Experimental HIV Drug Dolutegravir under FDA Review
The experimental integrase inhibitor dolutegravir may be the next new HIV drug on pharmacy shelves: ViiV Healthcare announced last week that it has requested regulatory approval of the drug in Europe, Canada, and the United States. The process included submitting a New Drug Application to the U.S. Food and Drug Administration (FDA) for dolutegravir for the treatment of HIV disease in adults and children at least 12 years of age.
Dolutegravir suppresses HIV replication by interfering with the “integration” step in the viral life cycle. After HIV enters a cell, it must convert its own genetic material, called ribonucleic acid (RNA), into the same form as the human cell’s genetic material, deoxyribonucleic acid (DNA), in order to make more copies of itself. HIV has an enzyme called integrase that binds to the newly created viral DNA and inserts it into the human cell’s DNA, which allows the cell to start producing viral proteins—the raw material for new copies of HIV. As the name suggests, integrase inhibitors work by inhibiting the activity of this integrase enzyme, thereby preventing the viral DNA from being integrated into the host cell’s genetic material and blocking this stage of HIV replication.
In advanced clinical trials, dolutegravir (previously known as S/GSK1349572) has proven both potent and safe in HIV-positive people starting treatment for the first time and in those with a prior history of treatment. “We are encouraged by the comprehensive data package supporting dolutegravir, and believe that it has the potential to offer an important new option for the treatment of both naïve and treatment-experienced patients with HIV,” said John Pottage, MD, chief scientific and medical officer at ViiV Healthcare, in a press release.
For an in-depth look at this antiretroviral agent’s progress through the development pipeline, see “Dolutegravir: A New Integrase Inhibitor in Development” in the BETA archive. To learn about the recent trial findings supporting the approval of this new drug, read Liz Highleyman’s concise reports on dolutegravir in treatment-naïve and treatment-experienced adults over at HIVandHepatitis.com.
An expanded access program makes this investigational drug available to adults whose HIV is resistant to the integrase inhibitors raltegravir or elvitegravir and who have limited treatment options. Click here for more information, including eligibility criteria.
Reilly O’Neal is a freelance writer and former editor of BETA.