Study Highlights Treatment Efficacy, Tolerability and Sequencing benefits of Viracept

Scottsdale US, June 8, 2001 - New data presented at an oral session during the 5th International Workshop on HIV Drug Resistance and Treatment Strategies, highlight the ability of Viracept (nelfinavir) to reduce the levels of HIV in the blood within first line therapy. Viracept, a widely used agent within initial HIV treatment, was shown to be of similar efficacy and tolerability to efavirenz, with the benefit of retaining further treatment options within its drug class.

‘While this study was designed to evaluate treatment switching, it is important to note the same proportion of patients in each stable treatment arm achieved a reduction in HIV to below the level of the assay detection and that tolerability was similar. Although no patients failed therapy due to drug resistance in the switching arm, treatment switching remains an innovative investigational strategy requiring further study.’ said Dr. Bonaventura Clotet, Head of HIV Unit and Director of Retrovirology Laboratory, Fundació irsiCaixa, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain. ‘The virological and clinical data for Viracept means that there is an increased likelihood of successful salvage therapy with other protease inhibitors if therapy is initiated with Viracept versus other PIs and this factor, combined with the excellent efficacy and safety profile, makes Viracept a wise choice for initial protease inhibitor therapy.’

The SWATCH study is an ongoing multicentre international trial which randomized 161 patients to one of three arms:

• d4T + ddi + efavirenz- (arm A)
• AZT+ 3TC + Viracept (nelfinavir)-(arm B)
• Switching between arm A and arm B every 3 months (arm C)

Data was presented on the 116 patients who have completed 48 weeks of therapy. An intent-to-treat analysis demonstrated that 60.5% of patients in both stable arms had less than 400 HIV-1 RNA copies/mL at week 48. The number of patients who discontinued from the study or required a change in therapy due to adverse events was the same in all three groups. A statistically significant increase in total cholesterol and triglycerides from baseline was seen in arm A after six months of therapy. This was the patient group who initiated continuous treatment with efavirenz, while no increase was observed in the patient arm on continuous Viracept therapy.

All the eight patients who failed to respond to therapy on the efavirenz stable arm had developed resistance to efavirenz, leaving no further treatment options from the current NNRTI class of anti-HIV drugs. The seven patients on the Viracept stable arm mainly acquired resistance to 3TC (lamivudine).

A significant increase in CD4 cells was seen in all arms and drug adherence was similar in the three treatment groups.

-ENDS-

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