|What is Stribild?
- Stribild, formerly known as "Quad," is a fixed-dose combination tablet containing four medications. Three of the four medications are active against HIV: the integrase inhibitor elvitegravir and the nucleotide/nucleoside reverse transcriptase inhibitors Viread (tenofovir) and Emtriva (emtricitabine). The fourth medication is cobicistat, a drug that has no activity against HIV, but is needed to boost the blood levels and effectiveness of elvitegravir.
- Stribild was developed by Gilead Sciences. It was approved by the U.S. Food and Drug Administration on August 27, 2012 for people starting HIV treatment for the first time.
- Stribild should be prescribed by a health care provider for patients who need all four of these drugs. At present, neither elvitegravir nor cobicistat can be purchased individually (FDA approvals of both drugs are pending). Viread and Emtriva are commercially available separately. They are also available in the fixed-drug combination tablet Truvada and are two of the active drugs in the fixed-drug combination tablets Atripla and Complera.
- Stribild is considered to be a complete one-pill, once-daily HIV treatment regimen.
- Both the Viread and the Emtriva in Stribild are active against the hepatitis B virus (HBV), the virus responsible for causing hepatitis B. See What about side effects? below for more important information regarding Viread, Emtriva, and hepatitis B.
- Gilead have established a patient assistance program (PAP) for people living with HIV who do not have private or public health insurance and are unable to afford Stribild. To learn more about the PAP for Stribild, call Gilead's U.S. Advancing Access program at 1-800-226-2056 between 9:00 AM and 8:00 PM (Eastern Time). For those with private health insurance, Gilead has established a program to help cover up to $200 toward each monthly Stribild co-payment. To learn more about this co-pay program, call 877-505-6986.
What is known about Stribild?
- Stribild is a tablet that will need to be taken daily. The correct dose is one pill taken once daily with food.
- Stribild should not be any more or less effective than elvitegravir, cobicistat, Viread and Emtriva taken as separate pills together. However, it is considered to be a much more convenient way of taking these for HIV drugs.
- Stribild has been compared to two popular complete HIV drug regimens in clinical trials. One clinical trial (Study 102) compared Stribild to Atripla. A second clinical trial (Study 103) compared Stribild to Norvir (ritonavir)-boosted Reyataz (atazanavir) plus Truvada. Both studies found Stribild to be comparable in terms of keeping viral load undetectable and boosting CD4 cell counts.
What about drug interactions?
- Stribild can lower or raise the levels of other medications in the body. Similarly, other medications may lower or raise the levels of some of the drugs in Stribild. Some of these interactions can cause your medications to be less effective or increase the risk of side effects.
- Tell your doctors and pharmacists about all medicines you take. This includes those you buy over-the-counter and herbal or natural remedies, such as St. John's wort. Bring all your medicines when you see a doctor, or make a list of their names, how much you take and how often you take them. Your doctor can then tell you if you need to change the dosages of any of your medications.
- Tell your doctors and pharmacists about all medicines you take. This includes those you buy over-the-counter and herbal or natural remedies, such as St. John’s Wort. Bring all your medicines when you see a doctor, or make a list of their names, how much you take, and how often you take them. Your doctor can then tell you if you need to change the dosages of any of your medications.
- The following medications should not be taken while you are being treated with Stribild:
Acid reflux/heartburn medications: Propulsid (cisapride)
Antibiotics: Rifadin (rifampin)
Antimigraine medications: Ergostat, Cafergot, Ercaf, Wigraine (ergotamine) or D.H.E. 45 (dihydroergotamine)
Pulmonary hypertension medications: sildenafil (Revatio; used to treat pulmonary hypertension)
Cholesterol-lowering drugs (statins): Zocor (simvastatin) and Mevacor (lovastatin)
Antipsychotics: Orap (pimozide)
Sedatives: Versed (midazolam) and Halcion (triazolam)
Enlarged prostate: Uroxatral (alfuzosin).
- Stribild is a complete drug regimen. It should not be combined with other HIV medications.
What about side effects?
- Lactic acidosis, which can be fatal, and severe liver problems have been reported in people taking nucleoside reverse transcriptase inhibitors (NRTIs). Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area.
- The Viread in Stribild may cause bone problems. Researchers are currently looking into the seriousness of this possible side effect. If you have a history of bone fracture or are at risk for osteopenia, your doctor may want to consider ordering bone scans on a regular basis while you are taking the Stribild. While it's not clear if calcium and vitamin D supplementation can help this side effect, it might be beneficial if you are taking the Quad.
- Stribild may be problematic for HIV-positive people who have a history of kidney problems (renal impairment). If you have a history of kidney problems, your doctor will need to order a simple laboratory test to calculate your "creatinine clearance," which is a measure of your kidney function. Depending on the results of this test, you may not be able to take Stribild. It is always important to be careful if using Stribild in combination with drugs that cause kidney problems or other drugs that are removed from the body by the kidneys.
- Common side effects, occurring in more than 10 percent of clinical trial participants who received Stribild, involved gastrointestinal symptoms, notably diarrhea and nausea. Fatigue occurred in 5 percent of study volunteers receiving Stribild; headache occurred in 7 percent. As for central nervous system problems, such as dizziness, insomnia and abnormal dreams, these were more common among patients who received Atripla compared with Stribild. Rash was also much more common among those who received Atripla. Compared with those who received Norvir-boosted Reyataz, clinical trial participants who took Stribild were less likely to experience jaundice (yellowing of the skins and eyes) and flatulence (gas).
- If you have hepatitis B and HIV and plan to stop taking Stribild, you need close medical follow-up and for several months your doctor might want to frequently check your liver enzymes after stopping treatment. This is because the Viread and Emtriva in Stribild are also active against the hepatitis B virus (HBV). If Stribild is stopped abruptly, it can cause liver disease to "flare" and damage the liver.
- See the "What about side effects?" sections of elvitegravir, cobicistat, Viread and Emtriva for additional possible side effects.
Who should not take Stribild?
- Before taking this medication, tell your doctor if you have: kidney disease; liver disease (including hepatitis B); or bone problems. In addition, tell your doctor if you are pregnant or planning to become pregnant; if you are breast feeding, and all your medical conditions, including if you have ever had mental illness or are using drugs or alcohol, if you have ever had seizures or are taking medications for seizures.
Where can I learn more about clinical trials involving Stribild?
- If you would like to find out if you are eligible for any clinical trials that include Stribild, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email email@example.com.