United States of America - A new pill to treat HIV infection -- combining two
previously approved drugs plus two new ones -- has been approved for adults
living with the virus that causes AIDS, US regulators said Monday, August 27.
single daily dose of Stribild provides a complete treatment regimen for HIV
infection, the US Food and Drug Administration said in a statement, and is
meant for people who have not already received treatment with other HIV drugs.
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.
combination HIV drugs like Stribild help simplify treatment regimens."
new pill, previously called Quad, is made by Gilead Sciences in California and
"should be available to patients by the end of the week," company
spokeswoman Erin Rau told AFP.
company said it tested the pill in two double-blind clinical trials of more
than 1,400 patients.
showed that Stribild performed as well or better than two other treatment
combinations, and brought virus readings down to undetectable levels in around
nine of 10 patients after 48 weeks.
that address the individual needs of patients are critical to enhancing
adherence and increasing the potential for treatment success," Gilead
chief John Martin said in a company statement.
some advocates say the new pill is priced far too high.
wanted to see (a price of) no more than the current drug," said Michael
Weinstein, president of the AIDS Healthcare Foundation, referring to Gilead's
previously approved three-in-one pill, Atripla. But he said the price will be
about a third higher than the three-pill combo.
new drug "is not a significant improvement over existing therapies,"
Weinstein told AFP, adding the cost will "severely limit access" to
the new medication.
is charging wholesalers $28,500 a year for the drug, but said it will provide
discounts to state assistance programs and has created a patient
financial-assistance program, Rau said.
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.
get the drug to HIV patients in the developing world, where millions lack
access to effective treatment options, generic versions are being developed --
with permission and help from Gilead -- by a number of Indian manufacturers and
the Medicines Patent Pool, a non-profit that helps facilitate generic
drug combines Truvada -- another Gilead offering approved in 2004, that
combines emtricitabine and tenofovir disoproxil fumarate to fight an enzyme
that HIV needs to replicate -- with elvitegravir, another enzyme-fighting drug,
and cobicistat, which enhances the effects of elvitegravir.
FDA said further study is required to determine the quad-drug's safety for
women and children, how resistance may develop, and whether the drug interacts
with other drugs.
will also be required to carry a label warning patients and health care
providers the drug can cause fatal side effects, including severe liver
problems, and a build-up of lactic acid in the blood. The FDA said the label is
also required for many other HIV-fighting drugs.
Gilead said that during the studies, "most adverse effects were mild to
moderate." The FDA said patients commonly experienced nausea and diarrhea.
drug also weakened bones and caused or worsened kidney problems -- both of
which will be mentioned in a warning on the drug's label.
was previously approved as a treatment for people infected with HIV to be used
in combination with other antiretroviral drugs.
July, it was also approved for use by healthy at-risk adults to prevent HIV,
the first-ever daily pill approved for that purpose.
year, the FDA also approved the first rapid HIV test that can be bought without
a prescription and taken at home. - Agence