The Food and Drug Administration (FDA) on Friday approved a new drug to treat HIV infection. The drug, made by an arm of Johnson & Johnson, will be sold under the name Edurant, and is designed to be used in combination with other antiretroviral drugs in HIV-positive adults who have not received any prior treatment or therapy.
Once-a-day Edurant, or rilpivirine, is a non-nucleoside reverse transcriptase inhibitor, which blocks replication of HIV and lowers the level of the virus in patients’ blood. It was approved by the government based on the results of clinical trials that involved more than 1,300 adults with HIV.
In the trials, patients were given either rilpivirine or efavirenz (Sustiva) — an older FDA-approved drug — in combination with other antiretroviral drugs, a treatment approach known as highly active antiretroviral therapy, or HAART.
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The results of the trials show that rilpivirine was as effective as efavirenz at reducing patients’ viral load, the FDA said. After 48 weeks of study, 83% of patients who took rilpivirine had undetectable levels of HIV in their blood, compared with 80% of patients who received efavirenz.
The agency said that patients who had a higher viral load at the start of treatment were less likely to respond to rilpivirine than patients with a lower viral load. In high viral-load patients, efavirenz worked better. Patients who failed therapy on rilpivirine also developed more drug resistance than patients taking efavirenz.
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However, patients were more likely to drop out of trials because of side effects if they were taking efavirenz. The most common side effects of rilpivirine 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.”
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Bloomberg News reports that the FDA’s approval of the first new anti-HIV drug in three years “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.