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New HIV Drug’s Trial Stopped Early after It is Found to be Highly Effective

Sandipan Talukdar |
The countries that were considered for conducting the trial have a significantly high rate of HIV infection in women.
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The HIV Prevention Trials Network study (HPTN 084) was evaluating the effectiveness of an antiretroviral drug named cabotegravir (CAB LA), which was aimed as a prophylactic against HIV infection in uninfected women. The clinical trial for the pre-exposure prophylaxis (PrEP) has now been stopped by the Data and Safety Monitoring Board (DSMB) citing the reason that this drug has been found highly effective in preventing the acquisition of HIV.

PrEP is a treatment for people who have not been exposed to the Human Immunodeficiency Virus (HIV) but are at very high risk of contracting it.

The trial was conducted in sub-Saharan African countries like Botswana, Kenya, Malawi, South Africa, eSwatini, Uganda and Zimbabwe. The HPTN 084 enrolled 3,223 women between the age of 18-45 years in 20 high risk areas in those countries.

The trial study was conducted against an already prescribed drug Truvada (tenofovir disoproxil fumarate/emticitabine)—TDF/FTC. The trial was randomised to two arms — Arm A consisting of CAB LA, administered through intramuscular injection once in two months and a daily oral TDF/FTC placebo; Arm B consisting of daily oral TDF/FTC and a placebo of intramuscular CAB LA once in two months.

The result that came out of the trial was that 38 women among those in the trial acquired HIV. Four among them were randomised to the CAB LA arm, which is long acting, and 34 were randomised to the daily oral FTC/TDF arm. This resulted in a HIV incidence rate of about 0.21% in the cabotegravir group and 1.79% in the daily oral TDF/FTC group. The CAB LA was thus found to be significantly effective (89%) in preventing HIV acquisition among women.

In both cases, the tolerance was found to be encouraging while adversity was mild or moderate.

The countries that were considered for conducting the trial have a significantly high rate of HIV infection in women. The need for a highly effective PrEP cannot be denied in these regions. While the oral dose of the PrEP was very effective, taking it daily always increases the chance of missing some dosage. A long-term effective prophylactic medication is obviously a better choice. The CAB LA also reduces the dose from 365 times a year for the oral medication to six dosages a year, which is significantly better. Moreover, the CAB LA arm has a long-term effect on the body.

ISSUES OF CONCERN:

While the long-term injection of CAB LA in six dosage a year seems to be encouraging, there remains several issues regarding safety and the pharmacological aspects of the drug.

  1. The trial took women in the age group of 18-45 years. What could be the efficacy and safety of the drug in adolescent girls still remains unclear. However, another trial HPTN084/1 has been started to assess this. A clearer picture will emerge only after results of the trial becomes available.

  2. Implementation of the long acting drug is also an important issue. The CAB LA medication needs an injection every two months. How this could be managed by the existing healthcare systems of the affected countries is still not very clear.

  1. The CAB LA arm has a long half-life, which means that the drug could be detected in the body for months after it is administered. However, the amount of drug that remains is not in a high quantity. The small amount of drug could also result in a drug resistant HIV following exposure to the virus afterwards, especially in the time gap between dosages.

  1. The cabotegravir belongs to the integrase inhibitor category. Early experience with another drug of this class named Dolutegravir was that the drug, when taken pre-conception, led to foetal neural tube defects (defects in the fetus). For this reason, all the participants of HPTN084 were also given a long-acting reversible contraceptive. Because of this protocol, very few women taking part in the HPTN084 trial became pregnant. Further monitoring in this regard is necessary.

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