After Recent NIH Study Proves Trizivir's Ineffectiveness, Nation's Largest AIDS Group Sends Letter to Medi-Cal Requesting Prior Authorization Status for Drug to Protect the Health of California's HIV/AIDS Patients and to Avoid Negative Fiscal Impact to State

LOS ANGELES, Jan. 5 /PRNewswire/ -- Following the results of a recent government study that questioned the efficacy of GlaxoSmithKline's (GSK) AIDS drug, Trizivir, a three drug in one tablet formulation, AIDS Healthcare Foundation (AHF), the nation's largest AIDS group, providing medical services to over 17,000 people in the United States, today sent a letter to the Deputy Director of Medi-Cal, California state's Medicaid program, requesting treatment authorization request (TAR) procedures be placed on GSK's fixed-dose combination AIDS drug.

AHF previously sent a letter (in October 2004) to the heads of all state Medicaid programs asking them to place treatment authorization request procedures on Trizivir for treatment naive patients in response to interim results from the 2003 National Institute of Health (NIH) study published in the New England Journal of Medicine. The study, known as ACTG 5095 (Adult AIDS Clinical Trial Group) showed that the three-in-one regimen failed to effectively combat the virus in HIV-positive patients who had never before received any antiretroviral treatment. This latest request by AHF follows the December 2005 publication of the final results of that study, which further reveal the ineffectiveness of the drug. AHF will now send similar letters to all state Medicaid programs throughout the country requesting that these new study findings be reviewed, and that implementation of treatment authorization request procedures be considered.

"As a treatment provider, AHF's number one priority is protecting the health of people living with HIV/AIDS, and we will persist in our efforts to inform patients and providers of the dangers of this drug when used as a stand-alone regimen," said AIDS Healthcare Foundation (AHF) President Michael Weinstein. "We also believe spending money on expensive treatments that have been proven to be ineffective, such as Trizivir, is not prudent use of state money when each of the medications in Trizivir is available individually, is less expensive, and is more clinically effective than in GSK's fixed dose form."

AHF's concern has been that physicians may continue to prescribe this fixed dose combination as a stand-alone regimen to treatment naive patients, therefore putting those patients at risk. The letter (text included below) intends to raise awareness about this important issue, and encourage states to take action to protect the health of HIV-positive individuals, as well as alert states to the unnecessary costs associated with prescribing this expensive, yet largely ineffective, combination.

Placing TAR procedures on Trizivir, rather than removing it completely from the Medicaid formulary, will still make it available to those for whom it is medically necessary -- the procedure simply requires that a physician fill out a request form if he/she deems it necessary to prescribe the drug. As stated in AHF's letter: "By implementing these procedures, you would ensure that treatment naive patients receive Trizivir only when absolutely medically necessary, and guarantee that better medication regimens are used for the vast majority of patients (thereby increasing health outcomes and maximizing the value of state Medicaid expenditures). At the same time, Trizivir would continue to be readily available for patients already taking HIV/AIDS medications."

In March 2003, the NIH suspended part of a three-arm, two-year government sponsored AIDS Clinical Trials Group Study (ACTG 5095) comparing AZT+3TC+abacavir (the components of Trizivir) to other regimens (Trizivir + Sustiva and Combivir + Sustiva) when early on in the study it found that the Trizivir combination when used as a stand-alone does not protect patients as well as some other combinations of medicines. The Trizivir-only arm of the study was stopped after a percentage of patients experienced virologic failure -- their viral load increased to a dangerous level much sooner than that of the patients in the other two arms of the study.

The full text of AIDS Healthcare Foundation's letter to the Deputy Director of California's Medicaid program follows:

January 5 2006

In light of recent clinical trial results, AIDS Healthcare Foundation would like to re-submit our request for treatment authorization request ("TAR") procedures to be placed on Trizivir, a product used to treat HIV/AIDS.

Our original request was based on the interim results from the Adult AIDS Clinical Trial Group (AACTG) 5095 study. The study was a comparison between Trizivir alone, and a four-drug (Trizivir + efavirenz) and a three-drug (Combivir + efavirenz) regimen. It revealed that subjects given Trizivir alone experienced accelerated virologic failure. To minimize the hazardous effects on subjects, these interim results led to discontinuation of the Trizivir-only arm of the trial, as well as a "Notice to Physicians" from the National Institute of Allergy and Infectious Diseases citing the dangers of prescribing Trizivir as a stand alone therapy in treatment naive patients.

In December 2005, final results for AACTG 5095 revealed still more information regarding patient response to Trizivir, in this case in combination with efavirenz. Dr. Gulick's study revealed no additional benefit from the use of the four-drug regimen (Trizivir + efavirenz) when compared to the three-drug regimen (Combivir + efavirenz). "After a median of 3 years of follow-up, the 3-drug efavirenz regimen proved similar to the 4-drug efavirenz combination with regard to virologic failure rate, time to virologic failure, CD4+ cell count gains, and frequency of grade 3 or 4 side effects."

The AACTG 5095 final results underscore the need for TAR procedures to be placed Trizivir, given the drug's ineffectiveness. We continue to be concerned that physicians not expert in HIV medicine may continue to prescribe it to naive patients, and that such prescriptions will have an adverse fiscal impact on the state

For the above reasons, AHF, a non-profit organization that provides HIV/AIDS medical services to some 17,000 people in the United States, requests that California place appropriate TAR procedures on Trizivir for ARV naive patients. By implementing these procedures, you would ensure that treatment naive patients receive Trizivir only when absolutely medically necessary, and guarantee that better medication regimens are used for the vast majority of patients (thereby increasing health outcomes and maximizing the value of state Medicaid expenditures). At the same time, Trizivir would continue to be readily available for patients already taking HIV/AIDS medications.

Thank you for your attention in this matter. If you have any questions, or require additional information, please do not hesitate to contact my office at 323-860-5200. I look forward to hearing from you.

Sincerely,

Michael Weinstein, President, AIDS Healthcare Foundation

Source: AIDS Healthcare Foundation

The market for new antibiotics and HIV/AIDS treatments was $6.2 billion in 2003 and is rising at an average annual growth rate of 9.1%. It is expected to reach $10.1 billion in 2008 - see Pandemic Control: Resistant Organisms and Emerging Threats for further details.

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