Prezista Gains Full Approval By FDA

The FDA has granted Johnson and Johnson approval for expanded use of their drug Prezista, a protease inhibitor. Prezista can now be prescribed as a 'first time' drug.for treatment naive patients. Prezista had previously been conditionally approved by the FDA in treatment experienced patients. The FDA has lifted that conditional approval, allowing Prezista to be used in all HIV patients. Prezista is paired with ritonivir in treatment of HIV. The only difference in dosage is Prezista is given twice daily to treatment experienced patients and only once for first time patients.

According to the manufacturers 48 week study, 84 percent of treatment naive patients reached an undetectible viral load (less than 50 copies/mL) versus78 percent of patients who were given the drug lopanavir. Additionally the drug has a much less chance of causing diarrhea (6 percent) versus lopanivir (13 percent). The drug also saw modest gains in improvement of other adverse effects including abdominal pain, nausea and vomiting. But the greatest advantage of Prezista over lopanavir was the greater numbers who achieved undetectible viral loads and the significant lowering of incidences of diarreah

The manufacture cautions that Prezista must be co-administered with 100 mg ritonavir and food to achieve the desired antiviral effect. Failure to correctly administer Prezista with ritonavir and food may result in a loss of efficacy of the drug. J and J also cautions that homeopathic drugs like St. Johns Wort may impair the efficacy of the drug. Information courtesy Johnson and Johnson.