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New HIV drug for resistant patients

Posted on: Friday, 23 June 2006, 20:20 CDT

WASHINGTON (Reuters) - U.S. health officials on Friday approved the use of a new HIV drug, made by Johnson & Johnson, in combination with related therapies to help treat patients who do not first improve with other treatment.

The drug, Prezista, is a protease inhibitor designed to treat resistant strains of HIV, the virus that causes AIDS.

The approval marks the New Jersey-based drugmaker's first entry into the $1.5 billion U.S. market for protease inhibitors, a class of drugs designed to suppress the virus and prevent it from replicating.

Also known as TMC114, the drug is given with a low dose of an older protease inhibitor called ritonavir, which slows the breakdown of Prezista in the body, increasing its concentration in a patient's system, the Food and Drug Administration said.

The human immunodeficiency virus that causes AIDS infects close to 40 million people worldwide, with more than 1 million in the United States. The U.S. Centers for Disease Control and Prevention estimates that 40,000 Americans become infected with HIV each year.

While many HIV therapies are now available, AIDS specialists and activists have said resistance to them is becoming a problem because the virus can quickly mutate and current drugs can become ineffective.

TRIAL RESULTS

JP Morgan analyst Michael Weinstein, in a note to clients on Wednesday, forecast Prezista sales of $65 million in the second half of 2006 and peak sales of $800 million to $900 million.

"I really expect it to be used quite widely even with the indication that it has," Dr. Tim Wilkin of Weil-Cornell Medical College, New York, who helped conduct one of the Prezista clinical trials, said in an interview before the approval.

J&J said the drug, which will be taken in combination with other HIV drugs, will have a wholesale cost of $25 a day.

Still, other doctors sounded a more cautious note.

Dr. Steven Deeks, an associate professor of medicine at the University of California, San Francisco, said he plans to delay prescribing the J&J drug for patients who are highly resistant to existing HIV drugs until he can combine it with a second compound that would work for these patients.

He said these drugs need to be partnered with another effective drug. "For many patients with truly highly resistant HIV, there is no drug yet to partner with it," Deeks said in an interview on Friday.

The FDA said it approved Prezista based on two six-month trials that found 70 percent of patients who had tried other therapies improved when they added Prezista and ritonavir to their drug cocktails compared with 21 percent of those who took ritonavir with other protease inhibitors.

In a separate release, Roche Holding AG said the trial showed that its anti-HIV drug Fuzeon, in combination with Prezista and ritonavir, resulted in undetectable virus levels in up to two-thirds of patients who had become resistant to other drugs.

Side effects of Prezista can include diarrhea, nausea and headache as well as mild to serious skin rashes. The risks for patients who have not undergone other treatments first is unknown, the agency said.

J&J must also conduct post-marketing studies, it said.

Prezista is the first of three advanced compounds in J&J's HIV franchise, which aims to combat HIV drug resistance.

Prezista will be followed by TMC125, a non-nucleoside reverse transcriptase inhibitor typically used in combination with other drugs expected to be launched in late 2008.

That will be followed by TMC278, a second non-nucleoside reverse transcriptase inhibitor.

J&J also is studying Prezista in comparison to currently approved protease inhibitors.

Shares in the company were up 66 cents, or 1 percent, at $61.98 in after-hours trade on the Inet exchange after earlier closing up 14 cents at $61.32 on the New York Stock Exchange.

Source: REUTERS

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