The pharmaceutical industry has dropped its lawsuit against the government of South Africa. The Pharmaceutical Manufacturers Association of South Africa, along with individual pharmaceutical companies, were trying to stop the country from importing and manufacturing generic versions of anti-HIV drugs. The Guardian newspaper, of Great Britain, reported that besides being a public relations disaster for pharmaceuticals, pursuing the lawsuit ran the risk of forcing them to detail business secrets surrounding their pricing, profits and source of funding for their research. In the United States, for example, a lot of tax-paid research through government agencies such as the National Institutes of Health (NIH) have helped bring HIV meds to market. The Wall Street Journal reported that five makers of the majority of the HIV drugs available in the U.S. (GlaxoSmithKline, Bristol-Myers Squibb, Roche, Boehringer Ingelheim and Merck) "pushed hard for a settlement" in an effort to avoid further harm to their reputation.
The maker of Sustiva (efavirenz) has applied for Food and Drug Administration (FDA) approval of a 600mg Sustiva tablet to be taken once a day. Right now, Sustiva is taken as three 200mg capsules once a day. The new tablet is about the same size as the capsule. A 300mg tablet formulation has also been applied for, allowing twice a day dosing (if you can tolerate it). The company is hoping to have the new tablets out early next year. Sustiva is a popular non-nuke drug that has been proven to be as effective as some of the protease inhibitors (see below). The most common side effects are nervous system symptoms (including abnormal dreaming, dizziness, insomnia, and impaired concentration) and mild to moderate rash.
Sustiva continues to do better at lowering viral load than Crixivan in head-to-head competition, for three years now. "This is important because patients and physicians are looking for treatment regimens that are powerful and durable yet simple to take. A regimen including Sustiva fits this profile and we now have proof that it can sustain its power for a long time," Madrid researcher Dr. José Arribas said in a company press release.
Using a strict analysis of "non-completer = failure," 52% of the people on Sustiva/Epivir/AZT (Retrovir) had less than 50 viral load, compared to 30% of the people on Crixivan/Epivir/AZT (Retrovir). However, Crixivan had to be taken every eight hours on an empty stomach, and that's hard to do. Also, Sustiva has a long "half-life." It lasts a long time in the body, so a missed dose is not as likely to lead to treatment failure. All of the people were taking anti-HIV drugs for the first time, and these people tend to do better at lowering viral load (the amount of HIV in their blood). Under NC=failure, anyone who stops taking medicine for any reason, such as moving out of the country, is counted as a failure for that regimen.
In a different study, more people were able to maintain undetectable viral load (again, less than 50) after switching to Sustiva from a protease inhibitor than the people who stayed on a PI. After an average of two years on a PI, 94% of people switching to Sustiva remained undetectable for another year, compared to 74% of the people who stayed on their PI. T-cell counts were the same. People may go off a PI because of side effects or rising viral load.
In a separate press release, Sustiva's manufacturer noted that 94% of people taking Sustiva with two nucleoside drugs (such as AZT and Epivir) in one study had undetectable viral load out to 48 weeks. This compared to 100% of a comparison group of prisoners who took medication under directly observed therapy (DOT). Of the people on the outside who were not taking a Sustiva combination, 70% had undetectable viral load. According to the release, "These data indicate the benefits of simple, but potent, regimens."
Tenofovir expanded access now has less strict requirements. The company has also applied for FDA approval. So those of you who get the drug for free will have to pay for it almost as soon as you receive it, but if you're desperate you don't have much choice. The once-daily drug is in a new class of HIV meds, nucleotide reverse transcriptase inhibitors. It can be hard to tolerate. Call 1-800-GILEAD-5 (445-3235) for more information.
National Cancer Institute researchers suggested in the Journal of the American Medical Association (JAMA) that three cancers should be added to the list of AIDS-defining illnesses. They reported that people with AIDS are 11 times more likely to have Hodgkin's disease, three times more likely to have lip cancer and twice as likely to have a type of testicular cancer. At this time, AIDS-defining cancers are non-Hodgkin's lymphoma, Kaposi's sarcoma and cervical cancer. NCI worked with the Danish Epidemiology Science Center on this study.
There's now a sequel to the highly readable and enjoyable Numb Toes and Aching Soles: Coping with Peripheral Neuropathy. The new book is called Numb Toes and Other Woes: More on Peripheral Neuropathy. Author John Senneff digs deeper into pain treatments, with special emphasis on new clinical studies and drugs just coming out of laboratories. Both books are written for patients as well as for their care providers, including medical professionals. The sequel provides more information on nutrient supplementation as an alternative treatment for treating peripheral neuropathy, nerve damage that is common in HIV, both with the virus itself and with the drugs used to fight it. Visit www.medpress.com or call toll free at 1-888-MED (633)-9898. The 280-page paperback is $22.95, plus $5 shipping and handling. We can't emphasize enough: talk to your doctor right away if you're taking Hivid, Videx or Zerit and you experience tingling in your hands or feet. That innocent tingling can turn into debilitating pain every day for the rest of your life if you don't do something right away! Unfortunately, once PN is established (you didn't do anything to try to stop it early enough), treatments seem to provide only minor and temporary relief.
New-Fill polylactic acid is now available in the U.S. through DAAIR (the Direct AIDS Alternative Information Resources, a buyers club in Manhattan). The treatment, available in France but still experimental here, has been getting good reviews from HIV treatment advocates for AIDS-related facial surgery in people who've developed sunken cheeks.
Nelson Vergel of PoWeR (Program for Wellness Restoration) and co-author of Built to Survive: A Comprehensive Guide to the Medical Use of Anabolic Steroids, Nutrition and Exercise for HIV+ Men and Women, reported that Dr. Peter Engelhard in Miami is performing New Fill injections (like DAAIR, he also imports the product with an FDA investigational number). Dr. Engelhard's number is 1-305-534-7255, and Nelson reports that he's getting flooded with calls. Dr. Engelhard was trained in France. One person said his fees are high and noted there are better prices with a surgeon in the San Diego area.
Other U.S. doctors will soon be training for the procedure. For more information, contact Nelson at PoWeRTX@aol.com or see also News Briefs in the March/April issue. Visit www.daair.org or call them tollfree at 1-888-951-5433.
A Missouri grocery store agreed to pay $80,000 in back wages and damages to a former deli worker, who believed he was fired because he was HIV-positive. Store staff had also disclosed his status to other people.
Marijuana in a Bottle
In light of the recent unanimous U.S. Supreme Court decision against medicinal marijuana, it's important to remember that an active ingredient of marijuana is still available in a capsule. The Supreme Court ruled that there is no "medical necessity" exemption to federal drug laws. As a result, medicinal use of marijuana is still illegal under federal law, even though it's allowed in several states. The prescription medicine is called Marinol -- how easy is that to remember? Marinol's manufacturer conducted a national survey which found that 93% of the people they talked to knew that marijuana is used for medicinal purposes, but only a third of them knew that there is a prescription drug available with a synthetic form of an active ingredient found in marijuana. Self-serving, true, but Marinol has a good reputation among HIV treatment advocates, who cite its pain relief, appetite stimulation and feel-good therapy. While some people respond better to smoking marijuana, Marinol avoids the bacteria and fungus that may be present in the real thing and also avoids the lung damages of smoking. (Hence the beauty of baked brownies.)
The Food and Drug Administration (FDA) sent a warning to HIV drug makers to change their ads. The FDA said ads should clearly convey that the drugs do not cure HIV, do not lower the risk of transmission and must be taken in combination with other HIV meds (with the "possible exception" of Trizivir, which is a triple combination in one pill). Also, many ads "show images that are not representative of patients with HIV infection," such as "robust individuals engaged in strenuous physical activity to healthy-looking individuals giving testimonials." In addition, "important limitations," including side effects causing physical deformities, including facial wasting, are not mentioned. All together, these criticisms make for ads that are "misleading," and are therefore in violation of FDA rules, the letter noted. The FDA gave pharmaceuticals three months to change their ads.
You would think that having less HIV in your blood would be an advantage. It ain't necessarily so.
Different studies have found that women have lower viral loads than men do, but yet they have the same risk of developing AIDS.
The latest report on this topic comes from the March 8 issue of the New England Journal of Medicine (NEJM). Researchers found that women who later developed AIDS had a median starting viral load almost five times less than the level found in men who progressed to AIDS (17,000 vs. 78,000). Even in the people who hadn't developed AIDS, the men started out with a viral load that was almost four times higher (41,000 vs. 12,000). T-cell counts for all of the men and the women, however, remained about the same from the beginning of infection to the development of AIDS.
So what does this say about women when looking at U.S. treatment guidelines, which specify that people should consider going on HIV meds when their T-cells drop to 350 or their viral load increases to more than 30,000 (bDNA, or the Chiron test) or 55,000 (RT-PCR, or the Roche test)? Doctors are wondering whether T-cells are more important than viral load in determining when to treat women. They're also wondering about the role of sex hormones and other biological differences in the development of AIDS. Research is still underway to figure out what's going on here.
The NEJM report came from one of the largest studies ever to examine gender-specific differences of HIV infection (although only 156 men and 46 women were involved). During the first years of HIV infection, women had significantly lower amounts of the virus in their blood than did men. "Despite early differences in viral load among men and women, as time went on, both men and women had a similar risk of developing AIDS," says lead author of the study Dr. Timothy R. Sterling, in a press release. "In addition, men and women experienced a similar rate of loss of their CD4+ T cells, the immune cells that decrease as a result of HIV infection." Researchers looked at a group of 200 men and women with a history of injection drug use who participated in a study called ALIVE (AIDS Linked to the Intravenous Experience), which began in 1988. ALIVE used the Roche test for measuring viral loads. Although 90% of the participants were black, the authors noted that neither race nor the route of acquisition of the virus has been found to make a difference in HIV progression. The often-cited study showing the risk of developing AIDS based on viral load levels comes from the Multicenter AIDS Cohort Study (MACS), a study of men.
The authors noted that
The American Academy of HIV Medicine (AAHIVM) has established criteria defining what it means to be a specialist among physicians and other health care workers treating people with HIV. According to an Academy press release, "The Academy's definition emphasizes that the base line criteria for an HIV specialist is the ability to demonstrate Continuous Professional Development (CPD) in the area of HIV treatment. This differs from other organizations' definitions that require only that an arbitrary number of patients are seen or units of Continuing Education are completed." The organization's minimum number of patients before being considered an HIV specialist is having treated 20 people with HIV within the past two years. It also announced that it expects to complete a list of "core competencies or 'body of knowledge' an HIV specialist should posses." AAHIVM reported that its recommendations "are concurrent with research studies indicating that medical costs are lowered and better health care results when an experienced AIDS specialist physician is consulted in the care of HIV/AIDS patients." For more information, visit www.aahivm.org. AAHIVM is located in Los Angeles.
Mourners on Saturday packed the funeral of Nkosi Johnson, a 12-year-old AIDS activist who died June 1. The downtown Johannesburg church in South Africa was filled to capacity with several hundred mourners, including former Zambian President Kenneth Kaunda. Banners showing a smiling Nkosi in a baseball cap asked mourners to "Let the love and courage of Xolani Nkosi Johnson fill your heart with determination to care for the infected and orphaned children of our land." Nkosi was born with HIV. He stirred audiences with his pleas for acceptance of HIV-infected people, winning international fame last July when he addressed the opening of the UN's 13th International AIDS Conference in Durban, South Africa. "We are all human beings. We are normal," he said in that speech. Tributes to Nkosi were interspersed between hymns in Zulu, Xhosa and English, with some mourners dancing in the pews, clapping their hands as others wept. -- CDC HIV/STD/TB Prevention News Update.
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