segunda-feira, março 06, 2006
O acesso alargado ao TMC125
O estudo DUET está também previsto em Portugal.
ATAC 06.03.06
NEW DRUGS CAN SAVE LIVES; AIDS Activists Urge Tibotec to be Compassionate towards HIV Salvage Patients
NEW YORK, NY (March 6, 2006) – The AIDS Treatment Activists Coalition , seeking to expand access to new drugs for people living with HIV who have run out of treatment options, is urging Tibotec Pharmaceuticals, a subsidiary of Johnson and Johnson, to provide compassionate access to their TMC 125 non nucleoside HIV investigational drug. Compassionate access is often the difference between life and death to help those patients.
Tibotec is the first company in the battle against AIDS to have two promising new drugs simultaneously under development (TMC 114, a protease inhibitor, and TMC 125, a non-nucleoside). Access to more than one active drug has shown to improve HIV control in patients with multiple-drug resistance. In separate studies, both drugs have shown to help reduce viral replication in treatment experienced patients. A small pilot study has shown that the combination of the two can suppress the virus to undetectable levels in patients who have failed all commercially available drugs without success.
ATAC and the European Community Advisory Board (ECAB) met with Tibotec a year ago, where they requested early access to the TMC drugs in combination for those who have run out of treatment options in a separate open label study that would not expose patients to the risk of having only one active agent. Unfortunately, Tibotec decided to open a 24-week forced placebo controlled study (DUET) that provides a 50 % chance of getting TMC 114 as a sole active agent. While ATAC appreciates Tibotec’s decision to combine both of their drugs in a study, it cautions that the placebo arm will fail to help those HIV patients most in need.
“Patients that have developed HIV drug resistance to all commercially available antiretroviral medications require access to at least two new active drugs to maximize their chances for treatment response and survival,” said Nelson Vergel, a salvage patient who founded SalvageTherapies.org and board member of the AIDS Treatment Activist Coalition. “Previous studies have shown that patients that start at least two new active drugs with an optimized background therapy (OBT) had a better response than those who only started one active drug with OBT.”
Drug resistance and its impact on HIV treatment is a major concern among AIDS activists. Most often antiretroviral medications stop working as a result of drug resistance. In fact, national statistics show that at least 46 % of people failing HIV medications and 13% of newly diagnosed have drug resistance. Some estimate the number of people living with multiple drug resistance that are taking their fourth HIV drug regimen at 64,000 in the United States.
According to Rob Camp, treatment activist with the Treatment Action Group (TAG) and ATAC, “When patients do not have any active agents in their OBT, adding a new active drug to that OBT is considered to be ‘sequential’ or ‘virtual mono-therapy.’ As observed in previous POWER studies, many of the 600 patients to be randomized to Tibotec’s placebo arm will obtain some degree of viral suppression in the short term, but benefits will be short-lived and resistance to TMC 114 will emerge in the 24 week time for those with no active agent in their OBT. This problem will limit the use of TMC 114 in the future as part of a fully suppressive regimen”
The DUET studies are important clinical trials for Tibotec; they need to be completed successfully so that etravirine (TMC 125) can be approved. They are also placebo-controlled studies. This means that half of the group of patients will receive etravirine (TMC 125) and the other half will receive a placebo of TMC 125. However, patients in both groups will receive darunavir (TMC 114) and OBT (any approved nucleoside reverse transcriptase inhibitor and/or the entry inhibitor Fuzeon).
Another option soon in the horizon is Merck’s integrase inhibitor which will be available through their phase III study. Patients will be allowed to use TMC 114 in this study, but the risks of virtual monotherapy are 33%, with a 16 week roll over time if patients fail on the OBT only arm.
For more information about this and other options for patients with multiple drug resistance, visit www.salvagetherapies.org
ATAC is a national coalition of AIDS activists, many living with HIV/AIDS working together to end the AIDS epidemic by advancing research and access in HIV/AIDS. For additional information about ATAC or salvage treatment options, contact Nelson Vergel by phone at 713-539-1978, or email at nelsonvergel@aol.com.
ATAC 06.03.06
NEW DRUGS CAN SAVE LIVES; AIDS Activists Urge Tibotec to be Compassionate towards HIV Salvage Patients
NEW YORK, NY (March 6, 2006) – The AIDS Treatment Activists Coalition , seeking to expand access to new drugs for people living with HIV who have run out of treatment options, is urging Tibotec Pharmaceuticals, a subsidiary of Johnson and Johnson, to provide compassionate access to their TMC 125 non nucleoside HIV investigational drug. Compassionate access is often the difference between life and death to help those patients.
Tibotec is the first company in the battle against AIDS to have two promising new drugs simultaneously under development (TMC 114, a protease inhibitor, and TMC 125, a non-nucleoside). Access to more than one active drug has shown to improve HIV control in patients with multiple-drug resistance. In separate studies, both drugs have shown to help reduce viral replication in treatment experienced patients. A small pilot study has shown that the combination of the two can suppress the virus to undetectable levels in patients who have failed all commercially available drugs without success.
ATAC and the European Community Advisory Board (ECAB) met with Tibotec a year ago, where they requested early access to the TMC drugs in combination for those who have run out of treatment options in a separate open label study that would not expose patients to the risk of having only one active agent. Unfortunately, Tibotec decided to open a 24-week forced placebo controlled study (DUET) that provides a 50 % chance of getting TMC 114 as a sole active agent. While ATAC appreciates Tibotec’s decision to combine both of their drugs in a study, it cautions that the placebo arm will fail to help those HIV patients most in need.
“Patients that have developed HIV drug resistance to all commercially available antiretroviral medications require access to at least two new active drugs to maximize their chances for treatment response and survival,” said Nelson Vergel, a salvage patient who founded SalvageTherapies.org and board member of the AIDS Treatment Activist Coalition. “Previous studies have shown that patients that start at least two new active drugs with an optimized background therapy (OBT) had a better response than those who only started one active drug with OBT.”
Drug resistance and its impact on HIV treatment is a major concern among AIDS activists. Most often antiretroviral medications stop working as a result of drug resistance. In fact, national statistics show that at least 46 % of people failing HIV medications and 13% of newly diagnosed have drug resistance. Some estimate the number of people living with multiple drug resistance that are taking their fourth HIV drug regimen at 64,000 in the United States.
According to Rob Camp, treatment activist with the Treatment Action Group (TAG) and ATAC, “When patients do not have any active agents in their OBT, adding a new active drug to that OBT is considered to be ‘sequential’ or ‘virtual mono-therapy.’ As observed in previous POWER studies, many of the 600 patients to be randomized to Tibotec’s placebo arm will obtain some degree of viral suppression in the short term, but benefits will be short-lived and resistance to TMC 114 will emerge in the 24 week time for those with no active agent in their OBT. This problem will limit the use of TMC 114 in the future as part of a fully suppressive regimen”
The DUET studies are important clinical trials for Tibotec; they need to be completed successfully so that etravirine (TMC 125) can be approved. They are also placebo-controlled studies. This means that half of the group of patients will receive etravirine (TMC 125) and the other half will receive a placebo of TMC 125. However, patients in both groups will receive darunavir (TMC 114) and OBT (any approved nucleoside reverse transcriptase inhibitor and/or the entry inhibitor Fuzeon).
Another option soon in the horizon is Merck’s integrase inhibitor which will be available through their phase III study. Patients will be allowed to use TMC 114 in this study, but the risks of virtual monotherapy are 33%, with a 16 week roll over time if patients fail on the OBT only arm.
For more information about this and other options for patients with multiple drug resistance, visit www.salvagetherapies.org
ATAC is a national coalition of AIDS activists, many living with HIV/AIDS working together to end the AIDS epidemic by advancing research and access in HIV/AIDS. For additional information about ATAC or salvage treatment options, contact Nelson Vergel by phone at 713-539-1978, or email at nelsonvergel@aol.com.
