The Conference on Retroviruses and Opportunistic Infections is a research meeting created to provide a forum for basic and clinical science investigators to present, discuss, and critique developments in the field of human retrovirology and related opportunistic complications. The subjects highlighted are: virology, immunology, vaccines, pathogenesis, disease mechanisms in humans and animal models, primary/acute infection, host-virus interactions, antiretroviral therapy (preclinical, clinical, and complications), clinical pharmacology, opportunistic infections, epidemiology and infection control, microbicides, pediatric/maternal-fetal/women's health, and diagnostics. Following are digests of major reports from the conference, as compiled by the National Prevention Information Network (NPIN) of the Centers for Disease Control and Prevention (CDC). For further information, see: http://www.retroconference.org/2001.
Delay in Starting Patients on AIDS Drugs
Under new guidelines, HIV-infected individuals are recommended to start treatment when their T-helper cell levels drop below 350, compared to 500 for the old treatment guidelines. Treatment is also advised when the amount of HIV in the patient's blood goes above 30,000 copies per milliliter as measured by branched DNA, or above 55,000 copies as measured by PCR testing; the old guidelines called for treatment when the amount of virus in the blood exceeded 10,000 on branched DNA or 20,000 on PCR. [For guidelines see: summary
below or http://www.retroconference.org/2001
U.S. Urged to Help Africa
Dr. Jeffrey Sachs, an economist at Harvard University, urged President George W. Bush and the AIDS activists present in Chicago to help purchase drugs for African nations and sell them at even deeper discounts than are provided by the drug companies themselves because the medicines are too expensive even now for African citizens; Sachs suggests a $2 billion annual budget for the program, which would amount to approximately $2 per person in the United States and other rich nations.(1)
Study in Six Cities Finds HIV in 30 Percent of Young Gay African-American Men
New research from the CDC indicates that 30 percent of young gay African-American men in the United States are infected with HIV. The study was conducted as a series of interviews with over 2,400 men in Baltimore, Dallas, Los Angeles, Miami, New York, and Seattle. All of the men interviewed were frequenters of bars and other social places usually attended by gay men. The data also revealed that among the young gay men studied, 15 percent of Hispanics, 7 percent of non-Hispanic whites, and 3 percent of Asian-Americans were HIV-positive. The CDC found that overall, 12.3 percent of gay and bisexual men between the ages of 23 and 29 were infected with HIV. The CDC's Dr. Robert Janssen, a co-author of the study, noted, "The rates are strikingly high and worrisome. We have not been putting adequate resources into gay men of color. And we definitely need to bolster our efforts in reaching them." The researchers reported that 46 percent of the men interviewed said they had engaged in unprotected anal intercourse in the past six months. There was a high level of dangerous sexual behavior in all six cities, with HIV prevalence ranging from 4.7 percent in Seattle to 18 percent in Dallas. The CDC researchers also expressed concern that only 29 percent of the 293 HIV-infected men interviewed were aware of their own infection and that fewer than 25 percent were receiving medical care or treatment.(2)Advertisement
Studies Look at Interruption in Taking AIDS Medicines
A number of studies focused on treatment interruptions for HIV-infected individuals. Martin Markowitz of the Aaron Diamond AIDS Research Center in New York studied 15 newly infected subjects who stopped taking their medications on their own and found that only three patients were able to keep their virus at low levels, while the others experienced declines in CD4 cell counts and saw declines in immune system improvements that the therapy had helped them attain. Meanwhile, Dr. Bruce Walker, a Harvard researcher, found that after just one instance of stopping therapy, four of 14 patients were able to keep their virus under control. Walker also reported that with more cycles on and off therapy, more patients were able to control HIV, and after a second treatment interruption, patients were able to control the virus for longer periods of time -- an average of six months after the second interruption, versus just one month after the first time they interrupted their AIDS treatments.(3)
CDC Aims to Cut New AIDS Infections in Half by Shifting Prevention Strategy
The CDC announced a major change in HIV prevention strategy, working to reduce by 50 percent the number of Americans who contract HIV each year. The program's new direction is to target people already infected with HIV and provide counseling against spreading the disease. Earlier HIV programs were designed to bring HIV awareness to those who were not infected with the virus. However, Dr. Helene Gayle, director of the CDC's National Center for HIV, STD, and TB Prevention, notes that focusing on infected people is possible now because potent AIDS drug therapies "have changed the landscape," making people much more willing to be tested and obtain care. The new initiative follows the report of a multi-city study at the conference which concluded that approximately 30 percent of gay African-American males will contract HIV before they turn 30 years old. Uncertainty over whether the funding will be approved by the new Bush administration has CDC officials concerned, however, as the new initiative may require an estimated $900 million annually to operate, at least $200 million more than the CDC's current annual budget for prevention efforts. Under the new program, the CDC would work to reduce the number of new HIV cases in the United States each year from 40,000 to 20,000.(4)
AIDS Drug Advances Heralded
Several presentations were made on experimental AIDS remedies that may circumvent the problems of negative side effects and viral resistance. Tibotec presented TMC-126, a compound that can bind to the HIV protease enzyme. Also presented was research indicating that Bristol-Myers Squibb's BMS-232632 protease inhibitor is as effective as nelfinavir without causing an increase in cholesterol or triglyceride levels. Fusion inhibitors such as the experimental T-1249 may offer hope for AIDS patients who have run out of treatment options, but the drugs cause many milder side effects.(5)
Mutation That Slows HIV May Play a Role in Hepatitis C
Scientists found several years ago that some people had a genetic cell mutation that could protect them from HIV or slow down the course of infection. A team of German scientists from the University of Bonn presented new findings regarding the same genetic mutation, suggesting that it appears to have a negative effect on people infected with the hepatitis C virus (HCV). Dr. Rainer Woitas, head of the German team, believes the new findings could have a great impact regarding the epidemiology of HCV infections and the development of anti-HIV drugs designed to target the mutation. The team's studies found that 7.8 percent of the 153 HCV-infected patients studied had the CCR5 mutation and that people with the genetic mutation had nearly four times the level of HCV in their blood in comparison to those without the mutation. Woitas' theory is that the mutation somehow disrupts the immune system in such a way that it has an adverse effect on hepatitis C, while simultaneously producing a protection against HIV.(6)
Study Reports Drug-Resistant Strains Have Increased to 14 Percent Among New HIV Cases
A new study of nine U.S. and Canadian cities from Dr. Susan J. Little of the University of California at San Diego indicates that drug-resistant strains of HIV have increased to 14 percent among newly infected individuals. The report revealed increased resistance in a group of 394 individuals who, because they had flu-like symptoms, were diagnosed as having HIV and treated within three months of infection. According to Dr. Little, resistance to one or more drugs was identified in 14 percent of the participants between 1999 and May 2000, up from 3.5 percent between 1995 and 1998. Furthermore, resistance to two or more of the three classes of AIDS drugs rose to 5.8 percent during the 1999 to 2000 period, up from 0.4 percent between 1995 and 1998. Dr. Little suggested that all newly infected people be tested for drug resistance, even if they do not plan to start drug treatment for a while, because the testing could help track the prevalence of resistant strains geographically for public health purposes.(7)
In Study, Cycling AIDS Drugs On and Off Appears to Do No Harm
New findings from a study of 10 patients suggest that it may be possible for some HIV-positive patients to cycle their drug therapies on and off with few or no negative effects. Although the study is small, Dr. Anthony S. Fauci, the head of the National Institute of Allergy and Infectious Diseases, noted, "This is a big deal to people. These people are positively inclined to being off-drug 50 percent of the time." Fauci and colleagues initiated the study with the hopes that HIV patients could be weaned off the drug therapies for extended periods of time. Meanwhile, a study of 24 patients who had a two-months on, one-month-off treatment cycle found that in most patients, the virus rebounded during the non-treatment month. More promising results were seen in a companion experiment that had cycles of seven days on and seven days off. The virus remained fully suppressed during the off weeks, although HIV was detected in the bloodstreams of two patients soon after they failed to restart their treatments.(8)
Belgian Firm Tests Drug Resistance of AIDS Patients
A Belgian genomics firm, Virco Group NV, reports that it has developed a quick test that will predict drug resistance in patients infected with HIV. Virco representatives explained that the test was created by comparing viral genetic detail from about 100,000 samples of patients who demonstrated drug resistance. Some estimates indicate that 10 percent to 20 percent of HIV patients in developed nations experience treatment failure within the first year of treatment, developing resistance to at least one drug. Current methods of testing for drug resistance, called phenotyping, can take up to three to four weeks to complete. The Virco "virtual Phenotype" test is much faster, producing results in about 10 days at a cost of $450 per test.(9)
Chances of HIV Infection
New research indicates that the chances of contracting HIV during an unprotected heterosexual encounter is about one in 588. The statistic was determined by observing and documenting 174 sexually monogamous couples in Rakai, Uganda, in which one partner was infected with HIV. The participants were given condoms, although they generally were not used, and the couples had intercourse about nine or 10 times a month. Over the course of the study, 38 individuals contracted HIV. The researchers had previously reported that the risk of HIV transmission is slight if the amount of HIV in their blood is low. The study was reported Thursday by Ronald H. Gray of Johns Hopkins University.(10)
Devices Keep AIDS Patients on Medication
Researchers reported the development of a device that helps HIV and AIDS patients keep up with their complex drug regimens. Dr. Adriana Andrade, a senior clinical pharmacologist at Johns Hopkins University in Baltimore, noted that up to 30 percent of people infected with HIV experience memory and other cognition difficulties -- problems that are particularly difficult when there is a complex treatment schedule to follow. To help with this, Andrade and colleagues created "Jerry the pharmacist," an experimental voice box that features flashing lights and tells patients when to take their medications. In a study, 83 percent of 21 patients who received standard antiretroviral education information were complying with their drug regimens after six months, compared to 90 percent of 22 patients who were using Jerry, which is officially known as a Disease Management Assistance System.(11)
Drugs Cut U.S. Mother-to-Child HIV Transmission
Dr. Alexjandro Dorenabum of Emeryville, Calif., reported a dramatic drop in U.S. mother-to-infant HIV transmissions as the result of antiretroviral drug use. Findings from the Pediatric AIDS Clinical Trials Group 316 indicate that with antiretroviral drugs, the transmission rate has dropped to about 1.5 percent. The researchers followed over 1,500 pregnant women and found that of the 17 HIV-infected infants born during the study, nine tested positive for HIV at birth, suggesting that transmission took place before delivery. It was also noted that the addition of nevirapine to the pregnant women's drug therapies did not decrease transmission rates any more than a placebo.(12)
Summary: Guidelines on the Use of Antiretroviral Therapy in HIV-Infected Adults and Adolescents (February 5, 2001)
The availability of an increasing number of antiretroviral agents and the rapid evolution of new information has introduced extraordinary complexity into the treatment of HIV-infected persons. In 1996, the Department of Health and Human Services and the Henry J. Kaiser Family Foundation convened the Panel on Clinical Practices for the Treatment of HIV to develop guidelines for the clinical management of HIV-infected adults and adolescents.
The panel's report recommends that care should be supervised by an expert, and makes recommendations for laboratory monitoring including plasma HIV RNA, CD4 cell counts and HIV drug resistance testing. The report also provides guidelines for antiretroviral therapy, including when to start treatment, what drugs to initiate, when to change therapy, and therapeutic options when changing therapy. Special considerations are provided for adolescents and pregnant women. As with treatment of other chronic conditions, therapeutic decisions require a mutual understanding between the patient and the health care provider regarding the benefits and risks of treatment. Antiretroviral regimens are complex, have major side effects, pose difficulty with adherence, and carry serious potential consequences from the development of viral resistance due to non-adherence to the drug regimen or suboptimal levels of antiretroviral agents. Patient education and involvement in therapeutic decisions is important for all medical conditions, but is considered especially critical for HIV infection and its treatment.
With regard to specific recommendations, treatment should be offered to all patients with the acute HIV syndrome, those within six months of HIV seroconversion, and all patients with symptoms ascribed to HIV infection. Recommendations for offering antiretroviral therapy in asymptomatic patients require analysis of many real and potential risks and benefits. In general, treatment should be offered to individuals with fewer than 350 CD4+ T cells/mm3 or plasma HIV RNA levels exceeding 30,000 copies/mL (bDNA assay) or 55,000 copies/mL (RT-PCR assay). The strength of the recommendation to treat asymptomatic patients should be based on the willingness and readiness of the individual to begin therapy; the degree of existing immunodeficiency as determined by the CD4+ T cell count; the risk of disease progression as determined by the CD4+ T cell count and level of plasma HIV RNA; the potential benefits and risks of initiating therapy in asymptomatic individuals; and the likelihood, after counseling and education, of adherence to the prescribed treatment regimen. Once the decision has been made to initiate antiretroviral therapy, the goals should be maximal and durable suppression of viral load, restoration and/or preservation of immunologic function, improvement of quality of life, and reduction of HIV-related morbidity and mortality. Results of therapy are evaluated primarily with plasma HIV RNA levels; these are expected to show a one-log10 decrease at eight weeks and no detectable virus (whom the preferred regimen has failed, due to limitations in the available alternative antiretroviral regimens that have documented efficacy; these decisions are further confounded by problems with adherence, toxicity, and resistance. In some settings it may be preferable to participate in a clinical trial with or without access to new drugs or to use a regimen that may not achieve complete suppression of viral replication. It is emphasized that concepts relevant to HIV management evolve rapidly. The Panel has a mechanism to update recommendations on a regular basis, and the most recent information is available on the HIV/AIDS Treatment Information Service website (www.hivatis.org).
- Wall Street Journal (www.wsj.com) (02/05/01) P. B2; Mark Schoofs.
- New York Times (www.nytimes.com) (02/06/01) P. A17; Lawrence K. Altman.
- Wall Street Journal (02/07/01) P. B11; Mark Schoofs.
- Wall Street Journal (02/07/01) P. A2; Mark Schoofs.
- Washington Post (www.washingtonpost.com) (02/06/01) P. A5; David Brown.
- New York Times (02/07/01) P. A14; Lawrence K. Altman.
- New York Times (02/08/01) P. A24; Lawrence K. Altman.
- Washington Post (02/08/01) P. A4; David Brown.
- Wall Street Journal (02/08/01) P. B13; Meera Louis.
- Washington Post (02/09/01) P. A5.
- United Press International (www.upi.com) (02/07/01); Ed Susman.
- Reuters Health Information Services (www.reutershealth.com) (02/08/01).
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