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The study was stopped because the data suggested that injections of the long-acting antiretroviral drug cabotegravir (CAB LA) are highly effective for HIV pre-exposure prophylaxis (PrEP) in women.
The HIV Prevention Trials Network (HPTN 084) study evaluating the long-acting injectable antiretroviral drug cabotegravir (CAB LA) for pre-exposure prophylaxis (PrEP) in non-HIV infected women was discontinued early from the Data and Safety study Monitoring Board (DSMB) as the results showed that CAB LA is highly effective in preventing the acquisition of HIV.
Women in sub-Saharan Africa continue to experience a high incidence of HIV. Although oral PrEP is highly effective in preventing HIV in women when taken as prescribed, patient adherence difficulties reduce its protective effect. Therefore, more effective and acceptable HIV prevention choices are needed for women. A long-acting injectable formulation has the potential to enhance the preventative effect without relying on adherence to a daily oral PrEP regimen.
HPTN 084 test design
In total, 3,223 sub-Saharan African women between the ages of 18 and 45 were enrolled in the study. Participants from 20 sites in seven countries were randomized into two arms:
- Arm A – CAB LA (as intramuscular injection every 8 weeks) and daily oral placebo of tenofovir disoproxil fumarate / emtricitabine (TDF / FTC).
- Arm B – Daily oral injection of TDF / FTC and intramuscular placebo CAB LA every 8 weeks.
Results
A total of 38 women in the study acquired HIV: four from the CAB LA arm and 34 in the FTC / TDF arm. Therefore, the HIV incidence rate was 0.21% in the CAB LA group and 1.79% in the FTC / TDF participants. The researchers stated that although both methods were highly effective in preventing HIV acquisition, CAB LA was 89% more effective than FTC / TDF.
Both drugs were well tolerated with most adverse events of mild or moderate severity. Injection site reactions were slightly higher in the CAB LA arm and gastrointestinal upset and nausea were more common in the FTC / TDF arm. There were no interruptions due to injection site reactions or injection intolerance in any of the study arms.
Availability CAB LA
Course participants, including those in the FTC / TDF arm will have CAB LA will be made available to them, according to reports. Those who do not wish to receive CAB LA will be offered FTC / TDF until the originally scheduled end date of the study.
Before it can be made more widely available, the results of the HPTN 084 study will need to be fully reviewed and submitted for regulatory approval. LA CAB and manufacturing capabilities will also need to be developed and further open label extension studies will be needed to address some remaining concerns, such as safety in adolescents and pregnant and lactating women.
The World Health Organization (WHO) has warned that while the results are encouraging, it is also important to moderate expectations because of these important safety and implementation issues that need to be addressed. As a result, WHO has said it will likely take more than a year for CAB LA to become more widely available.
A similar study (HPTN 083) of non-HIV infected cisgender men who have sex with transgender men and transgender women who have sex with men was prematurely discontinued by its DSMB in May 2020, after also showing that CAB LA was highly effective in preventing HIV acquisition in this group. The final analysis demonstrated the superiority of CAB LA over FTC / TDF for PrEP in the HPTN 083 study population.
WHO continues to recommend daily oral PrEP for the prevention of HIV acquisition in anyone at substantial risk of HIV.
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