by Bob Roehr
The FDA approved the first integrase inhibitor for the treatment of HIV on Oct. 12. The pharmaceutical company Merck developed the drug as raltegravir; it will be marketed under the name Isentress for $27 a day, or just under $10,000 a year.
Raltegravir is the first drug that interrupts HIV at the stage where the virus works its way into the DNA of the cell it has infected. Reverse transcriptase, protease, and entry inhibitors are other classes of approved drugs that block the virus at other stages of its life cycle.
The approval is for use in patients who have developed resistance to other classes of HIV drugs. It is based upon a pair of clinical trials in 699 heavily treatment experienced patients, through 24 weeks, where it was as effective as other drugs, had few side effects, and a unique resistance profile. Trials in drug-naive patients are underway. Isentress must be taken twice a day in combination with other active drugs.
The Fair Pricing Coalition, a group of AIDS activists who focus on the issue of drug pricing, had written to Merck in advance of the approval. It recognized the company's "outstanding commitment to fighting AIDS as well as a sensitive understanding of how pricing affects access to treatment."
It urged the company to balance its financial needs against those of people living with HIV and their ability to pay. "We urge, in the strongest terms possible, that Merck price this drug responsibly and not based on industry averages or what the market will bear."
From the treatment perspective, "when considering the price of Isentress, we must also consider what other drugs will need to be added to give it the greatest chance to succeed."
Citing what it held to be unjustified prices for recently introduced protease inhibitors, the Coalition said, "If Merck wishes to be a responsible corporate citizen, it cannot use overpriced drugs for comparison in setting the price of Isentress."
It noted that the drug compares favorably in terms of efficacy and side effects and said, "Merck will succeed handily at almost any reasonable price point, it does not need to charge an immorally high price just because others are doing so."
Martin Delaney, the founder of Project Inform, participated in those conversations with Merck. He said, "I don't think the price is all that bad; it's substantially lower than maraviroc and not many people seemed to complain about that one."
"The big disappointment is the sense of lost opportunity. This is Merck and we expected them to do better. We expected them to live up to the charter, which claims to put health above profits…At least they didn't stake out a new and higher price range."
Delaney said the big test will come when the drug is approved for broader use, where it will have a price advantage compared to most protease inhibitors. "If they hold the line on the price for a number of years while others keep raising theirs, we'll be happy to praise their action."
