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HIV/AIDS Treatment: A four-drug cocktail isn't any better than three-drug regimen

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CHICAGO - A four-drug cocktail isn't any better for treating newly

diagnosed HIV infection than the standard three-drug regimen,

according to a study that followed 765 patients for three years.

The finding is welcome news to patient advocates, despite the lack of a step

forward in treatment. Adding a fourth drug would have raised costs in an already

overburdened system in which some states report waiting lists of uninsured

patients who need help paying for their HIV drugs.

The annual cost per person for antiretroviral drug therapy in 2001

was about $11,000 a year, according to a previous study.

Murray Penner of the National Alliance of State and Territorial

AIDS Directors estimated that adding more drugs to already complex

regimens could cost health systems millions of dollars more.

" Keeping treatment regimens as simple as possible is also good news

for people living with HIV/AIDS as adherence (taking drugs as

prescribed) is better with easier and smaller regimens, " Penner said.

Adding a drug to the cocktail also could increase side effects and

the potential for dangerous drug interactions, said Jim Pickett of

the AIDS Foundation of Chicago.

The new study clears up a lingering question posed by the conflicting results of

prior studies. Some smaller studies had found a quicker effect at beating back

the virus when more drugs were added to the cocktail, while others found no

added benefit.

" Triple drug therapy has been the standard approach to treatment of

HIV infection for a decade or so, but there's always been a question

about whether we could do better with more drugs, " said study co-

author Dr. Dan Kuritzkes of Harvard's Brigham and Women's Hospital.

" This reaffirms the potency of the current standard of care, "

Kuritzkes said.

Researchers made the two drug cocktails equally easy for patients to

take, delivering both in five pills taken daily. Patients and their

doctors didn't know which cocktail they were getting.

The study will appear in Wednesday's Journal of the American

Medical Association and was released Sunday to coincide with the

opening of the 16th International AIDS Conference.

Researchers found that the four-drug cocktail, which added the HIV

drug abacavir, had no advantage in reducing the amount of virus in

patients' blood. Compared with standard therapy, it also didn't

increase levels of CD4 cells that fight infection.

" Over the entire course of the study, at no point did there seem to

be an advantage of the four-drug regimen, " Kuritzkes said.

Supported by grants from the National Institutes of Health,

the research was conducted at more than 40 U.S. sites. Several

pharmaceutical companies provided drugs. Some of the researchers,

including Kuritzkes, reported financial ties with the makers of HIV

drugs.

More than half the patients in the study were black or Hispanic and

almost 20 percent were female.

" It was a pretty diverse population that reflects the epidemic

today, " Kuritzkes said.

Black patients who took the drugs as directed did as well as white

patients, but blacks who did not adhere precisely to the drug routine returned

to high virus levels quicker than whites who didn't take the drugs as

prescribed. The reason for the difference wasn't clear, Kuritzkes said.

The study appears in a special issue of JAMA devoted to HIV/AIDS. The issue

includes another study conducted in Botswana that compared

breast-feeding and formula feeding for infants of HIV-positive

mothers. Fewer formula-fed infants became infected with HIV, but they risked

death from diarrhea and pneumonia because of a lack of

sanitary water for making the formula. Another study in the issue

found favorable patient outcomes after a rapid expansion of free

antiretroviral therapy programs in Zambia.

Source - http://news./s/ap/20060813/ap_on_he_me/aids_cocktail

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