At the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global (formerly ECCMID) conference in Barcelona, Spain, the use of long-acting combined antiretroviral therapy (ART) injectables for the prevention of HIV infection in Europe and Central Asia (ECA) was discussed at a symposium on HIV prevention.

Pre-exposure prophylaxis (PrEP) refers to ART taken by HIV-negative people to reduce the risk of HIV infection. Most commonly, PrEP is administered orally on a daily basis. Currently, World Health Organization (WHO) guidelines recommend PrEP for key populations considered to have an increased risk of HIV infection, such as sex workers, men who have sex with men (MSM), people who inject drugs (PWID), people in prisons and other closed settings, and transgender and gender diverse (TGD) people.

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However, the implementation of PrEP throughout the ECA region is suboptimal and varies markedly by country. High rates of PrEP usage are observed in the UK, France, Germany, and Spain, with these four countries responsible for 77% of total PrEP usage across the ECA region. In other countries in this region, such as Armenia, Lithuania, and Tajikistan, PrEP usage is too low to have any meaningful impact at the public health level. In many countries, certain groups such as undocumented migrants, people in prisons, and PWID remain ineligible for PrEP according to national legislation. However, even in cases where people are eligible for PrEP, usage is often suboptimal. For example, a study from France reported that only approximately 22% of MSM who are in need of PrEP are accessing it.

ViiV Healthcare’s long-acting injectable cabotegravir (CAB-LA) is a long-acting form of PrEP that is administered as an intramuscular injection every eight weeks. In July 2022, the WHO released guidelines recommending that CAB-LA be offered as an additional HIV prevention option for people at substantial risk of HIV infection. Enhanced usage of CAB-LA as PrEP could help to close some of the significant gaps in HIV prevention in ECA.

CAB-LA’s effectiveness in preventing HIV was determined in two major studies, HPTN 083 and HPTN 084. HPTN 083 enrolled 4,566 HIV-negative at-risk cisgender men and transgender women who have sex with men across 43 sites in the US, Latin America, Asia, and Africa. The relative risk reduction in HIV infections was 66% for participants who received CAB-LA as PrEP compared to those who received daily oral PrEP, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). While this result demonstrated that CAB-LA had a substantial advantage over oral PrEP, efficacy results obtained from the HPTN 084 study were even more definitive. In the HPTN 084 trial, 3,224 HIV-negative at-risk cisgender women ages 18-45 years across 20 sites in sub-Saharan Africa were recruited. The relative risk reduction in HIV infections was 88% in the CAB-LA PrEP arm compared to the TDF/FTC PrEP arm. Additionally, CAB-LA was found to be safe, as similar rates of adverse events (AEs) were observed among the groups receiving CAB-LA and TDF/FTC in these two studies.

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Key opinion leaders (KOLs) interviewed by GlobalData regarded CAB-LA as an important alternative option for prophylaxis. In particular, KOLs emphasised that the requirement for patients to receive CAB-LA in a clinic every other month has its advantages. This can improve adherence, as healthcare providers have a record of exactly when patients received each injection. Additionally, due to the stigma and discrimination that is still associated with HIV, some patients may be anxious about others finding their oral PrEP medication. Therefore, an injection administered in a clinic may represent a more discreet and desirable option.

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However, some KOLs also noted that the requirement for patients to receive an injection in a clinic every two months may still be too demanding a schedule for some and proposed that PrEP options that are even longer-acting would be highly beneficial. Drug developers are investing in longer-acting PrEP options that may address this need. ViiV Healthcare currently has an ultra-long-acting injectable cabotegravir (CAB-ULA) formulation in development.

Data from an ongoing Phase I trial shows that CAB-ULA has a pharmacokinetic profile that supports dose intervals of at least four months. Furthermore, Gilead’s capsid inhibitor lenacapavir is also being investigated in several late-stage clinical trials as a twice-yearly subcutaneous injection for PrEP.