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WORLD AIDS CONFERENCE: Crixivan + Efavirenz Combo Shows Good One-Year Efficacy GENEVA, SWITZERLAND -- July 2, 1998 -- AIDS researchers announced new results from two studies combining the potent HIV protease inhibitor, Crixivan(R) (indinavir sulfate), with a once-a-day, investigational non-nucleoside reverse transcriptase inhibitor, efavirenz, which show the combination is able to suppress HIV levels below detection for over one year. The first study showed sustained anti-HIV effectiveness with 89 percent of patients on Crixivan dosed every eight hours combined with efavirenz having HIV levels suppressed below detection (less than 400 copies/mL) for 60 weeks. A second combination study that used Crixivan dosed twice-daily showed 86 percent of patients had undetectable virus (under 400 copies/mL) after 16 weeks of treatment. Clinical studies of Crixivan in combination with efavirenz have demonstrated strong anti-HIV effects and a good tolerability profile in results presented at the conference. All treatment groups reported similar side effects, including nausea, diarrhea, fatigue and rash. After more than one year of treatment (60 weeks), 89 percent of patients who originally received Crixivan dosed at 1,000 mg every eight hours and efavirenz (600 mg once-daily) had levels of HIV below 400 copies/mL, compared to 68 percent of patients in the group that initially received Crixivan alone, and added efavirenz and d4T(b) after week 12. Patients were originally randomised to receive Crixivan three-times-a-day either alone or in combination with efavirenz. Longer-term data out to a year and a half (72 weeks) will be presented at the conference. The study included 101 patients who had not previously been on a protease inhibitor or on a non-nucleoside reverse transcriptase inhibitor, although 71 percent had prior treatment experience with a nucleoside reverse transcriptase inhibitor (nRTI) such as AZT. Current standard dosing of Crixivan is 800 mg every eight hours. A second study compared twice-daily Crixivan (1,200 mg every 12 hours) in combination with twice-daily efavirenz (300 mg every 12 hours) to standard dosing of Crixivan (800 mg every eight hours) combined with efavirenz dosed once-a-day. After 16 weeks of therapy, 86 percent of patients in the twice-daily group had HIV suppressed below detection (400 copies/mL) compared to 75 percent in the group receiving standard dosing of Crixivan. "If the combination of Crixivan and efavirenz continues to demonstrate long-term efficacy and tolerability it might become a regimen to consider for use as first-line therapy for patients with HIV," said Douglas Mayers, M.D., division head, division of infectious diseases, Henry Ford Hospital, Detroit, Michigan and investigator on the study. Additional results from a twice-daily dosing study of Crixivan (1,200 mg every 12 hours) in combination with AZT and 3TC (300 mg/150 mg twice-a-day) showed HIV levels suppressed to below detection (less than 500 copies/mL) in more than 70 percent of patients after 32 weeks of therapy. Results from a combination study of Crixivan (1,000 mg every 12 hours) and nelfinavir (750 mg, increased to 1,000 mg, every 12 hours) showed favourable drug level activity in the blood indicating that twice-daily therapy with this dual protease inhibitor combination may become a powerful anti-HIV treatment option. After 24 weeks of treatment, 61 percent of patients had undetectable viral loads (less than 400 copies/mL), 55 percent of whom had viral levels below 50 copies/mL (using an investigational assay). The study is continuing with increased doses of both medications, 1,200 mg of Crixivan and 1,250 mg of nelfinavir, both dosed twice-daily in order to gather additional efficacy information on this promising combination. There are some common medication and AIDS-related medication that should not be taken with Crixivan. Crixivan should not be administered concurrently with terfenadine, cisapride, astemiozole, triazolam, midazolam or ergot derivatives. Crixivan can be taken with a light meal or on an empty stomach. Crixivan is generally well-tolerated. There are side effects associated with protease inhibitors in general and Crixivan in particular. Some patients treated with Crixivan may develop kidney stones. For some, this can lead to more severe kidney problems including kidney failure. Drinking at least six glasses of water each day may help reduce the chance of forming a kidney stone. Other side effects reported include rapid breakdown of red blood cells and liver problems. As with other protease inhibitors, increased bleeding in some patients with hemophilia and increased blood sugar levels or diabetes have been reported. More information on: Crixivan E-mail this page to a friend or colleague! To print, use this version