African Truvada study halted, anti-HIV drug found ineffective for women
 

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posted Friday, April 22, 2011 - Volume 39 Issue 16

African Truvada study halted, anti-HIV drug found ineffective for women
by Mike Andrew - SGN Staff Writer

Family Health International (FHI), a nonprofit AIDS research organization, announced on April 18 that it was abandoning its study on the AIDS-prevention potential of the drug Truvada.

FHI said it made the decision because an interim review of data by the trial's independent data monitoring committee showed that they could not demonstrate Truvada's effectiveness even if their research continued to its planned conclusion.

The group launched the study two years ago and had enrolled about 2,000 women subjects in Kenya, Tanzania, and South Africa. Half the women were given Truvada and the others received a placebo.

As of last week, FHI said, 56 new HIV infections had occurred, half in each group.

'We were surprised by the outcome,' said Dr. Timothy Mastro, vice president of Health and Developmental Science at FHI. 'We were advised that there was no benefit to continue for the next several months.'

A number of possible reasons could have contributed to the findings, according to Mastro.

One reason, he said, could be that the women may not have been taking the medication as advised, if they were taking it at all. Or the medication might not work for women the way it seemed to work for men in a previous study.

'The final data have not been confirmed,' said Mastro. 'So at this point, all we can say is that the study was not able to conclude that Truvada works for women.'

Based on a University of California San Francisco (UCSF) study of men who have sex with men which was released in November of 2010, researchers had hoped that Truvada might prove to be an effective 'pre-exposure prophylaxis' (PrEP) drug, that might be used by HIV-negative people to prevent initial HIV infections.

CDC directors Kevin Fenton and Jonathon Mermin said the FHI study was 'well-conducted,' but expressed their disappointment at the results.

'These preliminary results are disappointing, especially given that this approach has already been shown to be effective in reducing HIV infection among men who have sex with men (MSM).' their statement said.

The UCSF study involved 2,499 Gay and Bi men and Transgender women in six countries, including the U.S. That study was, itself, controversial.

While the CDC was hopeful that Truvada might be effective as a PrEP drug, AIDS Healthcare Foundation - which describes itself as 'the nation's largest provider of HIV/AIDS medical care' - noted that the UCSF study showed only a 44% effectiveness rate.

AHF went to the expense of running full-page ads in major Gay newspapers warning that consistent condom use was a better preventative than Truvada.

'We are concerned about the implications of a recent study of pre-exposure prophylaxis (PrEP) using Gilead Sciences, Inc.'s drug Truvada using 2,500 Gay men and showing a 44% effectiveness rate in preventing HIV transmission. AHF supports continued research on HIV prevention, but opposes quick fixes that run the risk of contributing to the spread of HIV and drug-resistant viruses. Our community must consider these issues if we are going to offer up hundreds of thousands of Gay men for this totally misguided experiment,' the AFH statement said.

Two other large studies of PrEP in women are under way in sub-Saharan Africa and will continue.

Mitchell Warren, head of the AIDS Vaccine Advocacy Coalition in New York City, urged people not to extrapolate from the FHI study.

'It must be seen for what it is: the closure of a single trial in a field that has generated exciting results in the past,' he said.

The drug marketed as Truvada contains oral tenofovir and emtricitabine and is approved as an anti-retroviral medication for people who are already HIV-positive. It is manufactured by Gilead Sciences Inc.

Seattle's own Gay City Health Project is hosting a forum on PrEP on April 27. Titled 'The Magic Pill?' the forum asks the question, 'How far would you go to stay HIV-negative?'

It will be hosted by Aleksa Manila and Tony Buff, and features a panel of HIV/AIDS healthcare experts. Gay City's forum begins at 7:00 p.m. at Erickson Theater Off Broadway, 1524 Harvard Avenue.



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