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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.
Common side effects of Trizivir include:
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).
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 important side effects of Trizivir (abacavir, lamivudine, zidovudine)?
Serious and sometimes fatal hypersensitivity reactions involving several organs have been associated with abacavir, a component of Trizivir. Symptoms include fever, rash, nausea, vomiting, diarrhea, abdominal pain, fatigue, aches, shortness of breath, cough, and sore throat.
Patients should discontinue Trizivir if a hypersensitivity reaction is suspected. Patients who carry a certain genetic marker called HLA-B 5701 are at high risk for experiencing a hypersensitivity reaction to abacavir. Screening for the HLA-B 5701 allele is recommended prior to initiating therapy with abacavir.
Other important side effects of the abacavir component include:
- liver failure
- metabolic disturbance (lactic acidosis)
- decrease in blood cells,
- muscle pain
- weakness and nerve damage in the extremities (peripheral neuropathy).
Trizivir (abacavir, lamivudine, zidovudine) 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.
What drugs interact with Trizivir (abacavir, lamivudine, zidovudine)?
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
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HIV Early Signs and Stages
Human immunodeficiency virus or HIV, destroys important cells that fight disease and infection, which weakens a person's immune system. Some people with HIV don’t have any signs or symptoms. Early signs and symptoms of HIV infection include mononucleosis-like or flu-like symptoms, which include body aches, fever, and headache. Signs and symptoms begin around seven or eight years after HIV infection, which include weight loss, loss of energy and appetite, and swollen lymph nodes. There are 3 stages of HIV.
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AIDS (Acquired Immunodeficiency Syndrome)
AIDS is the advanced stage of HIV infection. Symptoms and signs of AIDS include pneumonia due to Pneumocystis jiroveci, tuberculosis, toxoplasmosis, seizures, weakness, meningitis, yeast infection of the esophagus, and Kaposi's sarcoma. Anti-retroviral therapy (HAART) is used in the treatment of AIDS.
Human Immunodeficiency Virus (HIV)
HIV (human immunodeficiency virus) infection left untreated causes AIDS (acquired immunodeficiency syndrome). Still incurable, AIDS describes immune system collapse that opens the way for opportunistic infections and cancers to kill the patient. Early symptoms and signs of HIV infection include flu-like symptoms and fungal infections, but some people may not show any symptoms for years. Highly active antiretroviral therapy (ART) is the standard treatment for HIV infection. These combination drug regimens have made HIV much less deadly, but a cure or vaccine for the pandemic remains out of reach. HIV is usually transmitted through sexual contact or sharing IV drug needles, but can also infect someone through contact with infected blood. Sexual abstinence, safe sex practices, quitting IV drugs (or at least using clean needles), and proper safety equipment by clinicians and first responders can drastically reduce transmission rates for HIV/AIDS.
HIV vs. AIDS
Human immunodeficiency virus causes HIV infection. Acquired immunodeficiency syndrome (AIDS) is a condition that results after HIV has extensively damaged a person's immune system. Risk factors for HIV and AIDS include use of contaminated needles or syringes, unprotected sex, STDs, receiving a blood transfusion prior to 1985 in the United States, having many sex partners, and transmission from a mother to her child.
HIV/AIDS Testing: Diagnosis and Monitoring
HIV/AIDS diagnosis and monitoring have come a long way from the days when a diagnosis was a death sentence. Crucial parts of the effective treatment regimens developed in the last 40 years are consistent monitoring of the viral load (the amount of virus in the blood), and the immune cell count, which function as biological markers of the disease’s progression. Doctors also must test for drug resistance.
HIV/AIDS Facts: What Is HIV?
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 (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 Medications List and Drug Charts
The ultimate goal of HIV treatment is getting the viral load down below detectable levels. As long as those viral load and antibody levels are below a proscribed range, people with HIV can stave off AIDS and other serious symptoms. Antiviral treatment options usually include combinations of two NRTIs, often referred to as "nucs," and a third drug, typically being a boosted protease inhibitor, a NNRTI, often called "non-nucs," and integrase strand transfer inhibitors.
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.
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Medications & Supplements
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.