May 7, 2015

May 7, 2015
Atripla No Longer Recommended as First-Line HIV Therapy

Welcome to another day in my life. Today is Thursday and I hope you are having a beary safe and great week so far. I have been staying low because of continuing fevers.

There has been another article about HIV treatment which I would like to share with you today. This month, the Department of Health and Human Services (DHHS) made some key changes to recommended first-line HIV treatment recommendations. With more than 25 HIV medications from six different drug classes now on the market—the DHHS recommendations are a guide for clinicians as they decide which antiretrovirals to prescribe their patients. Among other revisions, one significant change is that the NNRTI-based regimen in the widely-used combination pill Atripla (efavirenz/tenofovir/emtricitabine) was downgraded from a “recommended” regimen to an “alternative” regimen for people just beginning antiretroviral therapy (ART).

Atripla is a combination pill containing the NNRTI efavirenz plus the NRTI backbone of tenofovir/emtricitabine that’s done remarkably well since its approval by the FDA in 2006. As the first one-pill, once-daily complete HIV treatment regimen to hit the market, Atripla quickly became one of the most commonly prescribed and used drugs to treat HIV because of its ease of use. This is also due to efavirenz’s benefits: The drug provides robust viral suppression for many, works relatively well even when doses are missed and is less costly than many other HIV medications on the market. A study published in 2010 reported that almost a third of people with HIV in the U.S. taking ART were using Atripla. In 2011, global sales of Atripla reached $3.2 billion.

So what’s the problem with Atripla? It’s actually not a problem with the drug itself—it’s just that there are better alternatives.

Paul Sax, MD, clinical director of the HIV Program and Division of Infectious Diseases at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School, and a member of the DHHS panel that revamped the treatment guidelines, provides an explanation for why the efavirenz-based regimen in Atripla was moved off the recommended list—a move he called, “a pretty big deal.” In an editorial posted to the New England Journal of Medicine’s Journal Watch, Sax says that, “it comes down to progress we’ve made in improving side effects.”

Sax explains that “virtually everyone” who starts efavirenz gets some kind of central nervous system side effect—such as dizziness, abnormal dreams, depression, or grogginess—when they start taking the medication, which may or may not continue long-term. With many other good HIV treatment options out there, Sax says, it’s now easier to prescribe regimens that require less side effect management. The updated list of recommended first-line therapies now includes five regimens. One is a boosted protease inhibitor regimen (darunavir/ritonavir/TDF/emtricitabine). Four others contain an integrase inhibitor with an NRTI backbone:

Dolutegravir/abacavir/lamivudine (Triumeq)
Elvitegravir/cobicistat/TDF/emtricitabine (Stribild)

Hope you have a beary safe and great Thursday!

Until we meet again; here's wishing you health, hope, happiness and just enough.

big bear hug,

Daddy Dab