Medical HIV News Briefs Archives

FDA, Pfizer Warn of Possible Carcinogen in Antiretroviral Treatment Viracept
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47404
See other Drug Warnings

Gene in HIV Makes HIV-2 Susceptible to Immune System Response, Researchers Say
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47408
 

Full text of the notice is available from AIDSinfo: Pediatric Panel Notice on Nelfinavir. AIDS Info e news, Issue No. 39 | September 12, 2007

FDA Advisory Committee Unanimously Recommends Accelerated Approval of Raltegravir

On Wednesday, August 6, the Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee unanimously recommended accelerated approval of the anti-HIV drug, raltegravir, in combination with other antiretroviral therapy (ART) for the treatment of HIV infection in treatment-experienced patients. If approved, raltegravir will be the first of a new class of antiretroviral drugs, integrase inhibitors.

The committee's recommendation was based mainly on review of safety and efficacy results from studies that utilized raltegravir in combination with optimized background therapy in treatment-experienced HIV-infected patients who had previously failed antiretroviral therapies and who had resistance to at least one drug in each of three classes of oral ARTs. NIH At-A-Glance Volume 3 Issue 38, ISSN 1558-3228
 

UNITED STATES:
"FDA Cites Benefits of Merck HIV Drug for Patients Out of Options"
Associated Press, (08.31.2007) Matthew Perrone
On Friday, Food and Drug Administration officials said a review of Merck & Co.'s HIV drug Isentress suggests its safety profile is superior to other options available to patients who are failing treatment. FDA posted its review ahead of a Wednesday meeting on Isentress' safety and efficacy by an independent panel of experts. Granted priority review status earlier this year, regulators could decide Isentress' fate by October.  CDC Summary

Pfizer's Antiretroviral Maraviroc Reduces Viral Loads Among People Taking Additional Treatments, Study Says
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47629
 

See August Archives

Summaries

UNITED STATES:
"Pregnancy May Offer Some Protection Against Full-Blown AIDS"
Voice of America News, (09.19.2007) Joe De Capua
A new study says pregnancy may help protect HIV-positive women from developing AIDS. Senior author Dr. Timothy Sterling of Vanderbilt University said the study's findings for HIV-positive women taking antiretrovirals were unexpected. "We found that the women who became pregnant during the study period had a lower risk of progressing to AIDS-defining events or death than women who did not become pregnant. This was an observational study just looking at 759 women who were seen at some point during the study period, which was between January 1997 and December 2004."

The researchers found that the women who became pregnant were healthier, with higher CD4 counts and lower viral loads. They were also younger and more likely to receive therapy. After performing analyses to adjust for those factors, however, the authors found that women who became pregnant were still less likely to proceed to AIDS or death, according to Sterling. He said another study is needed to try to formally pinpoint the reason for the benefit.

"It could be that the pregnant women were highly motivated to have their HIV treated, obviously to prevent transmission into the fetus, and to take as good care of themselves as possible," Sterling suggested. He noted that the pregnant women had more frequent visits to the comprehensive care center the study used, were more likely to get dietary supplements, and were less likely to be using drugs.

Studies conducted before antiretrovirals came into use indicated that pregnancy showed either no increased risk of progression to AIDS or a lightly increased risk.

In an accompanying editorial, Dr. Kathryn Anastos wrote, "For women in higher-resource settings and perhaps for women in lower resource settings, the findings are… extremely important. "Women can now have greater confidence that, in addition to protecting their children from mother-to-child transmission with antiretroviral drugs, their own health will not be compromised by pregnancy," Anastos added.

The study, "Pregnancy and HIV Disease Progression During the Era of Highly Active Antiretroviral Therapy," and the editorial, "Good News for Women Living with HIV," appeared in the Journal of Infectious Diseases (2007;196(7):1044-1052 and 971-973 respectively).
 

UNITED STATES:
"FDA Cites Benefits of Merck HIV Drug for Patients Out of Options"
Associated Press, (08.31.2007) Matthew Perrone
On Friday, Food and Drug Administration officials said a review of Merck & Co.'s HIV drug Isentress suggests its safety profile is superior to other options available to patients who are failing treatment. FDA posted its review ahead of a Wednesday meeting on Isentress' safety and efficacy by an independent panel of experts. Granted priority review status earlier this year, regulators could decide Isentress' fate by October.

FDA is not bound by recommendations made from Wednesday's review, but it usually follows the panel's advice. If approved, Isentress would be the first of a new class of HIV integrase inhibitors, which are designed to block HIV from replicating in human cells.

The most common side effects reported with Isentress use were rashes and elevated creatine levels in the blood, said government scientists. In the clinical study of Isentress, the 13 deaths occurring among 900 patients taking the drug were not Isentress-related, FDA said.

On Wednesday, FDA will ask the outside panel reviewing Isentress whether Merck should be required to conduct post-approval studies of the drug.