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.
The 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.
“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.”
The 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.
The company said it tested the pill in two double-blind clinical trials of more than 1,400 patients.
Results 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.
“Therapies 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.
But some advocates say the new pill is priced far too high.
“We 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.
The new drug “is not a significant improvement over existing therapies,” Weinstein told AFP, adding the cost will “severely limit access” to the new medication.
Gilead 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.
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. To 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-making.
The 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.
The 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.
Stribild 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.
But Gilead said that during the studies, “most adverse effects were mild to moderate.” The FDA said patients commonly experienced nausea and diarrhea.
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.
In July, it was also approved for use by healthy at-risk adults to prevent HIV, the first-ever daily pill approved for that purpose.
This year, the FDA also approved the first rapid HIV test that can be bought without a prescription and taken at home.
yahoo
US Approves Once-a-day Pill To Treat HIV added by on
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Thank God for the drug
you manufactured the hiv virus so stop playing hero..give the pill for free just as u gave the virus for free
But pipo lets nt take th advntg of havg sex
This drug should be free,We hope that people wil remain faithful to there partiners even after this development remember God is love, let his mercy speak for those who made HIV virus after so many millions of lifes has dead!
This drug should be free,We hope that people wil remain faithful to there partiners even after this development remember God is love, let his mercy speak for those who made HIV virus after so many millions of lifes have dead!
Sad that people who breed anguish in other peope’s lives want to take advantage of other people’s misery!Give the drugs freely for obvious reasons!
That good news to HH…..Maybe the bitterness can go…Chikala kudwala kwake asirizira chufukushi kuli wa PF…
The topic is about HIV..how does HH come in…its true u r feeling the HEAT
Zambia has witnessed massive Development under PF govt, jobs v bn created, inflation well controled,kwacha stable,no more loadsheding.
well this so called stribild should not make us gullibly believe it is meant for man’s common good. let us as scientists try to buffer our people from potentially more fatal ailments that could, just could be introduced through the use of such a drug. let us be alert even as we look forward to an HIV free world. Radah!
GOD WE THANK YOU FOR WORKING THRU THESE PIPO.
GIVE THEM MORE WSIDOM TO FIND A REMEDY TO THIS PANDEMIC.
REMEMBER: “IF YOU ARE NOT INFECTED THEN U R AFFECTED”
GOD FORGIVE AND BLESS THIS GENERATION
AMEN
TWAPUSUKA AT LAST!! I knew man only man would save us!
Wow! who is the next lady? I will finish them in this hood. Yayayaya…. Ha.
The drug manufacture is charging the wholesalers the amount of $28,500 a year .what amount is the retailer charging the consumer?what is this drug financial asistance programs.i foresee this drug it wil be rarely swallowed by poor pipo because it is exorbitantly over prized.in this world their is nothing 4 free.so Hiv agony wil continue its intended purpose.
Let’s behave not ukulanyenyenga.
Let’s behave not ukulanyenganyenga.
The drug is but it is a tie coz it need pipo on who are not yet on treatment why?you rearcher wen do the rearch do it for all pipo.let hope the government of zambia wil get this drug as soo as posible coz we a told this drug wil be on the by next week
The drug is good but it is a tie coz it need pipo on who are not yet on treatment why?you rearcher wen do the rearch do it for all pipo.let hope the government of zambia wil get this drug as soon as posible coz we a told this drug wil be on the by next week
THE DRUG IS OKAY MANJE THE SIDE EFFECT…LIVER,KIDNEY,WEAKEN BONES NOT FOR PATIENTS TREATED WITH ANOTHER HIV DRUGS BEFORE
Fyabufi ba mambala…anyway lets wait and see
We want a cure not more arvs, this is a deliberate ploy to continue milking Africa of it’s hard earned forex by the West, shame on you.
You take that pill,another unknown disease will come up. Just see the so called fatal side effects.
Very unfair to those who are already on other drugs-why cant you chaps come up with the cure to all not being selective.
POPO
well God you have the best treatment without side effects and without any worries on your intentions as you provide the healing and YOU desire the best for all your pipo.We are challenged by the community that we are foolish to believe for total healing by just believing in you.one dossage cure would be the best.
thank God more drugs are being discovered now lets have them in Africa soon to alleviate the suffering
pls lets us ensure that we behave responsibly with coming this drug
who’ll spend 25,000 dollars 4 thos pills? twalichula; they should do something about the expence.
sorry i mean 28,500 dollars. tekwebati mutampeukula peciana mubulageti mwetukaciana hmmmmm?
sorry i mean 28,500 dollars. tekwebati mutampeukula peciana mumalageti mwetukaciana hmmmmm?
Imwe bafikala muleipusha fwebanwa,wats so new about a once per day pil?bcoz thats wat is in govt hospitals and its for free.
@Mojo this one reduces the virus to zero in just a year…!