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Updated Two-Year Trial Results Indicate That Elvitegravir Is As Effective And Safe As Isentress

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Published: Dec 12, 2011 11:17 am
Updated Two-Year Trial Results Indicate That Elvitegravir Is As Effective And Safe As Isentress

Updated results from a 96-week Phase 3 clinical trial continue to indicate that the investigational integrase inhibitor elvitegravir is as effective and safe as Isentress in previously treated people with HIV.

“These positive two-year data indicate that elvitegravir has the potential to be an important new once-daily treatment option for people living with HIV who have developed resistance to other therapies,” said Norbert Bischofberger, executive vice president of Research and Development and chief scientific officer of Gilead Sciences, which is developing elvitegravir, in a press release.

“In addition, we are very excited about elvitegravir’s role as part of our new Quad single-tablet regimen, which is currently in U.S. regulatory review,” he added.

Gilead stated that based on the results, the company plans to file for approval of elvitegravir from the United States Food and Drug Administration (FDA) in the second quarter of 2012.

Gilead also submitted a new drug application for its investigational Quad pill (cobicistat/elvitegravir/emtricitabine/tenofovir) to the FDA in October (see related AIDS Beacon news).

Elvitegravir belongs to a relatively new class of antiretroviral called integrase inhibitors. Currently, Isentress (raltegravir) is the only approved integrase inhibitor. It is approved both as a first-line treatment for HIV and for people who are treatment-experienced.

Gilead previously presented 48-week results from the Phase 3 clinical trial showing that elvitegravir was comparable in safety and efficacy to Isentress (see related AIDS Beacon news). On Friday the company released the full 96-week results.

The study included 702 participants, a majority of whom (63 percent) were resistant to two or more classes of antiretrovirals at the start of the trial.

Participants were randomly assigned to receive once-daily elvitegravir (150 mg or 85 mg) or twice-daily Isentress (400 mg). In addition, participants took a Norvir (ritonavir)-boosted protease inhibitor plus another antiretroviral.

The most common background regimen was Norvir-boosted Prezista (darunavir) plus Viread (tenofovir). Participants who took Reyataz (atazanavir) or Kaletra (lopinavir/ritonavir) received a lower dose of elvitegravir, 85 mg daily instead of 150 mg.

After 96 weeks, 48 percent of patients in the elvitegravir group achieved and maintained viral loads (amount of HIV in the blood) of less than 50 copies per milliliter, compared to 45 percent of patients in the Isentress group.

Gilead reported that the rates and types of side effects were also comparable, and that discontinuation rates due to side effects were similar between the two groups.

The company had previously reported that, after 48 weeks, the most common side effects in participants taking elvitegravir were diarrhea (12 percent of participants), upper respiratory tract infection (6 percent), bronchitis (5 percent), back pain (5 percent), depression (5 percent), sinus infection (4 percent), joint pain (4 percent), nausea (4 percent), and urinary tract infection (3 percent).

Gilead stated that it would present the full clinical trial results at a scientific conference in 2012.

For more information, please see the Gilead Sciences press release.

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