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to Section One | to Arts & Entertainment
posted Friday, November 7 2014 - Volume 42 Issue 45
Once-a-quarter injectable PrEP drug promising, early tests show
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Once-a-quarter injectable PrEP drug promising, early tests show

by Mike Andrew - SGN Staff Writer

A new study suggests that at least one injectable PrEP drug may provide protection against HIV infection if administered once every 16 weeks. A second drug being tested is far less promising, however.

Injectable PrEP meds that can be administered once a quarter would help address issues that make some HIV prevention activists reluctant to fully endorse PrEP. Many fear that patients will fail to adhere to the once-a-day regimen that oral PrEP meds require.

The results were discussed at the Research for Prevention (R4P) Conference in Cape Town, South Africa, at the end of October.

According to Bill Spreen of GlaxoSmithKline pharmaceuticals, researchers found that the drug cabotegravir almost completely eliminated HIV infections in a test group of monkeys.

Testing on human volunteers found that a dose of 500mg produces levels of the drug that can prevent HIV infection for as long as 16 weeks. The drug's 'half-life,' or rate of elimination in the body, is 25 times longer with the injectable formulation than with an oral cabotegravir pill.

Researchers calculated that an 800mg dose every twelve weeks should result in drug levels that are over eight times the amount needed to reduce viral replication by 90% - what HIV scientists call '90% inhibitory concentration (IC90).'

In the study, male subjects turned out to eliminate the drug considerably faster than women - from 2.8 times faster to 3.1 times faster. This is probably because women have higher levels of fatty tissue, which releases the drug more slowly.

Spreen said different doses for men and women might be needed if Phase II studies suggested this made a clinical difference. Those studies are scheduled to start next year.

Researchers also tested the concentration of cabotegravir in the subjects' genital tissues as well as in their blood, because that is where HIV enters the body in most cases.

Using a dose of 400mg, or half the dose to be taken into efficacy studies, they found that the concentration in tissues was considerably lower than it was in the blood.

The concentration in vaginal tissue was 28%, in the cervix 16%, and in the rectum only 8% of blood plasma concentrations. This is not surprising, however, because the same results are found when PrEP drugs are taken orally.

The other drug tested, rilpivirine, was not so promising, and it will probably not be tested as an injectable PrEP drug.

This drug was tested on laboratory mice that were genetically adapted to be vulnerable to HIV infection.

In one test, the mice were challenged with a single HIV strain a week after receiving the rilpivirine, and no mice were infected. In contrast, every mouse in the control group that received a placebo injection got HIV.

In the second test, the mice were challenged with three separate strains of HIV a week after receiving the PrEP injection, and were then challenged with a fourth strain a total of three weeks after getting the PrEP injection.

Only one out of eight mice became infected with one of the three viral strains, but another five mice became infected with the fourth strain of virus they received at week three, leading researchers to conclude that rilpivirine did not provide the lasting protection desired in an injectable PrEP drug.

Research presenter Olivia Snyder noted that mice metabolized drugs faster than either monkeys or humans, so that rilpivirine's effect could last longer in humans. Further experiments are going ahead to quantify the dosing interval needed, and the drug could have limited use as a treatment for some HIV patients.

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