Preferential Initiation of Long-Acting Injectable Versus Oral HIV Pre-Exposure Prophylaxis Among Women Who Inject Drugs.

Fifty-five of 62 women who inject drugs (WWID) selected long-acting cabotegravir (CAB-LA) over oral PrEP, and 51/55 received a first injection. More recent injection drug use and number of sexual partners were associated with selecting CAB-LA (P < .05). Findings provide preliminary evidence of a strong preference for longer-acting products among WWID.

Willingness to Use Long-Acting Injectable Cabotegravir and Associated Factors Among Men Who Have Sex with Men in Guangxi, China.

Cabotegravir (CAB-LA), the first long-acting injectable pre-exposure prophylaxis (PrEP), has been approved for use in the USA and is not currently on the market in China. However, willingness to use CAB-LA and associated factors among men who have sex with men (MSM) have not yet been evaluated in China. A cross-sectional study was conducted in Guangxi, China, in 2022 recruiting 1,006 MSM. Their mean age was 30.2 years, 74.2% had college or above education, and 48.6% had a monthly income between 3,000 and 5,999 Chinese yuan (CNY). Most (73.4%) had previously heard of PrEP while few (8.3%) had ever used this type of preventative medication. Willingness to use CAB-LA was 79.8% and was positively associated with eight variables: younger age, being married to a woman, having a low monthly income, having six or more male partners in the past six months, having only regular male partners in the past month, having a high perceived risk of HIV infection, and history of using PrEP. Ten other variables were not significantly associated with willingness to use CAB-LA. Among 894 participants who were willing to use or did not definitely reject using CAB-LA, the main concerns about CAB-LA were its side effects (90.2%), efficacy (63.6%), and high cost (58.2%). Only 14.7% were willing to pay more than 1,200 CNY (~US$180) every two months to use CAB-LA. The preferred injection places were centers for disease control facilities, hospitals, and social organizations. Many (89.0%) said that they would recommend CAB-LA to their male sexual partners. We conclude that willingness to use CAB-LA was high among MSM in Guangxi. However, implementation of CAB-LA faces tough challenges due to its high cost and the low use of PrEP. Peer education may play a large role in the implementation of CAB-LA in China.

Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe.

The global burden of HIV remains unacceptably high despite significant progress made in HIV treatment and prevention. There is an urgent need to scale up the comprehensive HIV prevention strategies that include pre-exposure prophylaxis (PrEP). Oral PrEP is highly effective in preventing HIV acquisition when taken regularly, but this remains a challenge for some at-risk individuals. Therefore, there is a need for other HIV prevention options. The dapivirine vaginal ring (DVR) and long-acting injectable cabotegravir (CAB-LA) are novel biomedical interventions that are safe and efficacious for HIV pre-exposure prophylaxis, as demonstrated in recently completed clinical trials. Timely roll-out and scalability of efficacious interventions depend on the registration process with the national medicine regulatory authorities (NMRAs). The Medicines Control Authority of Zimbabwe (MCAZ) was the first NMRA globally to approve the DVR in July 2021 and the first in Africa to approve CAB-LA for HIV prevention in July 2022. The regulatory review process for DVR and CAB-LA by MCAZ took 4.5 and 5.5 months, respectively. This efficient review process of the two interventions by MCAZ, a regulatory body in a resource-limited setting, provides important lessons to shorten timelines between the completion of the clinical development process and the registration of essential medicines.

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

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.