New HIV listings added to Pharmaceutical Schedule

Consumer Media Release
March 14 07

Gilead - Viread and Emtriva PHARMAC listings

New HIV listings added to Pharmaceutical Schedule

From April 1 2007, Viread R (tenofovir disoproxil fumarate) and Emtriva R
(emtricitabine) will be available on the PHARMAC Pharmaceutical Schedule Sections B and H.

Viread and Emtriva are new options in HIV management in New Zealand.
Viread as well as Emtriva are for use in combination with other HIV medications for the treatment of HIV infection in adults. Viread is provided as a tablet and is dosed as one tablet, taken once daily, with or without food. Emtriva is a capsule and dosed as one tablet, taken once daily with or without food.
Both Viread and Emtriva can be taken together along with a third agent as part of combination HIV therapy.

Dr Mark Thomas commenting on the availability of these new agents Viread and Emtriva said that, “Once daily regimens are an advantage for HIV treatments because of the important aspects in regards to adherence”
Viread, the first in a new class of antiretroviral agents, the nucleotide analogues and
has a similar mechanism of action to the nucleoside reverse transcriptase inhibitors (NRTIs).

Viread possesses a unique viral resistance profile, has proven efficacy in all stages of HIV infection, including patients with multiple drug resistant virus and has demonstrated excellent short and long-term tolerability and is administered in a simple one-pill once-daily formulation.1

Emtriva is one of the most potent nucleoside agents2, staying in the body well in excess of the 24 hour dosing period. It has a mean intracellular half life of 39 hours and a long plasma half life (10 hours) where plasma levels exceed IC90 for longer than 80 hours. This means that Emtriva supports confident once daily dosing.

Dr Richard Meech said Viread and Emtriva offer valuable new treatment options for patients, many of whom may now have limited or no treatment options due to viral resistance or treatment limiting toxicity with currently available HIV medications and with the recent numbers of people diagnosed with HIV this year having these drugs available is positive.

On the basis of the latest evidence, Viread and Emtriva have been elevated to preferred drug status in all major HIV treatment guidelines (International AIDS Society Treatment Guidelines, the US Department of Health and Human Services HIV Treatment Guidelines and the British HIV Treatment Guidelines).

The most common adverse events of Viread and Emtriva are nausea, vomiting and fatigue.

Viread and Emtriva come in pack sizes of 30. Viread tablets are 300mg and Emtriva are 200 mg.

Viread and Emtriva are registered trademarks of Gilead Sciences, Inc

References

Data Sheets and where available

1. Viread Data Sheet

2.Saag,M et al Efficacy and Safety of emtricitabine vs stavudine in combination therapy with antiretroviral naïve patients. JAMA, July 2004 Vol 292, No2 pp180-190

3. Dr Richard Meech is with the Hawkes Bay District Health Board and Dr Mark Thomas is with the Infectious Diseases Unit at Auckland Hosipital

Issued by Ogilvy Public Relations Worldwide on behalf of Gilead Sciences

For Further information contact:

Rachel Robertson
Ogilvy PR
(09) 358 8221
(021) 920 293

References

Data Sheets and where available

1.Saag,M et al Efficacy and Safety of emtricitabine vs stavudine in combination therapy with antiretroviral naïve patients. JAMA, July 2004 Vol 292, No2 pp180-190

2.Gallant J E et al. Tenofovir DF, Emtricitabine, and Efavirenz vs. Zidovudine, Lamivudine, and Efavirenz for HIV. New England Journal of Medicine 2006 ;354 :251-60

3.Pozniak A L et al. Tenofovir disoproxil fumarate, emtricitabine and efavirenz versus fized-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patinets. Virologic, immunologic and morphologic changes: A 96 week analysis. J Acquir Immune Defic Syndr 2006;00:000-000

EMTRIVA capsules are a Prescription Medicine containing emtricitabine 200 mg

EMTRIVA belongs to a group of antiviral medicines, called nucleoside reverse transcriptase inhibitors (NRTIs). And is used to treat Human Immunodeficiency Virus (HIV) infection in adults. This medicine must be taken in combination with other anti-HIV medicines.
Do not use if you are allergic to emtricitabine or any of the other ingredients of EMTRIVA.

Do not take EMTRIVA if you are over the age of 65 before discussing this with your doctor.

You must tell your doctor if you are allergic to foods, dyes, preservatives or any other medicines, if you are pregnant, trying to become pregnant or breast feeding, if you have or have ever had liver problems including hepatitis B infection, if you have or have ever had kidney problems..
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Side effects can include Headache, Nausea, Diarrhoea, Muscle pain and weakness, Dizziness, Skin rash, Changes in skin colour on the palms of the hands or soles of the feet, Fatigue/Tiredness, Difficulty sleeping, Abnormal dreams, Pain, Vomiting and Problems with digestion.

Redistribution, accumulation or loss of body fat may occur in people receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.

Tell your doctor immediately if you experience Severe stomach pain or cramps, Nausea or Vomiting or if you experience fast breathing
Tell your doctor or pharmacist if you notice any of these symptoms or if you get other side effects while taking EMTRIVA.

Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of drug resistance.
This medicine is Fully Funded after it has been prescribed by a doctor who specialises in the treatment of HIV infection. If you wish to continue receiving treatment with EMTRIVA it is important you remain under the care of a hospital or doctor who specialises in the treatment of HIV infection.

Distributed in New Zealand by :
Gilead Sciences (NZ)
Level 23, 188 Quay Street
Auckland

VIREAD film coated tablets are a Prescription Medicine containing Tenofovir 300mg.
VIREAD belongs to a group of antiviral medicines, called nucleotide reverse transcriptase inhibitors and is used to treat Human Immunodeficiency Virus (HIV) infection in adults. This medicine must be taken in combination with other anti-HIV medicines

Do not use if you are allergic to tenofovir, tenofovir disoproxil fumarate or any of the other ingredients of VIREAD tablets.
Do not take VIREAD tablets if you are under the age of 18 years or over the age of 65 before discussing this with your doctor.

You must tell your doctor if you are allergic to foods, dyes, preservatives or any other medicine, if you are pregnant, trying to become pregnant or breast feeding, if you have or have ever had kidney problems, you have or have ever had abnormal bones or bone difficulties. Or if yu have Hepatitis B.

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop, if you are taking didanosine.

Side Effects can include Nausea, Diarrhoea, Vomiting, Flatulence, Dizziness, Fatigue/tiredness, Headache, Skin rash or Difficulty breathing.
Redistribution, accumulation or loss of body fat may occur in people receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat

Tell your doctor immediately if you experience Severe stomach pain or cramps, Nausea or Vomiting or if you experience fast breathing.
Tell your doctor or pharmacist if you experience any of these symptoms or if you notice anything else that is making you feel unwell, even if it is not on this list.

Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of drug resistance
This medicine is Fully Funded after it has been prescribed by a doctor who specialises in the treatment of HIV infection. If you wish to continue receiving treatment with VIREAD it is important you remain under the care of a hospital or doctor who specialises in the treatment of HIV infection.

Distributed in New Zealand by :
Gilead Sciences (NZ)
Level 23, 188 Quay Street
Auckland

TAPS : PP3859

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