About twice as many patients using the experimental injectable fusion inhibitor enfuvirtide achieved an undetectable HIV viral load, as did patients who only received optimal treatment, researchers said at the XIV International AIDS Conference. In the T-20 versus Optimzed Regimen Only (TORO) study, researchers said that 51% of patients taking enfuvirtide – formerly known as T-20 – were able to achieve at least a one log fall in circulating virus, compared with 29.1% of patients who were only receiving the best available therapy to control HIV. About 37% of patients on enfuvirtide achieved an undecteable viral load using a 400-copy limit assay compared with 16.4% of patients on optimal therapy. About 20% of patients on enfuvirtide achieved an undetectable viral load using the 50-copy limit assay compared with 7.3% of patients on optimal therapy. The percentage of people achieving decreased viral loads increased during the course of the 24-week trial conducted at 49 sites in the USA, Canada, Mexico and Brazil. Recruiters enrolled 326 patients into the T-20 arm of the study, giving them the twice-daily self-injected drug enfuvirtide, and another 165 patients who received just optimal treatment. ‘‘In these studies, the patients were heavily pre-treated and were running out of options,’’ said Dr. Bonaventura Clotet, head of the HIV section at Hospital Germans Trias I Pujo, Barcelona, one of the TORO investigators. ‘‘For us to then observe twice the percentage of patients achieving a reduction in their viral load below detectable levels in the study arms that contained T-20 in comparison to the study arms that only contained the currently available antiretrovirals is remarkable and far better than anyone had expected,’’ Dr. Clotet said.
Epidemics sweeping Asian cities
Explosive epidemics of infection with the virus that causes AIDS is sweeping across major urban cities of Asia, fuelled by striking increases in the percent of injecting drug users with the incurable disease. International researchers reported troubling increases of HIV infection among drug users in Ho Chi Minh City (Saigon) in Vietnam and Tagliatti City, in the central Asian area of Russia. In addition, scientists found rapidly increasing rates of infection among drug users in Western Europe, and they expressed concern that the war against terror in Afghanistan could trigger a new outbreak of HIV/AIDS in neighboring Pakistan due to disruption of drug use patterns. ‘‘These outbreaks are happening in dozens of cities around the world,’’ said Dr. Alex Wodak, director of the alcohol and drug treatment service at St. Vincent's Hospital, Sydney, Australia. And in Pakistan, epidemiologists surveying usage patterns of injecting drug users, said that the war on terror disrupted heroin supplies from Afghanistan, moving drug users in Lahore to increase injecting drug use, said Steffanie Strathdee, associate professor of epidemiology at Johns Hopkins University, Baltimore, Maryland.
Race, ethnicity and response to HAART
A person's race or ethnicity does not appear to affect his or her response to highly active antiretroviral therapy (HAART) for the treatment of HIV infection, researchers in Denmark reported. ‘‘We saw no differences in virologic or clinical outcomes based on the race of a person or where that person's origin of birth is,’’ said Dr. Soren Jensen-Fangel, MD, a researcher in the department of infectious diseases at Aarhus University Hospital. In a poster exhibition researchers scrutinized the medical records of 524 adult HIV-infected patients who were treated on HAART regimens before April 2001. The study included 389 Caucasians and 135 non-Caucasians, three-quarters of whom were from sub-Saharan Africa. After fulfilling pretreatment requisites, 91% of the non-Caucasians and 93% of the Caucasians were deemed to be candidates for the HAART therapy. Dr. Jensen-Fangel said the HAART therapy selected was the choice of the patient's doctor. The researchers found that after 1 year on HAART about 78% of the non-Caucasians and 76% of the Caucasians had achieved a viral load that was undetectable by the 500-copy assay used in the study.
Gay men level of AIDS awareness concern in USA
Most young gay men in the USA are unaware that they are infected with the virus that causes AIDS, government researchers said. ‘‘Clearly, unrecognized infection with human immunodeficiency virus is a problem in men who have sex with men,’’ said Duncan MacKeller, an epidemiologist with the Centers for Disease Control and Prevention, Atlanta, Georgia. ‘‘A substantial number of young gay and bisexual men of all races have HIV, do not know they are infected, do not think they are at risk, are not getting tested and may be unknowingly transmitting the virus to their partners,’’ he said. In a presentation at the 14th International AIDS Conference MacKeller said that of 5719 young gay men tested in six cities – Baltimore, MD, Dallas, TX, Los Angeles, CA, New York, NY, and Seattle, WA – 573 or about 10% of them tested positive for HIV, the virus that causes AIDS. ‘‘That is a high percentage of infected individuals,’’ MacKeller saidÒ ‘‘But what is more alarming it that most of those young men – aged 15 to 29 – aren't aware of their status. Of those 573 infected individuals, MacKeller said that 440 men or 77% were unaware they were infected. Broken down by ethnic group, he said 91% of African–American men who have sex with men were unaware of the were infected; 70% of Latinos were unaware of their HIV status and 60% of Caucasians were unaware of the fact that they had the disease and could infect others.
Visceral adipose tissue that often appears in HIV-infected patients on highly active antiretroviral therapy (HAART) may be reduced by treated with recombinant human growth hormone, researchers reported. In the Serostim for the Treatment of Adipose Redistribution Syndrome (STARS) study, 239 patients in the USA were treated with either 4 mg of growth hormone daily, 4 mg of growth hormone every other day or placebo, if they had developed visceral adipose tissue accumulation but did not develop pre-diabetic insulin resistance – both frequent symptoms observed in lipodystrophy syndrome. ‘‘The results of the STARS study indicate that growth hormone has a potential role in the treatment of body composition issues associated with lipodystrophy,’’ said Dr. Donald Kotler, MD, Professor of medicine at Columbia University and chief of the gastroenterology at St. Luke's Roosevelt Hospital, New York, ‘‘which is an important finding for a condition that has a significant impact on HIV positive patients in the USA who experience some form of fat maldistribution or lipodystrophy.’’ Dr. Kotler said the lipodystrophy syndrome can include wasting of fat in the face, arms and legs; increases in adipose tissue in the belly or on the shoulders, as well as metabolic changes that include increases in cholesterol and triglycerides and insulin resistance. Because insulin resistance may also develop with growth hormone administration, patients with that part of the lipodystrophy spectrum were excluded from the trial. Computer tomography and other imaging technologies were used to help masked evaluators to determine if there were visible improvements in the patients’ appearance. Dr. Kotler said that patients taking the daily regimen of growth hormone were able to demonstrate a statistically significant decrease in adipose tissue compared to the placebo group. The women in the group achieved an average decrease of 13.5% of adipose tissue, and the men achieved a 9.2% decline in adipose tissue. The patients on the alternate day schedule did not achieve a reduction that reached statistical significance, he said.
Argentina: care of children born to HIV-infected mothers
All babies born to mothers taking various regimens of highly active antiretroviral therapy (HAART) appear to be free of HIV infection, researchers in Argentina reported. ‘‘HAART initiated during pregnancy showed efficacy and favorable safety profile in mothers and exposed newborns in this population,’’ said Dr. Patricia Coll, MD, of Hospital Fernandez, Buenos Aires. She and her colleagues attempted to assess the efficacy of perinatal HAART in preventing HIV transmission in a non-breastfeeding population as well as to analyze safety of the treatment regimen on the woman and their drug exposed newborns. In the prospective trial, 78 women were enrolled and observed through their pregnancies while taking different multidrug therapies – most frequently the non-nucleoside reverse transcriptase inhibitor nevaripine and the idouvine/lamivudine combination drug Combivir, Dr. Coll reported. About 80% of the women elected to have their children delivered by Cesarean section. As of 2 June 2 2002, 66 of the children have tested seronegative after having undergone two tests 6 months after birth. Seven of the children in the study were withdrawn from the protocol and five other children have had just one test. One other child – one of four that were born pre-term – died, but Dr. Coll said that the death was not considered to be due to an event related to antiretroviral therapy. One set of twins were born in the cohort. On average, the women began HAART treatment 20 weeks into the pregnancy.
Effective treatment programs in developing countries
Doctors said that a concerted effort to extend state-of-the-art AIDS treatment programs into poor nations of the world will deliver dramatic and effective results – without creating globe-threatening resistant virus. That's because in those resource poor setting the virus has not mutated and is highly vulnerable to the anti-AIDS drugs – unlike the situation in Western countries which resistant virus transmission already means some drugs are no longer appropriate for even newly-diagnosed patients. ‘‘There is a whole world of susceptible virus out there,’’ said Dr. Scott Hammer, Professor of medicine at Columbia University, New York. More than 90% of people infected by HIV have never received any antiretroviral treatment. ‘‘When we begin to treat these people, we will see dramatic results,’’ said Dr. Stephano Vella, head of the Italian anti-HIV/AIDS program in Rome and president of the International AIDS Society, the sponsor of the conference which has drawn more than 15 000 scientists, activist and related health care personnel. ‘‘We saw dramatic results even when we treated people in the Western world who had been heavily pretreated with a catastrophic use of suboptimal therapy,’’ Vella said. Suboptimal therapy leads to mutations in the virus which block potency of the drugs. ‘‘One of the objections of people who have argued against treating people in developing countries had been a fear that we would create drug resistance,’’ Vella said. ‘‘We can use the lessons we have learned in the West on how not to treat HIV infection to make sure we do it correctly when treating people in the developing countries.’'
Lidocaine patch treatment of HIV-associated peripheral neuropathy
In a pilot study, researchers reported that a lidocaine patch appears to effectively treat HIV-associated peripheral neuropathy. Doctors from the Veterans Affairs Long Beach Healthcare System in California enrolled 10 patients in the study to determine if the patches could bring some measure of relief to patients suffering from painful peripheral neuropathy. Overall, Dr. Stephen Berman, MD, from the VA system found that the patients reported significant improved in the intensity of the pain, in sharpness of pain, in how ‘‘hot’’ the pain felt, in how sensitive their skin was to the touch, in how unpleasant the pain was, in how deep the pain felt and how intense the surface pain felt to the patients. ‘‘Since the beginning of the HIV epidemic, peripheral sensory neuropathy has been recognized as a complication of HIV infection,’’ Dr. Berman said. ‘‘Peripheral neuropathy is one of several HIV-associated conditions which is seen as frequently, if not more frequently, since the advent of highly active antiretroviral therapy.’’ Two of the nine patients who completed the study said their condition was ‘‘very much improved’'; five of the patients said their condition was ‘‘much improved’'; one patient reported minimal improvement, and one other patient reported no change from use of the patch.