Wall Street Journal - February 14, 2003
Vanessa Fuhrmans, Staff Reporter

The 1,216-patient study, the first to compare the two drugs directly, found that Viramune, an AIDS medicine that its maker Boehringer Ingelheim GmbH sells at a U.S. wholesale price of $366.94 for a month's supply, successfully suppressed AIDS virus levels in 70% of those who took it over 48 weeks. That is the same rate of success as Bristol-Myers Squibb Co.'s Sustiva, a comparable drug that costs $449.64 a month.

Joep Lange, professor of internal medicine at the University of Amsterdam, presented the data Friday at the 10th Conference on Retroviruses and Opportunistic Infections in Boston. He conducted the trial with the International Antiviral Therapy Evaluation Center, an independent international group that conducts clinical research on HIV treatments, though Boehringer Ingelheim sponsored the study.

The finding could shift some of the market between the drugs, particular in the U.S., where Sustiva is prescribed almost two times as often as Viramune.

Both drugs are non-nucleoside reverse transcriptase inhibitors, an alternative that requires fewer pills than the protease inhibitors that revolutionized AIDS treatment in the mid-90s. But Sustiva, launched in 1998, has been more aggressively promoted by Bristol-Myers, and it has bigger studies backing it that suggest better efficacy. The Department of Health and Human Services also recommends it as the preferred drug in its class.

But the cost of treating AIDS has exploded in the past several years, and programs that provide the drugs to more than 80,000 HIV-infected Americans without adequate health coverage are in a budget crisis. More than 1,000 patients are on state-program waiting lists for treatment because some have closed enrollment, and the lists are getting longer.

Given a cheaper alternative for a key AIDS medicine, many state programs may start encouraging Viramune instead, said William Arnold, chair of the working group for state-run AIDS Drug Assistance Programs, or ADAP.

"If people feel the efficacy is the same, there will be implications," he said, adding that both ADAP and the Department of Health review their recommendation lists on a regular basis because of new clinical evidence.

"Even if programs don't make a change to their formularies, it doesn't mean that, through the grapevine, there won't be some nudging."

Professor Lange cautioned that the two drugs aren't as easily interchangeable as allergy or headache medicines. There are many reasons why a patient might not tolerate one drug or do better on the other.

"What's reassuring is that doctors and patients know they have alternatives," he said. "They don't have to worry that one might not be as effective as the other."

Write to Vanessa Fuhrmans at vanessa.fuhrmans@wsj.com
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