August 11, 2003
Gilead Initiates Study 934, a 48-Week Clinical Trial Evaluating Viread and Emtriva versus Combivir
FOSTER CITY, Calif., Aug 11, 2003 (BUSINESS WIRE) -- Gilead Sciences (Nasdaq: GILD) today announced that the company has initiated enrollment in Study 934. This Phase III study is designed to assess the efficacy of a once-daily regimen containing Viread(R) (tenofovir disoproxil fumarate) and Emtriva(TM) (emtricitabine) in combination with efavirenz versus a regimen containing Combivir(R) (lamivudine 150 mg/zidovudine 300 mg), which is dosed twice daily, and efavirenz.
"We are pleased that this important study is underway, particularly because there is increasing demand in the medical community for once-daily regimens for HIV," said John C. Martin, PhD, President and CEO of Gilead Sciences. "We believe that data obtained from this clinical trial will help physicians design the best regimens for their patients."
Study 934 is an open-label, multicenter clinical trial that will enroll 300 HIV-infected patients in the United States and Europe. Participants in one arm of the study will receive Viread 300 mg, Emtriva 200 mg and efavirenz 600 mg, all dosed once daily. Patients in the comparator arm will receive Combivir (lamivudine 150 mg/zidovudine 300 mg) twice daily and efavirenz 600 mg once daily. All participants will be treatment-naive, meaning they will not previously have received antiretroviral therapy.
The Centers for Disease Control and Prevention (CDC) estimate that 950,000 Americans are infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS). Approximately 360,000 infected individuals are receiving antiretroviral treatment for HIV infection in the United States today.
In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in a controlled study of Viread of 24 weeks duration and in a controlled, dose ranging study of Viread of 48 weeks duration. Both studies were conducted in treatment-experienced adults with evidence of HIV-1 viral replication despite ongoing antiretroviral therapy. Studies in antiretroviral-naive patients are ongoing; consequently, the risk-benefit ratio for this population has yet to be determined.
Viread is the first nucleotide analogue reverse transcriptase inhibitor (NtRTI) approved for the treatment of HIV in the United States and Europe. The drug works by blocking reverse transcriptase, an enzyme involved in the replication of HIV. Viread is dosed as one tablet once daily taken orally with a meal.
In clinical trials and expanded access programs, approximately 10,000 patients have been treated with Viread alone or in combination with other antiretroviral products for periods up to four years. To date, an estimated 150,000 patients have been prescribed Viread as part of their combination regimen. Assessment of adverse reactions is based on two studies (902 and 907) in which 653 treatment-experienced patients received treatment with Viread 300 mg (n=443) or placebo (n=210) for 24 weeks followed by extended treatment with the drug. Adverse event rates in the Viread group were similar to those in the placebo-treated patients. The most common adverse events in these patients were mild to moderate gastrointestinal events, such as nausea, diarrhea, vomiting and flatulence. Laboratory abnormalities observed in clinical studies occurred with similar frequency in the Viread and placebo-treated groups.
In clinical practice, a number of adverse events, including renal impairment, nausea, rash and asthenia (weakness) have been reported. Renal impairment occurred most often in patients with underlying systemic or renal disease, or in patients taking concomitant nephrotoxic agents. 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.
In the United States, Emtriva is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. This indication is based on the analyses of plasma HIV RNA levels and CD4 cell counts in two Phase III clinical trials of Emtriva of 48 weeks duration in antiretroviral-naive patients and antiretroviral treatment-experienced patients who were virologically suppressed on an HIV treatment regimen. In antiretroviral treatment-experienced patients, the use of Emtriva may be considered for adults with HIV strains that are expected to be susceptible to Emtriva as assessed by genotypic or phenotypic testing.
The drug is a nucleoside analogue reverse transcriptase inhibitor (NRTI) that works by blocking reverse transcriptase, an enzyme involved in the replication of HIV. Emtriva is dosed as one capsule once daily taken orally with or without food. More than 2000 HIV-infected adults have been treated with Emtriva for periods of 10 days to 200 weeks in Phase I, II and III clinical trials.
Assessment of adverse events is based on pooled data from two Phase III studies in which 571 treatment-naive and 440 treatment-experienced patients received Emtriva (n=580) or a comparator drug (n=431) for 48 weeks. The most common adverse events that occurred in patients receiving Emtriva were headache, diarrhea, nausea and rash, which were generally of mild to moderate severity. Approximately one percent of patients discontinued participation in the clinical studies due to these events. All adverse events were reported with similar frequency in Emtriva and control treatment groups with the exception of skin discoloration, which was reported with higher frequency in the group treated with Emtriva. Skin discoloration, manifested by hyperpigmentation (excess pigmentation) on the palms and/or soles, was generally mild and asymptomatic. The mechanism and clinical significance of this adverse event are unknown.
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. In chronic hepatitis B infected patients exacerbations of hepatitis B have been reported after discontinuation of Emtriva, and patients co-infected with HIV and HBV should be closely monitored after stopping Emtriva treatment. Patients with renal impairment should be carefully monitored and may require dose interval adjustments.
An application for marketing approval of Emtriva for the treatment of HIV was submitted to the European regulatory authorities in December 2002. On July 24, 2003, the European Union's Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), recommended granting Marketing Authorisation for Emtriva in the 15 member states of the European Union.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has seven marketed products and focuses its research and clinical programs on anti-infectives. Headquartered in Foster City, CA, Gilead has operations in the United States, Europe and Australia.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk related to the stability, pharmacokinetics and ultimately the company's ability to obtain regulatory approval of a co-formulation of Emtriva and Viread and the risk that the EMEA may not follow the recommendation of the CPMP and grant regulatory approval of Emtriva in the European Union. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2002 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.
Viread is a registered trademark and Emtriva is a trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences or full U.S. prescribing information on Viread or Emtriva, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com.
SOURCE: Gilead Sciences
Gilead Sciences Susan Hubbard, 650-522-5715 (Investors) James Loduca, 650-522-5908 (Media)
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