Classes
DEA Class; Rx
Common Brand Names; Trizivir
- HIV, ART Combos
Description
Combination of three nucleoside reverse transcriptase inhibitors (NRTIs)
Used for the treatment of human immunodeficiency virus (HIV) infection
Triple NRTI therapy is not considered highly active antiretroviral therapy (HAART); virologic failure occurs sooner and more often compared to an efavirenz-containing regimen
Indications
Indicated Indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in patients who weigh at least 40 kg
Contraindications
Hypersensitivity to any component
Moderate or severe hepatic impairment
Presence of HLA-B*5701 allele
Adverse Effects
- Nausea
- Headache
- Fatigue
- Malaise
- Vomiting
- Rash
- Fever/chills
- Anxiety
- Depression
- Increased triglyceride levels
- Diarrhea
- Increased amylase
- Neutropenia
- Increased ALT
- Increased CPK
- Ear infection
- Nose/throat infection
- Viral infection
Warnings
Immune reconstitution syndrome reported with combination ART; during the initial treatment phase, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis); autoimmune disorders (eg, Grave disease, polymyositis, and Guillain-Barré syndrome) have also been reported
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogues, including abacavir, lamivudine, and zidovudine (components of the combination product); a majority of these cases have been in women; female gender and obesity may be risk factors; suspend dosing in those who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
Use has been associated with increased risk of myocardial infarction in observational studies, but not in a meta-analysis of 26 randomized trials; caution with risks for coronary heart disease and minimizing modifiable risk factors, including smoking, hypertension, and hyperlipidemia, prior to use
Use caution when treating in combination with interferon alfa with or without ribavirin in HIV/HBV; monitor for hepatic decompensation, neutropenia, or anemia and reduce interferon dose and or ribavirin or discontinue if toxicity occurs
Discontinue therapy as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both in co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin
Exacerbation of anemia reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine; coadministration of ribavirin and zidovudine not advised
Pregnancy and Lactation
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the drug during pregnancy
The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection
Maximum Dosage
Abacavir 600 mg/day; lamivudine 300 mg/day; zidovudine 600 mg/day.
Abacavir 600 mg/day; lamivudine 300 mg/day; zidovudine 600 mg/day.
>=40 kg: abacavir 600 mg/day; lamivudine 300 mg/day; zidovudine 600 mg/day.
< 40 kg: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Lamivudine/zidovudine/abacavir
tablet
- 150mg/300mg/300mg