May 5, 2010
Whitehouse Station, N.J. -- Today, Merck & Co., Inc., and the ADAP Crisis Task Force (ACTF) announced a series of key initiatives to help struggling state AIDS Drug Assistance Programs (ADAPs) continue to provide people living with HIV access to medicines. The ACTF is pleased that, among these initiatives, Merck is:
"On behalf of the nearly two hundred thousand clients that ADAPs serve, we applaud Merck for its continued commitment to HIV," said Dwayne Haught, manager, HIV Medication Program for the Texas Department of State Health Services and a spokesperson for the ADAP Crisis Task Force. "Merck's history of HIV research, along with its responsible pricing and related efforts to help alleviate the current funding crisis facing ADAPs, is consistent with Merck's track record of working to help ensure access to treatments such as CRIXIVAN and ISENTRESS for the people most in need."
"These actions come at a time when federal funding for ADAPs remains flat and state funding continues to decrease, making it difficult for the ADAP programs to provide access and care to the patients they serve," said Lynda Dee, spokesperson for the Fair Pricing Coalition. "The Fair Pricing Coalition commends Merck for its long-standing commitment to providing access to treatment and welcomes Merck's new initiatives to help with the current funding crises."
The ACTF, a group of state ADAP and AIDS directors that is convened by NASTAD, requested that drug companies consider implementation of cost control measures, such as a price freeze of HIV drugs to ADAPs to help mitigate the current financial crises. In response, Merck established an expanded Special Pricing Program for its HIV medicines for eligible ADAPs. The expanded Special Pricing Programs for ISENTRESS and CRIXIVAN will begin July 1, 2010 and extend through Dec. 31, 2013. The price freeze extension follows Merck's earlier agreement with the ACTF in 2008 to freeze the price of ISENTRESS to eligible ADAPs at its launch price. The extension of its price freeze on CRIXIVAN to eligible ADAPs will also last through Dec. 31, 2013. When it announced its voluntary price freeze in 2003, Merck was the first company to freeze the price of an anti-retroviral (ARV) drug to ADAPs. Merck will reassess these programs in 2014, after implementation of the U.S. government's newly expanded Medicaid program and subsidized private health insurance plans mandated by health care reform legislation (Patient Protection and Affordable Care Act).
In addition to the expanded Special Pricing Program for ISENTRESS and CRIXIVAN, Merck is committed to assisting eligible ADAPs with cash flow and to reducing the number of patients waiting to receive treatment. As such, the Company has changed its existing state invoice payment process to accelerate the payment of Merck rebates to eligible ADAPs.
Merck's commitment to patients' access to its products is evidenced through its HIV SUPPORTTM program, which helps patients who have been prescribed ISENTRESS or CRIXIVAN by providing personalized support and patient advocacy regarding individual reimbursement issues. The SUPPORTTM program also offers patient assistance, which may include providing ISENTRESS or CRIXIVAN free of charge to eligible patients. Information about the SUPPORT Program can be obtained by calling 1-800-850-3430 or at www.isentress.com.
Patients who are on ADAP waiting lists or who are awaiting ADAP approval may be eligible to receive ISENTRESS or CRIXIVAN for free through the SUPPORTTM program.
In addition to the SUPPORT Program, Merck has a co-pay assistance program in the U.S. for eligible patients on ISENTRESS who are commercially insured and have co-pays or coinsurance above $30, up to $400 per prescription. With this program, eligible patients can receive savings off their out-of-pocket costs for 12 prescriptions prior to the programs expiration in July 2011. Information about the co-pay assistance program can be obtained by calling 866-350-9232 or at www.isentress.com.
ISENTRESS is indicated in combination with other ARV agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. This indication is based on analyses of plasma HIV-1 RNA levels up through 48 weeks in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class ARV (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatmentnaive adults.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
The safety and efficacy of ISENTRESS have not been established in pediatric patients.
ISENTRESS does not cure HIV or AIDS and does not prevent passing HIV to others.
Healthcare providers should know that immune reconstitution syndrome has been reported in patients treated with ARV therapy, which may necessitate further evaluation and treatment.
Creatine kinase elevations were observed in subjects who received ISENTRESS. Myopathy and rhabdomyolysis have been reported; however, the relationship of ISENTRESS to these events is not known. ISENTRESS should be used with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medication known to cause these conditions.
In treatment-naive patients receiving ISENTRESS, the most commonly (greater than or equal to two percent in either treatment group) reported drug-related clinical adverse event (AE) of moderate or severe intensity and at a higher incidence compared to efavirenz was insomnia (4 percent vs. 3 percent).
In treatment-experienced patients receiving ISENTRESS, the most commonly (greater than or equal to 2 percent in either treatment group) reported drug-related clinical AEs of moderate or severe intensity and at a higher rate compared to placebo were headache (rate of 3-to-1, per 100 patient years), nausea (rate of 2-to-1, per 100 patient years), asthenia/weakness (rate of 2-to-1, per 100 patient years) and fatigue (rate of 2-to-1, per 100 patient years).
ISENTRESS is a single 400 mg tablet taken twice daily without regard to food. The dose of ISENTRESS should be increased during coadmistration with rifampin to 800 mg twice daily.
Coadmistration with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 may reduce plasma concentrations of ISENTRESS. Based on the results of drug interaction studies and the clinical trials data, no dose adjustment of ISENTRESS is required when coadministered with other ARV agents. Also, preclinical studies show that ISENTRESS is not metabolized by cytochrome P450 enzymes.
CRIXIVAN, a protease (PRO-tee-ase) inhibitor, in combination with other antiretroviral agents is indicated for the treatment of HIV infection. This indication is based on two clinical trials of approximately one year's duration that demonstrated: 1) a reduction in the risk of AIDS-defining illnesses or death; 2) a prolonged suppression of HIV RNA.
CRIXIVAN is not a cure for HIV infection nor does it reduce the transmission of HIV. CRIXIVAN should only be taken in combination with other drugs for HIV.
Concomitant use of CRIXIVAN with the cholesterol-lowering medicines lovastatin, simvastatin, or rosuvastatin is not recommended. Caution should be exercised if HIV protease inhibitors, including CRIXIVAN, are used concurrently with atorvastatin. The interaction of CRIXIVAN with pravastatin and fluvastatin is not known. The risk of myopathy including rhabdomyolysis may be increased when HIV protease inhibitors, including CRIXIVAN, are used in combination with these statin drugs.
In patients treated with CRIXIVAN, acute hemolytic anemia, including death in some patients, and hepatitis, including hepatic failure and death, have been reported. There have also been reports of hyperglycemia and new onset or exacerbation of preexisting diabetes mellitus in patients receiving protease inhibitors.
Nephrolithiasis/urolithiasis has occurred in clinical studies in adult patients (12.4 percent; range across individual trials, 4.7 percent to 34.4 percent) and in pediatric patients (29 percent) receiving CRIXIVAN. The cumulative frequency of nephrolithiasis events increases with increasing exposure to CRIXIVAN; however, the risk over time remains relatively constant. In some cases, nephrolithiasis/urolithiasis has been associated with renal insufficiency or acute renal failure and pyelonephritis with or without bacteremia. If signs or symptoms of nephrolithiasis/urolithiasis occur (including flank pain with or without hematuria or microscopic hematuria), temporary interruption (e.g., 1 to 3 days) or discontinuation of therapy may be considered. Adequate hydration (at least 48 ounces daily for adults) is recommended in all patients treated with CRIXIVAN.
Taking CRIXIVAN with any products containing St. John's wort, an herbal supplement, is not recommended because it has been shown to substantially decrease concentrations of CRIXIVAN and may lead to loss of virologic response and possible resistance to CRIXIVAN or to the class of protease inhibitors.
The recommended dosage of CRIXIVAN is 800 mg (usually two 400 mg capsules) orally every 8 hours. CRIXIVAN must be taken at 8 hour intervals and should be administered without food but with water one hour before or two hours after a meal. CRIXIVAN should not be coadministered with orally administered midazolam. Caution should be used with coadministration of CRIXIVAN and parenteral midazolam.
CRIXIVAN is an inhibitor of cytochrome P450 enzymes, CYP3A4. Coadministration of CRIXIVAN and drugs primarily metabolized by CYP3A4 may result in increased plasma concentrations of the other drug. Coadministration of CRIXIVAN and other drugs that inhibit CYP3A4 may result in increased plasma concentrations of CRIXIVAN.
Side effects occurring in 2 percent or more of patients taking CRIXIVAN included: fever, nausea, nephrolithiasis/urolithiasis, headache, asthenia/fatigue, and anemia.
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