Gilead Sciences Expands U.S. Patient Assistance Program to Help People Living With HIV Gain Faster Access to Therapy
FOSTER CITY, Calif.--(BUSINESS WIRE)--April 20, 2004--
Commitment to Access Program Simplifies Drug Access for Patients Most in Need
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it is expanding and simplifying its U.S. patient assistance program, Commitment to Access, which provides patients who have limited payment options access to Gilead medications free of charge. The redesigned program now 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. Commitment to 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.
While the patient assistance program has traditionally allowed prescribing physicians to make referrals to the program, Commitment to Access has now been expanded to enable allied healthcare professionals to serve as patient advocates and also make referrals. In addition to physicians, patients can work with nurses, nurse practitioners, physician assistants, case managers and social workers to gain access to the program.
Unlike some patient assistance programs, Commitment to Access enables patients to have immediate access to HIV therapeutics. To enroll patients, a prescriber or patient advocate completes a simple form and then calls the Commitment to Access toll-free help line. A reimbursement counselor initiates the enrollment process during this call and if program qualifications are met, the patient advocate provides the patient with a voucher. The patient may then take the voucher and prescription to a local pharmacist to receive the initial 30-day supply of Viread(R) (tenofovir disoproxil fumarate) and/or Emtriva(TM) (emtricitabine). Unlike other assistance programs, no copayment is required. Refill medications will be sent directly to the office of the prescriber or patient advocate. The program also provides patients with Hepsera(R) (adefovir dipivoxil) for the treatment of chronic hepatitis B and Vistide(R) (cidofovir injection) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. Program eligibility is determined in consultation with patient assistance counselors and requires documentation.
"The redesign of Commitment to Access reflects our dedication to ensuring that people living with HIV have the most rapid access possible to Gilead antiretroviral medications," said John C. Martin, PhD, President and CEO of Gilead Sciences. "As part of our ongoing quest to improve our programs, we consulted with our community advisors, and the end result is a program that provides user-friendly solutions for physicians and patients. Expedited access to therapy is especially important in the field of HIV, where patients are often not diagnosed until they are quite ill. Commitment to Access helps ensure patients face fewer delays in accessing potentially life-saving medication."
"Patient assistance programs are a vital part of the HIV treatment landscape," said Philippe Chiliade, MD, Medical Director of the Whitman Walker Clinic, a non-profit community-based health organization serving a diverse population in Washington, D.C. "The Commitment to Access program will have a significant impact on the patients who need treatment options but have no way to access them."
In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Assessment of adverse reactions, as described in the U.S. package insert, is based on one study of treatment-experienced patients and one study of treatment-naive patients. In Study 907, a total of 550 treatment-experienced patients received treatment with Viread 300 mg (n=368) or placebo (n=182) for 24 weeks followed by extended treatment with the drug. In Study 903, a total of 600 patients received treatment with Viread (n=299) or stavudine (n=301) in combination with lamivudine and efavirenz for 48 weeks. The most common adverse events in these patients were dizziness and mild to moderate gastrointestinal events, such as nausea, diarrhea, vomiting and flatulence.
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, though some cases have appeared in patients without identified risk factors. 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 patients co-infected with HIV and the hepatitis B virus, exacerbations of hepatitis B have been reported in patients after discontinuation of Viread. 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.
In the United States, Emtriva is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. In the European Union, Emtriva is indicated in combination with other antiretroviral agents for the treatment of HIV in adults and children.
Assessment of adverse events, as described in the U.S. package insert, 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 Emtriva treated group. Skin discoloration, manifested by hyperpigmentation (excess pigmentation) on the palms and/or soles, was generally mild and asymptomatic. The mechanism and clinical significance 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 patients co-infected with HIV and chronic hepatitis B, exacerbations of hepatitis B have been reported in patients after discontinuation of Emtriva. Patients with renal impairment should be carefully monitored and may require dose interval adjustments.
Hepsera, the first nucleotide analogue for the treatment of chronic hepatitis B, is administered as a once-daily 10 mg tablet and works by inhibiting HBV DNA polymerase, an enzyme involved in the replication of the virus in the body. To date, Hepsera has been studied in 35 clinical trials and has been prescribed to approximately 24,000 patients. Hepsera is now available in the United States and 13 countries in Europe, including the important market of Italy. In April 2002, Gilead signed a licensing agreement with GlaxoSmithKline (GSK), granting to GSK rights to commercialize Hepsera in Asia, Latin America and other territories. Hepsera has been launched in five Asian markets to date including Hong Kong and Singapore.
In the United States, Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The adverse reactions considered at least possibly related to treatment, reported in less than 3 percent of patients in the first 48 weeks in Hepsera pivotal clinical studies were asthenia (weakness), headache, abdominal pain, nausea, flatulence, diarrhea and dyspepsia. With extended treatment, mild to moderate increases in serum creatinine were observed uncommonly in patients with chronic hepatitis B and compensated liver disease treated with Hepsera for a median of 49 weeks and a maximum of 109 weeks. Changes in serum creatinine were observed very commonly in patients with pre- and post-transplantation lamivudine-resistant liver disease and multiple risk factors for changes in renal function who were treated with Hepsera for up to 129 weeks, with a median time on treatment of 19 and 56 weeks, respectively. Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with antiviral therapies for hepatitis B, including Hepsera. Special warnings and precautions for use are included in the package insert regarding monitoring of renal function, post-treatment exacerbations of hepatitis, use in patients with underlying renal impairment, patients co-infected with HIV, the occurrence of nucleoside analogue-associated lactic acidosis and severe hepatomegaly with steatosis.
Vistide is an antiviral for the treatment of cytomegalovirus retinitis in patients with AIDS. Vistide was cleared for marketing in the United States in June 1996 and in Europe in May 1997.
In the United States, Vistide is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). The safety and efficacy of Vistide have not been established for treatment of other CMV infections (such as pneumonitis or gastroenteritis), congenital or neonatal CMV disease, or CMV disease in non HIV-infected individuals.
Renal impairment is the major toxicity of Vistide. Cases of acute renal failure resulting in dialysis and/or contributing to death have occurred with as few as one or two doses of Vistide. To reduce possible nephrotoxicity, intravenous prehydration with normal saline and administration of probenecid must be used with each Vistide infusion. Renal function (serum creatinine and urine protein) must be monitored within 48 hours prior to each dose of Vistide and the dose of Vistide modified for changes in renal function as appropriate. Vistide is contraindicated in patients who are receiving other nephrotoxic agents. Neutropenia has been observed in association with Vistide treatment. Therefore, neutrophil counts should be monitored during Vistide therapy. Vistide is indicated only for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome. In animal studies cidofovir was carcinogenic, teratogenic and caused hypospermia.
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 six 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 that could cause actual results to differ materially from those referred to in the forward-looking statements. 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, Hepsera and Vistide are registered trademarks and Emtriva is a trademark of Gilead Sciences, Inc.