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Related to Coviracil: rilpivirine, Tenofovir, elvitegravir



Pharmacologic class: Nucleoside reverse transcriptase inhibitor

Therapeutic class: Antiretroviral

Pregnancy risk category B

FDA Box Warning

• Drug has caused lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) when used alone or in combination with other antiretrovirals.

• Drug isn't indicated for chronic hepatitis B virus (HBV) infection. Safety and efficacy haven't been established in patients co-infected with HBV and human immunodeficiency virus (HIV). Discontinuation has led to severe acute HBV exacerbations. Monitor hepatic function closely.


Inhibits activity of HIV-1 reverse transcriptase by competing with natural substrate and by its incorporation into nascent viral DNA, thereby halting viral replication


Capsules: 200 mg

Oral solution: 10 mg/ml in 170-ml bottles

Indications and dosages

HIV-1 infection, with other antiretrovirals

Adults ages 18 and older: 200-mg capsule P.O. daily or 240 mg (24 ml) oral solution P.O. once daily

Children ages 3 months to 17 years weighing more than 33 kg (73 lb): 200-mg capsule P.O. once daily

Children ages 3 months to 17 years weighing less than 33 kg (73 lb): 6 mg/kg oral solution P.O. daily to maximum of 240 mg (24 ml) once daily

Children ages 0 to 3 months: 3 mg/kg oral solution P.O. once daily

Dosage adjustment

• Renal impairment


• Hypersensitivity to drug or its components


Use cautiously in:
• renal impairment
• increased risk for lactic acidosis or hepatic impairment
• obese patients
• elderly patients
• children (safety and efficacy not established).


• Give with or without food.
• Know that drug must be given with other antiretrovirals.
• Know that capsule can be given to child weighing more than 33 kg if child can swallow an intact capsule.

Adverse reactions

CNS: dizziness, headache, insomnia, abnormal dreams, depression, peripheral neuritis or neuropathy, paresthesia

EENT: rhinitis

GI: nausea, vomiting, diarrhea, abdominal pain, dyspepsia

Hepatic: hepatotoxicity

Metabolic: cushingoid appearance (buffalo hump, moon face),lactic acidosis

Musculoskeletal: joint pain, myalgia

Respiratory: increased cough

Skin: rash, skin discoloration (hyperpigmentation on palms and soles)

Other: body fat redistribution


Drug-drug.Tenofovir disoproxil fumarate: increased emtricitabine effect

Drug-diagnostic tests.Alanine aminotransferase, amylase, aspartate aminotransferase, bilirubin, creatine kinase, lipase, triglycerides: increased levels

Glucose: increased or decreased level

Neutrophils: decreased count

Patient monitoring

Monitor closely (especially in females and obese patients) for signs and symptoms of lactic acidosis and hepatotoxicity, even if patient doesn't have marked transaminase elevations.
• Assess neurologic status, checking especially for depression, peripheral neuropathy, and paresthesia.
• Monitor neutrophil count, lipid panel, liver function tests, and blood glucose level.

Monitor patient closely for several months after drug withdrawal. Severe, acute exacerbations of hepatitis B virus (HBV) have been reported after discontinuation in patients co-infected with HBV and HIV.
• Monitor nutritional and hydration status in light of GI adverse effects and underlying disease.
• Watch for cushingoid appearance and body fat redistribution.

Patient teaching

• Tell patient to take a missed dose as soon as he remembers. However, if it's almost time for next dose, tell him to skip the missed dose and take next dose as scheduled.

Instruct patient not to change dosage or stop taking drug unless prescriber approves.
• Tell patient drug should be taken only in combination with other drugs that treat HIV.

Instruct patient not to take this drug if already taking Altripla (combination of efavirenz, emtricitabine, and tenofovir), Combivir (combination of lamivudine and zidovudine), Epivir (lamivudine), Epzicom (combination of abacavir and lamivudine), Trizivir (combination of abacavir, lamivudine, and zidovidine), or Truvada (combination of emtricitabine and tenofovir), because these drugs contain the same or similar ingredients.

Tell patient to immediately report signs or symptoms of lactic acidosis-unusual tiredness or muscle pain, difficulty breathing, stomach pain with nausea and vomiting, coldness, dizziness or light-headedness, or fast or irregular heartbeat.

Instruct patient to immediately report signs or symptoms of liver problems-unusual tiredness, yellowing of skin or eyes, dark urine, lightcolored feces, appetite loss, nausea, or pain in lower abdominal area.
• Advise patient to report adverse CNS reactions and to use good judgment about driving and other hazardous activities.
• Caution patient that drug may cause depression. Tell him to notify prescriber if he develops symptoms.
• Inform patient that drug may cause body fat redistribution, dark areas on palms and soles, and rash.
• Tell female patient to inform prescriber if she is pregnant or plans to become pregnant.
• Caution HIV-positive patient not to breastfeed.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


(ĕm′trĭ-sĭt′ə-bēn′, -sī′tə-)
An antiviral drug, C8H10FN3O3S, that is a nucleoside reverse transcriptor inhibitor and is used in combination with other drugs to treat HIV infection or to reduce the risk of HIV infection.


a retroviral.
indication This drug is used with other retrovirals to treat HIV infection.
contraindication Known hypersensitivity to this drug prohibits its use.
adverse effects Adverse effects of this drug include headache, abnormal dreams, depression, dizziness, insomnia, neuropathy, paresthesia, arthralgia, myalgia, cough, change in body fat distribution, rash, and skin discoloration. Common side effects include nausea, vomiting, diarrhea, anorexia, abdominal pain, and dyspepsia.


A synthetic analogue of cytosine that acts as an inhibitor of HIV reverse transcriptase. The drug is taken once a day in combination with other antiretroviral drugs to treat HIV infection. It is also active against the hepatitis B virus.
References in periodicals archive ?
With our recent news regarding the FDA's acceptance of our Coviracil NDA, we expect our operating expenses to increase in 2003.
Once Gilead has entered the market with a new co-formulated product, consisting of Viread and Coviracil combination, dosed once a day that is as potent but without the side effects associated with AZT, the drug could become the standard of care.
He continued, "Consistent with our previous guidance when we submitted our NDA, the FDA granted Coviracil a standard review.
Gilead has recognized this potential and brings the experience of its team to ours, allowing us to more fully realize the potential of Coviracil and our other compounds in development.
Following recent discussions with the FDA, Triangle now plans to submit a New Drug Application (NDA) early this fall for Coviracil in the treatment of HIV.
amp;uot;We expect data to be presented on Triangle's most significant commercial compound Coviracil (FTC) at the upcoming Retrovirus conference in San Francisco,&uot; said King.
Nasdaq: VIRS) reported yesterday and today on the antiviral activity and tolerability of Coviracil (emtricitabine) and clevudine (formerly L-FMAU), its two compounds being separately tested for the treatment of chronic hepatitis B virus (HBV).
has two product candidates in pivotal Phase II/III trials: Coactinon, a non-nucleoside reverse transcriptase inhibitor and Coviracil (FTC), a reverse transcriptase inhibitor for the treatment of both HIV and HBV infection.
We also are looking forward to presenting new data from ongoing clinical trials involving Coviracil and clevudine for the treatment of hepatitis B at the 52nd Annual Meeting of the American Association for the Study of Liver Diseases to be held from November 9 through November 13, 2001 in Dallas, Texas.
The Company also announced today that, because of the probable delay in the filing of a New Drug Application ("NDA") for Coviracil for the treatment of HIV, it is taking steps to significantly lower its cash usage to a targeted average of approximately $5 million a month through 2002, from an average of approximately $8 million a month for the twelve-month period ending June 30, 2001.
We have completed two Phase III clinical trials for Coviracil (HIV) and are nearing completion of enrollment for the final Phase III clinical trial involving Coactinon(R) (HIV).