FDA Approves new Two-drug HIV Treatment
The US Food and Drug Administration (FDA) has approved a new two-drug regimen for HIV that reports suggest could shake up the $22 billion market for products to treat the immune deficiency.
The fixed-dose pill called Juluca, which contains the active ingredients dolutegravir and rilpivirine, is manufactured by ViiV, a company specializing in HIV that is majority owned by GlaxoSmithKline and has Pfizer and Japanese pharmaceutical producer Shionogi as shareholders.
Juluca is recommended to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of the drug. Juluca is not recommended for use in combination with any other medications.
Up to now, the standard treatment for patients living with HIV has been to suppress the virus with a regimen of three or four pills, to keep the level of HIV in the blood low while reducing symptoms as well as side effects. However, “limiting the number of drugs can help reduce toxicity for patients,” Debra Birnkran, director of the division of antiviral products in the FDA’s Center for Drug Evaluation and Research, said in announcing the approval.
The safety and efficacy of Juluca in adults were evaluated in two US clinical trials with 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Participants were randomly assigned to continue their current regimen or switch. Results showed the new regimen was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs, the FDA said.
Gilead Sciences also has a new two-drug treatment for HIV, which it is currently testing. In the trials, the drugmaker’s bictegravir is being used in combination with emtricitabine/tenofovir alafenamide (FTC/TAF).
The investigational single tablet regimen is claimed to bring together the potency of bictegravir with the demonstrated efficacy and safety profile of the FTC/TAF backbone, Norbert Bischofberger, Gilead's chief scientific officer, said in announcing the new development earlier this year. The company said at the time it planned to submit applications for approvals in the US and the EU during 2017.