Brand Name: Stribild
Generic Name: Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate, Quad
Stribild is a treatment for HIV that includes four drugs in each tablet: elvitegravir, emtricitabine, tenofovir disoproxil fumarate, and cobicistat. The U.S. Food and Drug Administration has approved Stribild for use by adults. A doctor prescribes these medications when a patient has not taken other HIV medication forms.
Read the FDA description of Stribild.
Stribild is not a cure for HIV. It helps reduce how quickly the HIV virus is able to multiply. Stribild includes three antiretroviral drugs and cobicistat. Cobicistat is not an HIV drug but instead prolongs the action of the other drugs in the combination. Treatment with this medication results in an increase in the number of CD4+ immune system cells in the body. By boosting the immune system, Stribild helps a patient to be better able to fight off infection.
The adult dose of Stribild is one tablet taken daily, with food. Each tablet contains elvitegravir 150 milligrams (mg), cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg. Treatment with Stribild is not recommended for patients who have an estimated creatinine clearance below 70 milliliters (mL) per minute. Since Stribild is a fixed-dose combination tablet, it should be discontinued if the patient’s estimated creatinine clearance falls below 50 mL per minute while being treated with Stribild. It’s not possible to reduce the dose of emtricitabine and tenofovir disoproxil fumarate for patients with kidney disease.
Before Stribild is used, patients should be tested for hepatitis B infection and the estimated creatinine clearance. Urine glucose and urine protein should be tested and documented in all patients.
This information is a summary. Before starting this medication, discuss questions with your healthcare provider and make sure you understand dosage instructions.
Tell your doctor before taking Stribild if you:
- are breastfeeding or planning on breastfeeding, as the HIV virus and Stribild can be transmitted to the baby
- are pregnant or planning on becoming pregnant
- have bone problems, such as osteoporosis
- have kidney disease or have had kidney problems from taking any drug
- have liver problems, such as hepatitis B or C.
- Taking Stribild can worsen symptoms of liver disease. A doctor should always test patients for hepatitis B before prescribing Stribild.
Always tell your physician about any prescription medications or herbal remedies you are taking.
Patients should not take Stribild with other HIV medicines. Stribild contains a complete HIV treatment.
Some medications can adversely interact with Stribild. Some drugs should not be combined with Stribild, while the physician may adjust the dose of other drugs that interact. Drugs that interact with Stribild include:
- alpha-1-adrenoceptor antagonists, such as alfuzosin
- antibiotics, including erythromycin, clarithromycin and aminoglycosides (usually given in the hospital)
- antimycobacterial medications, such as rifampin
- ergot derivatives, including dihydroergotamine (Migranal), ergonovine (such as Ergotrate), ergotamine (Ergomar), and methylergonovine (Methergine)
- GI motility agents, including cisapride
- dipivoxil (Hepsera), another HIV medication
- HMG-CoA reductase inhibitors (statins), such as lovastatin (Mevacor), Lipitor, and Zocor
- some herbal remedies, including St. John’s wort
- neuroleptic medications, such as Pimozide
- phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil (Viagra)
- sedative or hypnotic medications, including triazolam (Halcion)
Possible Adverse and Emergency Side Effects
There are severe and emergent side effects of these medications. Report to your medical provider immediately if you experience:
- decrease in bone mineral density, detected through bone density scans. This could increase the likelihood you will experience a bone break.
- lactic acidosis or excess acid in the blood
- signs of drug-induced liver disease (steatosis) that causes liver enlargement. Signs include unexplained fatigue, light-colored bowel movements, a general feeling of being unwell, or pain in the right upper portion of the abdomen.
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Stribild. When treatment is started, patients whose immune system responds may develop an inflammatory response to current residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment.
Changes in kidney function, potentially leading to acute kidney failure, in patients who take Stribild and high-dose nonsteroidal anti-inflammatory drugs (NSAIDs) or multiple NSAIDS. (See section below on Stribild and kidney impairment.)
Severe and acute worsening of Hepatitis B, in patients who are treated with Stribild and then stop the drug, have occurred. Stribild is not approved for the treatment of chronic hepatitis B.
Possible Nonemergency Side Effects
The following side effects may occur, but do not usually represent an emergency. Discuss with your doctor or healthcare professional if they continue or are bothersome:
- changes in the distribution of body fat, such as an increasing amount of fat on the neck
- difficulty sleeping
- nausea or stomach upset. Taking Stribild with food can help to reduce stomach-upset symptoms.
Stribild and Kidney Impairment
A large decrease of kidney function and cases of acute kidney failure and Fanconi syndrome (kidney filtering damage with severely increased blood levels of phosphate), have been reported with the use of tenofovir, one drug that is in Stribild.
It’s recommended that the estimated creatinine clearance should be evaluated in all patients before starting Stribild treatment and as clinically appropriate during therapy with Stribild. Estimated creatinine clearance, urine glucose and urine protein should be documented in all patients prior to initiating therapy. Initiation of Stribild in patients with estimated creatinine clearance below 70 mL per minute is not recommended. Patients at risk of kidney disease or reduced kidney function, or whose kidney function has been decreased while taking Hepsera (a treatment for hepatitis B), should be regularly monitored during Stribild treatment.
Stribild should not be used in patients who are currently being treated with a drug known to be potentially damaging to the kidney or who recently used such a drug like high-dose or more than one NSAID. Some patients with HIV, who had risk for kidney disease but appeared to be stable on tenofovir, who were then started on high dose or multiple NSAIDs, have had acute kidney failure. Some patients required hospitalization and dialysis. Alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction.
Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of potential kidney damage and require an immediate evaluation of kidney function, in patients who are at risk.
Additionally, serum phosphorus should be measured in patients at risk for kidney impairment. Cobicistat (a component of Stribild) may cause small changes in serum creatinine (which can mean a small decrease in creatinine clearance). Patients whose serum creatinine (a measure of kidney function) increases more than 0.4 mg per deciliter (dL) from their pre-treatment level should be closely watched for kidney safety.
The emtricitabine and tenofovir DF components of Stribild are primarily eliminated by the kidney. Stribild should be discontinued if the estimated creatinine clearance falls below 50 mL per minute, since there is no way to adjust the dose for these drugs, with the fixed-dose combination Stribild tablet.
This list may not describe all possible side effects. Call your doctor or healthcare provider for advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Stribild should be stored at room temperature room temperature (77 degrees Fahrenheit/25 degrees Celsius). Stribild may be stored at 59 to 86 degrees Fahrenheit (15 to 30 degrees Celsius) for brief periods. Always keep Stribild in its original container, with the container tightly closed. Do not use the medication if the seal over the Stribild bottle is broken or missing.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
FDA WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY W/ STEATOSIS, INCL. FATAL CASES, ASSOCIATED W/ NUCLEOSIDE ANALOGUE USE ALONE OR IN COMBINATION; SUSPEND TX IF CLINICAL OR LABORATORY FINDINGS SUGGEST LACTIC ACIDOSIS OR HEPATOTOXICITY.
NOT APPROVED FOR HBV INFECTION: SAFETY AND EFFICACY NOT ESTABLISHED IN HIV/HBV CO-INFECTION; SEVERE ACUTE HBV EXACERBATIONS IN HBV/HIV CO-INFECTED PTS WHEN Discontinuing EMTRICITABINE OR TENOFOVIR; MONITOR HEPATIC Function CLOSELY FOR AT LEAST SEVERAL MONTHS IN HBV/HIV CO-INFECTED PTS WHO discontinue ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR DISOPROXIL; INITIATE ANTI-HBV treatment IF NEEDED.
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