The Adult AIDS Clinical Trials Group (AACTG) created quite a stir in 2004 when it reported finding a racial difference in treatment response in a substudy. African Americans participants were more likely (20% of them) to have a genetic basis for clearing Sustiva from their bodies more slowly than Whites (3%), and thus experienced more side effects. Might Sustiva—a very popular and effective drug—really be more toxic in African Americans as a group due to decreased clearance from the body?

Dr. Edwin DeJesus and colleagues reported no difference in side effect profiles between people of color and Whites. They conducted a post-hoc analysis of available 24-week results from an on-going 48-week study. None of the 86 White study participants dropped out due to nervous system symptoms (the primary Sustiva side effect), vs. two of the 59 Black participants and one of the 34 Latino participants. Discontinuation for any other reason was also similar between the three groups.

The VEST-QD (A1466-206) study switched people with undetectable viral load from a protease inhibitor regimen to a Sustiva-based one. There was also no racial difference in the people who remained undetectable after switching to Sustiva. The AACTG reported an association between the genetic marker and nervous system symptoms, but this association disappeared out to six months time despite the continued high blood levels of Sustiva. Dr. DeJesus reported his group’s findings at the International AIDS Society conference held in July in Brazil.

Also in October, the FDA approved dosing recommendations for Norvir for children ages one month to two years of age. “The recommended dosage of [Norvir] in children older than one month is 350 to 400 mg/m² twice daily by mouth and should not exceed 600 mg twice daily. [Norvir] should be started at 250 mg/m² and increased at two to three day intervals by 50 mg/m² twice daily. If patients do not tolerate 400 mg/m² twice daily due to adverse events, the highest tolerated dose may be used for maintenance therapy in combination with other antiretroviral agents, however, alternative therapy should be considered. When possible, dose should be administered using a calibrated dosing syringe.”

Findings from PACTG (Pediatric AIDS Clinical Trials Group) Study 310 in 37 children ages 2 to 14 years old and PACTG Study 345 in 41 children ages one month to two years old found that Norvir leaves the body faster than it does in adults. Therefore, the children had lower concentrations of the drug in their blood. The FDA also reported that side effects and adverse events in studies and in use once the drug came to market were similar to those seen in adults. “Vomiting, diarrhea, and skin rash/allergy were the only drug-related clinical adverse events of moderate to severe intensity observed in 2% of pediatric patients enrolled in Norvir clinical trials. The following Grade 3-4 laboratory abnormalities [moderate to serious] occurred in 3% of pediatric patients who received treatment with Norvir either alone or in combination with reverse transcriptase inhibitors: neutropenia [lowered white blood cell count] (9%), hyperamylasemia [an increase in amylase, a pancreatic enzyme that breaks down starches] (7%), thrombocytopenia [lowered platelets] (5%), anemia (4%), and elevated AST [liver enzymes] (3%).”

In September, the FDA approved three generic formulations of Retrovir (zidovudine, AZT) for the U.S. With the expiration of Retrovir’s patent, these versions were given the green light: zidovudine tablets, 300 mg, manufactured by Roxane Laboratories of Columbus, Ohio; 300 mg tablets made by Ranbaxy Laboratories Limited of Guragon, India; and 300 mg tablets and 50 mg/5mL oral solution, manufactured by Aurobindo Pharma LTD. of Hyderabad, India.

Illinois Governor Rod Blagojevich signed on to a first-of-its-kind bill in August that launches the state into a massive, government-wide initiative to address the AIDS epidemic among African Americans. AIDS activists say no previous federal or state law has marshaled a similarly wide swath of public resources for work specifically targeting the Black epidemic.

Dubbed the African American HIV/AIDS Response Act, the new law follows a June U.S. Centers for Disease Control and Prevention report that estimated African Americans account for nearly half of all HIV infections in the country. In Illinois, where African Americans make up only about 15% of the population, they account for 51% of diagnosed AIDS cases.

The new legislation, which takes effect January 1, 2006, calls on the state to establish point people for the initiative in the Governor’s office, the Department of Human Services, the Department of Health, and the Department of Corrections. A panel consisting of representatives from each of these agencies and from three HIV/AIDS service organizations, along with two former prisoners, will develop an annual report for Governor Blagojevich on the state of AIDS among Illinois’ African American residents.

The bill also mandates that “high-traffic” state agencies, such as the Department of Motor Vehicles and the secretary of state’s office, create space for community-based HIV/AIDS organizations to conduct rapid HIV testing.

But the aspects of the bill that have been called both its most ambitious and its most controversial seek to get a handle on the still-shadowy epidemic behind bars. According to the U.S. Department of Justice, the AIDS case rate in the nation’s jails and prisons is three and half times that of the general population. Illinois’ prison epidemic is more intense than any in the Midwest, with 1.3% of inmates known to be positive.

Under order of the new law, the Illinois Department of Corrections and county jails will be required to offer free voluntary testing and counseling to all inmates upon and during incarceration, as well as immediately prior to their release. Case managers will be assigned to help positive inmates transitioning out of incarceration and refer them to support services on the outside.

In addition, researchers at the University of Chicago will conduct a study to examine the correlation between incarceration and HIV infection. Prison health advocates nationally have long complained that correctional facilities rarely allow such research.

Tibotec’s TMC-114 protease inhibitor (PI) expanded access program (EAP) began rolling out in late October, as this issue went to press. The purpose of this EAP is to gather safety data and to provide early access to a new PI to those whose treatment options are limited to none. Participants must have received treatment from three of the major classes of drugs, including two different PI-based regimens.

Test Positive Aware Network was recently awarded a $3,000 general operating grant from the Until There’s a Cure Foundation. Until There’s A Cure is a national organization dedicated to eradicating HIV/AIDS by raising awareness and funds to combat this pandemic.