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Schering’s vicriviroc, an antiviral that inhibits the CCR5 receptor in HIV 1 strains, may face similar issues seen in Pfizer’s initial launch of its CCR5 antagonist Selzentry, physicians told Pharmawire. Selzentry’s need for a trofile assay was a hindrance to the drug’s initial launch and made it a niche player, they added.
Monogram Biosciences’ trofile assay is the diagnostic used to determine whether patients will respond to the anti-viral Selzentry.
Dr Richard Haubrich, professor of medicine in the division of infectious diseases at UCSD, said with the CCR5 antagonist vicriviroc, patients will also have to take the trofile assay that is currently used with Selzentry. ”It’s more an issue of cost. There’s never an urgency to switch someone [to another drug],” he said.
Monogram Biosciences recently released an enhancement for their assay, and it will make it easier, but won’t reduce the cost, said Haubrich. In the near term, Selzentry would probably not be used for treatment-naïve patients, he added.
Earlier this month, New York Medicaid recently established coverage and reimbursement for Monogram’s trofile assay.
Although the trofile assay requires 18 days for turnaround, that does not seem to be the key issue, as a resistance profile has to be done for any HIV patient, which takes the same amount of time, explained Haubrich.
Bob Consalvo, a spokesperson for Schering, said the company is looking at other assays. ”I know Monogram is working on a next generation assay that is more sensitive, but we are also looking at assays from other companies,” he said.
Vicriviroc is currently in Phase III for treatment-experienced patients and Phase II for treatment-naïve HIV patients.
By the time the drug reaches the market, the assay environment will have changed, and there should be other competitors developing the trofile assay, he said. ”It might be a different pricing situation,” added Consalvo.
Schering is ”keenly aware of” the pricing situation, and added that access to the assay is important. ”Beyond just pricing issues, there might be competition to ameliorate that to some degree,” he said.
”The test and the cost are a potential issue. I think the extent to which the need to perform the test and costs, are barriers [which] vary a lot from region to region,” said Dr Daniel Kuritzkes, head of the section of retroviral therapeutics for the division of AIDS at Harvard Medical School.
In certain States, where the average cost for HIV care is less generous, or for people with certain private insurance plans with large co-pays, the price of the trofile assay could be more of a hurdle, said Kuritzkes.
”It’s certainly more expensive than the resistance test. In some patients, it does pose a problem,” he added.
The other issue is that the drug will only work in approximately half of the HIV patients, as CCR5 antagonists target a host receptor, and blocks the entry of the virus in that way, both Haubrich and Kuritzkes said.
”That would reduce the number of patients that would potentially be eligible for treatment. In roughly half of the patients, the HIV virus has mutated over time, so it’s not affected by [CCR5 drugs],” said Kuritzkes.
Schering has a current market cap of USD 30bn.
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