What is Trizivir (abacavir, lamivudine, zidovudine)?
Anti-HIV drugs are often used in combination to increase HIV suppression and to reduce the chance of the HIV developing resistance to any single drug. Trizivir does not reduce the transmission of HIV among individuals, and it does not cure HIV or AIDS.
Drug interactions of Trizivir include:
- sorbitol-containing medicines,
- stavudine, doxorubicin,
- nucleoside analogues (e.g., ribavirin),
- interferon alfa,
- and other bone marrow suppressive or cytotoxic agents.
Tell your doctor if you are pregnant or plan to become pregnant before using Trizivir; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Trizivir during pregnancy.
Use of Trizivir by nursing women has not been adequately studied. HIV-infected mothers should not breastfeed because of the potential risk of transmitting HIV to an infant that is not infected.
What are the side effects of Trizivir?
What are the common side effects of Trizivir?
Common side effects of Trizivir include:
What are the serious side effects of Trizivir?
Serious side effects of Trizivir include:
- hypersensitivity reactions (symptoms include fever, rash, nausea, vomiting, diarrhea, abdominal pain, fatigue, aches, shortness of breath, cough, and sore throat),
- liver failure,
- metabolic disturbance (lactic acidosis),
- decrease in blood cells,
- muscle pain,
- and weakness and nerve damage in the extremities (peripheral neuropathy).
What drugs interact with Trizivir?
In a trial of 11 HIV-1 infected subjects receiving methadone maintenance therapy with 600 mg of Ziagen twice daily (twice the currently recommended dose), oral methadone clearance increased. This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.
Coadministration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures. When possible, avoid use of sorbitol-containing medicines with lamivudine-containing medicines.
Agents Antagonistic With Zidovudine
Concomitant use of zidovudine with the following drugs should be avoided since an antagonistic relationship has been demonstrated in vitro:
- Nucleoside analogues, e.g., ribavirin
Hematologic/Bone Marrow Suppressive/Cytotoxic Agents
Coadministration with the following drugs may increase the hematologic toxicity of zidovudine:
- Interferon alfa
- Other bone marrow suppressive or cytotoxic agents
Trizivir side effects list for healthcare professionals
The following adverse reactions are discussed in other sections of the labeling:
- Serious and sometimes fatal hypersensitivity reactions.
- Hematologic toxicity, including neutropenia and anemia.
- Symptomatic myopathy.
- Lactic acidosis and severe hepatomegaly with steatosis.
- Exacerbations of hepatitis B.
- Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C.
- Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine.
- Immune reconstitution syndrome.
- Myocardial infarction.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Serious And Fatal Abacavir-Associated Hypersensitivity Reactions
In clinical trials, serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of Trizivir. These reactions have been characterized by 2 or more of the following signs or symptoms:
- gastrointestinal symptoms (including nausea, vomiting, diarrhea, or abdominal pain);
- constitutional symptoms (including generalized malaise, fatigue, or achiness);
- respiratory symptoms (including dyspnea, cough, or pharyngitis).
Almost all abacavir hypersensitivity reactions include fever and/or rash as part of the syndrome.
Other signs and symptoms have included lethargy, headache, myalgia, edema, arthralgia, and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with these hypersensitivity reactions.
Physical findings have included lymphadenopathy, mucous membrane lesions (conjunctivitis and mouth ulcerations), and maculopapular or urticarial rash (although some patients had other types of rashes and others did not have a rash). There were reports of erythema multiforme. Laboratory abnormalities included elevated liver chemistries, elevated creatine phosphokinase, elevated creatinine, and lymphopenia, and abnormal chest x-ray findings (predominantly infiltrates, which were localized).
Additional Adverse Reactions With Use Of Trizivir
Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a frequency greater than or equal to 5% during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily compared with indinavir 800 mg 3 times daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily from CNA3005 are listed in Table 1.
Table 1. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2-4, Greater than or Equal to 5% Frequency) in Therapy-Naive Adults (CNA3005) through 48 Weeks of Treatment
|Adverse Reaction||ZIAGEN plus
(n = 262)
(n = 264)
|Malaise and fatigue||12%||12%|
|Nausea and vomiting||10%||10%|
|Fever and/or chills||6%||3%|
|Viral respiratory infections||5%||5%|
Five subjects receiving abacavir in CNA3005 experienced worsening of pre-existing depression compared to none in the indinavir arm. The background rates of pre-existing depression were similar in the 2 treatment arms.
Laboratory abnormalities in CNA3005 are listed in Table 2.
Table 2. Treatment-Emergent Laboratory Abnormalities (Grades 3/4) in CNA3005
|Laboratory Parameter||ZIAGEN plus
(n = 262)
(n = 264)
|Elevated CPK (>4 x ULN)||18 (7%)||18 (7%)|
|ALT (>5.0 x ULN)||16 (6%)||16 (6%)|
|Neutropenia (<750/mm3)||13 (5%)||13 (5%)|
|Hypertriglyceridemia (>750 mg/dL)||5 (2%)||3 (1%)|
|Hyperamylasemia (>2.0 x ULN)||5 (2%)||1 (<1%)|
|Hyperglycemia (>13.9 mmol/L)||2 (<1%)||2 (<1%)|
|Anemia (Hgb ≤6.9 g/dL)||0 (0%)||3 (1%)|
|ULN = Upper limit of normal.
n = Number of subjects assessed.
Other Adverse Events
In addition to adverse reactions in Tables 1 and 2, other adverse events observed in the expanded access program for abacavir were pancreatitis and increased GGT.
The following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular: Myocardial infarction.
Skin: Suspected Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases. There have also been reports of erythema multiforme with abacavir use.
Abacavir, Lamivudine, And/Or Zidovudine
Body as a Whole: Redistribution/accumulation of body fat.
Endocrine and Metabolic: Gynecomastia.
General: Vasculitis, weakness.
Hypersensitivity: Sensitization reactions (including anaphylaxis), urticaria.
Musculoskeletal: Arthralgia, myalgia, muscle weakness, rhabdomyolysis.
Respiratory: Abnormal breath sounds/wheezing.
Skin: Alopecia, erythema multiforme, Stevens-Johnson syndrome.
Trizivir (abacavir, lamivudine, zidovudine) is a combination of antiviral medications used for treating infections with the human immunodeficiency virus (HIV). Anti-HIV drugs are often used in combination to increase HIV suppression and to reduce the chance of the HIV developing resistance to any single drug. Trizivir does not reduce the transmission of HIV among individuals, and it does not cure HIV or AIDS. Common side effects of Trizivir include nausea, diarrhea, vomiting, weight loss, and difficulty sleeping. Serious side effects of Trizivir include hypersensitivity reactions (symptoms include fever, rash, nausea, vomiting, diarrhea, abdominal pain, fatigue, aches, shortness of breath, cough, and sore throat), pancreatitis, liver failure, metabolic disturbance, and more.
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Human Immunodeficiency Virus (HIV)
HIV (human immunodeficiency virus) infection left untreated causes AIDS (acquired immunodeficiency syndrome). The human immunodeficiency virus (HIV) is a type of virus called a retrovirus, which can infect humans when it comes in contact with tissues that line the vagina, anal area, mouth, or eyes, or through a break in the skin. HIV infection is generally a slowly progressive disease in which the virus is present throughout the body at all stages of the disease. Three stages of HIV infection have been described. The initial stage of infection (primary infection), which occurs within weeks of acquiring the virus, often is characterized by the flu- or mono-like illness that generally resolves within weeks. The stage of chronic asymptomatic infection (meaning a long duration of infection without symptoms) lasts an average of eight to 10 years without treatment. The stage of symptomatic infection, in which the body's immune (or defense) system has been suppressed and complications have developed, is called the acquired immunodeficiency syndrome (AIDS). The symptoms are caused by the complications of AIDS, which include one or more unusual infections or cancers, severe loss of weight, and intellectual deterioration (called dementia). When HIV grows (that is, by reproducing itself), it acquires the ability to change (mutate) its own structure. These mutations enable the virus to become resistant to previously effective drug therapy. The goals of drug therapy are to prevent damage to the immune system by the HIV virus and to halt or delay the progress of the infection to symptomatic disease. Therapy for HIV includes combinations of drugs that decrease the growth of the virus to such an extent that the treatment prevents or markedly delays the development of viral resistance to the drugs. The best combination of drugs for HIV are those that effectively suppress viral replication in the blood and also are well tolerated and simple to take so that people can take the medications consistently without missing doses.
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HIV (human immunodeficiency virus) is the precursor infection to AIDS (acquired immunodeficiency syndrome). HIV is transmitted through blood and genital secretions; most people get it through sexual contact or sharing needles for illegal IV drug use. HIV can be controlled by a strict drug regimen, but left unchecked, it leads to AIDS. In AIDS, the immune system collapses and the body falls prey to secondary, opportunistic infections and cancers that typically kill the person.
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HIV/AIDS Infection Transmission and Prevention
HIV (human immunodeficiency virus) is spread through contact with genital fluids or blood of an infected person. The spread of HIV can occur when these secretions come in contact with tissues such as those lining the vagina, anal area, mouth, eyes (the mucus membranes), or with a break in the skin, such as from a cut or puncture by a needle.
HIV Life Expectancy and Long-term Outlook
With early diagnosis and proper treatment, people with HIV can live a healthy and long life. There is no generalized definitive period for which a person with HIV can live.
When should you start HIV medication?
Nearly everyone who is infected with HIV (human immunodeficiency virus) should start antiviral medication therapy as soon as they are diagnosed. Older guidelines recommended delaying treatment to help reduce the potential for drug side effects and viral resistance to treatment. Current thinking theorizes that early treatment may preserve more of the body's immune function.
What Are the Side Effects of HIV Medications?
It’s important to know the potential side effects of all the drugs you take to control your HIV infection, as well as potential drug interactions. All of the NNRTIs (nonnucleoside analogue reverse transcriptase inhibitors), for example, are associated with important drug-drug interactions so they must be used with caution in patients on other medications. Learn more about the side effects of the drugs in standard treatment regimens.
Treatment & Diagnosis
- HIV-AIDS FAQs
- HIV Treatment, Medications, and Prevention
- HIV: Two Patients Face The Diagnosis
- HIV Treatment - To Interrupt or Not
- Unprotected Sex Between HIV-Infected Partners: What's the Harm?
- HIV Transmission and Progression to AIDS Continues
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- Babies On The Breast Of HIV Moms
- Generic AIDS Drug Effective - And Now?
- HIV Urine Test Approved
- HIV / AIDS Conference Update 2005 - Index
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- Can HIV Cause Kaposi's Sarcoma?
- Do You Need Antiretroviral Therapy for HIV with No Symptoms?
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- Baby "Cured" of HIV Infection
Medications & Supplements
- abacavir/lamivudine/zidovudine - oral, Trizivir
- What Are NNRTIs In Antiretroviral Therapy for HIV Infection?
- How Effective Is ART for HIV Infection?
- What ART Drugs Prevent HIV Entry into the Human Immune Cell?
- Triumeq (abacavir, dolutegravir, and lamivudine)
- How Do Integrase Strand-Transfer Inhibitors Work in Antiretroviral Therapy for HIV Infection?
- What Are NRTIs in Antiretroviral Therapy For HIV Infection?
- How Do Protease Inhibitors Work in Antiretroviral Therapy for HIV Infection?
- What Are the Single-Tablet ART Regimens for HIV Infection?
- Dovato (dolutegravir and lamivudine)
- Epzicom (abacavir sulfate and lamivudine)
- abacavir, lamivudine, zidovudine (Trizivir)
- Temixys (lamivudine and tenofovir disoproxil fumarate)
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.