Atripla downgrade

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12 May 2015

The US Department of Health and Human Services (DHHS) has downgraded the widely-used combination pill Atripla. 

Atripla (efavirenz/tenofovir/emtricitabine) has gone from being classed a ‘recommended’ regimen to an ‘alternative’ regimen for people beginning HIV treatment, meaning it is no longer considered a first-line therapy. The DHHS recommendations act as a guide for clinicians deciding which drugs to prescribe patients.

Atripla was the first one-pill, once-daily complete regimen to hit the market and quickly became one of the most commonly prescribed drugs to treat HIV. This was, in part, because of the effectiveness of the efavirenz component: the drug provides vigorous viral suppression, works well even when doses are missed and is cheaper than many other HIV medications on the market. A 2010 study found almost a third of people with HIV in the US who were on antiretroviral therapy were using Atripla. In 2011, sales topped $US3.2bn worldwide.

Ironically, it’s the efavirenz element that appears to be behind the reasoning to lower Atripla’s ranking. Commonly, people starting out on efavirenz experience side effects such as dizziness, bizarre dreams, depression, or grogginess. Describing the downgrade as a "pretty big deal", Paul Sax — a professor at Harvard Medical School and a DHHS panelist — said the decision was due to a wider choice of treatment options. "It comes down to progress we’ve made in improving side effects," he said.