Table of Contents
PrEP (pre-exposure prophylaxis) involves administering antiretroviral agents to HIV-negative individuals to prevent acquisition of HIV during high-risk exposures UNAIDS. CAB-LA is an injectable integrase strand transfer inhibitor (INSTI) designed to form a muscle depot that slowly releases drugs over eight weeks, markedly reducing the burden of daily usage. World Health Organization (WHO).
How does it work?
Cabotegravir binds the HIV integrase enzyme, preventing the integration of viral DNA into host cell genomes, a critical early step in the HIV life cycle hptn.org. Its long-acting formulation maintains protective plasma concentrations for eight weeks following each 600 mg intramuscular injection FDA Access Data.
Clinical Evidence of Efficacy
HPTN 083: Men Who Have Sex with Men & Transgender Women
In a randomized, double-blind trial of 4,566 participants, CAB-LA reduced HIV incidence by 66 % compared with daily oral tenofovir–emtricitabine (0.37 % vs. 1.22 % annual incidence) hptn.orgThe Lancet.
HPTN 084: Cisgender Women
A Phase 3 study in sub-Saharan Africa involving 3,224 cisgender women found that CAB-LA achieved an 88 % lower HIV acquisition risk compared to oral PrEP (0.15 % vs. 1.85 % annual incidence) The LancetPubMed.
Meta-Analysis & Additional Data
A recent Lancet HIV analysis confirms combined efficacy reductions of 66–89 % across key populations and underscores consistent safety across diverse cohorts The Lancet.
How safe is long-acting PrEP?
Injection-Site Reactions
Most users experience mild to moderate injection-site reactions (pain, swelling, nodules) that resolve within days without intervention UNAIDS.
Systemic Adverse Events
Rare elevations in liver enzymes have been reported; WHO guidelines recommend liver and renal function testing at Week 4 and every six months thereafter World Health Organization (WHO).
HIV Testing Requirements
To prevent inadvertent treatment of acute HIV (which can promote resistance), a negative HIV-1 test (rapid or lab-based) is mandated within 72 hours before each injection World Health Organization (WHO).
Regulatory Approvals & Global Roll-Out
U.S. FDA Approval
On December 21, 2021, the FDA approved Apretude for HIV PrEP in adults and adolescents weighing ≥ 35 kg, following an oral lead-in phase (Vocabria tablets) and two initial injections one month apart U.S. Food and Drug Administration.
WHO Recommendations
In July 2022, WHO guidelines endorsed CAB-LA as an additional PrEP option for those at substantial risk, highlighting implementation considerations and the need for HIV testing algorithms World Health Organization (WHO).
International Adoption
Over 50 countries including Thailand have approved CAB-LA for PrEP, with submissions under review in many others; the WHO Tracker maps global rollout status PrEPWatch.
How much does injectable PrEP cost?
Branded List Prices
In the U.S., the Wholesale Acquisition Cost for a 600 mg injection is USD 4,025.22, translating to roughly USD 28,176 annually for a full seven-dose regimen US Pricing.
Generic Cost-of-Goods Analysis
Clinton Health Access Initiative estimates generic CAB-LA could be manufactured at scale for USD 14–18 PPPY, assuming medium-scale volumes and technology transfer Clinton Health Access Initiative.
Licensing & Access
ViiV Healthcare’s July 2022 voluntary licensing agreement with the Medicines Patent Pool enables generic production in 90 LMICs, a critical step toward reducing prices and expanding access Medicines Patent Pool.
Future Directions in Injectable HIV Prevention
Ultra-Long-Acting Agents
Lenacapavir, a capsid inhibitor in trials, has demonstrated sustained therapeutic levels for six months after a single injection, potentially further reducing visit frequency Gilead.
Pregnancy & Special Populations
Sub-studies from HPTN 084-01 indicate CAB-LA may be safe and effective in pregnant and lactating women, with no dose adjustments required PrEPWatch.
Combination & Delivery Strategies
Integrating injectables with on-demand telehealth, community-based delivery, and digital adherence tools promises to tailor prevention to individual needs and contexts The Guardian.
Is it available in Thailand?
While this article focuses globally, the lessons from clinical trials, regulatory milestones, and cost-of-goods analyses provide a blueprint for countries like Thailand to plan rollout, negotiate pricing, and implement monitoring. Achieving cost-effective thresholds in middle-income settings will hinge on generic entry, pooled procurement, and integration into existing PrEP and HIV prevention infrastructures.
References
HPTN. HPTN 083 Study Demonstrates Superiority of Cabotegravir. AIDS 2020 Virtual. hptn.org
Delany-Moretlwe S, Hughes J, Bock P, et al. Cabotegravir for the Prevention of HIV-1 in Women. Lancet. 2022;399(10335):1779–1789. The Lancet
FDA. FDA Approves First Injectable Treatment for HIV PrEP (Apretude). Dec 21, 2021. U.S. Food and Drug Administration
WHO. Guidelines on Long-Acting Injectable Cabotegravir for HIV Prevention. 2022. World Health Organization (WHO)
AVAC/PrEPWatch. 2024 Q4 Global PrEP Tracker. Mar 2025. PrEPWatch
UNAIDS. Oral PrEP in National HIV Programmes: 2015 Thailand Case Study. UNAIDS
ViiV Healthcare US Pricing. Apretude (600 mg/3 mL) List Price. 2025. US Pricing
Medicines Patent Pool. License for Cabotegravir LA via MPP. Jul 2022. Medicines Patent Pool
Gilead. Lenacapavir Sustained 6-Month Plasma Concentrations. May 2020. Gilead
The Lancet HIV. Efficacy & Safety of CAB-LA vs Oral PrEP: HPTN 083 & 084. 2023. The Lancet
PubMed. HPTN 084 Safety & Efficacy Results. 2021. PubMed
FDA Label. Apretude Extended-Release Label. 2024. FDA Access Data
WHO News. WHO Recommends Long-Acting Cabotegravir for PrEP. Jul 28, 2022. World Health Organization (WHO)
CHAI. Generic CAB-LA COGS Analysis. Oct 2022. Clinton Health Access Initiative
PrEPWatch. CAB-LA Evidence Gap Tracker: Pregnancy Sub-Studies. 2024. PrEPWatch
