Fuzeon (T-20) was approved by the U.S. Food and Drug Administration (FDA) in March. The twice-daily injections were approved for people with HIV drug experience whose antiviral therapy is failing to work for them. Fuzeon is the first in a new class of anti-HIV drugs to hit the market: fusion inhibitors. It literally prevents HIV from infecting (fusing to) cells. The best use would be in someone who also has another active drug to add to their regimen along with the Fuzeon. People taking Fuzeon are advised to seek medical evaluation immediately if they develop signs or symptoms suggestive of pneumonia, such as cough with fever, rapid breathing and shortness of breath. They should also beware of an allergic reaction. Fuzeon is a peptide, which is expensive and difficult to produce. As a result, there are two major access problems: cost (more than $20,000 per year) and production. See the January/February Annual HIV Drug Guide
for more information.
did not find information on the Nkosi Johnson AIDS Foundation before presstime for the orphans resource list in the March/April issue. The Web site is http://nkosi.iafrica.com
. Nkosi Johnson is the South African child who spoke at the 2000 International AIDS Conference and died of AIDS, but not before helping to start an organization that would help other orphans.
New Detroit Program
The Detroit LIGHT House now has a specialized substance abuse treatment program (intensive outpatient with home visits) for people with HIV. The program focuses on African Americans and men who have sex with men (MSM). Services include one-on-one and groups dealing with topics such as emotional management and recovery (drug use, relapse prevention, health, depression, anxiety and AIDS). Free housing provided to eligible clients. Legal and financial counseling is available. For more information, call (313) 832-1300.
The Center for Positive Connections is hosting its 6th annual Poz HeteroCruise October 12-19th, leaving from San Juan, Puerto Rico. Reservations must be made by May 12, or as soon as possible. Payments must also begin the sooner the better. For more information call toll free (888) POS-CONN (767-2666) or visit www.positiveconnections.org
. TCPC, located in Miami, is an organization for HIV-positive heterosexuals.
Scientists have started a non-profit database of HIV drug mutations, the HIV Resistance Response Database Initiative. It hopes to collect data from doctors around the world. Efforts include responding to clinician inquiries. RDI was founded by Brendan Larder. Members include Julio Montaner of the British Columbia Centre for Excellence in HIV/AIDS, Victor DeGruttola of Harvard University and Scott Wegner of the U.S. Military HIV Research Group. Visit www.hivrdi.org
Women's Web Site
The United Nations Development Fund for Women (UNIFEM) with UNAIDS (United Nations Programme on HIV/AIDS) has developed a comprehensive Web site on women and HIV/AIDS. UNIFEM notes that, "Programmes on HIV/AIDS are beginning to mainstream gender. ... Best practices are being identified. And women are increasingly being regarded as active participants in bringing about change, rather than helpless victims." Visit www.GenderandAIDS.org
AIDS Vaccine Fails
The first AIDS vaccine to reach an advanced stage of research (Phase III) showed no difference when compared to placebo (fake drug). Overall, people in the study were infected with HIV whether or not they received the vaccine (about 6% each). Results are out to three years with more than 5,000 people at high risk of infection.
VaxGen, the manufacturer of AIDSVAX, reported that the vaccine seems to have protective ability for African Americans and Asians. However, the numbers of these people in the study were so small, they were basically irrelevant until much more research takes place. The statement served to mislead people, some of whom called the claim of ineffectiveness of the vaccine "racist." Gay Men's Health Crisis, an HIV-service organization in New York City, called the company's statement "grossly premature."
VaxGen can, of course, continue studies to see if the vaccine may indeed protect certain populations. Raising money for this may be difficult with the disappointing results of this trial. However, many vaccine advocates were optimistic. They noted that while the results were poor, the importance of the effort was huge.
AIDSVAX was supposed to stop HIV from reproducing by blocking one of its proteins, gp120. There are more HIV vaccines in development which work in different ways. The company has another vaccine in the works, in Thailand, with results also expected this year.
The U.S. Department of Health and Human Services (DHHS) awarded two grants for the search of a smallpox vaccine that can be used by people with a compromised immune system. Such a group includes people with HIV and those on cancer chemotherapy. Preliminary results may come as early as this year.
It was hard to believe that President Bush could really be an advocate for people with HIV, despite his pledge of $15 billion for fighting AIDS in Africa and the Caribbean during his January State of the Union address. Sure enough, the President basically took back his pledge later by saying that only organizations that do not perform or advocate for abortions can receive money. This makes it virtually impossible for medical clinics and other organizations that help people with HIV get money for AIDS treatment as outlined in the President's proposal. The President said organizations can get money by setting up separate facilities for AIDS work. This too is virtually impossible.
News From the 10th Conference on Retroviruses and Opportunistic Infections, Held in Boston in February
Prisoners and HIV
Researchers noted that "as many as 20% of HIV-infected persons in the U.S. enter and leave a correctional facility each year." Lead researcher Dr. David Wohl told Reuters news service that areas of the country with high rates of HIV also have high rates of incarceration, "and we were wondering if this is more than just a coincidence." The researchers talked with 80 prisoners, more than half of them women, and again after they were released (83% of them at the time of the report). They found that half of the ex-inmates had sex within a week after leaving prison. Although most of the people getting out of prison (64%) had a main partner without HIV or with unknown HIV status, 24% of them had unprotected sex with the partner. (In the year before incarceration, 78% had unprotected sex with the partner.) The University of North Carolina research team reported that, "Given their current sex behavior 31% of releasees felt that it was very likely or somewhat likely that they would infect their HIV-negative main partner."
Other research has found a high risk of HIV infection among partners of former prisoners. The health risks are thought to be so high, one Chicago blood bank refuses donations from anyone ever locked up for 48 hours.
Final 48 weeks results from the NEAT study are in for the new formulation of Agenerase. GW433908 (908 for short) is a protease inhibitor with a low pill burden -- two tablets twice a day. It was compared to Viracept (five tablets twice a day), both given with Epivir and Ziagen.
908 twice a day "showed evidence of greater efficacy" than Viracept. In people who had more than 100,000 viral load at the start of treatment (half of the participants), 67% of the 908 group had less than 400 viral load, compared with 35% of the people on Viracept.
Overall, the number of people who went below 400 viral load was 66% for 908 and 48% for Viracept. (Under 50 copies, it was 908 - 58% and Viracept - 42%.)
Half of the group of 249 participants had less than 200 T-cells. Both drugs increased T-cells by 200. TheBody.com reported that the drop-out rate was more than 30% for 908 and 46% for Viracept. The report noted that perhaps the advanced disease stage of so many of the patients made therapy more difficult to tolerate. Many participants were from poor countries in Central and South America, although most were from the U.S.
908 is expected to be dosed once a day with Norvir. It's also hoped that 908 is active against resistant virus.
908 vs. Kaletra
Now here's a drug to beat. Kaletra is a potent protease inhibitor, even for people with extensive drug resistance.
In the CONTEXT study, Kaletra and 908 both showed a strong response in people who had already experienced viral load failure on therapy (defined as more than 1,000). About half of the participants had advanced disease -- less than 260 T-cells. These are preliminary results from six months of treatment.
Using intent-to-treat analysis (a strict standard), the percentage of people getting below 50 viral load at 24 weeks was 48 for Kaletra, 42 for 908 once daily and 40 for 908 twice daily. T-cell increases were around 65 for all groups.
In this study, 908 was given with a small dose of Norvir, either once or twice a day. Two nucleoside drugs (the class of drugs that includes Retrovir and Ziagen) were added with the use of resistance testing, to make sure the nukes were effective in the participants. The 320 people in the study were from 13 countries, most from the U.S.