European Commission approves GlaxoSmithKline’s HIV triple therapy Trizivir
17 January 2001. Related: Antiretrovirals.
The European Commission (EU) has approved GlaxoSmithKline’s triple combination HIV therapy Trizivir, the company announced on Thursday. The product, which combines abacavir (Ziagen), lamivudine (Epivir), and zidovudine (Retrovir), will be launched in the United Kingdom within the next 2 weeks and gradually rolled out in the other 14 EU member states.
Citing varying pricing policies between EU member states, a GlaxoSmithKline spokesman was unable to say whether the combination product would be any cheaper than taking the 3 drugs individually.
In a statement, the company said that “It is recommended that treatment is started with abacavir, lamivudine, and zidovudine separately for the first 6 [to] 8 weeks. The choice of Trizivir should be based not only on potential adherence criteria but mainly on expected efficacy and risk related to the 3 compounds.”
Demonstration of benefit of Trizivir is mainly based on results of studies performed in treatment naive patients with non-advanced disease. In treatment experienced patients and those with higher viral load (greater than 1000,000 copies/mL) choice of therapy needs special consideration.
The most common side-effects are gastrointestinal symptoms (nausea with or without vomiting and diarrhoea). As Trizivir contains abacavir all warnings and cautions regarding abacavir hypersensitivity reactions apply. This includes never interrupting and restarting treatment.
Trizivir is already approved in the United States, Mexico, Chile, Ghana, and Malawi.
“…a GlaxoSmithKline spokesman was unable to say whether the combination product would be any cheaper than taking the 3 drugs individually ” Patients, health care providers and treatment activists will be surprised and delighted if Trizivir is priced cheaper than zidovudine, lamivudine and abacavir prescribed separately.
The (expected) increased prescribing costs of Trizivir should require properly controlled clinical trials demonstrating adherence and other benefits over the separate components. Data showing a clear advantage would allay concerns that such incestuous co-formulating is driven primarily by marketing concerns rather than patient need.
The European Commission (EU) has approved GlaxoSmithKline’s triple combination HIV therapy Trizivir, the company announced on Thursday. The product, which combines abacavir (Ziagen), lamivudine (Epivir), and zidovudine (Retrovir), will be launched in the United Kingdom within the next 2 weeks and gradually rolled out in the other 14 EU member states.
Citing varying pricing policies between EU member states, a GlaxoSmithKline spokesman was unable to say whether the combination product would be any cheaper than taking the 3 drugs individually.
In a statement, the company said that “It is recommended that treatment is started with abacavir, lamivudine, and zidovudine separately for the first 6 [to] 8 weeks. The choice of Trizivir should be based not only on potential adherence criteria but mainly on expected efficacy and risk related to the 3 compounds.”
Demonstration of benefit of Trizivir is mainly based on results of studies performed in treatment naive patients with non-advanced disease. In treatment experienced patients and those with higher viral load (greater than 1000,000 copies/mL) choice of therapy needs special consideration.
The most common side-effects are gastrointestinal symptoms (nausea with or without vomiting and diarrhoea). As Trizivir contains abacavir all warnings and cautions regarding abacavir hypersensitivity reactions apply. This includes never interrupting and restarting treatment.
Trizivir is already approved in the United States, Mexico, Chile, Ghana, and Malawi.
“…a GlaxoSmithKline spokesman was unable to say whether the combination product would be any cheaper than taking the 3 drugs individually ” Patients, health care providers and treatment activists will be surprised and delighted if Trizivir is priced cheaper than zidovudine, lamivudine and abacavir prescribed separately.
The (expected) increased prescribing costs of Trizivir should require properly controlled clinical trials demonstrating adherence and other benefits over the separate components. Data showing a clear advantage would allay concerns that such incestuous co-formulating is driven primarily by marketing concerns rather than patient need.