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FDA Approves a New Drug To Treat HIV

The Food and Drug Administration (FDA) approved a new drug to treat HIV infection on Friday. 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.

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. [Read More]