Studies continue to support the effectiveness, durability, and ease-of-use of FORTOVASE^® (saquinavir). FORTOVASE is an enhanced formulation of INVIRASE^® (saquinavir mesylate). The most recent data on FORTOVASE were presented at the 6^th Conference on Retroviruses and Opportunistic Infections in Chicago; they demonstrated both the potency and the durability of FORTOVASE’s anti-HIV effect in combination regimens. These data were again presented in Geneva during the European Launch Symposium for FORTOVASE on May 8, 1999.

FORTOVASE: Consistent, Powerful Outcome

The TIDBID Study (M61018)

Data have been presented showing the continued effectiveness of twice-daily dosing of FORTOVASE as part of a triple combination regimen. This 48-week randomized, open-label, multicenter study compared FORTOVASE 1200 mg TID + 2 new nucleoside analogs (NAs) to either FORTOVASE 1600 mg BID + 2 new NAs or FORTOVASE 1200 mg BID + VIRACEPT 1250 mg BID + 1 new NA. Subjects were antiretroviral-naïve or NA-experienced (but naïve to at least one NA) with HIV-RNA level >5,000 (3.7 log₁₀) and no CD4 restrictions. The study includes an option to intensify treatment at week 16.

These preliminary data support the potency of twice-daily administration of FORTOVASE. Providing twice-daily regimens will make it easier for people infected with HIV to adhere to their treatment regimens by making these regimens more convenient while retaining the dramatic survival benefits of protease inhibitors.

The NV 15355 Study

One of the driving forces behind the novel data analyses being undertaken by Roche and the clinical investigators involved in the FORTOVASE studies is to provide information which will allow physicians to further improve upon the results being achieved with FORTOVASE. In the case of NV 15355, Roche and the clinical investigator team have identified predictive indicators of potential treatment success or failure. These indicators can guide physicians and patients in making informed decisions designed to achieve maximum treatment success.

NV 15355 is an open-label study designed to compare the effects on viral load of the hard-gel capsule formulation of saquinavir (INVIRASE) -- to the enhanced soft-gel capsule formulation of saquinavir (FORTOVASE) -- in the antiretroviral-naïve individuals (viral load >5,000 (4.40 log₁₀) copies/ml) when used in combination with two nucleoside reverse transcriptase inhibitors (nRTIs).

Dr. C Tsoukas of Montreal General Hospital, Montreal, has presented data showing that using on treatment analysis, 80% of subjects taking FORTOVASE were <400 copies/ml and 75% were <50 copies/ml at week 72. Using the most stringent analysis (ITT with missing values equals failure),¹ 50% of subjects taking FORTOVASE subjects maintained <400 copies/ml and 47% maintained <50 copies/ml at week 72. These data again highlight the durability of FORTOVASE-containing combination regimens.

NV 15355 is one of the first studies to actually provide this insight into the predictive value of crossing the 400/ml and 50 copies/ml levels of viral suppression. Specifically, subjects who did not reach <400 copies/ml at week 12 were at risk of virologic failure by week 72. Week 12 seems to be too soon to predict virology failure at week 72 for those who did not reach <50 copies/ml, however inability to reach <50 copies/ml at week 24 was predictive of virologic failure at week 72.