HIV/AIDS Newsroom: November 1, 2000
Adverse Effects of Antiretroviral Therapy
10/21/00; Vol. 356, No. 9239, P. 1423; Carr, Andrew; Cooper, David A.
HIV-infected individuals who begin highly active antiretroviral therapy (HAART) should be aware of the drugs' potential adverse effects and toxicities. AIDS patients are now using combination therapy for longer periods of time, which means more complications are being seen. Mitochondrial toxicity may start gradually, or right away. Two features of this condition are peripheral neuropathy and renal tubular acidosis. Diagnosing of such a toxicity is hard if the patient is taking other similar drugs. Drug hypersensitivity, which typically shows as a rash and fever, is nearly 100 times more common in HIV patients than in the general public. However, about half of the cases of antiviral hypersensitivity resolve themselves without treatment. The lipodystrophy syndrome is an adverse effect first identified two years ago. Features of the condition include fat loss in the arms, legs, face, and buttocks, with accumulated fat in the abdomen, breasts, and "buffalo hump" area on the back. The syndrome has not been associated with differences in testosterone levels. Diabetes is also more frequent in HAART-taking patients, and 15 percent have glucose tolerance that is hindered. It is not known why lipodystrophy occurs, but there are several theories, including the possible inhibition of lipid proteins. The metabolic effects of lipodystrophy can lead to cardiovascular disease and heart attacks in a previously not at-risk group. The only way to stop fat accumulation, in theory, is to stop therapy, but increased exercise can stop the accumulation. Anabolic steroids can only partly help hide fat loss in the legs or face. Specific adverse effects exist for each drug. Zidovudine has risks of anemia, headache, nausea, and fatigue, as do most of the drugs. The most common complaint, nausea, is frequent with zidovudine and didanosine. Diarrhea and vomiting are frequently seen effects of the protease inhibitors.
Immune Response Corp., a California biotechnology company, reportedly tried to stop publication of an AIDS study by Dr. James Kahn of the University of California at San Francisco that discusses the use of Remune therapeutic HIV vaccine. The study is published in today's Journal of the American Medical Association, whose deputy editor Drummond Rennie, said patients have the right to know about the vaccine trial. The $30 million study tested the vaccine for two years on people with HIV infection. The results indicate that the number of people with declining health was the same for both groups: those who received the vaccine and those who received placebo shots. Immune Response contends that detailed data from 250 patients in the study of 2,527 should be included in the report. The company says those 250 patients, who had their blood tested more often, had a better immune response to the vaccine than the control group. Because combination antiviral therapy came out during the study, fewer people got sick during the study than the researchers had initially predicted. After two years in the study, a total of 53 people in each group had worsened or died. Kahn and colleagues determined there was no benefit to the vaccine in terms of survival or health improvement rates, and their report did mention the 250 people with better responses. The report did not, however, say the patients taking Remune had a greater drop in viral load compared to the placebo group.
Few Drugs for the Needy
Washington Post (www.washingtonpost.com)
11/01/00; P. A1; Finkel, David
In the African country of Malawi, AIDS treatment consists of a hospital bed to lie in, for those who are lucky. For those who can afford better conditions, Mwaiwathu Private Hospital in Blantyre offers a clean bed, comfortable sheets, and for those who can afford it, dual drug therapy for AIDS. The total number of Malawian patients who receive America's standard triple-drug therapy is estimated to be 30, compared to the over 1 million people in Malawi who are infected with HIV. Many patients know only little about these drugs, the cost of which is prohibitive for most anyhow. Malawi has about 10 million people and last year lost 70,000 to AIDS. Those who can afford Mwaiwathu Private Hospital are typically businessmen, who do not live in huts but in houses. Yasaya is a patient at the hospital and had been sick for a year before being diagnosed with HIV. The public hospital in Malawi, meanwhile, is overcrowded and lacks resources; patients often sleep on the floor. The difference between the hospitals is not only comfort, but opportunity. Yasaya is offered the chance for antiretroviral medications, which have been available for nearly 13 years, but are unknown to most of the patients. One month of the drug Crixivan, a protease inhibitor, costs $500, which is Yasaya's monthly salary. Malawi's government has at least produced a framework for dealing with AIDS, which includes more testing, education, and hope, but not treatment. Dr. Cooper Nyirenda offers Yasaya AZT and 3TC, two drugs for AIDS treatment, but neither one being a protease inhibitor. The drugs are kept at Queen Elizabeth Central Hospital and are sold at a reduced price to those who can afford them. The drugs were obtained in a deal made with Glaxo Wellcome in 1998, which offered a 25 percent discount. In May of this year, Glaxo and four other companies offered discounts of up to 85 percent for poor countries; however, Malawi's deal was already made. The difference between Mwaiwathu Hospital and Queens hospital is stark. At Queens, over 70 percent of the patients have HIV/AIDS or related illnesses, compared to 30 percent at Mwaiwathu. Family members often do the job of nurses, because of a shortage of help. Dr. Nyirenda comes up with a plan for Yasaya to take Combivir and Crixivan for three months, the point at which his employer may refuse to continue paying for the drugs. Then Yasaya will start the dual therapy. A problem with the drug supply at the pharmacy makes Yasaya receive Viracept instead of Crixivan, as he becomes the 31st person in Malawi to start triple-drug therapy against AIDS.
South African President Thabo Mbeki's comments regarding AIDS have caused his approval rating to fall from 70 percent to 50 percent in the past year. Mbeki has questioned the link between HIV and AIDS -- one that most scientists accept -- and has suggested that poverty is a direct factor behind the disease. His frequent statements about poverty causing AIDS have hurt his image as a competent leader, and the government now working on damage control by creating an advertising campaign stressing condoms and abstinence. The government has also formed an international marketing council to reduce perceptions about crime and AIDS. While some analysts say Mbeki is losing popularity because of a fall in the economy, AIDS workers report that some people now believe risky sex is okay, since the president and scientists he backs have minimized HIV's role and suggested that poverty contributes more to AIDS.
The Food and Drug Administration has granted Bristol-Myers Squibb permission to sell a new once-a-day formula of its HIV treatment Videx that causes fewer adverse events, such as diarrhea. According to Bristol-Myers representative John Kouten, Videx EC is the only HIV treatment currently available in a once-daily formula. Providing simple HIV dosing schedules has become increasingly important, as patients are required to take several drugs at different times of the day and non-compliance can result in increased drug resistance, Kouten notes.
A study from Dr. Diana Dell of Duke University Medical Center shows that high school students know little about human papillomavirus (HPV), which is linked to cervical cancer. Approximately 15 percent of sexually active adults in America and Canada have HPV, said Dell, who interviewed 523 inner-city students in Toronto. According to a report in the November issue of the journal Obstetrics and Gynecology (2000;96: 653-656), 87 percent of the students had not heard of HPV. The researchers also note that only 39 percent of the sexually active young women knew who should get a Pap smear, which can detect abnormal cells.
A 19-year-old woman in Kansas City, Missouri, has won her case against a former boyfriend who did not tell her he had venereal diseases. The woman claimed that his failure to disclose the infection has made her need medical treatment for life. The decision may be appealed.
As of the end of September, China had recorded 20,711 cases of HIV infection -- a 37 percent increase compared to the same time last year. The Xinhua news agency, quoting the health ministry, said that most of the new HIV infections were among people between the ages of 20 and 29, with injection drug users accounting for 72 percent of cases. Chinese experts in the state media estimate that the actual number of HIV infections is much higher, about 500,000 throughout the country. Furthermore, according to United Nations estimates, unless aggressive actions are taken, there will be 10 million HIV cases in China by 2010.
Researchers in Philadelphia have found evidence that the immune systems of HIV-infected teenagers can rebound quickly after highly active antiretroviral therapy (HAART). "The research suggests adolescent patients have a more robust immune system, and we should start treating them very aggressively early on," said Dr. Steven D. Douglas, of The Children's Hospital of Philadelphia. "But that's just speculation." The study included 192 HIV-positive and 78 HIV-negative youths. Compared to the uninfected group, the HIV-infected individuals had lower CD4 cell counts; but one surprising discovery was that the infected teenagers had much higher CD8 cells counts than the HIV-negative teens. The finding reinforces a theory that HIV-positive adolescents have functioning thyroid tissue and stronger immune systems than HIV-infected adults, so they, thus, may have better cytotoxic T-lymphocyte and other responses than both HIV-infected adults or children.