Endurant is a new HIV drug from Johnson & Johnson. It was approved by the Food and Drug Administration today. This week, there are AIDS/HIV awareness campaigns taking place all over the globe. This week marked HIV/AIDS vaccine awareness day (May 18th). The idea behind vaccination awareness is to encourage trials that push toward finding a viable vaccine to prevent AIDS and HIV from spreading.
To help researchers uncover vaccination and treatment for illness associated with HIV and AIDS, the research community needs HIV positive individuals to reach out to research communities and participate in clinical trials. On the other end of the spectrum, the HIV and AIDS community needs support and empathy from HIV negative community. Finding a comfort zone between the two communities helps bring about solutions and newer, effective products for the varied HIV and AIDS communities. The FDA approved Edurant for use because different populations respond differently to various medicines.
Edurant was approved after phase II and phase III trials showed a lower viral load in 83 percent of participants.
Edurant is taken once a day and works because it prevents the HIV virus from replicating. The safety and effectiveness of Edurant is based on 48-week data from two Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week (with extension to 192 weeks) trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz (another FDA-approved NNRTI for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs. Edurant should be taken with food and its known side effects are depression, rash, headache and insomnia.
Edurant was created to help other drugs working inside of the system to reduce HIV cells inside of the bloodstream. Studies on Edurant show the HIV tablet is just as effective as another drug, Sustiva. Sustiva has been on the market since 1998 and is also used with other medications. The FDA noted that participants who did not respond to Edurant found better success with Sustiva.
But participants who had higher viral loads, or a large presence of HIV antibodies, were less likely to respond positively to treatment than those with lower viral loads. Shipments of Edurant are expected by mid June. Overall, the pill is slightly less expensive than Sustiva. Edurant prices are $21 per 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.
Edurant is manufactured by Raritan, N.J-based Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.
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