Studies Also Highlight Real-World VIRACEPT Experience, Effectiveness

LISBON, 26 October, 1999 – A new study exploring ways to simplify HIV treatment and enhance patient convenience has shown that twice-daily dosing of the protease inhibitor VIRACEPT (nelfinavir mesylate) is as effective as its standard three-times daily dose. Data presented today show that VIRACEPT, administered in a convenient 1250mg twice-daily (BID) dose, offered equivalent, sustained efficacy and safety at up to 96 weeks of therapy compared to its standard dose.

The VIRACEPT twice-daily study demonstrates that physicians can offer patients therapy that is much easier to live with and is effective long-term against HIV. The VIRACEPT BID study illustrates that physicians can make long-term anti-HIV therapy more convenient to help patients succeed on treatment without sacrificing potency.

These data, combined with important new insight from last month’s ICAAC meeting in San Francisco illustrating that VIRACEPT induced the least amount of HIV cross-resistance when compared to all other currently available PI’s, continue to support the power, tolerability and flexibility of VIRACEPT in real-world settings.

The VIRACEPT BID study, presented today at the Seventh European Conference on Clinical Aspects and Treatment of HIV-Infection, evaluated 554 HIV-positive individuals who had received less than 6 months prior antiretroviral therapy. Trial participants were randomized to receive either VIRACEPT 1250mg twice daily or VIRACEPT 750mg three times daily, in combination with the nucleoside analogues (NAs) d4T and 3TC. Baseline characteristics indicated that participants had a high median baseline viral load of 100,000 copies/mL and a median CD4 cell count of 296 cells/mm3.

The data showed that, at both 48 and 96 weeks, patients receiving the VIRACEPT twice-daily dose experienced results that were quite comparable to those patients receiving the standard VIRACEPT three-times-a-day dose. Standard and ultrasensitive viral load measurements, as well as CD4 cell counts, all reflected this parallel trend.

Both doses of VIRACEPT were equally well-tolerated. Only four cases of fat redistribution disorders were reported in each treatment group during the initial
48-week study period

A sub-study measuring VIRACEPT blood levels of patients also indicated that the twice-daily dosing regimen maintained VIRACEPT at therapeutic concentrations throughout the dosing interval.

For further information on this study, please refer to the accompanying VIRACEPT data backgrounder.


Pan-European Studies Support Real-World Treatment Success with VIRACEPT

Data from three studies from the United Kingdom, Italy and Spain highlighted VIRACEPT advantages in real-world settings. These data, combined with data from controlled clinical trials, continue to support VIRACEPT safety, efficacy and durability.

A study of 690 patients at Chelsea and Westminster Hospital, London, the largest HIV clinic in Europe, compared how various protease inhibitors impact overall treatment success in the real world, outside the clinical setting. The study, which looked at anti-HIV effectiveness and tolerability, found that VIRACEPT achieved the highest rate of HIV-RNA suppression and the lowest patient discontinuation rate among all PI’s studied, as well as compared to nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI). At 6 months, 81% of patients receiving VIRACEPT had viral load measurements below 500 copies/mL; only 17% of VIRACEPT patients discontinued therapy during the course of the study. For further information on this study, please refer to the accompanying VIRACEPT data backgrounder.

A prospective, multicenter study of 1,209 patients in conjunction with 10 Italian Departments of Infectious Diseases examined how often adverse events were experienced by people receiving PI-containing regimens, and to what degree these adverse events led to treatment discontinuation. The study found that patients receiving VIRACEPT experienced the lowest incidence of adverse events leading to discontinuation (22%); conversely, 48% of patients receiving ritonavir and 38% of those receiving indinavir, respectively, discontinued therapy due to adverse events.

The most common adverse events with VIRACEPT in this trial were gastrointestinal, although the incidence rate was lower than that reported with either of the ritonavir regimens used in the cohort. However, data on VIRACEPT side-effect management presented last month at ICAAC indicated that these gastrointestinal effects could be minimized largely by administration of calcium dietary supplements or psyllium.

A third study examined the effectiveness of VIRACEPT therapy in 26 patients in clinics in Spain who had never received anti-HIV treatment. The study found that VIRACEPT combined with 2 NAs led to suppression of HIV viral load below 400 copies/mL in 96% of patients after 6 months of treatment. No serious adverse events were reported and no patients discontinued VIRACEPT therapy over the period of follow-up, underlining the tolerability of this regimen.


Roche – Innovating Healthcare

The cutting-edge data optimizing VIRACEPT convenience while maintaining its power, and the growing database of real-world success stories resulting from VIRACEPT therapy, illustrate Roche’s ongoing commitment to helping people with HIV succeed on their anti-HIV treatments.