Abacavir, Lamivudine, and Zidovudine
(a BAK a veer, la MI vyoo deen, & zye DOE vyoo deen)
- 3TC, Abacavir, and Zidovudine
- Azidothymidine, Abacavir, and Lamivudine
- AZT, Abacavir, and Lamivudine
- Compound S, Abacavir, and Lamivudine
- Lamivudine, Abacavir, and Zidovudine
- ZDV, Abacavir, and Lamivudine
- Zidovudine, Abacavir, and Lamivudine
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Trizivir: Abacavir sulfate 300 mg, lamivudine 150 mg, and zidovudine 300 mg [contains fd&c blue #2 (indigotine)]
Generic: Abacavir sulfate 300 mg, lamivudine 150 mg, and zidovudine 300 mg
Brand Names: U.S.
- Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)
The combination of abacavir, lamivudine, and zidovudine is believed to act synergistically to inhibit reverse transcriptase via DNA chain termination after incorporation of the nucleoside analogue as well as to delay the emergence of mutations conferring resistance.
Use: Labeled Indications
HIV infection: Treatment of HIV-1 infection alone or in combination with other antiretroviral agents.
Limitations of use: Limited data exist on use alone in patients with higher baseline viral load levels (>100,000 copies/mL).
Hypersensitivity to abacavir, lamivudine, zidovudine, or any component of the formulation; patients positive for HLA-B*5701 allele; moderate or severe hepatic impairment.
Canadian labeling: Additional contraindications (not in US labeling): Hepatic impairment (regardless of severity of impairment); ANC <750 cells/mm3; hemoglobin <7.5 g/dL or 4.65 mmol/L
HIV-1 infection, treatment: Oral:
US labeling: One tablet twice daily.
Canadian labeling: ≥40 kg: One tablet twice daily. Note: Not recommended for patients <40 kg.
Refer to adult dosing.
HIV-1 infection, treatment: Children and Adolescents ≥40 kg: Refer to adult dosing. Note: Not recommended for pediatric patients <40 kg. The Canadian labeling does not include an indication for use in patients <18 years.
Dosing: Renal Impairment
CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl <50 mL/minute: Use is not recommended (use dose-adjusted individual components).
Dosing: Hepatic Impairment
Mild impairment (Child-Pugh class A): Use is not recommended (use dose-adjusted individual components).
Moderate to severe hepatic impairment (Child-Pugh Class B or C): Use is contraindicated.
Canadian labeling: Use is contraindicated (regardless of severity of impairment).
Administer without regard to food.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Acyclovir-Valacyclovir: May enhance the CNS depressant effect of Zidovudine. Monitor therapy
Amodiaquine: Zidovudine may enhance the neutropenic effect of Amodiaquine. Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Monitor therapy
Clarithromycin: May enhance the myelosuppressive effect of Zidovudine. Clarithromycin may decrease the serum concentration of Zidovudine. Management: Monitor response to zidovudine closely when used with clarithromycin, and consider staggering zidovudine and clarithromycin doses when possible in order to minimize the potential for interaction. Consider therapy modification
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination
Dexketoprofen: May enhance the adverse/toxic effect of Zidovudine. Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination
DOXOrubicin (Conventional): May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin (Conventional) may diminish the therapeutic effect of Zidovudine. Consider therapy modification
DOXOrubicin (Liposomal): May enhance the adverse/toxic effect of Zidovudine. DOXOrubicin (Liposomal) may diminish the therapeutic effect of Zidovudine. Consider therapy modification
Emtricitabine: LamiVUDine may enhance the adverse/toxic effect of Emtricitabine. Avoid combination
Fluconazole: May decrease the metabolism of Zidovudine. Monitor therapy
Ganciclovir-Valganciclovir: May enhance the adverse/toxic effect of Zidovudine. Specifically, hematologic toxicity may be enhanced. Monitor therapy
Interferons: May enhance the adverse/toxic effect of Zidovudine. Interferons may decrease the metabolism of Zidovudine. Monitor therapy
Methadone: May increase the serum concentration of Zidovudine. Monitor therapy
Methadone: May diminish the therapeutic effect of Abacavir. Abacavir may decrease the serum concentration of Methadone. Monitor therapy
Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy
Probenecid: May decrease the metabolism of Zidovudine. Monitor therapy
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
Protease Inhibitors: May decrease the serum concentration of Zidovudine. Monitor therapy
Protease Inhibitors: May decrease the serum concentration of Abacavir. Monitor therapy
Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of Zidovudine. Monitor therapy
Ribavirin (Oral Inhalation): Zidovudine may enhance the adverse/toxic effect of Ribavirin (Oral Inhalation). Specifically, the risk/severity of anemia may be increased. Management: Due to significantly increased risk of anemia, consider even closer monitoring for anemia than routinely recommended. Alternative therapies should be considered when clinically possible, particularly for patients with other risk factors. Consider therapy modification
Ribavirin (Systemic): Zidovudine may enhance the adverse/toxic effect of Ribavirin (Systemic). Specifically, the risk/severity of anemia may be increased. Management: Due to significantly increased risk of anemia, consider even closer monitoring for anemia than routinely recommended for ribavirin. Alternative therapies should be considered when clinically possible, particularly for patients with other risk factors. Consider therapy modification
Rifamycin Derivatives: May decrease the serum concentration of Zidovudine. Exceptions: Rifabutin. Monitor therapy
Stavudine: Zidovudine may diminish the therapeutic effect of Stavudine. Avoid combination
Tenoxicam: May enhance the adverse/toxic effect of Zidovudine. Monitor therapy
Teriflunomide: May increase the serum concentration of OAT3 Substrates. Monitor therapy
Trimethoprim: May increase the serum concentration of LamiVUDine. Monitor therapy
Valproate Products: May increase the serum concentration of Zidovudine. Monitor therapy
See individual agents as well as other combination products for additional information. Frequency not always defined.
Central nervous system: Headache (13%), fatigue (12%), malaise (12%), depression (6%), anxiety (5%),
Dermatologic: Skin rash (5%)
Endocrine & metabolic: Increased amylase (2%), increased serum triglycerides (grade 3-4: 2%), increased gamma-glutamyl transferase, redistribution of body fat
Gastrointestinal: Nausea (19%), nausea and vomiting (10%), diarrhea (7%), pancreatitis
Hematologic & oncologic: Neutropenia (5%)
Hepatic: Increased serum ALT (6%)
Hypersensitivity: Hypersensitivity (1% to 9%; based on abacavir component; higher risk in carriers of the HLA-B*5701 allele)
Immunologic: Immune reconstitution syndrome
Infection: Viral infection (5%)
Miscellaneous: Fever and chills (6%)
Neuromuscular & skeletal: Increased creatine phosphokinase (7%)
Respiratory: ENT infection (5%)
<1% (Limited to important or life-threatening): Abdominal pain, allergic sensitization (including anaphylaxis), alopecia, anemia, anorexia, aplastic anemia, cardiomyopathy, decreased appetite, dyspepsia, erythema multiforme, exacerbation of hepatitis B (posttreatment), gynecomastia, increased serum bilirubin, increased serum transaminases, insomnia, lactic acidosis, liver steatosis, lymphadenopathy, myalgia, myasthenia, oral mucosa hyperpigmentation, paresthesia, peripheral neuropathy, rhabdomyolysis, seizure, sleep disorder, splenomegaly, Stevens-Johnson syndrome, stomatitis, thrombocytopenia, urticaria, vasculitis, wheezing
Concerns related to adverse effects:
• Fat redistribution: May cause redistribution of fat (eg, buffalo hump, peripheral wasting with increased abdominal girth, cushingoid appearance).
• Hematologic toxicity: [US Boxed Warning]: Zidovudine has been associated with hematologic toxicities (eg, neutropenia, anemia); use with caution in patients with bone marrow compromise (eg, granulocyte count <1000 cells/mm3 or hemoglobin <9.5 g/dL). Canadian labeling contraindicates use if ANC <750 cells/mm3 or if hemoglobin <7.5 g/dL (4.65 mmol/L). Frequent complete blood counts are recommended in patients with advanced HIV-1 disease. Dosage interruption may be needed if anemia or neutropenia develops.
• Hypersensitivity reactions: [US Boxed Warning]: Serious hypersensitivity reactions (sometimes fatal) have occurred in patients taking abacavir (in Trizivir). Patients who carry the HLA-B*5701 allele are at a higher risk for a hypersensitivity reaction to abacavir, although hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with Trizivir or reinitiation of therapy with Trizivir unless patients have had a previously documented HLA-B*5701 allele assessment. Discontinue Trizivir if a hypersensitivity reaction is suspected. Trizivir is contraindicated in patients who have the HLA-B*5701 allele or in patients with a prior hypersensitivity reaction to abacavir. Reintroduction of Trizivir or any other abacavir-containing product can result in life-threatening or fatal hypersensitivity reactions, even in patients who have no history of hypersensitivity to abacavir therapy. Such reactions can occur within hours. Additionally, allele-positive patients (including abacavir treatment naive) should have an allergy to abacavir documented in their medical record. Reactions usually occur within 9 days of starting abacavir; ~90% occur within 6 weeks, although these reactions may occur at any time during therapy (HHS [adult] 2015). These reactions usually include signs or symptoms in 2 or more of the following groups: fever; rash; gastrointestinal (eg, nausea, vomiting, diarrhea, abdominal pain); constitutional (eg, generalized malaise, fatigue, achiness); respiratory (eg, dyspnea, cough, pharyngitis). Other signs and symptoms include lethargy, headache, myalgia, edema, abnormal chest x-ray findings, arthralgia and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with hypersensitivity reactions. Physical findings (lymphadenopathy, mucous membrane lesions, and rash [maculopapular, urticarial or variable]) may occur. Erythema multiforme has also been reported. Laboratory abnormalities (eg, elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia) may occur. Trizivir should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible. Following a hypersensitivity reaction, Trizivir SHOULD NOT be restarted because more severe symptoms may occur within hours, including LIFE-THREATENING HYPOTENSION AND DEATH. If Trizivir is to be restarted following an interruption in therapy not associated with symptoms of a hypersensitivity reaction, carefully evaluate the patient for previously unsuspected symptoms of hypersensitivity. Do not restart if hypersensitivity is suspected or cannot be ruled out regardless of HLA-B*5701 status. If Trizivir is restarted, continually monitor for symptoms of a hypersensitivity reaction. Make the patient aware that reintroduction should only take place if medical care is readily accessible.
• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves’ disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.
• Lactic acidosis/hepatomegaly: [US Boxed Warning]: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues; use with caution in patients with risk factors for liver disease (risk may be increased with female gender, obesity, pregnancy or prolonged exposure) and suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (transaminase elevation may/may not accompany hepatomegaly and steatosis).
• Myopathy: [US Boxed Warning]: Prolonged use of zidovudine has been associated with symptomatic myopathy and myositis.
• Pancreatitis: Pancreatitis has been observed with abacavir, lamivudine and zidovudine; rule out pancreatitis in patients who develop signs/symptoms (eg, nausea/vomiting, abdominal pain, elevated lipase and amylase) during therapy.
• Chronic hepatitis B: [US Boxed Warning]: Exacerbation of hepatitis B (including fatalities) has been reported with discontinuation of lamivudine in coinfected HIV/HBV patients; monitor hepatic function (eg, serum ALT) and HBV viral DNA closely for several months after discontinuing Trizivir in coinfected patients.
• Coronary heart disease: Use has been associated with an increased risk of myocardial infarction (MI) in observational studies; however, based on a meta-analysis of 26 randomized trials, the FDA has concluded there is not an increased risk. Consider using with caution in patients with risks for coronary heart disease and minimizing modifiable risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, and smoking) prior to use.
• Lamivudine-resistant HBV: Emergence of HBV virus variants associated with resistance to lamivudine have been reported in HIV-1 infected subjects who have received lamivudine-containing antiretroviral regimens in the presence of HBV coinfection.
• Renal impairment: Trizivir, as a fixed-dose combination tablet, should not be used in patients with CrCl <50 mL/minute.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Duplicate therapy: Concomitant use of other abacavir-, emtricitabine-, lamivudine-, or zidovudine-containing products with this fixed-dose combination product should be avoided.
• Pediatric patients <40 kg: Trizivir, as a fixed-dose combination tablet, should not be used in patients <40 kg or those requiring dosage adjustment.
• Therapy-experienced patients: Patients with prolonged prior nucleoside reverse transcriptase inhibitor (NRTI) exposure or presence of HIV-1 isolates containing multiple mutations conferring resistance to NRTIs have limited response to abacavir. The potential for cross resistance between abacavir and other NRTIs should be considered when evaluating new regimens in therapy experienced patients.
Blood glucose, CBC with differential, serum creatine kinase, CD4 count, HIV RNA plasma levels, bilirubin, serum transaminases, triglycerides, serum amylase; HLA-B*5701 genotype status prior to initiation of therapy and prior to reinitiation of therapy in patients of unknown HLA-B*5701 status; signs and symptoms of hypersensitivity, particularly in patients untested for the HLA-B*5701 allele; signs and symptoms of pancreatitis; observe for appearance of opportunistic infections
Pregnancy Risk Factor
Animal reproduction studies have not been conducted with this combination. The HHS Perinatal HIV Guidelines generally do not recommend this combination in antiretroviral-naive pregnant women due to inferior virologic activity (HHS [perinatal] 2016). See individual agents.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, joint pain, anxiety, drowsiness, nausea, vomiting, or diarrhea. Have patient report immediately to prescriber signs of allergic reaction with organ failure (fever, rash, fatigue, flu-like signs, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, cough, or difficulty breathing), signs of bone marrow depression (neutropenia or anemia), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), loss of strength or energy, angina, depression, severe dizziness, passing out, mouth sores, muscle pain, burning or numbness feeling, shortness of breath, edema, change in body fat, or signs of infection (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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Other brands: Trizivir