Studies investigate ability of Viracept^® to preserve future treatment options in HIV infection

Budapest, Hungary, May 29 2001. At a meeting of international leaders in HIV/AIDS research, the main topic discussed was how to use the response patterns of the HIV virus to antiretroviral drugs and improve the long term treatment outcomes for people living with HIV.

The options explored were the best treatment sequencing strategies for the preservation of future therapy options for people with HIV. ‘Over the last five years we have learned some very important things about the treatment of HIV. Using the drugs available to us today therapy must be life-long and we need to recognize and expect that patients will eventually fail on drug regimens. Therefore, it is critical to wisely chose an initial drug combination based on the ability to preserve subsequent treatment options’ commented Dr. Joseph Gathe, Donald R Watkins Foundation, Houston, Texas, US. ‘The use of nelfinavir (Viracept) first line preserves two sequential future protease inhibitor regimens’.

Among the key data presented were studies which show that the main virus mutation selected by Viracept therapy, known as D30N, is unique and does not confer cross-resistance to other protease inhibitors. This means that in the majority of patients, other protease inhibitors remain effective against HIV after Viracept treatment.

‘HIV virus containing the mutation D30N is less able to replicate than HIV virus previously unexposed to anti-HIV drugs, this increases the likelihood of successful salvage therapy with other protease inhibitors’ said Dr. Bonaventura Clotet, Head of HIV Unit and Director of Retrovirology Laboratory, Fundació irsiCaixa, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain. ‘These virological and clinical data, combined with the excellent efficacy and safety profile, makes nelfinavir a wise choice for initial protease inhibitor therapy.’

Data published recently in the journal AIDS (2001;15:609-615) also report that initial treatment with Viracept may provide HIV patients with more future treatment options.

In addition to the discussions on Viracept data, key studies highlighting the treatment challenges and appropriate use of protease inhibitors boosted with a low dose of ritonavir were also raised at the meeting. Data were presented by Dr. Sharon Walmsley, Associate Director, Immunodeficiency Clinic, Toronto General Hospital, Toronto, Canada on 186 patients from five clinical trials and case studies on the use of 1600mg Fortovase plus low dose ritonavir (Fortovase/r) in a once-daily regimen.

The overall efficacy results of once-daily Fortovase/r from these five clinical trials demonstrated that the virus levels of more than 80% of the patients were reduced to less than 400 copies per ml within 24 weeks. An improvement in the ability of patients to adhere to therapy by switching to once- daily Fortovase/r was also demonstrated.

‘There are many people living with HIV who, for various lifestyle or medical reasons, may be able to comply or adhere to therapy better with once-daily regimens’ said Dr. Sharon Walmsley. ‘The once-daily Fortovase/r treatment regimen may also reduce toxicity and cut therapy costs.’

The studies with once-daily Fortovase/r have generated no major safety concerns to date. Limited shifts in plasma lipid levels have occurred over 24 weeks and the majority of adverse events seen were gastrointestinal (nausea, vomiting, diarrhoea) in nature.

‘This clinical update has provided both physicians and patients with information to help address some of the challenging aspects of treating HIV/AIDS, including strategies to successfully sequence protease inhibitors and enhance long-term suppression of the virus,’ said Dr. Anton Pozniak, Consultant Physician, Department of HIV/GU Medicine, Chelsea and Westminster Hospital, London, UK, when closing the symposium. ‘The extremely promising data on the use of Fortovase/r as once-daily therapy offers a new effective and tolerable option which is likely to benefit many people affected by this virus’.

-ENDS-

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