144-Week Data from Gilead's Study 934 Comparing Truvada® to Combivir® Both in Combination with Sustiva® Presented At International AIDS Society Meeting in Sydney

Business Wire, July 23, 2007

Loss of limb fat, a marker for lipodystrophy, was observed among patients receiving Combivir/Sustiva. Among 269 patients with available data, median total limb fat was significantly less in patients receiving Combivir/Sustiva compared to patients receiving Truvada/Sustiva (5.4 vs 7.9 kg; p<0.001) at week 144. Among patients with data available at 48 and 144 weeks, median total limb fat decreased significantly in the Combivir/Sustiva arm (from 6.0 kg to 4.9 kg; n=49, 38) and increased significantly in the Truvada/Sustiva arm (from 7.4 kg to 8.3 kg; n=51, 48).

Data from this analysis have not been reviewed by the U.S. Food and Drug Administration.

Important Product Safety Information About Truvada and Atripla

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Truvada and Atripla are not approved for the treatment of chronic hepatitis B virus (HBV) infection and their safety and efficacy have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Viread or Emtriva, which are components of Truvada and Atripla. In some of these patients treated with Emtriva, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV and HBV and discontinue Truvada or Atripla. If appropriate, initiation of anti-hepatitis B treatment may be warranted.

It is important for patients to be aware that anti-HIV medicines including Truvada and Atripla do not cure HIV infection or AIDS and do not reduce the risk of transmitting HIV to others.

Additional Important Information About Truvada

Truvada is a fixed-dose combination tablet containing 200 mg of emtricitabine (Emtriva) and 300 mg of tenofovir disoproxil fumarate (Viread). In the United States, Truvada is indicated in combination with other antiretroviral agents, such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors, for the treatment of HIV-1 infection in adults.

It is not recommended that Truvada be used as a component of a triple nucleoside regimen. Truvada should not be coadministered with Atripla, Emtriva, Viread or lamivudine-containing products, including Combivir (lamivudine/zidovudine), Epivir([R]) or Epivir-HBV([R]) (lamivudine), Epzicom(TM) (abacavir sulfate/lamivudine) or Trizivir([R]) (abacavir sulfate/lamivudine/zidovudine). In treatment-experienced patients, the use of Truvada should be guided by laboratory testing and treatment history.

Emtricitabine and tenofovir are principally eliminated by the kidneys. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of Viread, a component of Truvada. It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy with Truvada and as clinically appropriate during therapy. Routine monitoring of calculated creatinine clearance and serum phosphorous should be performed in patients at risk for renal impairment. Dosing interval adjustment and close monitoring of renal function are recommended in all patients with creatinine clearance 30-49 ml/min. Truvada should be avoided with concurrent or recent use of a nephrotoxic agent.