by Mike Andrew - SGN Staff Writer

The U.S. Food and Drug Administration (FDA) has approved a new drug to treat HIV infection, the agency announced on May 20.

The drug, rilpivirine, will be marketed under the name Edurant. It is manufactured by Johnson & Johnson.

It was approved based on the results of clinical trials that involved 1,368 adults with HIV.

Two clinical tests ran for 48 weeks, and one ran for 96 weeks with an extension, to a total of 192 weeks.

In the trials, patients were given either Edurant or Sustiva - an older FDA-approved drug - in combination with other antiretroviral drugs, a treatment approach known as 'highly active antiretroviral therapy,' or HAART.

The results of the trials show that Edurant was just as effective as Sustiva at reducing patients' viral load, the FDA said.

After 48 weeks of study, 83% of patients who took Edurant had undetectable levels of HIV in their blood, compared with 80% of patients who received Sustiva.

The FDA said that patients who had a higher viral load at the start of treatment were less likely to respond to Edurant than patients with a lower viral load. In high viral-load patients, Sustiva worked better.

Patients who failed therapy on Edurant also developed more drug resistance than patients taking Sustiva.

However, patients were more likely to drop out of trials because of side effects if they were taking Sustiva than the new drug.

The most common side effects of Edurant reported by patients included depression, insomnia, headache, and rash.

'Patients may respond differently to various HIV drugs or experience varied side effects,' said Edward Cox, FDA's director of antimicrobial products, in a statement. 'FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy.'

Endurant is designed to be used in combination with other antiretroviral drugs in HIV-positive adults who have not received any prior treatment or therapy.

To be taken once a day, with food, Edurant is a non-nucleoside reverse transcriptase inhibitor, which blocks replication of HIV and lowers the level of the virus in patients' blood.

Edurant prices are $21 per 25 mg pill, or around $7,700 per year. Sustiva currently costs around $7,200 per year, and is sold in adult doses of 600 mg per daily dose.

Bloomberg News reported that the FDA's approval of the new drug 'clears a hurdle for a planned combination pill with Gilead Science Inc.'s Truvada that may generate more than $1 billion in annual sales.'

Because antiretroviral drugs like Edurant do not cure HIV, they are meant to be taken every day for the lifetime of the patient.

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