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Simple and Compact Ziagen/Combivir Regimen Results in Superior Efficacy Compared to Protease Inhibitor-Based Regimen for the Treatment of HIV.

BASINGSTOKE, England, July 10 /PRNewswire/ --

Shire Pharmaceuticals Group plc (Nasdaq: SHPGY)(LSE: SHP.L, TSE: SHQ) announces that new research findings were presented today regarding a Ziagen/Combivir regimen at the 1st International AIDS Society Conference on HIV Pathogenesis and Treatment.

The new findings show that a 2 tablet twice daily regimen of Ziagen (abacavir) and Combivir (a fixed dose combination of zidovudine and lamivudine), both manufactured by GlaxoSmithKline, provides superior efficacy as compared to the more complex indinavir + Combivir regimen and was associated with better tolerability and improved adherence during 48 weeks of therapy. The results, released for the first time today, highlight the benefit that a regimen, with significant improvements in tolerability and adherence, can have in the treatment of HIV-infected patients.

In the primary efficacy analysis at 48 weeks, (Intent to Treat, Missing/Switch=Failure, viral load <400 copies/mL) the Ziagen + Combivir arm was found to be statistically superior (p=0.002), with 66% of patients achieving an undetectable viral load, compared to 50% of patients taking the PI-based regimen. Conducting the same analysis by viral load strata, demonstrated that Ziagen + Combivir was more effective than the PI-based regimen in patients who entered the study with a plasma viral load <100,000 copies HIV-1 RNA/mL. In patients who had higher plasma viral load at entry (>100,000 copies HIV-1 RNA/mL at baseline), the Ziagen + Combivir combination was at least equivalent to the PI-based regimen.

Commenting on the results, a lead investigator on the study, Assistant Professor, Dr Asda Vibhagool, from Ramathibodi Hospital, Bangkok, Thailand, said:

"For the long-term management of HIV-infected patients, the preferable treatment needs to provide a balance of three essential elements -- potency, adherence and tolerability -- to achieve clinical success. The triple nucleoside option in this study has demonstrated at least equivalent efficacy in patients with both low and high viral load at entry because it is more tolerable due to fewer adverse effects and because it is easy to adhere to due to the simplicity of the regimen."

A total of 72% of subjects in the Ziagen + Combivir group reported >95% adherence, compared with 45% of subjects in the indinavir + Combivir regimen (p<0.001). Fewer drug-related adverse events were reported in the Ziagen + Combivir group compared to the indinavir + Combivir combination -- 65% and 87% respectively (p<0.001).

The 48 week data, comes from a randomised, open-label, multi-centre, equivalence trial, involving 342 therapy-naive adults. The study compared the durability of antiviral response, safety, tolerance and adherence to the triple nucleoside reverse transcriptase inhibitor (NRTI) regimen containing Ziagen + Combivir to the PI indinavir in combination with Combivir. Patients in the Ziagen + Combivir group received four tablets per day; one tablet each of Combivir and Ziagen twice daily, with no food or water requirements. Patients in the indinavir + Combivir group received eight capsules/tablets per day; one Combivir tablet twice daily and two indinavir capsules three times daily, with food and water requirements.

These results demonstrate that the 2 tablet, twice daily Ziagen + Combivir combination is at least as effective as PI-based triple therapy, with the added benefits of simplicity and enhanced patient adherence to therapy. The GlaxoSmithKline fixed-dose combination tablet, Trizivir, containing abacavir, lamivudine and zidovudine, administered as a single tablet twice daily, may further enhance these benefits.

Treatment with Ziagen + Combivir is generally well tolerated. The most serious adverse event associated with Ziagen is a hypersensitivity reaction. Across clinical studies approximately 4% of subjects receiving Ziagen developed a hypersensitivity reaction, usually in the first six weeks of therapy. The presentation is variable but is characterised by the appearance of symptoms indicating multi-organ/body-system involvement. Almost all patients developing hypersensitivity reactions will have fever and/or rash as part of the syndrome, however reactions have occurred without rash or fever. Other symptoms may include but are not limited to nausea, vomiting, diarrhoea, abdominal pain, dyspnoea, cough, sore throat, malaise, lethargy, and myalgia. Patients who develop a hypersensitivity reaction must discontinue Ziagen and must never be rechallenged with Ziagen, or any other medicinal product containing abacavir (Trizivir).

Under agreement, Shire receives royalties from GlaxoSmithKline on sales of lamivudine for use in treatment of HIV/AIDS (3TC/Epivir/Combivir/Trizivir). GlaxoSmithKline has the right to develop, manufacture and sell lamivudine worldwide, except in Canada, where Shire and GlaxoSmithKline have formed a commercialization partnership.

Ziagen, 3TC, Epivir, Combivir, and Trizivir are trademarks of the GlaxoSmithKline group of companies.For further information please contact:


Shire Pharmaceuticals Group plc

Shire is a fast growing international specialty pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, oncology/haematology, antivirals and biologics. The Group has a global sales and marketing infrastructure with a broad portfolio of products and its own direct marketing capability in the US, Canada, UK, Republic of Ireland, France, Germany, Italy and Spain, with plans to add Japan by 2004. Shire also covers the other significant pharmaceutical markets indirectly through distributors.

Shire's interest in the Pacific Rim is managed through Shire's regional office based in Singapore. Shire's global search and development expertise has to date successfully provided 18 marketed products, while the current pipeline of 24 projects includes 9 that are post Phase II. M&A activity of the Group during the past six years has resulted in six completed mergers and acquisitions. To enhance the potential for future growth Shire is actively searching to acquire further development projects as well as marketed products and continues to evaluate M&A opportunities that offer a good strategic fit and add shareholder value.

More details on Shire are available on the Shire website at .

THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties, including but not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialisation, the impact of competitive products, patents, and other risks and uncertainties, including those detailed from time to time in periodic reports, including the Annual Report filed on Form 10K by Shire with the Securities and Exchange Commission.
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Publication:PR Newswire
Geographic Code:4EUUK
Date:Jul 10, 2001
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