Ten years ago, the use of potent anti-HIV drug combinations revolutionized AIDS care. Since Viread was introduced in 2001, Gilead’s antiretroviral therapies have grown to become the cornerstone of HAART for many patients, helping transform HIV infection into a long-term treatable disease. This year’s introduction of Atripla in the United States and its pending approval in the European Union signify a landmark in AIDS therapy – the first time HIV patients can take a complete HAART regimen in a single, once-daily tablet.
the availability of long-term clinical data on combination regimens has never been more important. That is why we design and conduct clinical trials to support use of our products and demonstrate their established safety and tolerability profiles.
This year we reported data from two long-term clinical trials of Viread, which is prescribed by itself and as part of Truvada and Atripla. In August 2006, we reported 96-week data from Study 934, our ongoing clinical trial comparing a once-daily regimen of Viread, Emtriva and efavirenz (the components of Atripla) to a regimen of twice-daily Combivir and once-daily efavirenz. In September 2006, we reported long-term data from Study 903E, an extension of a pivotal Phase III clinical trial. These data evaluated the safety and efficacy of treatment with Viread, lamivudine and efavirenz out to five years.
Early diagnosis is critical in order to maximize HAART effectiveness and extend survival for HIV-positive people. Recent studies show that many patients are diagnosed with HIV infection at an advanced stage of the disease, when treatment is less effective.
In September 2006, the U.S. CDC recommended HIV testing become a routine part of medical care for all Americans aged 13 to 64. The U.S. CDC believes routine HIV testing may help identify the estimated 250,000 people in the United States who do not realize they are infected, therefore potentially reducing the annual rate of new infections. Earlier diagnosis and treatment may significantly extend lives. If diagnosed soon after infection, the life expectancy of HIV-positive patients can be extended by as much as 35 years.
With HIV patients living longer and the potential for more patients being diagnosed and referred to care,
