GlaxoSmithKline’s Tivicay (dolutegravir) has just been approved by the FDA to treat a broad population of HIV-1-infected patients, including both infected adults who have never taken HIV therapy (treatment-naïve) as well as those who’ve participated in experimental treatments.
The drug, which acts to inhibit the strand transfer of integrase (a viral enzyme that inserts its genome on the DNA of host cells) has also been approved for children ages 12 years and older weighing at least 40 kilograms (kg).
“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” explained Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”
The most common side effects observed during clinical studies were insomnia and headache, although some patients did suffer from serious side effects such as hypersensitivity reactions and abnormal liver function in participants co-infected with hepatitis B and/or C.
To learn more about other HIV treatments and resources readers can contact the HIV Medicine Association at 1300 Wilson Blvd., Suite 300, Arlington, VA 22209 703 299-1215.