Long-Acting Injectable Antiretroviral Drugs for Pregnant and Breastfeeding Women: Current Advances, Challenges, and Future Directions.

  • Abstract
  • Literature Map
  • Similar Papers
Abstract
Translate article icon Translate Article Star icon
Take notes icon Take Notes

This review explores the promise and challenges of integrating long-acting antiretroviral agents-cabotegravir, lenacapavir, and cabotegravir-rilpivirine-into HIV prevention and treatment programs for pregnant and breastfeeding populations. It aims to examine current evidence, implementation experiences, and barriers to equitable access. Emerging data support the efficacy and safety of long-acting agents during pregnancy and breastfeeding. Recent clinical trials have begun to include pregnant women by design, and national demonstration projects have successfully introduced injectable PrEP in maternal health settings. These developments signal growing recognition of the need for inclusive research and service delivery models. Long-acting antiretrovirals have the potential to transform maternal HIV prevention and treatment. However, challenges such as delayed inclusion in trials, policy constraints, limited product choice, high costs, and funding limitations persist. Addressing these gaps is critical to ensuring equitable access and informing future research and implementation strategies.

Similar Papers
  • Research Article
  • Cite Count Icon 12
  • 10.1002/jia2.26095
The importance of the "how": the case for differentiated service delivery of long-acting and extended delivery regimens for HIV prevention and treatment.
  • Jul 1, 2023
  • Journal of the International AIDS Society
  • Anna Grimsrud + 11 more

Long-acting and extended delivery (LAED) regimens for HIV treatment and prevention offer unique benefits to expand uptake, effective use and adherence. To date, research has focused on basic and clinical science around the safety and efficacy of these products. This commentary outlines opportunities in HIV prevention and treatment programmes, both for the health system and clients, that could be addressed through the inclusion of LAED regimens and the vital role of differentiated service delivery (DSD) in ensuring efficient and equitable access. The realities and challenges within HIV treatment and prevention programmes are different. Globally, more than 28 million people are accessing HIV treatment-the vast majority on a daily fixed-dose combination oral pill that is largely available, affordable and well-tolerated. Many people collect extended refills outside of health facilities with clinical consultations once or twice a year. Conversely, uptake of daily oral pre-exposure prophylaxis (PrEP) has consistently missed global targets due to limited access with high individual cost and lack of choice contributing to substantial unmet PrEP need. Recent trends in demedicalization, simplification, additional method options and DSD for PrEP have led to accelerated uptake as its availability has become more aligned with user preferences. How people currently receive HIV treatment and prevention services and their barriers to adherence must be considered for the introduction of LAED regimens to achieve the expected improvements in access and outcomes. Important considerations include the building blocks of DSD: who (provider), where (location), when (frequency) and what (package of services). Ideally, all LAED regimens will leverage DSD models that emphasize access at the community level and self-management. For treatment, LAED regimens may address challenges with adherence but their delivery should provide clear advantages over existing oral products to be scaled. For prevention, LAED regimens expand a potential PrEP user's choice of methods, but like other methods, need to be delivered in a manner that can facilitate frequent re-initiation. To ensure that innovative LAED HIV treatment and prevention products reach those who most stand to benefit, service delivery and client considerations during development, trial and early implementation are critical.

  • Research Article
  • Cite Count Icon 165
  • 10.1097/01.aids.0000390709.04255.fd
Combination prevention: a deeper understanding of effective HIV prevention
  • Oct 1, 2010
  • AIDS
  • Catherine A Hankins + 1 more

Evidence-informed and human rights-based combination prevention combines behavioural, biomedical, and structural interventions to address both the immediate risks and underlying causes of vulnerability to HIV infection, and the pathways that link them. Because these are context-specific, no single prescription or standard package will apply universally. Anchored in 'know your epidemic' estimates of where the next 1000 infections will occur and 'know your response' analyses of resource allocation and programming gaps, combination prevention strategies seek to realign programme priorities for maximum effect to reduce epidemic reproductive rates at local, regional, and national levels. Effective prevention means tailoring programmes to local epidemics and ensuring that components are delivered with the intensity, quality, and scale necessary to achieve intended effects. Structural interventions, addressing the social, economic, cultural, and legal constraints that create HIV risk environments and undermine the agency of individuals to protect themselves and others, are also public goods in their own right. Applying the principles of combination prevention systematically and consistently in HIV programme planning, with due attention to context, can increase HIV programme effectiveness. Better outcome and impact measurement using multiple methods and data triangulation can build the evidence base on synergies between the components of combination prevention at individual, group, and societal levels, facilitating iterative knowledge translation within and among programmes.

  • PDF Download Icon
  • Research Article
  • Cite Count Icon 5
  • 10.33696/aids.6.051
Bending the Curve Through Innovations to Overcome Persistent Obstacles in HIV Prevention and Treatment
  • Jan 1, 2024
  • Journal of AIDS and HIV Treatment
  • Tamer A Addissouky + 4 more

Background: HIV/AIDS remains a major global public health challenge despite significant progress in treatment. New infections and HIV-related deaths persist, fueled by disparities in prevention and care access. Purpose: This review synthesizes recent advances across key domains - from vaccine development to novel treatments to omics approaches – that collectively hold promise for ending the HIV/AIDS pandemic. Main body: Multiple innovative HIV vaccine platforms are now in early-phase trials, including mRNA vaccines as well as conserved epitope and mosaic constructs for broader immunogenicity. Long-acting injectable antiretrovirals represent a major milestone in HIV treatment, while gene editing techniques offer future curative potential. Leveraging multi-omics data through genomics, transcriptomics, proteomics, and metabolomics provides systems-level insights into viral persistence and new therapeutic opportunities. The gut microbiome is increasingly recognized as a mediator of HIV progression, spurring research into probiotic/prebiotic supplementation and fecal transplantation. Across these domains, integration of artificial intelligence and machine learning will likely accelerate discovery. Conclusion: Despite past setbacks, the HIV cure effort has renewed momentum. Translating emerging tools like long-acting antiretrovirals and omics profiling into broader clinical application could bend the pandemic’s trajectory. Innovation must be paired with ensuring equitable access to maximize global impact.

  • Research Article
  • Cite Count Icon 39
  • 10.1007/s10900-010-9310-1
Desire for, and Uptake of HIV Tests by Ghanaian Women: The Relevance of Community Level Stigma
  • Sep 14, 2010
  • Journal of Community Health
  • Emmanuel F Koku

Voluntary counseling and testing (VCT) has been recognized as the crux of HIV surveillance, prevention and treatment programs. Since 2000, Ghana government has launched a number of HIV prevention and treatment programs intended to increase VCT services. Despite these efforts, uptake of testing is still low, though many women reported interest in getting tested. The disconnect between intention and action is attributable to several factors, including HIV-related stigma. The study used data from the 2003 Ghana Demographic and Health Survey and fitted complementary log-log models to regress women's desire for and uptake of an HIV test on levels of personal and community stigma. Consistent with findings from previous research, the study revealed significant associations between a number of socio-demographic and socio-cognitive variables and the desire for and uptake of an HIV test by Ghanaian women. Most significantly, the study showed that widespread stigma in the community exert greater negative effects on individuals who endorse stigmatizing beliefs and predispositions, compared to their peers with more favorable attitudes. Since community level educational and risk reduction programs have demonstrable influences on reducing HIV stigma, it is imperative that the Ghana government's ongoing anti-stigma campaigns and other HIV prevention programs take cognizance of the role of community stigma in influencing HIV testing.

  • PDF Download Icon
  • Research Article
  • Cite Count Icon 20
  • 10.1186/s12889-019-7291-2
Evaluation of community-based HIV self-testing delivery strategies on reducing undiagnosed HIV infection, and improving linkage to prevention and treatment services, among men who have sex with men in Kenya: a programme science study protocol
  • Jul 23, 2019
  • BMC Public Health
  • Parinita Bhattacharjee + 18 more

BackgroundHIV prevalence among men having sex with men (MSM) in Kenya is 18.2%. Despite scale-up of HIV testing services, many MSM remain unaware of their HIV status and thus do not benefit from accessing HIV treatment or prevention services. HIV self-testing (HIVST) may help address this gap. However, evidence is limited on how, when, and in what contexts the delivery of HIVST to MSM could increase awareness of HIV status and lead to early linkage to HIV treatment and prevention.MethodsThe study will be embedded within existing MSM-focused community-based HIV prevention and treatment programmes in 3 counties in Kenya (Kisumu, Mombasa, Kiambu). The study is designed to assess three HIV testing outcomes among MSM, namely a) coverage b) frequency of testing and c) early uptake of testing. The study will adopt a mixed methods programme science approach to the implementation and evaluation of HIVST strategies via: (i) a baseline and endline bio-behavioural survey with 1400 MSM; (ii) a socio-sexual network study with 351 MSM; (iii) a longitudinal qualitative cohort study with 72 MSM; (iv) routine programme monitoring in three sites; (v) a programme-specific costing exercise; and (vi) mathematical modelling. This protocol evaluates the impact of community-based implementation of HIV self-testing delivery strategies among MSM in Kenya on reducing the undiagnosed MSM population, and time for linkage to prevention, treatment and care following HIV self-testing. Baseline data collection started in April 2019 and the endline data collection will start in July 2020.DiscussionThis study is one of the first programme science studies in Sub-Saharan Africa exploring the effectiveness of integrating HIVST interventions within already existing HIV prevention and treatment programmes for MSM in Kenya at scale. Findings from this study will inform national best approaches to scale up HIVST among MSM in Kenya.

  • Research Article
  • Cite Count Icon 22
  • 10.7448/ias.16.3.18934
Global Action to reduce HIV stigma and discrimination
  • Nov 1, 2013
  • Journal of the International AIDS Society

Global Action to reduce HIV stigma and discrimination

  • Front Matter
  • Cite Count Icon 7
  • 10.1002/phar.2922
Consensus recommendations for use of long-acting antiretroviral medications in the treatment and prevention of HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy, Canadian HIV and Viral Hepatitis Pharmacists Network, European AIDS Clinical Society, and Society of Infectious Diseases Pharmacists.
  • Jul 1, 2024
  • Pharmacotherapy
  • Elizabeth M Sherman + 17 more

Five long-acting (LA) antiretrovirals (ARVs) are currently available in a limited number of countries worldwide for HIV-1 prevention or treatment-cabotegravir, rilpivirine, lenacapavir, ibalizumab, and dapivirine. Implementing use of LA ARVs into routine clinical practice requires significant changes to the current framework of HIV-1 prevention, treatment, and service provision. Given the novelty, complexity, and interdisciplinary requirements needed to safely and optimally utilize LA ARVs, consensus recommendations on the use of LA ARVs will assist clinicians in optimizing use of these agents. The purpose of these recommendations is to provide guidance for the clinical use of LA ARVs for HIV-1 treatment and prevention. In addition, future areas of research are also identified and discussed.

  • Research Article
  • Cite Count Icon 14
  • 10.1186/s43058-021-00156-3
Implementation determinants and mechanisms for the prevention and treatment of adolescent HIV in sub-Saharan Africa: concept mapping of the NIH Fogarty International Center Adolescent HIV Implementation Science Alliance (AHISA) initiative
  • May 22, 2021
  • Implementation Science Communications
  • Gregory A Aarons + 4 more

IntroductionAdolescent HIV prevention and treatment is a high priority for youth healthcare in sub-Saharan Africa.MethodsThis study employed concept mapping to identify factors that impact the implementation of HIV prevention and intervention programs for adolescents in sub-Saharan Africa. Key stakeholders including researchers, policymakers, and non-governmental organization (NGO) personnel constituting membership of the NIH-sponsored Adolescent HIV Prevention and Treatment Implementation Science Alliance responded to the question: “In your experience, what factors have facilitated or hindered implementation of evidence-based HIV prevention or treatment for adolescents in sub-Saharan Africa?” Participants generated statements in response to the focus question, sorted them into thematically relevant groups, and rated each statement on its importance and changeability.ResultsThrough data analyses and participant feedback, 15 distinct themes were derived. “Workforce/Workflow” and “HIV Stigma and Adolescent Development” were rated highest for importance, and “Threshold Conditions for Treatment” and “Structure of Implementation Efforts” were rated most changeable.ConclusionsUnderstanding implementation science determinants and mechanisms can facilitate the uptake of successful implementation and sustainment strategies for the prevention and treatment of HIV in a given context. We placed determinants and mechanisms within the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to provide greater contextual integration with broader theories in implementation science. Implementers across multiple disciplines can use these findings to improve the scale-up of evidence-based practices for adolescent HIV prevention and treatment in sub-Saharan Africa. Implementation approaches that consider the determinants and mechanisms identified in this study and integrated in implementation frameworks will likely have utility for other health conditions and contexts.

  • PDF Download Icon
  • Research Article
  • Cite Count Icon 18
  • 10.1002/jia2.25807
Silver linings: how COVID-19 expedited differentiated service delivery for HIV.
  • Oct 1, 2021
  • Journal of the International AIDS Society
  • Anna Grimsrud + 2 more

Silver linings: how COVID-19 expedited differentiated service delivery for HIV.

  • Research Article
  • Cite Count Icon 24
  • 10.1177/1049732310375818
Altruism and Peer-Led HIV Prevention Targeting Heroin and Cocaine Users
  • Jul 16, 2010
  • Qualitative Health Research
  • Mark R Convey + 3 more

Peer-delivered HIV prevention and intervention programs play an important role in halting the spread of HIV. Rigorous scientific analysis of the aforementioned programs has focused on the immediate reduction of risk-related behaviors among the target populations. In our longitudinal study of the Risk Avoidance Partnership Peer Intervention for HIV, we assessed the long-term behavioral effects of a peer-led HIV intervention project with active drug users. Initial analysis of the qualitative data highlights the role of altruism as a motivator in sustaining peer educators beyond the immediate goals of the project. We contend that altruism found in volunteers is an important factor in maintaining long-term participation in HIV intervention programs and initiatives using peer educators.

  • Research Article
  • 10.31690/ipplanet.2024.v012i03.013
“Innovations in HIV treatment: The role of long-acting antiretrovirals examining the advancements in HIV therapy, particularly long-acting injectable antiretrovirals”
  • Jan 1, 2024
  • Innovations in Pharmacy Planet
  • Neha Dubey

The landscape of HIV treatment is undergoing a significant transformation with the introduction of long-acting antiretrovirals (LA-ARVs), offering a promising alternative to traditional daily oral regimens. This review examines the current advancements in LA-ARVs, focusing on their mechanisms, clinical efficacy, and potential to improve patient outcomes. LA-ARVs, such as cabotegravir and rilpivirine, delivered through injectable formulations, have demonstrated effective viral suppression with less frequent dosing, addressing challenges such as adherence and pill fatigue commonly associated with daily antiretroviral therapy. Clinical trials, including ATLAS and FLAIR, highlight their efficacy across diverse patient populations, with favorable safety profiles. Key advantages of LA-ARVs include enhanced adherence, reduced risk of drug resistance, and improved quality of life, particularly for individuals facing barriers to daily oral therapy. However, limitations such as high costs, the need for regular healthcare access, and long-term safety concerns present challenges to widespread adoption. Future developments in LA-ARVs, including next-generation drugs and expanded applications in preexposure prophylaxis, are poised to revolutionize personalized HIV care. As research progresses, LA-ARVs hold the potential to reshape the treatment paradigm, offering a more convenient and sustainable approach to managing HIV.

  • Research Article
  • Cite Count Icon 6
  • 10.1097/qai.0000000000001243
Promotion of Research on the HIV Continuum of Care in the United States: The CFAR HIV Continuum of Care/ECHPP Working Group.
  • Feb 1, 2017
  • JAIDS Journal of Acquired Immune Deficiency Syndromes
  • Alan E Greenberg + 2 more

Promotion of Research on the HIV Continuum of Care in the United States: The CFAR HIV Continuum of Care/ECHPP Working Group.

  • Research Article
  • Cite Count Icon 24
  • 10.1111/j.1365-3156.2008.02176.x
Changing roles and responses of health care workers in HIV treatment and care
  • Nov 1, 2008
  • Tropical Medicine & International Health
  • Divya Rajaraman + 1 more

A key limiting factor in the scale up and sustainability of HIV care and treatment programmes is the global shortage of trained health care workers. This paper discusses why it is important to move beyond conceptualising health care workers simply as 'inputs' in the delivery of HIV treatment and care, and to also consider their roles as partners and agents in the process of health care. It suggests a framework for thinking about their roles and responses in HIV care, considers the current evidence base, and concludes by identifying key areas for future research on health care workers' responses in HIV treatment and care in low and middle income settings.

  • Research Article
  • Cite Count Icon 31
  • 10.1136/sextrans-2014-051991
Estimating the impact of the US President's Emergency Plan for AIDS Relief on HIV treatment and prevention programmes in Africa
  • Jun 8, 2015
  • Sexually Transmitted Infections
  • Laura M Heaton + 6 more

BackgroundSince 2004, the US President's Emergency Plan for AIDS Relief (PEPFAR) has supported the tremendous scale-up of HIV prevention, care and treatment services, primarily in sub-Saharan Africa. We evaluate the...

  • Research Article
  • Cite Count Icon 5
  • 10.3947/ic.2014.46.2.139
HIV Stigmatization Harms Individuals and Public Health.
  • Jan 1, 2014
  • Infection & Chemotherapy
  • Jun Yong Choi

There have been many successful stories about HIV treatment and prevention during the past three decades of the AIDS epidemic. Among the successful stories, HIV chemotherapy has been a major medical accomplishment in the past two decades and has dramatically reduced the morbidity and mortality of those with access to care [1]. Since a controlled trial demonstrated the efficacy and safety of combination antiretroviral therapy (cART) to treat HIV infection, virologic suppression, immune reconstitution, and long-term survival of HIV infected persons have been achievable goals. Even though HIV infection is currently a controllable disease for patients on successful cART, people living with HIV/AIDS (PLWHA) are still suffering from social stigmatization in many countries, including South Korea [2, 3, 4]. Kittner et al. [3] reported 36.1% of German HIV subjects rated to feel guilty in relation to their infection, and they concluded HIV infected patients in Germany still suffer from an elevated level of anxiety and depression that was related with internal stigmatization. Stigma has been characterized as self, or internalized, stigma, which can limit self-efficacy and empowerment; perceived stigma, the sense of what others think or how they might treat persons thought or known to have HIV; and experienced stigma, the actual experience of discrimination, exclusion, or other social sanctions based on perceived HIV status. As Kittner et al. [3] pointed out, patients from the Asia-Pacific region including Korea tend to be more anxious to lose family and friends after disclosure than other regions [2]. One study assessed the prevalence of stigmatizing attitudes in Korean adolescents from 2006 to 2011 [4]. The responders discriminated significantly against those with HIV/AIDS, reporting attitudes such as being disgusted by PLWHA, contact avoidance of PLWHA, and blaming those with HIV for their infection. A global cross-sectional survey of perceived HIV-related stigma among 2,035 PLWHA from North America, Europe, Latin America, Africa, and the Asia-Pacific region including South Korea has been performed [5]. The survey showed 37% of responders reported loneliness as a result of their HIV status. Depression was reported by 27%. While 96% reported disclosing their HIV status to at least one person, 17% of patients who reported being in long-term sexual relationships had not disclosed their status to their partner. The authors concluded that perceived HIV stigma, isolation, and discrimination were persistent even 30 years into the HIV pandemic. Stigmatization is harmful for individuals with HIV/AIDS because it results it social isolation and various mental illnesses such as depression and anxiety [2, 6]. Depression is the most common mental illness among HIV-infected persons, affecting up to 50% of PLWHA. The higher prevalence of depression in HIV infected persons (20-40% versus 7% in general population) is due to stigma, sexual dysfunction, side effects of cART, co-morbidities, and so on. In addition, depression can cause non-adherence to cART [7]. Song et al. [6] found that depressed Korean patients were more likely to miss clinical appointments. Poor adherence to cART is associated with virological failure, HIV resistance, and decreased survival. From the perspective of public health, HIV-related stigma is a major barrier for people to access HIV testing, care, and treatment services [8]. Late presentation into care and delay in cART initiation likely generates more secondary HIV infections, increases morbidity and mortality, diminishes responses to cART, and causes higher health care expenditures. As a result, enhancing early diagnosis, access to care, and treatment are very important tasks for public health. Interventions to reduce HIV-related stigma are associated with improvements in access to HIV prevention and care services [9, 10]. Multidisciplinary HIV/AIDS experts developed recommendations for addressing stigma in the HIV/AIDS epidemic [8]. They offered recommendations to overcome the key challenges of defining, measuring, and reducing HIV/AIDS-related stigma and assessing the impact of stigma on HIV prevention and treatment program effectiveness. We need to develop a comprehensive framework for HIV/AIDS stigma and encourage the use of valid and reliable stigma measures by researchers and program implementers. Stigma-reduction strategies should be developed at the intrapersonal, interpersonal, community, institutional, and governmental levels. Addressing HIV-related stigma will benefit individual and public health by improving the mental health and treatment adherence of individuals and encouraging early testing, access to care, and treatments. Multidisciplinary and multifaceted approaches to reduce HIV/AIDS-related stigma should be developed.

Save Icon
Up Arrow
Open/Close
  • Ask R Discovery Star icon
  • Chat PDF Star icon

AI summaries and top papers from 250M+ research sources.

Search IconWhat is the difference between bacteria and viruses?
Open In New Tab Icon
Search IconWhat is the function of the immune system?
Open In New Tab Icon
Search IconCan diabetes be passed down from one generation to the next?
Open In New Tab Icon