Isentress, just a nice story

[John2038]

Randy Gaston had few options left. The drugs were no longer helping him fight HIV.

So Gaston's doctor suggested he participate in a clinical trial in Palm Springs last year testing a new drug for patients who had become resistant to other HIV medications.

“Nothing seemed to work,” recalled Gaston of Cathedral City. “When this clinical trial came along, I jumped at it.”

A year after the federal Food and Drug Administration approved use of Isentress, patients such as Gaston and medical experts say it appears to work, improving the condition of some HIV patients and sparking hope that drug makers may develop similar medications.

The drug was hailed as an important new treatment for HIV patients. Isentress is the brand name of raltegravir, a drug made by New Jersey-based Merck & Co.

“It gives great promise in people whose virus is resistant to many of the other available drugs,” said Roy Steigbigel, a professor of medicine at Stony Brook University in New York who co-authored a report on raltegravir in the New England Journal of Medicine.

It takes about a year after a drug is available before people learn much about it, said Mark Milano, an HIV treatment educator at the AIDS Community Research Initiative of America in New York.

“If nothing serious has shown up in that year, that's a good thing,” said Milano, who has been using Isentress since December.

Unlike many HIV drugs, Isentress is taken orally only twice a day and tends to have fewer side effects. It has not been approved for first-time HIV medication users.

As part of the clinical trial, Gaston was on a combination of four drugs, including Isentress. Within 30 days, he said, his viral load level, the amount of HIV in his blood system, dropped from 100,000 to being undetectable.

“I was ready to go celebrate,” said Gaston, 46. “It was great.”

Gaston, who learned he was HIV positive in 1988, said he struggled for years to find the right combination of medicines. Now, he hopes to return to work teaching customers how to use ultrasound diagnostic medical equipment.

“It has done wonders for my mental status,” he said. “I'm hopeful that it will work for me long term, that I wouldn't have to change medication again.”

Nationally, nearly 450,000 people live with AIDS, according to the Kaiser Family Foundation. California, with 14 percent of the reported AIDS cases through 2006, ranks second to New York with 17.9 percent, according to Kaiser.

Rep. Mary Bono Mack, R-Palm Springs, and other advocates have pushed for more federal funding for research.

“Continued innovation in this field is especially critical in the desert where so many long-term survivors reside and are in need of additional treatment options,” she said.

For six months last year, the Desert AIDS Project in Palm Springs served as a clinical trial for Isentress in which patients were offered the drug along with other medications.

The group serves 2,300 HIV patients, offering housing assistance, medical care and other services. But officials estimate 7,500 people are living with HIV in the area, which has a growing gay population and attracts patients from San Francisco and as far as Ft. Lauderdale, Fla.

Geoff Zamboni, the project's director of medical services, said drugs such as Isentress offer patients “stabilization.”

“That's the best we can hope for right now with any drug,” he said.

Advocates hope drug companies will study Isentress and develop other drugs so HIV patients taking medications for the first time can use them.

“We do need the new class of drugs,” said Dr. Homayoon Khanlou, chief of medicine for the AIDS Healthcare Foundation, the nation's largest provider of medical care services. “There are not many newer agents in the pipeline.”

Like many HIV drugs, Isentress was on the FDA's fast track for approval. It took about six months. Advocates and lawmakers have pressed the FDA to speed up approval process.

“People are dying now,” said Milano, adding that safety studies continue after FDA approval. “If we wait five more years to get the drugs out, people will avoid the risks, but they will also be dead.”

The FDA had cautioned, however, that the long-term effect of Isentress is unknown and that its safety in children younger than 16 had not been studied. According to FDA officials, there are no reports of safety issues with the drug.

Milano started using Isentress in December after he was diagnosed with anal cancer and needed to get his viral load level down quickly. In three weeks, his viral load dropped from about 1 million to about 50.

“We just wanted that first drop and it did that,” said Milano, whose is in remission. “It's worked quite well for me.”

http://www.mydesert.com/apps/pbcs.dll/article?AID=2008811180314