skip to content


Issue No. 15 | April 16, 2010

News and Features

FDA Updates Product Labeling for Sustiva (Efavirenz)

“The Food and Drug Administration recently approved revisions to the package insert for Sustiva (efavirenz), a non-nucleoside reverse transcriptase inhibitor, for both capsules and tablets…

“As of July 2009, the Antiretroviral Pregnancy Registry has received prospective reports of 661 pregnancies exposed to efavirenz-containing regimens, nearly all of which were first trimester exposures (606 pregnancies). Birth defects occurred in 14 of 501 live births (first trimester exposure) and 2 of 55 live births (second/third-trimester exposure). …

“Monitoring of liver enzymes before and during treatment is recommended for patients with underlying hepatic disease, including hepatitis B or C infection; patients with marked transaminase elevations; and patients treated with other medications associated with liver toxicity. … Liver enzyme monitoring should also be considered for patients without pre-existing hepatic dysfunction or other risk factors. …

“Posaconazole: Avoid concomitant use unless the benefit outweighs the risks[.]

“Maraviroc: Refer to the full prescribing information for maraviroc for guidance on coadministration with efavirenz. …

“Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with hepatic impairment, caution should be exercised in administering Sustiva to these patients …

“Some patients taking Sustiva have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.”

The complete revised label is available at the FDA Web site.

More information is available:

Study Suggests HIV Can Break Down Epithelial Cell Barrier to Cause Infection

“Researchers have identified a previously unknown way that women are infected with HIV, the virus that causes AIDS.

“HIV can break down and penetrate the epithelial cell barrier (designed to keep out infection) in the intestinal and female genital tract during intercourse, according to the study published online April 8 in PLoS Pathogens.

“Prior to this study, many scientists believed that HIV invaded women's reproductive tract after some sort of trauma, such as a small tear during intercourse. This is the first time researchers have pinpointed HIV itself as the possible culprit. ...

“‘This is a significant step forward in defining where prevention strategies, such as microbicides and vaccines, need to focus. Instead of trying to stop HIV from infecting the target cells underneath the [protective barrier], we need to think about ways to stop the virus from attaching to epithelial cells themselves,’ lead researcher Charu Kaushic, an associate professor in the Centre for Gene Therapeutics at McMaster University in Hamilton, Ontario, said in a university news release.”

More information is available:

Late-Stage Clinical Trials of 4-in-1 HIV Medication Begin

“Gilead Sciences Inc. announced Monday it is launching late-stage clinical trials of its ‘Quad’ four-in-one HIV tablet. The company plans to run two studies. One will compare Quad with Gilead’s three-in-one HIV treatment Atripla; it will involve about 700 patients, run for 96 weeks, and take place at 130 sites in the United States and Puerto Rico. The other trial will compare Quad with the combination of Norvir, Reyataz, and Truvada; it will involve about 700 patients, run for 96 weeks, and take place at more than 200 sites in North and South America, Europe, and Asia Pacific. Quad contains elvitegravir, cobicistat, and the two elements of Truvada, emtricitabine and tenofovir. The newest component, cobicistat, is designed to boost blood levels of antiretrovirals like elvitegravir. Later this quarter, Gilead plans an additional study to compare cobicistat with Norvir. In that trial, patients will receive a combination of cobicistat, Truvada and Reyataz, or Norvir, Truvada and Reyataz.”

More information is available:

*Second study mentioned in article is unavailable on as of April 16, 2010.