Elvitegravir/cobicistat/emtricitabine/tenofovir, sold under the brand name Stribild, also known as the Quad pill, is a

fixed-dose combination A combination drug or a fixed-dose combination (FDC) is a medicine that includes two or more active ingredients combined in a single dosage form. Terms like "combination drug" or "combination drug product" can be common shorthand for a FDC pr ...

antiretroviral medication Antiviral drugs are a class of medication used for treating viral infections. Most antivirals target specific viruses, while a broad-spectrum antiviral is effective against a wide range of viruses. Unlike most antibiotics, antiviral drugs do n ...

for the treatment of

HIV/AIDS Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual ...

Elvitegravir Elvitegravir (EVG) is an integrase inhibitor used to treat HIV infection. It was developed by the pharmaceutical company Gilead Sciences, which licensed EVG from Japan Tobacco in March 2008. The drug gained approval by the U.S. Food and Drug ...

emtricitabine Emtricitabine (commonly called FTC, systematic name 2',3'-dideoxy-5-fluoro-3'-thiacytidine), with trade name Emtriva (formerly Coviracil), is a nucleoside reverse-transcriptase inhibitor (NRTI) for the prevention and treatment of HIV infection i ...

and

tenofovir disoproxil Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for preven ...

directly suppress viral reproduction.

Cobicistat Cobicistat, sold under the brand name Tybost, is a medication for use in the treatment of human immunodeficiency virus infection (HIV/AIDS). Its major mechanism of action is through the inhibition of human CYP3A proteins. Like ritonavir (Norv ...

increases the effectiveness of the combination by inhibiting the liver and gut wall enzymes that metabolize elvitegravir. It is taken

by mouth Oral administration is a route of administration where a substance is taken through the mouth. Per os abbreviated to P.O. is sometimes used as a direction for medication to be taken orally. Many medications are taken orally because they are i ...

. The drug is manufactured by

Gilead Sciences Gilead Sciences, Inc. () is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and C ...

. An increase in the serum

creatinine Creatinine (; ) is a breakdown product of creatine phosphate from muscle and protein metabolism. It is released at a constant rate by the body (depending on muscle mass). Biological relevance Serum creatinine (a blood measurement) is an importa ...

level (a marker of kidney function) may increase with use of Elvitegravir/cobicistat/emtricitabine/tenofovir. This is caused by inhibition of tubular secretion of creatinine in the

nephron The nephron is the minute or microscopic structural and functional unit of the kidney. It is composed of a renal corpuscle and a renal tubule. The renal corpuscle consists of a tuft of capillaries called a glomerulus and a cup-shaped structure ...

by cobicistat. An increase of up to 0.3 mg/dL is expected; if serum creatinine level increases by 0.4 mg/dL or more, further evaluation for other causes of

acute kidney injury Acute kidney injury (AKI), previously called acute renal failure (ARF), is a sudden decrease in kidney function that develops within 7 days, as shown by an increase in serum creatinine or a decrease in urine output, or both. Causes of AKI are c ...

is recommended.

Society and culture

Legal status

Elvitegravir/cobicistat/emtricitabine/tenofovir gained approval by the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) on August 27, 2012, for use in adults starting

antiretroviral treatment The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of multiple ...

for the first time as part of the fixed dose combination.

Economics

Gilead's stated wholesale price of Stribild is per patient, per year. Gilead maintains that its pricing is comparable to other HIV medications on the market. Elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild) is priced at 39 percent higher than emtricitabine/rilpivirine/tenofovir (Complera), a three-drug HIV regimen approved a year earlier. At the time of Complera's approval, there were concerns about the wholesale cost of efavirenz/emtricitabine/tenofovir (Atripla), which is marketed by Gilead and

Bristol-Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the lar ...

. HIV drug prices have increased substantially. Atripla, a combination therapy released in 2006, was priced at per person, per year. Atripla's wholesale prices have risen to the level of Complera's at . Rising drug costs and HIV cases, combined with tighter state budgets may burden the AIDS Drug Assistance Program (ADAP) to the breaking point. Kaiser Family Foundation reports that ADAP provided HIV drug benefit to 138,000 people in 2011, with a waiting list totaling 2,030 HIV-positive individuals. Many states including California, Colorado, Georgia, and Virginia are considering measures to cut ADAP spending.

References

FDA label

Stribild: High cost of new HIV drug may not be worth the benefit

External links

* CYP3A4 inhibitors Fixed dose combination (antiretroviral) Gilead Sciences Hepatotoxins {{antiinfective-drug-stub