Separate Study Shows Sustained Anti-HIV Benefit at 96 Weeks of Standard Treatment

LISBON, 25 October, 1999 – Preliminary data from a study of HIV-positive patients indicate that a new once-a-day (QD) regimen of the protease inhibitor FORTOVASE^® (saquinavir), when combined with a ‘mini dose’ of ritonavir (another protease inhibitor), achieves therapeutic levels of saquinavir throughout the 24-hour dosing interval.

"By studying the once-a-day FORTOVASE combination regimen in people with HIV, we’ve taken another important step toward making effective treatment more simple for patients," said Dr. Richard Hoetelmans of the Department of Pharmacy and Pharmacology at Slotervaart Hospital, Amsterdam.

The once-a-day FORTOVASE regimen could simplify the treatment schedule and significantly reduce the number of anti-HIV pills a patient must take while maintaining saquinavir blood concentrations. Studies of the once-a-day combination in people with HIV are ongoing.

The study, presented today at the Seventh European Conference on Clinical Aspects and Treatment of HIV-Infection by Dr. Hoetelmans, looked at 7 patients treated with the combination of INVIRASE 400mg BID + ritonavir 400mg BID who were then switched to FORTOVASE 1600mg + ritonavir 200mg QD. The study investigated blood levels of saquinavir as well as HIV levels and key metabolic markers following 14 days of therapy with the once-a-day regimen.

This QD study represents the first insight into how a once-a-day, protease inhibitor-containing regimen actually provides blood plasma levels of anti-HIV drug in people who are HIV-infected. It showed that the once-daily regimen provided therapeutic levels of saquinavir; furthermore, all patients in the study maintained viral suppression (<400 copies/mL) over the 14-day interval.

The FORTOVASE 1600mg QD + ritonavir 200mg QD regimen was generally well-tolerated over the course of the pharmacokinetic study. Importantly, there was also some reduction seen in fasting triglyceride levels (from 3.1 to 2.3 mmol/L; p= 0.067). Many researchers believe that triglyceride and cholesterol elevations and other lipid abnormalities may contribute to long-term problems such as lipodystrophy (the redistribution of body fat associated with some anti-HIV medications), and premature cardiovascular disease.

These results build on the data from the pharmacokinetic study in uninfected volunteers presented at the ICAAC conference last month in San Francisco by Dr. Michael Saag of the University of Alabama - Birmingham.

Dr. Hoetelmans commented that, "In this study, we have pursued the dose of 1600mg FORTOVASE QD with 200mg of ritonavir QD. Based upon our own data, combined with the data on the 1600mg FORTOVASE + 100mg ritonavir presented by Dr. Saag at last month’s ICAAC meeting, we will be further investigating what the optimal ‘mini’ dose of ritonavir should be."

FORTOVASE Shows Long-Term Efficacy, Safety and Durability at 96 Weeks

Reinforcing the power and durability of FORTOVASE, data were also presented that demonstrated a sustained virological response in patients who received FORTOVASE as part of a standard triple-drug regimen after 96 weeks of treatment.

Researchers analyzed data from a total of 83 patients who first participated in the NV 15355 and the SPICE studies, and were ultimately rolled over into a single longer-term trial. Entry criteria for the study included having a viral load of <400 copies/mL at the closure of those studies. The researchers looked at the long-term safety and durability of anti-HIV activity with FORTOVASE as part of a double, triple or quadruple drug regimen.

Of the 16 patients receiving FORTOVASE 1200mg TID in combination with nucleoside analogues and who had evaluable data at 96 weeks therapy, all had a plasma viral load <50 copies/mL and had a mean increase in CD4 count of 338 cells/mL above baseline.