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Press Release

Kivexa® ▼, a new one-a-day combination tablet for treatment of HIV is launched today

GSK
Posted on: 06 Jan 05

Issued Thursday 6th January 2005, London

   

Kivexa (abacavir/lamivudine), the first once-a-day, fixed-dose combination of two nucleoside reverse transcriptase inhibitors (NRTIs) with potent and durable virological control and a low risk of cross resistance, launches in the UK today.

 

Treatment with Kivexa will, in one single daily pill, provide the double NRTI backbone component of triple therapy.  Kivexa contains both the nucleosides Epivir (lamivudine) and Ziagen (abacavir) in the same daily dosage as the existing available components.

 

The major benefit of Kivexa for HIV patients and clinicians, is that it may help to keep future treatment options open. HIV patients require life long treatment to enable them to remain virologically controlled. Even with the most up to date medicines, patients are likely to need a number of therapy changes as resistance mutations arise and their current treatment is no longer efficacious.  The medication they are on at the time of treatment failure determines the mutation type and hence what subsequent treatment options remain efficacious.

 

Using Kivexa in treatment-naïve patients leaves a range of subsequent treatment options open should the patient experience virological failure and require a change of therapy.

 

In addition to this major benefit, clinical studies using the components abacavir and lamivudine in combination as part of an HIV therapy, observed that the drug effectively controls HIV up to 120 weeks with an effective reduction in the viral load and continuing improvement in CD4 count.1 The backbone combination of Epivir and Ziagen has been widely studied and used, resulting in a well established tolerability profile.

 

Commenting on the availability of Kivexa, Anna Maria Gerretti, Consultant Virologist at the Royal Free Hospital in London, said, “Adherence to treatment can be a real problem for people living with HIV. Patients with erratic adherence are at greater risk of developing resistance. Even with very good adherence, a patient is likely to require a change of treatment at some stage. The choice of initial treatment is an important factor in determining the patients’ long term health. ”

 

Dr Eric LeFevre, of GSK, commented: ‘’I am really excited to be involved with the launch of a new product which is not only convenient and efficacious for patients just starting out on their HIV therapy, but may also help to benefit their care in the long term.’’

 

GlaxoSmithKline have an extensive HIV portfolio, now including Kivexa. GSK continue to invest in HIV therapy with a number of new treatments in the pipeline, and continue to support health care professionals in the diagnosis and treatment of HIV. GSK is committed to improving the health of people with HIV and is actively involved in working in partnership with many local community initiatives.

 

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

-ends-

 

For more information please contact Red Door Communications:

Caroline Tatum, 020 8392 8049, ctatum@rdcomms.com

Romilly Cook, 020 8392 8066, rcook@rdcomms.com

 

Notes to editor:

Kivexa is indicated for use in antiretroviral therapy (ART)-naïve as well as treatment-experienced HIV-infected adults.

·          Kivexa is licensed for once a day dosing in antiretroviral combination therapy.

·          The EPV40001 trial demonstrated the equivalence of both 3TC and ABC as once daily components of a triple therapy combination regimen vs. the same triple therapy regimen administered twice daily. The adverse event profile was similar across the treatment arms. 2  The CNA30021 trial, comparing once daily ABC vs. twice daily ABC alongside 3TC + efavirenz (EFV) in HIV patients, showed that the proportion of patients achieving viral load of <50 copies/ml across was similar across both treatment arms.3  There was no increase in the incidence of adverse events with once daily ABC use compared with twice daily. 3

·          A Phase III study, CNA30024, indicated that in treatment naïve patients with HIV, twice daily therapy with ABC + 3TC + efavirenz (EFV) was as effective over 48 weeks for the proportion of patients achieving viral load of <50 copies/ml as a twice daily regimen of zidovudine (AZT) + 3TC + EFV.4  Time to loss of virological response was also similar in both treatment arms.CNA30024 trial Additionally, the CD4+ cell count response was significantly better in the ABC+3TC+EFV group compared to the AZT+3TC+EFZ group, and there were no new safety concerns. 4

·         

KIV/PRL/04/16973/1

No phenotypic cross resistance to tenofovir, ZDV or stavudine was observed in patients with virological failure on first-line ABC QD + 3TC QD +EFV. Furthermore, in 3 pivotal studies, no phentypic cross-resistance to TDF was observed after virological failure on first-line regimens containing ABC BD + 3TC BD +EFV.  5,6,7

 

 

References:

.

1.       Gathe J et al. HIV DART 2004: Frontiers in Drug Development for Antiretroviral Therapies, Montego Bay, Jamaica, December 12-16, 2004

2.       Bowonwatanuwong C et al. A randomised open label study to investigate abacavair and lamivudine as once daily components of a triple combination regimen EPV40001. Poster 004.1st IAS Buenos Aires 2001

3.       Gazzard B, DeJesus E, Cahn P et al Abacavir once daily plus lamivudine in combination with efavirenz is well tolerated and effective in the treatment of antoretroviral therapy naïve adults with HIV-1 Infection . The ZODIAC (CNA30021) study. Oral presentation H1722b. ICAAC 2003, Chicago USA.

4.       DeJesus, E, et al. Clin Infect Dis. 2004; 39: 1038-46.

5.       Craig, C, et al. 7th International Congress on Drug Therapy in HIV Infection, P98, Glasgow, UK, 14-18 November, 2004.

6.        Craig, C, et al. 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, USA, 2004. Poster 551.

7.       Irlbeck, D, et al. 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, California, USA, 2004. Abstract 661.

Editor's Details

Caroline Tatum
Red Door Communications
020 8392 8049
ctatum@rdcomms.com

Last updated on: 27/08/2010

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