New Drugs for drug-resistant HIV patients

[Guest guest]

New medications aid drug-resistant HIV patients

The findings bring " the opportunity for a new life, " one doctor says.

By Jia-Rui Chong, Times Staff Writer

February 28, 2007. In what some are hailing as the most important development in

HIV therapy in a decade, two new classes of drugs have been found to block virus

replication in patients resistant to existing drugs, researchers said Tuesday.

The two new classes, called integrase inhibitors and CCR5 inhibitors,

doubled the number of patients in a group of studies whose infections

could be brought under control, researchers said at the Conference on

Retroviruses and Opportunistic Infections at the Los Angeles

Convention Center.

This is " a pivotal moment " for patients who have become resistant to

most AIDS drugs, said Dr. Daar, chief of HIV medicine at

Harbor-UCLA Medical Center in Torrance. Daar, who was not involved in

the research, estimated that about 20% of his patients are resistant

to the existing classes of drugs.

Given the serious problems in treating drug-resistant patients, Daar

said, the findings bring " the opportunity for a new life. "

Dr. Mellors, chief of infectious diseases at the University of

Pittsburgh, said the new findings hearken back to the introduction in

the 1990s of the powerful drugs that converted HIV infection from a

mostly fatal disease to one that could be managed for long periods of

time.

" This is really a remarkable development in the field, " said Mellors,

who was not involved in the studies.

Closest to federal approval is maraviroc, developed by Pfizer Inc. The

drug binds to a receptor on the surface of human cells known as CCR5,

preventing HIV from locking on and entering the cells.

Maraviroc represents the first class of HIV drugs to target the human

immune system rather than the virus itself.

Other companies have attempted to bring out CCR5 inhibitors, but with

little success. Trials with GlaxoKline's candidate, aplaviroc,

were halted in 2005 because the drug caused liver toxicity.

Dr. Mayer of Pfizer reported on studies of maraviroc in 1,049

patients in 13 countries: 840 received the experimental drug in

combination with their regular drug regimen, while the rest received a

placebo and their regular drugs.

About 44% of the patients receiving maraviroc saw their blood HIV

concentrations fall to undetectable levels after 24 weeks of therapy,

Meyer said, compared with 23% of those receiving the placebo.

Experts think the drug could be approved by the Food and Drug

Administration by the end of the year.

The second new drug is Merck & Co.'s raltegravir, formerly known as

MK-0158. It blocks an HIV enzyme called integrase, one of three

enzymes used by the virus to copy itself in immune cells.

Dr. from the University of New South Wales in Australia

and Dr. Roy Steigbigel from State University of New York at Stony

Brook reported on two studies involving 699 patients, two-thirds of

whom received raltegravir in addition to their regular HIV drugs. Both

studies were funded by Merck.

About 62% of the patients receiving raltegravir saw the HIV in their

blood fall to undetectable levels after 16 weeks, compared with 35% of

those receiving the standard drugs alone, the researchers said.

The drug, which has been fast-tracked by the FDA, was well tolerated

by patients.

Gilead Sciences Inc. also has an integrase inhibitor in earlier stages

of testing and will present results today.

" The big question now is how will these drugs be used in practice, "

said Dr. Bartlett, an epidemiologist at s Hopkins University,

who was not connected to the studies. " If they become first-line

drugs, that could mean a paradigm shift. "

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_____________________

" Man Singh " <mansing@...>