Fortovase Twice A Day vs Three Times a Day

Cal Cohen reported on preliminary 24 and 48 week data for the TIDBID study which compares a Fortovase twice daily regimen with a Fortovase 3 times per day regimen and a regimen containing Fortovase (FTV) twice daily combined with nelfinavir twice daily.

This is a randomized, open-label, phase III study which plans to enroll 825 people. The study primary endpoint is 24 weeks with a treatment extension to 48 weeks. Patients were stratified by baseline viral load: 5,000 to 30,000 copies/ml vs >30,000 copies/ml. The patients were also stratified by treatment naïve vs experienced but I’m only reporting the naïve data here. There were about 3 times as many naïve enrolled in study than experienced. The range of viral loads in the <30,000 strata was about 2100 to 30,000 and in the >30,000 strata it was 30,000 to about 3 million.

The study compared:

Baseline: As reported by investigators the mean baseline viral loads including all study participants (naïve & experienced) were about 60,000 copies/ml in the FTV TID regimen, 52,000 in the FTV BID regimen, and 57,000 in the FTV+NFV arm. The mean CD4s were about 312 in each arm.

Discontinuations: Investigators reported 8%, 11% and 12% failed to return in the FTV TID, FTV BID, and FTV+NFV BID arms, respectively. Discontinuations for adverse events were 5%, 7%, and 9% in the 3 arms, respectively.

Viral Load Results:

Adverse events: