard to government planning, and determines the threshold price at which CAB for PrEP is as cost-effective as TDF/FTC oral PrEP.

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Acceptability of Injectable Pre-exposure Prophylaxis among People who Inject Drugs in Three Urban U.S. Settings

This article from BMC Infectious Diseases examines acceptability of injectable PrEP amongst people who inject drugs in the US.