New daily pill to treat HIV approved in US

New daily pill to treat HIV approved in US

New daily pill to treat HIV approved in US

US has approved a new once-a-day pill to treat HIV infection, by combining previously okayed drugs and two new ones for adults living with the deadly virus that causes AIDS.

Daily dose of the combination pill 'Stribild' provides a complete treatment regimen for HIV infection and is meant for people who have not already been treated with other HIV drugs, the US Food and Drug Administration (FDA) said in a statement.

"Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens," said Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

"New combination HIV drugs like Stribild help simplify treatment regimens," Cox said.
The new pill, made by Gilead Sciences, was tested in more than 1,408 patients, in two double-blind clinical trials.

Results showed between 88 per cent and 90 per cent of patients treated with Stribild had an undetectable amount of HIV in their blood, compared with 84 per cent treated with Atripla and 87 per cent treated with Truvada plus atazanavir and ritonavir.

This is Gilead's third single-tablet anti-HIV combination therapy, the company noted, adding it is still seeking approval for the newest offering in Australia, Canada and the European Union.

Generic versions are being developed by a number of Indian manufacturers and the Medicines Patent Pool, a non-profit that helps facilitate generic drug-making to take the drug to developing world, where millions lack access to effective treatment options.

The drug combines previously approved Truvada that combines emtricitabine and tenofovir disoproxil fumarate, and elvitegravir, and cobicistat.

The FDA said further study is required to determine the quad-drug's safety for women and children.

Like labels of many other drugs used to treat HIV, Stribild's label carries a Boxed Warning alerting patients and health care professionals that the drug can cause a build up of lactic acid in the blood and severe liver problems, both of which can be fatal.

The drug also weakened bones and caused or worsened kidney problems, both of which will be mentioned in a warning on the drug's label.

Truvada was previously approved as a treatment for people infected with HIV to be used in combination with other antiretroviral drugs.