Newsday - February 8, 2001
Laurie Garrett
Chicago - The AIDS epidemic in Europe and North America has reached a critical juncture:
The available treatments are increasingly resulting in spread of drug-resistant forms of the virus. New infection rates appear to be rising. And there is confusion about whether anti-HIV medicines adequately decrease the risk of person-to-person spread of the virus.
About 3,000 scientists at this week's Eighth Annual Retrovirus Conference find themselves facing a bewildering array of policy questions, all of which have implications not only for their patients, but also for the course of the epidemic.
It is becoming apparent to the scientists that what may be best for individual patients might not be good for the health of the public as a whole, or for the future course of the epidemic. That divergence was noted when two federal agencies called for very different approaches to the epidemic:
The U.S. Centers for Disease Control and Prevention launched a campaign to get more Americans tested and, if found HIV-positive, to immediately begin taking the course of anti-HIV medications.
The National Institutes of Health called for delaying such treatment until a patient's condition has deteriorated.
The therapy, dubbed HAART for highly active anti-retroviral therapy, was unveiled at the 1996 retrovirus meeting, which heralded experimental successes. It went on to revolutionize HIV treatment.
Small studies then showed that when patients took a daily cocktail of drugs, all traces of HIV seemed to disappear from their bloodstreams. Subsequent studies demonstrated that these cocktails might be able to eradicate the virus from a person's body. Almost overnight, thousands of HIV patients in developed countries went on the HAART regimen.
This week the Nobel Peace Prize-winning Mdecins Sans Frontires (Doctors Without Borders) announced it has struck a deal with Cipla Ltd. of India to manufacture knock-off HAART packages for Third World countries, mostly in Africa, at a cost of $350 per patient per year. That brings the drugs within the financial reach of humanitarian organizations that hope to distribute them to the continent where 70 percent of the world's HIV patients live.
The demand comes amid signs of increasing rates of infection in the wealthy world. The British Public Health Service reported last month that 2000 was "the highest ever for new HIV diagnosis in the U.K." Dutch health authorities said this week that 10 percent of new HIV infections there involve drug-resistant strains.
In the United States, the number of people infected is unknown, due to privacy concerns. "And I would like to argue that this needs to be reconsidered," the CDC's Dr. Kevin DeCock told the conference. "In 1999 CDC recommended HIV reporting be done by name...Those who go uncounted count for nothing."
Two critical trends appear to be emerging from available U.S. data. First, more people are having unsafe sex. And a high number of new infections involve strains of the virus that are resistant to one or more of the drugs in the HAART cocktail.
The CDC estimates there are about 450,000 Americans who are on HAART but still have detectable viruses in their blood. And another 360,000 are going untreated.
One public health strategy would be to strive to get those roughly 800,000 Americans onto a HAART protocol, banking on the hope that people whose viral loads are lowered are unlikely to be contagious to their sexual and drug-use partners.
There is one study that suggests such a strategy might be wise. The Johns Hopkins University effort looked at married couples in Uganda in which one partner was HIV-positive, the other HIV- negative, and neither was taking HAART drugs. The researchers concluded that the spouses who became infected during the study were those whose mates had the highest numbers of viruses in their blood.
This week the CDC's Dr. Robert Janssen unveiled SAFE, or the Serostatus Approach to Fighting the HIV Epidemic, which aims to raise awareness, driving more Americans to get tested and, if found HIV- positive, to take HAART. The goal is to "cut infections from an estimated 40,000 to 20,000 per year by 2005," Janssen said.
The National Institutes of Health's new treatment guidelines dramatically reversed previous recommendations, now calling for delaying therapy until a patient's condition has deteriorated.
That new position rests on three considerations:
Evidence shows that HAART drugs now must be taken for life, rather than just for a few years. But since the drugs are toxic, and viruses develop resistance, a delay may buy patients more years free of drug side-effects as well as lower the burden of resistant viruses.
Patients on HAART also may have viruses reproducing and hiding in places that have powerful public health implications: pharynx, rectum, vagina and cervix. An individual might have no detectable viruses in his or her blood but still pose a significant threat to a sexual partner.
There is evidence that the HAART drugs may be less effective with each passing day, because the rising tide of unsafe sex is leading to the spread of drug-resistant strains of HIV.
Dr. Robert Siliciano of Johns Hopkins University School of Medicine in Baltimore explained that HIV retreats when threatened by HAART, taking up residence in a population of immune system cells found all over the body.
"These are cells that are not doing anything," Siliciano said. The viruses quietly multiply inside the memory cells, he said, and can emerge eventually in drug resistant form.
In a study with implications for sexual transmission, a University of Washington team examined rectal biopsies from gay men who were doing well on HAART. In every man, HIV was rampant in his rectal mucosa.
A Harvard University study showed that HIV-positive women actively shed virus in their vaginal mucosa, and often it is drug-resistant HIV.
Reports were also presented of increasing unsafe sexual behavior on the part of HIV-positive men and women. In the Bronx, Dr. Joseph McGowan and his colleagues at Bronx-Lebanon Hospital Center questioned 256 HIV-positive men and women, 63 percent of whom were African-American, and 35 percent Hispanic. He found that immediately after being diagnosed, the respondents were careful to use condoms, not share needles and generally protect their partners. But within a year, half the women had returned to having intercourse with HIV- negative partners without use of condoms. So had 29 percent of the heterosexual males and 60 percent of the homosexual men.
A national CDC survey of gay men ages 23 to 29 conducted in six cities-including New York- found that 12.3 percent were HIV- positive. Half admitted to having sex without a condom during the previous six months.
A study by Robert Hogg of the University of British Columbia in Vancouver, pointed to increased difficulty in controlling the virus. Hogg reported that a group that began taking HAART in the fall of 1999 were more likely to have progressed to full-blown AIDS and death than were patients who started the therapy in 1996.
Among studies pointing to drug-resistant viruses, most striking was a five-year-long survey by Dr. Susan Little of the University of California in San Diego. She analyzed the viruses in 394 people, counting only those who exhibited more than a tenfold reduction in susceptibility to one or more HAART drugs.
Between 1995 and 1998 the prevalence of resistance to any drug was 3.5 percent, she said in an interview, but from 1999 to 2000 it was 14 percent.
Cross-resistance, in which two or more classes of antiretrovirals were resisted, also rose.
A CDC survey conducted between 1997 and 1999 in 10 cities- including New York-found that 3.5 percent of newly infected individuals had drug-resistant viruses.
So how should we view HAART-as a public health asset, or threat?
"When you don't have a cure, treatment is not a prevention," Dr. Helene Gayle, who heads up the CDC's AIDS efforts, said in an interview. "...Still, I think everyone here would argue that there must be some public health impact from having a lower viral load," due to taking HAART.
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