FDA changes labeling for Viread
BY Advocate.com Editors
August 19 2003 11:00 PM ET
The Food and Drug Administration on Monday approved label changes to Gilead Science's nucleotide reverse transcriptase inhibitor Viread to reflect new data from an ongoing study of treatment-naive patients taking the medication as part of first-line therapy. The label was changed to include new dose recommendations for patients with kidney impairment, a new warning about HIV-hepatitis B coinfection, dose recommendations for using Viread with Videx (ddI), and updated information on the drug's effects on the body's bones. The original label stated that Viread should be taken with food, but the new label changes also say the medication can be taken without food.
The new label changes state that because renal impairment, including acute renal failure and Fanconi syndrome, have been reported in patients taking Viread, doctors should avoid using the drug with or recently following the use of other drugs that affect kidney function. Patients taking Viread also should be carefully screened for underlying kidney disease before beginning the medication. Because the safety and efficacy of Viread has not been determined for HIV-positive patients also coinfected with hepatitis B, and due to reports that Viread users may experience increased hepatitis B disease progression after stopping the medication, the FDA recommends that coinfected patients be closely monitored for any signs of hepatitis complications. The use of Viread also may result in increased blood-based levels of ddI when the drugs are taken together, and adults on a Viread-ddI regimen should have their ddI dosing reduced to 250 milligrams, according to the new label changes. The new label also notes that some Viread users have experienced slight decreases in bone mineral density in the spine, hip, and arms. Bone monitoring should be considered for HIV patients who have a history of bone fracture or are at substantial risk for osteopenia.