Stribild Once-A-Day HIV Pill Approved By FDA
Stribild, a new drug to treat HIV infection, was recently approved by the FDA.
The once-a-day, single dose pill combines two previously approved drugs plus two new ones.
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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.
HIV Couples: When They’ve Got It, But You Don’t
HIV isn’t the first topic that comes up when most couples start dating. You may not know the HIV status of your partner. You might not even have been tested yourself.
It can be very difficult to talk about HIV status, but it’s very important for couples to discuss this, not only for health, but to achieve a greater degree of trust and intimacy in the relationship.
So what are the most important facts that couples need to know?
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Couples with one person who is HIV-positive and one who is HIV-negative are sometimes called “serodiscordant” or “mixed serostatus”. “Sero-” refers to blood serum.
“Serostatus” refers to whether someone has HIV infection or not.
What Are the Special Issues for Mixed Couples?
People in mixed-status relationships face all the same things as other couples. But there are some extra issues:
• The HIV-positive partner might focus on not infecting their partner. The HIV-negative partner may concentrate on taking care of the other person. This can cause a serious lack of balance in the relationship.
• HIV can cause changes in the body. Anti-HIV medications may have unpleasant side effects. This might give the HIV-positive partner negative feelings about their body and their health. It may be difficult to feel attractive and have a normal romantic relationship.
• Fear of transmitting HIV can cause an excess of caution. This might even stop all sexual activity.
• Try to have open discussions about your desires, your fears, and your limits. Agree on ways of sexual expression that fit with the level of risk you are comfortable with. Talking to a sexual or relationship counselor can help.
Reducing the Risks
Antiviral medications (antiretrovial therapy or ART) control HIV infection very well.
The good news about taking ART is how well it works. There is no cure for AIDS and ART won’t get rid of HIV infection, but it can help you live a full, healthy life.
ART can also make it very unlikely that you will pass HIV infection to your partner. If you maintain an undetectable viral load, chances are good that you won’t pass your HIV infection to your partner. However, there are several important things to remember:
• You have to take ART very regularly for it to work. Fact Sheet 405 has more information on adherence to treatment.
• An “undetectable” viral load does not mean zero. It means there is not enough HIV in your blood sample to show up on the test.
• The viral load test measures virus in the blood. It doesn’t tell you about virus in sexual fluids (sperm or vaginal fluids.)
• The viral load test result was for when your sample was taken, not today. Viral load can change quickly, especially if you get sick with a cold or flu, or even if you get vaccinated.
Even with all these warnings, it is very rare for someone who is taking ART and has an undetectable viral load to infect a partner.
Using a Condom
It is rare for a partner with an undetectable viral load to transmit HIV. However, it still makes sense to take extra steps such as using a condom.
Condoms are very effective at preventing the spread of HIV. They must be used correctly, every time you have sex. If you can get used to using condoms, you can relax and enjoy yourselves more during sexual activity.
Other Ways to Reduce Risk
• Risk is lower if the infected partner is taking antiretroviral medications.
• If so, take every scheduled dose of medications.
• Avoid sexual activity during any infection: a sexually transmitted disease, or even a cold or flu.
• Avoid sexual activity within a couple of weeks after getting any vaccinations.
If You Are Exposed to HIV …
If a condom breaks, or if you forget to use one, anti-HIV medications might prevent transmission. Talk to your doctor about PEP, “Post-Exposure Prophylaxis.” This has not yet been proven to avoid transmission between sex partners. Do not just take a few doses of your partner’s medication! That might not be the right treatment. For PEP to work, it must be started very soon after exposure to HIV. Discuss PEP with your doctor in advance so that you know what your options will be in case something happens that exposes the negative partner to HIV.
Having Children If The Man Has HIV
Recent studies show that it is possible to “wash” the sperm of an HIV-infected man so that it can be used to fertilize a woman and produce a healthy baby. These procedures are effective, but very expensive. A recent cost estimate was about $10,000, and medical insurance will probably not cover the cost. It can be very difficult to find a place to have sperm washing done.
Having Children If The Woman Has HIV
Without treatment, up to 35% of pregnant women with HIV can pass the infection to their newborns. With proper treatment, the risk of passing HIV to newborns drops to 2%.
Artificial insemination, a simple procedure, places the man’s sperm into the woman’s vagina. This allows pregnancy without exposing the man to HIV.
If a woman with HIV becomes pregnant, she should be very careful to stay healthy during pregnancy. Be sure to discuss pregnancy with your health care provider, preferably before becoming pregnant. Your provider will help you with the treatment you need to reduce the chance your baby will be infected. Also, avoid breastfeeding a newborn. This can transmit HIV.