Wall Street Journal - February 28, 2005
Marilyn Chase, Staff Reporter

Tibotec Pharmaceuticals, a unit of Johnson & Johnson, of New Brunswick, N.J., will enlarge studies of its compound TMC114 after the drug successfully lowered virus levels of AIDS patients with resistance to other drugs, said Richard Haubrich, a researcher from the University of California at San Diego.

Taking the highest doses of the twice-daily oral drug for 24 weeks lowered levels of the AIDS virus in the blood by about 97% from baseline levels at the start of the study, Dr. Haubrich said. Mostly mild side effects included headaches and gastric upset. He presented his findings in the closing sessions of the conference on Friday.

John Mellors, a professor of medicine and an AIDS researcher at the University of Pittsburgh who wasn't involved in the Tibotec study, said the drug is the "most promising" among new members of the family known as protease inhibitors, which quash an enzyme needed by the AIDS virus to reproduce.

Panacos Pharma Inc., of Gaithersburg, Md., unveiled its drug PA457, the first of a new class of AIDS antivirals that are known as "maturation inhibitors" because they thwart the release of mature infectious virus particles. In a placebo-controlled study, 24 patients experienced a statistically significant drop in blood virus levels with mostly mild side effects so far, company researcher David Martin said.

One drug candidate that fell by the wayside was a Merck & Co. compound called number 870810, the first of a new family of drugs called integrase inhibitors. Although the drug lowered virus levels by nearly 98% and was well-tolerated in a study of 30 people with HIV, the company is discontinuing the compound because of liver toxicity in dog studies, said Susan Little, a researcher at UCSD. Merck, of Whitehouse Station, N.J., will pursue other compounds in the same class, she said.

As a group, AIDS antiviral therapies have extended lives of individual patients by as much as 15 years, for a collective two million years of life saved in the U.S. since such drugs came into use in the late 1980s, said Rochelle Walensky of Harvard Medical School. She said her study with co-workers at Harvard, Massachusetts General Hospital, Yale, Cornell and Boston University represents "an underestimate" of the drugs' benefit.

Despite more than 20 drugs on the market and many more in the pipeline, far too few patients are now able to access needed treatment, U.S. health statisticians said Friday.

With more than 900,000 Americans infected with HIV, and 485,000 who require urgent treatment, only about 56% of those in need receive antiviral drugs, said Eyasu Teshale of the Centers for Disease Control and Prevention in Atlanta.
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