Safety and efficacy of long-acting injectable cabotegravir as preexposure prophylaxis to prevent HIV acquisition

Fonner, Virginia A.; Ridgeway, Kathleen; Straten, Ariane Van Der; Lorenzetti, Lara; Dinh, Nhi; Rodolph, Michelle; Schaefer, Robin; Schmidt, Heather-Marie A; Nguyen, Van Thi Thuy; Radebe, Mopo; Peralta, Hortencia; Baggaley, Rachel

doi:10.1097/qad.0000000000003494

Cited by 20 publications

(16 citation statements)

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“…A protocol was reviewed by the WHO and prospectively registered in PROSPERO (CRD42021285299). Database searches and article screening were conducted concurrently with a review on safety and efficacy of CAB‐LA as PrEP (CRD42021290713) [22]. Results are reported separately.…”

Section: Methodsmentioning

confidence: 99%

Systematic review of the values and preferences regarding the use of injectable pre‐exposure prophylaxis to prevent HIV acquisition

et al. 2023

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Introduction: Pre-exposure prophylaxis (PrEP) is an important HIV prevention option. Two randomized trials have provided efficacy evidence for long-acting injectable cabotegravir (CAB-LA) as PrEP. In considering CAB-LA as an additional PrEP modality for people at substantial risk of HIV, it is important to understand community response to injectable PrEP. We conducted a systematic review of values, preferences and perceptions of acceptability for injectable PrEP to inform global guidance. Methods: We searched nine databases and conference websites for peer-reviewed and grey literature (January 2010−September 2021). There were no restrictions on location. A two-stage review process assessed references against eligibility criteria. Data from included studies were organized by constructs from the Theoretical Framework of Acceptability. Results: We included 62 unique references. Most studies were observational, cross-sectional and qualitative. Over half of the studies were conducted in North America. Men who have sex with men were the most researched group. Most studies (57/62) examined injectable PrEP, including hypothetical injectables (55/57) or placebo products (2/57). Six studies examined CAB-LA specifically. There was overall interest in and often a preference for injectable PrEP, though there was variation within and across groups and regions. Many stakeholders indicated that injectable PrEP could help address adherence challenges associated with daily or on-demand dosing for oral PrEP and may be a better lifestyle fit for individuals seeking privacy, discretion and infrequent dosing. End-users reported concerns, including fear of needles, injection site pain and body location, logistical challenges and waning or incomplete protection. Discussion: Despite an overall preference for injectable PrEP, heterogeneity across groups and regions highlights the importance of enabling end-users to choose a PrEP modality that supports effective use. Like other products, preference for injectable PrEP may change over time and end-users may switch between prevention options. There will be a greater understanding of enacted preference as more end-users are offered anti-retroviral (ARV)-containing injectables. Future research should focus on equitable implementation, including real-time decision-making and how trained healthcare providers can support choice. Conclusions: Given overall acceptability, injectable PrEP should be included as part of a menu of prevention options, allowing end-users to select the modality that suits their preferences, needs and lifestyle.

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Section: Methodsmentioning

confidence: 99%

Systematic review of the values and preferences regarding the use of injectable pre‐exposure prophylaxis to prevent HIV acquisition

et al. 2023

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“…Respondents in this and other studies were concerned about potential side effects 12 39. The present analysis showed that pain at the injection site and the potential for rash were rated worse than a potential headache from LA-PrEP.…”

Section: Discussionmentioning

confidence: 61%

“…Together, these studies suggest high proportions of MSM in disparate settings are interested in LA-PrEP; however, these are hypothetical willingness studies, and real-world studies are needed. The logistical challenges of service delivery, uptake and adherence remain 12. Real-world choice and effectiveness should be monitored and evaluated to understand the impact of LA-PrEP on HIV prevention alongside DO PrEP as well as other prevention measures.…”

Section: Discussionmentioning

confidence: 99%

“…High effectiveness and cost were the most important features of LA-PrEP for this sample, as in other DCE among MSM,31–35 indicating these features may be critical aspects to emphasise during LA-PrEP implementation to improve uptake by US MSM. LA-PrEP (as CAB-LA) has proven to be more efficacious than TDF-based oral PrEP at preventing HIV acquisition, likely due to both pharmacokinetics and more attainable adherence (avoiding the daily burden of oral PrEP) 12. Unsurprisingly, respondents preferred an effective product.…”

Section: Discussionmentioning

confidence: 99%

“…In 2021, the FDA approved a long-acting injectable PrEP (LA-PrEP)7 after successful safety and efficacy trials 8–11. In pooled analysis, long-acting cabotegravir (CAB-LA), a version of LA-PrEP, showed a 79% reduction in relative risk compared with tenofovir disoproxil fumarate-based oral PrEP 12. Since current data are from controlled trials, real-world effectiveness and implementation evaluations of LA-PrEP are needed 12.…”

Section: Introductionmentioning

confidence: 99%

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Willingness and preferences for long-acting injectable PrEP among US men who have sex with men: a discrete choice experiment

Cole,

Glick,

Campoamor

et al. 2024

BMJ Open

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IntroductionCabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA-PrEP) was shown to be safe and effective in multiple clinical trials. Increasing uptake and persistence among populations with elevated risk for HIV acquisition, especially among men who have sex with men (MSM), is critical to HIV prevention.ObjectiveThis analysis aims to understand potential users’ preferences for LA-PrEP, with audience segmentation.DesignWillingness to use and preferences for LA-PrEP were measured in HIV-negative, sexually active MSM in the 2020 American Men’s Internet Survey. Respondents answered a discrete choice experiment with paired profiles of hypothetical LA-PrEP characteristics with an opt-out option (no LA-PrEP). Conditional and mixed logit models were run; the final model was a dummy-coded mixed logit that interacted with the opt-out.SettingUS national online sample.ResultsAmong 2506 MSM respondents, most (75%) indicated a willingness to use LA-PrEP versus daily oral PrEP versus no PrEP. Respondents were averse to side effects and increasing costs and preferred increasing levels of protection. Respondents preferred a 2-hour time to obtain LA-PrEP vs 1 hour, with a strong aversion to 3 hours. Overall, there was an aversion to opting out of LA-PrEP, with variations: those with only one partner, no/other insurance or who were Black, Indigenous or People of Colour were significantly less likely to prefer LA-PrEP, while those who were Hispanic/Latino, college educated and <40 years significantly preferred LA-PrEP.ConclusionsA large proportion of MSM expressed a preference for LA-PrEP over daily oral pills. Most respondents chose LA-PrEP regardless of cost, clinic time, side effects or protection level; however, preferences varied by sociodemographics. These varied groups likely require tailored intervention strategies to achieve maximum LA-PrEP uptake and persistence.

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HIV vaccination: Navigating the path to a transformative breakthrough—A review of current evidence

Scott,

Worku

2024

Health Science Reports

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Background and AimHuman immunodeficiency virus (HIV) remains a significant global health challenge, with approximately 39 million people living with HIV worldwide as of 2022. Despite progress in antiretroviral therapy, achieving the UNAIDS “95‐95‐95” target to end the HIV epidemic by 2025 faces challenges, particularly in sub‐Saharan Africa. The pursuit of an HIV vaccine is crucial, offering durable immunity and the potential to end the epidemic. Challenges in vaccine development include the lack of known immune correlates, suitable animal models, and HIV's high mutation rate. This study aims to explore the current state of HIV vaccine development, focusing on the challenges and innovative approaches being investigated.MethodsIn writing this review, we conducted a search of medical databases such as PubMed, ResearchGate, Web of Science, Google Scholar, and Scopus. The exploration of messenger ribonucleic acid vaccines, which have proven successful in the SARS‐CoV‐2 pandemic, presents a promising avenue for HIV vaccine development. Understanding HIV‐1's ability to infiltrate various bodily compartments, establish reservoirs, and manipulate immune responses is critical. Robust cytotoxic T lymphocytes and broadly neutralizing antibodies are identified as key components, though their production faces challenges. Innovative approaches, including computational learning and advanced drug delivery systems, are being investigated to effectively activate the immune system.Results and ConclusionsDiscrepancies between animal models and human responses have hindered the progress of vaccine development. Despite these challenges, ongoing research is focused on overcoming these obstacles through advanced methodologies and technologies. Addressing the challenges in HIV vaccine development is paramount to realizing an effective HIV‐1 vaccine and achieving the goal of ending the epidemic. The integration of innovative approaches and a deeper understanding of HIV‐1's mechanisms are essential steps toward this transformative breakthrough.

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Safety and efficacy of long-acting injectable cabotegravir as preexposure prophylaxis to prevent HIV acquisition

Cited by 20 publications

References 33 publications

Systematic review of the values and preferences regarding the use of injectable pre‐exposure prophylaxis to prevent HIV acquisition

Systematic review of the values and preferences regarding the use of injectable pre‐exposure prophylaxis to prevent HIV acquisition

Willingness and preferences for long-acting injectable PrEP among US men who have sex with men: a discrete choice experiment

HIV vaccination: Navigating the path to a transformative breakthrough—A review of current evidence

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