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A literature review found that long-acting injectable cabotegravir is effective for the prevention of HIV; however, it may increase the risk of resistance to integrase strand transfer inhibitors in individuals with infection at the initiation or during the treatment process.

Human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) pose a significant health burden, warranting the imminent need for effective prevention tools to limit the acquisition and transmission of the disease. 

This systematic review and meta-analysis pooled the currently available evidence regarding the safety and efficacy of long-acting injectable cabotegravir (CAB-LA). The outcomes that were investigated in the study included HIV infection, sexual behavior, adverse events, pregnancy-associated adverse events, and resistance to the drug. The study’s findings are published in the journal AIDS.

Participant Characteristics

A total of four studies met the inclusion criteria, which included 8120 participants. Of these individuals, 4114 were given CAB-LA. The study population did not include individuals who inject drugs, pregnant women, or breastfeeding women. While the majority of the population consisted of cis-men and cis-women, a total of eight study participants were transgender men.

CAB-LA Shows Significant Reduction in Incident HIV Infections

Of the 3857 participants from two efficacy studies who were randomized to receive CAB-LA, 2 had baseline infections and 15 had incident HIV infections. On the contrary, 75 participants in the daily tenofovir/emtricitabine (TDF-FTC) group developed incident HIV infections. The difference in incident infections across the two groups was statistically significant.

CAB-LA Group Experienced Frequent Injection Site Reactions

The study identified no significant differences in study groups based on the development of grade 2 or higher adverse events. The included studies indicated frequent injection site reactions in the CAB-LA group participants. There were no pregnancy-related adverse events observed in association with CAB-LA administration.

Significant Integrase Strand Transfer Inhibitor Resistance Mutations Detected in CAB-LA Group

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Of the participants in the CAB-LA group, 19 had drug resistance results available, and seven of these cases had resistance mutations against integrase strand transfer inhibitor (INSTI), which was statistically significant compared to oral preexposure prophylaxis (PrEP).

Sexual Behavior and Hormone-Related Associations

The use of oral contraceptives affected the pharmacokinetics of CAB-LA, with reduced peak CAB concentration compared to female participants who were not using oral contraceptives. This study did not assess the potential reverse drug–drug interaction of CAB-LA on oral contraception. One of the studies included in this review reported seven incident cases of sexually transmitted infections.


Fonner, V. A., Ridgeway, K., Van Der Straten, A., Lorenzetti, L., Dinh, N., Rodolph, M., Schaefer, R., Schmidt, H. A., Nguyen, V. T. T., Radebe, M., Peralta, H., & Baggaley, R. (2023). Safety and efficacy of long-acting injectable cabotegravir as preexposure prophylaxis to prevent HIV acquisition. AIDS, 37(6), 957–966. https://doi.org/10.1097/qad.0000000000003494