The new regimen offers potent boosted efficacy with impressive tolerability

Basel, Switzerland, 19 June — Roche today announced that the Committee for Proprietary Medicinal Products (CPMP) has granted a positive opinion for both INVIRASE™ and FORTOVASE™ (saquinavir) to include co-administration with a low dose of ritonavir for the treatment of human immunodeficiency virus (HIV). It is anticipated that the corresponding Commission Decision is expected by the end of August 2002* enabling for the first time the use of this newly recommended "boosted" saquinavir regimen across the EU.

The new schedule allows for the use of both saquinavir formulations, INVIRASE™ and FORTOVASE™, at a new dosage of 1000mg BID in combination with ritonavir 100mg BID. The new saquinavir/ritonavir schedule is also recommended in the new draft WHO guidelines "Scaling up antiretroviral therapy in resource limited settings: Guidelines for a public health approach".

The positive recommendation for the new regimen was based upon preliminary data from the maxCmin 1 study comparing the new boosted saquinavir regimen with ritonavir-boosted Crixivan. The 24-week data for this study showed that the boosted saquinavir regimen was effective in reducing the level of HIV in the blood to undetectable levels in 76% of patients versus 61% in the boosted Crixivan arm. There were fewer discontinuations due to adverse events in the boosted saquinavir arm of the maxCmin 1 study versus the boosted Crixivan arm, underscoring the exceptional tolerability of boosted saquinavir in this newly recommended 1000/100mg BID schedule.

"The new boosted 1000/100 saquinavir/ritonavir BID regimen will offer people living with HIV a convenient, highly effective treatment option with a favorable safety profile. The good tolerability of this new boosted dosage of saquinavir should allow patients to stay on their medication more easily, with a positive impact on their quality of life," said Dr. Mike Youle, Director of AIDS Research, Royal Free Hospital, London.

Saquinavir is a member of the class of anti-HIV drugs known as protease inhibitors (PIs). PIs block a part of the HIV reproduction process involving the HIV protease, thus preventing the formation of new infectious HIV particles . Saquinavir is almost always used in combination with at least two other anti-HIV drugs and has been shown to significantly improve survival and reduce the occurrence of AIDS defining events for people infected with HIV. Saquinavir is not a cure for HIV.

Boosting saquinavir with low doses of ritonavir allows more saquinavir to be absorbed into the blood and keeps saquinavir in the body for longer. The benefit for patients is that using this approach it is possible to reduce the dosing frequency together with the required number of capsules while still maintaining therapeutic drug levels.

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche’s innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people’s well-being and quality of life.

Editors’ Note:

Full prescribing information available upon request.

* The expected Commission Decision is valid for all EU countries, including Norway and Iceland. For all EU enlargement countries (CADREAC), an application will be submitted after the Commission Decision is available.

Lizz Fort, Ketchum                                Iris Wiesel, Roche
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