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HIV Doctors May Treat All Infected, Adding Thousands: When To Start HAART Debate
  By John Lauerman
Oct. 29 (Bloomberg) -- More HIV patients in the U.S. should be given access to powerful, costly drugs at an earlier stage of infection to save lives, infectious-disease doctors said.
Less than 500,000 of about 1.1 million Americans with HIV are now treated with Bristol-Myers Squibb Co.'s Sustiva, Gilead Sciences Inc.'s Truvada and other drugs, said Michael Saag, a University of Alabama at Birmingham AIDS researcher. Under guidelines set this year, therapy usually begins when CD4 immune-system cells fall to 350 per cubic milliliter of blood.
A study reported this weekend at a medical meeting in Washington said raising that level to 500 would save lives. Paul Sax, a Harvard Medical School AIDS expert who helped write the current guidelines, and other doctors are now saying that research and other evidence may soon force changes to the recommendations that would put all HIV patients on the drugs, even when the immune system doesn't appear severely affected.
``We may be heading for a time when all patients are benefiting from HIV treatment,'' Sax said in an Oct. 27 interview at the scientific meeting of the American Society for Microbiology.
HIV attacks CD4 cells that coordinate the immune system's defenses against viruses and bacteria. Until the guidelines were changed this year, doctors were counseled to hold off treatment until levels of protective CD4 cell dropped to 200 from a normal level of about 1,000 cells, before treating people without symptoms.
Heart, Liver Disease
Doctors held off on drug treatment as long as possible because heart and liver disease are associated with long-term use of the HIV drugs.
An increasing number of studies, though, have suggested that non-AIDS related complications, such as heart disease and cancer, are even more common among patients not getting AIDS medicines, even when their CD4 levels are relatively high, Sax said. Patients generally take AIDS drugs for their entire lives, once they've started.
The U.S. Department of Health and Human Services in January and the International AIDS Society in August raised their recommendations for treating patients without symptoms to 350 CD4 cells. Even that much of a change may add 100,000 to those in therapy, Scott Hammer, a Columbia University AIDS researcher, said in August.
$600,000 in Costs
Treating a single U.S. AIDS patient, including the use of drugs such as Gilead's Atripla, GlaxoSmithKline Plc's Ziagen and Epzicom, and other medications, costs about $600,000 over a lifetime. HIV care accounts for more than $17 billion in annual U.S. spending, according to the Kaiser Family Foundation.
Bristol-Myers' Sustiva sold $963 million worldwide last year, Epzicom sold $648 million and Gilead's Truvada was the top-selling AIDS drug last year with $1.6 billion.
An analysis released Oct. 26 at the infectious disease conference showed that people treated above the new, 350-cell recommendation lived longer than those who waited for their CD4 levels to fall.
Earlier drug treatment may protect the immune system from viral damage that can't be repaired, Sax said.
``It's looking more and more like whatever deleterious effects the medications have is outweighed by controlling the virus and maintaining immune status,'' he said.
There are potential risks to early treatment. HIV patients who don't take all their medicines might develop resistant virus that may require them to switch to more toxic, expensive drugs. However, people who take medications consistently rarely develop resistance, said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases.
`No Answer Yet'
Not all doctors are ready to sign on to the proposal. More research is needed that looks directly at the best time to start treatment for AIDS, which affects about 33 million people worldwide, said Kevin DeCock, director of HIV/AIDS at the United Nations' World Health Organization in Geneva. A trial being considered by the National Institutes of Health to look at this question would take years to complete.
``We have more than 3 million people on therapy and we still don't have an answer about the optimal time to start,'' DeCock said in an interview at the conference. ``We haven't capitalized on our opportunities to learn more.''
Studies have suggested that people whose HIV is under control, with virus undetectable in their blood by conventional tests, are less likely to spread it to other people. All this has put the question of when to treat HIV back on the front burner, Fauci said.
``This is very, very actively on everyone's mind,'' he said yesterday in a telephone interview. ``The new data seem to indicate that there's an advantage to starting earlier.''
Ready to Prescribe
Sax said he's already ready to prescribe HIV treatment for any patient who wants it, no matter what their CD4 cell levels are, as long as it appears they have the resources to stay on the drugs. That may be minority viewpoint, though.
At the meeting of 15,000 infectious disease experts, Sax polled a roomful of hundreds of doctors whether they would treat an infected woman with CD4 cell levels of 700, twice the current recommended level: more than four out of five said no, he said.
Expanding the guidelines further will probably require time and consideration of more studies, said John Bartlett, a Johns Hopkins University AIDS researcher who also helped write the current guidelines.
``I think there are still few people who are ready to go all the way and recommend treating everyone,'' he said in an interview at the conference. ``It's still too early for any kind of a decision.''
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