August 18, 2004
Gilead Expands Initiatives Providing Access to New HIV Therapy Truvada in United States and Abroad
Provides Truvada to 68 Developing Countries at No-Profit Pricing Truvada Added to Patient Assistance Program in United States
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 18, 2004-- Gilead Sciences, Inc. (Nasdaq:GILD) has announced that it will provide access to Truvada(TM) (emtricitabine and tenofovir disoproxil fumarate) through Gilead's global Access Program and Advancing Access(TM) Program. Truvada combines the active ingredients of Emtriva(R) (emtricitabine) and Viread(R) (tenofovir disoproxil fumarate) into one tablet, taken once a day in combination with other antiretroviral agents.
Truvada was granted approval from the U.S. Food and Drug Administration (FDA) on August 2, 2004. Gilead's global Access Program, which was initiated in April 2003, will offer Truvada at no profit in 68 countries including every country in Africa and in 15 additional countries in other parts of the world classified as "least developed" by the United Nations. Gilead plans to conduct additional stability studies to support the use of Truvada in Climatic Zones III and IV, or hot and humid climates. The Advancing Access Program will offer Truvada to patients in the United States who cannot obtain reimbursement or afford to pay for the product.
"We believe that Truvada represents an important treatment option for physicians and patients around the world," said John C. Martin, PhD, President and CEO, Gilead Sciences. "Access to anti-HIV medication is key to our ability to combat this global disease. Gilead is pleased to add Truvada to these existing programs, and we will continue our efforts to ensure that Truvada is available as expeditiously as possible to those individuals who can benefit from its attributes."
Gilead's Global Access Program
Since its inception, Gilead's global Access Program has provided access to Viread, which is a component of the new combination pill Truvada, at a no-profit price. Viread will continue to be available through the program.
Gilead's global Access Program makes both drugs available to private and public programs treating people with HIV/AIDS in the 68 resource-limited countries. The program will provide Truvada for US$29.75 per month, or US$0.99 per day. In July 2004, Gilead announced a reduction in the no-profit price of Viread, to US$24.71 for a 30-day supply, or US$0.82 per day. This was nearly a 37 percent reduction in the original no-profit price of Viread, resulting from improvements in the manufacturing process for Viread and increased economies of scale.
In addition to providing HIV therapy at no-profit prices, Gilead's global Access Program is designed to meet the needs of treaters in resource-challenged settings by providing a streamlined and rapid review of requests, and direct purchasing.
Request forms can be submitted via the Internet or by email, mail or fax. The company is prepared to ship product to qualifying programs as soon as request forms are reviewed and approved. Requests are reviewed by independent experts, and programs requesting drug are evaluated based on their ability to provide quality and sustainable patient care. Gilead takes appropriate steps to ensure that drug shipments reach their intended destination.
Complete program information and request forms are available at www.gileadaccess.org. Programs without Internet access can call Gilead's global Access Program in the United States at 1-800-GILEAD-5 (1-800-445-3235) or 1-650-574-3000 or in Uganda at +256-41-340-806.
Advancing Access Program
Gilead's patient assistance program, recently renamed "Advancing Access," provides access to Gilead medications for U.S. patients who cannot obtain reimbursement or afford to pay for their Gilead medications. The program enables people living with HIV who meet program criteria to access antiretroviral medications on the same day they visit their physician and receive a prescription. Advancing Access also helps individuals find insurance coverage for their medications and provides Gilead's therapeutics to those individuals until other support covering the cost of Gilead medications becomes available. Unlike some patient assistance programs, Advancing Access enables patients to have immediate access to HIV therapeutics.
While the patient assistance program has been available for a number of years, Advancing Access was expanded earlier this year to give U.S. patients immediate access to Gilead's HIV therapeutics, now including Truvada. To enroll a patient, a prescriber or patient advocate completes an enrollment form and calls the Advancing Access toll-free help line. A reimbursement counselor initiates the enrollment process during this call and if the patient meets program qualifications he or she will receive a voucher from the patient advocate. The patient may then take the voucher and prescription to a local pharmacist to receive the initial 30-day supply of Truvada. Unlike some other assistance programs, no copayment is required. Refill medications are sent directly to the office of the prescriber or patient advocate.
The program also provides patients with Viread, Emtriva, Hepsera(R) (adefovir dipivoxil) and Vistide(R) (cidofovir injection). Program eligibility is determined in consultation with patient assistance counselors and requires documentation.
Additional information about Advancing Access is available in the United States at 1-800-GILEAD-5 (1-800-445-3235).
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. Safety and efficacy studies using Truvada tablets or using Emtriva and Viread in combination are ongoing.
Both components of Truvada have been studied individually, as part of multi-drug regimens and have been found to be safe and effective. Since Emtriva and lamivudine (3TC) are comparable in their structure, resistance profiles, and efficacy and safety as part of multi-drug regimens, existing data from the use of lamivudine and Viread in combination have been extrapolated to support the use of Truvada tablets for the treatment of HIV-1 infection in adults. Therefore, in treatment-naive patients, Truvada should be considered as an alternative to the combination of Viread and lamivudine for those patients who might benefit from a once-daily regimen. In treatment-experienced patients, the use of Truvada should be guided by laboratory testing and treatment history.
Truvada works by blocking reverse transcriptase, an enzyme crucial for viral replication. By interfering with the replication process, Truvada, when combined with other anti-HIV medication, can help lower the amount of HIV, or "viral load" in a patient's body and increase the number of immune system cells (called T cells or CD4 cells). Both of these changes are generally associated with improving a patient's health and decreasing the likelihood of AIDS-related illnesses.
There are no study results demonstrating the effect of Truvada on clinical progression of HIV-1, and it is not recommended that Truvada be used as a component of a triple nucleoside regimen.
Important Safety Information
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 is not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada 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 Emtriva or Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Truvada and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
No drug interaction studies have been conducted using Truvada. Drug interactions have been observed when didanosine, atazanavir or lopinavir/ritonavir is co-administered with Viread, a component of Truvada, and dose adjustments may be necessary. Data are not available to recommend a dose adjustment of didanosine for patients weighing less than 60 kg. Patients on atazanavir or lopinavir/ritonavir plus Truvada should be monitored for Truvada-associated adverse events which may require discontinuation. Truvada should not be used with Emtriva or Viread, or other drugs containing lamivudine, including Combivir(R), Epivir(R), Epivir-HBV(R), Epzicom(TM) or Trizivir(R).
Changes in body fat have been observed in patients taking Viread, Emtriva and other anti-HIV medicines. The cause and long-term health effect of these conditions are unknown.
Two hundred eighty-three patients have received combination therapy with emtricitabine (Emtriva) and tenofovir disoproxil fumarate (Viread) with either a non-nucleoside reverse transcriptase inhibitor or protease inhibitor for 24 to 48 weeks in ongoing clinical studies. Based on these limited data, no new patterns of adverse events were identified and there was no increased frequency of established toxicities.
Adverse events that occurred in more than 5 percent of patients receiving Emtriva with other antiretroviral agents in clinical trials include abdominal pain, asthenia (weakness), headache, diarrhea, nausea, vomiting, dizziness and rash. Approximately 1 percent of patients discontinued participation because of 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 Emtriva treated group. Skin discoloration, manifested by hyperpigmentation on the palms and/or soles was generally mild and asymptomatic. The mechanism and clinical significance are unknown.
Adverse events that occurred in more than 5 percent of patients receiving Viread with other antiretroviral agents in clinical trials include headache, nausea, diarrhea, vomiting, rash and depression. Less than 1 percent of patients discontinued participation because of gastrointestinal events. Renal impairment, including serious cases, has been reported. Renal impairment occurred most often in patients with underlying systemic or renal disease or in patients taking concomitant nephrotoxic agents, though some cases have appeared in patients without identified risk factors. Decreases in bone mineral density (BMD) at the lumbar spine and hip have been seen with the use of Viread. The clinical significance of changes in BMD and biochemical markers is unknown and follow-up is continuing to assess long-term impact.
It is important that patients be aware that HIV medications must be taken as part of combination regimens and do not cure HIV infection, nor do they reduce its transmission.
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 North America, 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. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. Risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2003 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.
Truvada and Advancing Access are trademarks and Viread, Emtriva, Hepsera and Vistide are registered trademarks of Gilead Sciences, Inc.
For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com.
CONTACT: Gilead Sciences, Inc.
Amy Flood, 650-522-5643
Jenna Conley, 650-522-5078
SOURCE: Gilead Sciences, Inc.