3-in-1 pill represents a first in HIV treatment
given the green light by the US Food and Drug Administration (FDA)
in a response to patients' increasing demands for convenient
combined treatments.
The fast-track approval of Atripla represents the first-ever once-daily single tablet regimen (STR) for HIV intended as a stand-alone therapy or in combination with other antiretrovirals.
Not only does it reduce the multiple numbers of pills sufferers were previously required to take, but the pill also represents a big push to prevent the emergence of drug-resistant strains of the virus, which can develop when people fail to take all their medication.
FDA approval of the drug means that Atripla is likely to receive a European license, possibly next year.
The drug cocktail mixes Gilead Sciences' Truvada (tenofovir and emtricitabine) and Bristol Myer Suibb's Sustiva (efavirenz) and will be marketed in the US as Atripla. Merck, which holds the rights to efavirenz, has also been involved in the drug's production
"The availability of Atripla marks the culmination of ten years of efforts to simplify dosing while helping to achieve and maintain effective viral suppression for adults infected with HIV-1," said John Bartlett, MD, Johns Hopkins University.
2006 marks the 25th anniversary of the start of the AIDS epidemic. The first cases of HIV/AIDS were reported by the US Centers for Disease Control and Prevention (CDC) in the June 5, 1981 issue of the Morbidity and Mortality Weekly Report (MMWR).
Today, the CDC estimates that more than one million US citizens are infected with HIV, the virus that causes AIDS. Of these, approximately 25 per cent are unaware of their infection.
Although HIV treatment options have expanded rapidly in recent years, the CDC estimates that 216,000 Americans who are HIV positive and eligible for antiretroviral treatment are currently not receiving it.
"We appreciate the recognition by the FDA of this important therapeutic advance, and with their approval of Atripla in just over two months, patients will now have rapid access to the first once-daily single tablet regimen for the treatment of HIV-1 infection in adults," said John Martin, President and CEO of Gilead Sciences.
"With the approval of Atripla, Bristol-Myers Squibb continues two decades of progress in the development and commercialization of medications to treat HIV. Partnering with Gilead, we are able to address another area of need for adults infected with HIV-1," said Anthony Hooper, President, US Pharmaceuticals, Bristol-Myers Squibb.
"Atripla is an important step forward as we continue our focus on discovering, developing and providing innovative treatments for serious diseases."
The three drugs in this pill come from two classes of anti-HIV drugs. Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI), and emtricitabine and tenofovir disoproxil fumarate are both nucleoside reverse transcriptase inhibitors (NRTIs).
All three active ingredients work by blocking reverse transcriptase, an enzyme necessary for HIV replication.
