FDA Approves New HIV Treatment

[monarc]

http://www.medicalnewstoday.com/releases/226524.php

FDA Approves New HIV Treatment

The U.S. Food and Drug Administration approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).

Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor (NNRTI). The drug works by blocking HIV viral replication. Edurant is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood. Edurant is a pill taken once a day with food.

"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

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 was as effective as efavirenz in lowering viral load. In the Edurant and efavirenz groups, 83 percent and 80 percent of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.

The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping (insomnia), headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.

Edurant does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

Edurant is manufactured by Raritan, N.J.-based Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

[Hellraiser]

The U.S. Food and Drug Administration approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).

What?  Why would this be only for the treatment naive?

[monarc]

What?  Why would this be only for the treatment naive?

I guess this could be:

In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.

I wonder if subjects got so resistant that the other drugs wouldn't work anymore.

[Miss Philicia]

What?  Why would this be only for the treatment naive?

This is accurate, though I realize it's the reverse of the most recent FDA approvals (Prezista, Isentress, etc.) details are mentioned here: http://www.aidsmeds.com/archive/Edurant_1619.shtml

Edurant may be less effective—able to keep viral load undetectable for at least a year—for people beginning an Edurant-based regimen with a pre-treatment viral load of greater than 100,000 copies, compared with those with a pre-treatment viral load of less than 100,000 copies.
 
Compared with patients who took the NNRTI Sustiva (efavirenz) plus Truvada (tenofovir/emtricitabine) in clinical trials, people living with HIV who used Edurant plus Truvada were more likely to see their viral loads rebound while on treatment. Edurant-treated patients were also more likely to develop drug resistance to Truvada, compared with those using Sustiva.

[Hellraiser]

This is accurate, though I realize it's the reverse of the most recent FDA approvals (Prezista, Isentress, etc.) details are mentioned here: http://www.aidsmeds.com/archive/Edurant_1619.shtml

I was waiting for this drug to swap to it, I guess that idea is out the window now.

[Miss Philicia]

I was waiting for this drug to swap to it, I guess that idea is out the window now.

I'd be less underwhelmed by this new drug, and not bothered by the resistance issue (which seems perhaps no worse than Isentress) if it exhibited a marked decrease in the CNS issues that Sustiva has, but while IIRC they are indeed less in the studies, I'm not sure it's what one could call "greatly less". I think it may have been 3% of participants versus 7% for the Sustiva group. We shall see. I guess I shouldn't poo-poo a~50% reduction.

That said there are still two more once-daily options coming from Gilead. I'm going to a Gilead sponsored HIV treatment presentation on 7 June and will see if I learn more about when they expect approval.

[surf18]

My dr was going to switch me and I'm not treatment naive. Ko'd it because I'm on nexium.

[Hellraiser]

I'd be less underwhelmed by this new drug, and not bothered by the resistance issue (which seems perhaps no worse than Isentress) if it exhibited a marked decrease in the CNS issues that Sustiva has, but while IIRC they are indeed less in the studies, I'm not sure it's what one could call "greatly less". I think it may have been 3% of participants versus 7% for the Sustiva group. We shall see. I guess I shouldn't poo-poo a~50% reduction.

That said there are still two more once-daily options coming from Gilead. I'm going to a Gilead sponsored HIV treatment presentation on 7 June and will see if I learn more about when they expect approval.

Please do and bring some information back for me   I may have been thinking that the new B-tripla was supposed to use this drug in it's formulation, but a lot of this information was being talked about when I was newly diagnosed so it flew over my head at the time.

http://www.youtube.com/watch?v=N6uEMOeDZsA

[flip408]

I think naive and non naive are on different FDA approval tracks.  For example there would be a clinical trial for treatment naive and a separate clinical trial for non naive.  Seems like they would do the treatment naive first, followed by non naive. 

I am on the rilpivirene/truvada trial for non naive, phase 3, I am at week 12 of 48 week study.

[Miss Philicia]

Seems like they would do the treatment naive first, followed by non naive. 

No, for the past decade it's been the reverse -- emphasis always on patients with resistance issues. Silly, really isn't it -- let's just let them die off!