Frequently Asked Questions

abacavir/lamivudine/zidovudine

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Trizivir

Antiviral combinations


Abacavir/lamivudine/zidovudine has caused severe and sometimes fatal allergic reactions. Contact your doctor right away if you develop fever; rash; nausea, vomiting, diarrhea, or stomach pain; cough, sore throat, or trouble breathing; unusual tiredness or achiness; or general feeling of being unwell. Do NOT take abacavir/lamivudine/zidovudine again or take any other medicine that contains abacavir if you have had an allergic reaction to abacavir/lamivudine/zidovudine. You may be at risk for an even more severe allergic reaction. If you stop taking abacavir/lamivudine/zidovudine for any other reason, even for a few days, and you are not allergic to it, check with your doctor before restarting it.

Patients who have a certain gene type called HLA-B*5701 have an increased risk of having an allergic reaction to abacavir. A lab test may be performed before you start abacavir/lamivudine/zidovudine to see if you have this gene type. Discuss any questions or concerns with your doctor.

Zidovudine (a component of abacavir/lamivudine/zidovudine) has been associated with severe bone marrow problems, such as low white blood cell levels (neutropenia) and anemia. The risk may be greater in patients with advanced HIV infection. Tell your doctor right away if you have symptoms of anemia (eg, unusual tiredness or weakness or an infection (eg, fever, chills, persistent cough or sore throat, decreased or painful urination).

Muscle pain or aches have occurred with long-term use of zidovudine. Tell your doctor if you develop these effects.

High levels of lactic acid in the blood (lactic acidosis) and severe liver problems, including fatal cases, have been reported in patients taking certain HIV medicines, such as abacavir/lamivudine/zidovudine. The risk may be greater in women, in patients who are very overweight, or in patients who have a history of liver problems. It may also be increased in patients who have taken certain HIV medicines for a prolonged period of time. Tell your doctor immediately if you have dark urine; fast or irregular heartbeat; pale stools; rapid or difficult breathing; severe or unusual drowsiness, dizziness, or light-headedness; sluggishness; stomach pain (with or without nausea or vomiting); unusual muscle pain or tenderness; unusual tiredness or weakness; or yellowing of the eyes and skin. Contact your doctor right away if you start to feel unusually cold, especially in your arms and legs, or if you have a general feeling of being unwell.

Severe worsening of hepatitis B virus (HBV) has been reported in patients who have both HIV and HBV infection and have stopped taking lamivudine. Patients who have both HIV and HBV infection need close medical follow-up to check for worsening liver problems for at least several months after stopping lamivudine. Be sure to keep all doctor and lab appointments.


Abacavir/ lamivudine/ zidovudine is used for:

Treating HIV infection. Abacavir/lamivudine/zidovudine is used alone or in combination with other medicines.

Abacavir/lamivudine/zidovudine is a nucleoside reverse transcriptase inhibitor (NRTI) combination. It works by blocking HIV from reproducing.

Do NOT use abacavir/ lamivudine/ zidovudine if:

  • you are allergic to any ingredient in abacavir/lamivudine/zidovudine
  • you weigh less than 90 pounds (40 kilograms)
  • you have liver problems (eg, an enlarged liver, abnormal liver function tests, kidney problems, high levels of lactic acid in the blood [lactic acidosis])
  • you are taking doxorubicin, emtricitabine, ribavirin, stavudine, zalcitabine, or any medicine containing abacavir, lamivudine, or zidovudine

Contact your doctor or health care provider right away if any of these apply to you.

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Before using abacavir/ lamivudine/ zidovudine:

Some medical conditions may interact with abacavir/lamivudine/zidovudine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney problems, heart problems (eg, heart attack), high blood pressure, high cholesterol, diabetes, pancreatitis, blood or bone marrow problems, muscle problems, hepatitis B infection, or nerve problems
  • if you have a history of high levels of lactic acid in the blood or are at risk of liver problems
  • if you smoke, drink alcohol, or are very overweight
  • if you are taking any other medicine for HIV infection
  • if you have been tested and know whether or not you have a gene type called HLA-B*5701

Some MEDICINES MAY INTERACT with abacavir/lamivudine/zidovudine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Ganciclovir, interferon alfa, ribavirin, other bone marrow suppressive medicines, or cytotoxic medicines because they may increase the risk of bone marrow problems. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of bone marrow problems
  • Probenecid or valproic acid because they may increase the risk of abacavir/lamivudine/zidovudine's side effects
  • Doxorubicin or zalcitabine because the effectiveness of both medicines may be decreased
  • Methadone or stavudine because their effectiveness may be decreased by abacavir/lamivudine/zidovudine

This may not be a complete list of all interactions that may occur. Ask your health care provider if abacavir/lamivudine/zidovudine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use abacavir/ lamivudine/ zidovudine:

Use abacavir/lamivudine/zidovudine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Abacavir/lamivudine/zidovudine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get abacavir/lamivudine/zidovudine refilled.
  • Abacavir/lamivudine/zidovudine comes with a warning card that provides information about recognition of allergic reactions. Carry the warning card of allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking abacavir/lamivudine/zidovudine.
  • Take abacavir/lamivudine/zidovudine by mouth with or without food.
  • Taking abacavir/lamivudine/zidovudine at the same time each day will help you remember to take it.
  • Take abacavir/lamivudine/zidovudine on a regular schedule to get the most benefit from it.
  • Continue to take abacavir/lamivudine/zidovudine even if you feel well. Do not miss any doses.
  • If you miss a dose of abacavir/lamivudine/zidovudine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than 1 dose of abacavir/lamivudine/zidovudine, contact your doctor.

Ask your health care provider any questions you may have about how to use abacavir/lamivudine/zidovudine.

Important safety information:

  • Abacavir/lamivudine/zidovudine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use abacavir/lamivudine/zidovudine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Tell your doctor or dentist that you take abacavir/lamivudine/zidovudine before you receive any medical or dental care, emergency care, or surgery.
  • Drinking alcohol while taking abacavir/lamivudine/zidovudine may cause an increased risk of side effects. Talk to your doctor before drinking alcohol while you are taking abacavir/lamivudine/zidovudine.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Abacavir/lamivudine/zidovudine is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking abacavir/lamivudine/zidovudine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • If you stop taking abacavir/lamivudine/zidovudine even for a few days (eg, if you run out of your medicine and do not get it refilled right away), contact your doctor before you start taking it again. You may experience a serious allergic reaction if you stop taking abacavir/lamivudine/zidovudine and then start again.
  • Abacavir/lamivudine/zidovudine does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Abacavir/lamivudine/zidovudine may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start abacavir/lamivudine/zidovudine.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking abacavir/lamivudine/zidovudine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Diabetes patients - Abacavir/lamivudine/zidovudine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Patients who have a certain gene type called HLA-B*5701 have an increased risk of a severe or even fatal allergic reaction to abacavir/lamivudine/zidovudine. A lab test may be performed before you start abacavir/lamivudine/zidovudine to see if you have this gene type. Discuss any questions or concerns with your doctor.
  • Lab tests, including CD4 counts, complete blood cell counts, and liver function tests, may be performed while you use abacavir/lamivudine/zidovudine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Abacavir/lamivudine/zidovudine should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking abacavir/lamivudine/zidovudine while you are pregnant. Abacavir/lamivudine/zidovudine is found in breast milk. Do not breast-feed while taking abacavir/lamivudine/zidovudine. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or abacavir/lamivudine/zidovudine to the baby.

Possible side effects of abacavir/ lamivudine/ zidovudine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; joint pain; mild muscle pain; nervousness; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (fever; rash; tiredness; achiness; nausea; diarrhea; vomiting; stomach pain; sore throat; hives; itching; difficulty breathing; cough; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest, jaw, or arm pain or discomfort; decreased urination; depression; fainting; fever, chills, or persistent sore throat; mouth ulcers; muscle pain, cramping, or weakness; numbness, tingling, or pain in the hands and feet; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness; shortness of breath; sudden, unusual sweating; swelling; symptoms of lactic acidosis (eg, fast or irregular heartbeat; feeling cold, especially in your arms and legs; rapid or difficult breathing; severe or unusual drowsiness, dizziness, or light-headedness; sluggishness; stomach pain with nausea and vomiting); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the eyes or skin); unusual bleeding or bruising; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion, dizziness, drowsiness, headache, nausea, seizures, sluggishness, or vomiting.

Proper storage of abacavir/lamivudine/zidovudine:

Store abacavir/lamivudine/zidovudine at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep abacavir/lamivudine/zidovudine out of the reach of children and away from pets.

General information:

  • If you have any questions about abacavir/lamivudine/zidovudine, please talk with your doctor, pharmacist, or other health care provider.
  • Abacavir/lamivudine/zidovudine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take abacavir/lamivudine/zidovudine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about abacavir/lamivudine/zidovudine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to abacavir/lamivudine/zidovudine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using abacavir/lamivudine/zidovudine.

Issue Date: February 4, 2015
Database Edition 15.1.1.002
Copyright © 2015 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Not all side effects for abacavir / lamivudine / zidovudine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to abacavir / lamivudine / zidovudine: oral tablet

In addition to its needed effects, some unwanted effects may be caused by abacavir / lamivudine / zidovudine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking abacavir / lamivudine / zidovudine:

More common
  • Chills
Less common
  • Abdominal or stomach pain
  • cough
  • diarrhea
  • fever
  • headache
  • muscle weakness
  • nausea
  • numbness or tingling of the face, feet, or hands
  • pain in the joints
  • pain in the muscles
  • pale skin
  • shortness of breath
  • skin rash
  • sore throat
  • swelling of the feet or lower legs
  • swelling of the feet or lower legs
  • unusual feeling of discomfort or illness
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin
Rare
  • Black, tarry stools
  • blood in the urine or stools
  • pinpoint red spots on the skin
  • unusual bleeding or bruising

Some of the side effects that can occur with abacavir / lamivudine / zidovudine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Bone pain
  • loss of appetite
  • sleeplessness
  • trouble sleeping

For Healthcare Professionals

Applies to abacavir / lamivudine / zidovudine: oral tablet

General

The adverse effects are sometimes difficult to distinguish from the symptomatology observed during the clinical course of AIDS, as well as from the possible adverse effects of other drugs used in the treatment of HIV infection. Many of the side effects associated with nucleoside reverse transcriptase inhibitor therapy (myopathy, pancreatitis, liver failure, lactic acidosis, etc.) are attributable to their direct toxic effect on mitochondria which causes decreased mitochondrial energy-generating capacity.[Ref]

Hypersensitivity

Abacavir hypersensitivity is a clinical syndrome affecting multiple organs generally characterized by a sign or symptom in two or more of the following groups:
(1) Fever
(2) Rash
(3) Gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain)
(4) Constitutional (including generalized malaise, fatigue, or achiness)
(5) Respiratory (including dyspnea, cough, or pharyngitis)

A strong predictor of hypersensitivity reaction may be the presence of human leukocyte antigen subtype B*5701 (HLA-B*5701). Analyzing past studies, patients testing positive for the HLA-B*5701 allele had a greater risk (61% to about 70%) of developing hypersensitivity reactions with abacavir, while patients without the HLA-B*5701 allele had a low risk (less than 1% to 4%); therefore, screening for the HLA-B*5701 allele is recommended prior to starting abacavir treatment. Therapy with an abacavir-containing regimen is not recommended for HLA-B*5701-positive patients and should be considered only with close medical supervision under exceptional conditions where potential benefit outweighs the risk. Considerably less frequently, HLA-B*5701-negative patients may experience hypersensitivity reaction with abacavir.

Abacavir should be permanently discontinued as soon as a hypersensitivity reaction is suspected. Severe or fatal hypersensitivity reactions can also occur within hours after restarting abacavir in patients who have no identified history or unrecognized symptoms of this reaction. It should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible, to minimize the risk of a life-threatening hypersensitivity reaction.[Ref]

Hypersensitivity side effects associated with abacavir have included serious and sometimes fatal hypersensitivity reactions. Frequently observed signs and symptoms have included, but were not limited to, fever, skin rash (maculopapular, urticarial, or variable appearance), fatigue, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, malaise, achiness, dyspnea, and cough. Other symptoms of abacavir hypersensitivity have included lethargy, myolysis, edema, abnormal chest X-ray (infiltrates), paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions (conjunctivitis and stomatitis), elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia. Hypersensitivity reaction (Grades 2 to 4; 8%) has been reported when abacavir was administered with lamivudine and zidovudine. Sensitization reactions (including anaphylaxis) and urticaria have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Gastrointestinal

Gastrointestinal side effects of at least moderate intensity have included nausea (19%), nausea and vomiting (10%), and diarrhea (7%) when abacavir was administered with lamivudine and zidovudine. Abdominal cramps have been reported. Oral ulcerations and lesions have been observed with the use of lamivudine and flatulence has been reported with the use of zidovudine. Pancreatitis was observed in the expanded access program. Abdominal pain, anorexia and/or decreased appetite, pancreatitis, oral mucosal pigmentation, stomatitis, and dyspepsia have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Hepatic

Severe acute exacerbations of hepatitis, including fatalities, have been reported in patients coinfected with hepatitis B virus and HIV-1 who have discontinued antihepatitis B therapy, including lamivudine. The causal relationship to stopping lamivudine treatment is unknown.[Ref]

Hepatic side effects have included elevated ALT (greater than 5 times ULN; 6%) and liver function test abnormalities when abacavir was administered with lamivudine and zidovudine. The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration. One patient with preexisting hepatitis B developed acute hepatic failure two weeks after starting zidovudine therapy. Increased gamma-glutamyltransferase was observed in the expanded access program. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Hepatic decompensation, sometimes fatal, has been reported in patients coinfected with HIV-1 and hepatitis C virus who were receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin. Lactic acidosis and hepatic steatosis, elevated bilirubin, elevated transaminases, and posttreatment exacerbations of hepatitis B have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Nervous system

Nervous system side effects of at least moderate intensity have included headache (13%) when abacavir was administered with lamivudine and zidovudine. Generalized seizures, status epilepticus, confusion, paresthesia, somnolence, vertigo, and Wernicke's syndrome have been reported, although rarely, with the use of zidovudine. Insomnia and other sleep disorders, paresthesia, peripheral neuropathy, seizures, and dizziness have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Other

Other side effects of at least moderate intensity have included malaise and fatigue (12%), fever and/or chills (6%), and non-site-specific pain (less than 1%) when abacavir was administered with lamivudine and zidovudine. Weakness has been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Metabolic

Metabolic side effects have included elevated creatine phosphokinase (greater than 4 times ULN; 7%), hypertriglyceridemia (greater than 750 mg/dL; 2%), hyperamylasemia (greater than 2 times ULN; 2%), and hyperglycemia (greater than 13.9 mmol/L; less than 1%). Redistribution and/or accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients taking antiretroviral agents; however, a causal relationship has not been established. Although progressive subcutaneous fat wasting has been attributed to the use of protease inhibitors, nucleoside reverse transcriptase inhibitors may have an independent contribution. Hyperglycemia and redistribution/accumulation of body fat have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Progressive subcutaneous fat wasting has been observed in patients naive to protease inhibitors, however, not to the same degree as in patients on a combination regimen that includes a protease inhibitor.[Ref]

Dermatologic

Bluish or brownish-black discoloration of nails has developed during the first month or two of zidovudine therapy and usually disappeared within 2 months if the drug was discontinued. Discoloration has occurred as longitudinal streaks or transverse bands.

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. Due to overlap of clinical signs and symptoms between abacavir hypersensitivity and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be permanently discontinued in such cases.[Ref]

Dermatologic side effects of at least moderate intensity have included skin rashes (5%) when abacavir was administered with lamivudine and zidovudine. Hair loss has been associated with lamivudine therapy in a few patients. Several cases of nailbed hyperpigmentation have been associated with zidovudine. Leukocytoclastic vasculitis with eosinophilia and fever has also been reported with the use of zidovudine. Rash and Sweet's syndrome have been reported with abacavir. Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported during postmarketing experience with abacavir. Alopecia, erythema multiforme, and Stevens-Johnson syndrome have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Hematologic

Hematologic side effects have included neutropenia (less than 750/mm3; 5%) when abacavir was administered with lamivudine and zidovudine. The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration. Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen. Hematologic toxicity (including neutropenia and severe anemia) has been reported with zidovudine. Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, thrombocytopenia, and splenomegaly have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Zidovudine has been associated with hematologic toxicity (including neutropenia and severe anemia), particularly in patients with advanced HIV-1 disease. Abacavir / lamivudine / zidovudine should be used with caution in patients with bone marrow suppression indicated by granulocyte count below 1000 cells/mm3 or hemoglobin less than 9.5 g/dL. Frequent blood counts are strongly recommended in patients with advanced HIV-1 disease treated with abacavir / lamivudine / zidovudine. Periodic blood counts are recommended for HIV-1-infected individuals and patients with asymptomatic or early HIV-1 disease.[Ref]

Musculoskeletal

In one zidovudine study, myalgias and elevated creatine phosphokinase occurred in 8% of treated patients with a CD4 cell count less than 200/mm3, and in none of the patients with higher CD4 cell counts. Dosage reduction has not affected the course of myopathy, although drug discontinuation sometimes resulted in improvement of symptoms, generally within a month. Muscle biopsy has shown atrophic and sometimes necrotic fibers, ragged-red fibers, and large accumulations of mitochondrial and fibrillar sarcoplasmic inclusions.[Ref]

Musculoskeletal side effects of at least moderate intensity have included musculoskeletal pain (5%) when abacavir was administered with lamivudine and zidovudine. Myopathy and myositis, with pathological changes similar to that produced by HIV-1 disease, have been associated with prolonged use of zidovudine. Myalgia, arthralgia, muscle weakness, creatine phosphokinase elevation, and rhabdomyolysis have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Psychiatric

Psychiatric side effects of at least moderate intensity have included depressive disorders (6%), anxiety (5%), and worsening of preexisting depression when abacavir was administered with lamivudine and zidovudine. Other psychiatric side effects reported with the use of zidovudine have included isolated cases of mania, anxiety, and grandiosity.[Ref]

Immunologic

Immunologic side effects of at least moderate intensity have included ear/nose/throat infections (5%) and viral respiratory infections (5%) when abacavir was administered with lamivudine and zidovudine. Immune reconstitution syndrome has been reported. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution. The emergence of lamivudine-resistant hepatitis B virus (HBV) has been reported in HIV-1-infected patients who were treated with lamivudine-containing regimens in the presence of coinfection with HBV.

Cardiovascular

Cardiovascular side effects have included rare cases of reversible congestive heart failure, syncope, and vasodilation with zidovudine. Myocardial infarction has been reported during postmarketing experience with abacavir. Cardiomyopathy and vasculitis have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

A study investigating the frequency of myocardial infarction (MI) in patients taking combination antiretroviral treatment showed an increased risk of MI with the use of abacavir within the previous 6 months; however, these results are not conclusive. The manufacturer reviewed its own clinical study databases and although the results of the analysis are inconclusive, they did not show an excess risk of MI. A meta-analysis conducted by the FDA showed no statistically significant difference in MI events between patients who received abacavir and those who did not.[Ref]

Respiratory

Respiratory side effects have included nasal symptoms and cough in patients treated with lamivudine and zidovudine simultaneously. Abnormal breath sounds/wheezing have been reported during postmarketing experience with abacavir, lamivudine, and/or zidovudine.[Ref]

Genitourinary

Genitourinary side effects have included gynecomastia during postmarketing experience with abacavir, lamivudine, and/or zidovudine.

Renal

Renal side effects of at least moderate intensity have included renal signs/symptoms (not specified) in less than 1% of patients when abacavir was administered with lamivudine and zidovudine.

Ocular

Ocular side effects have included a case of macular edema deemed definitively associated with zidovudine in a patient with a history of anterior uveitis secondary to syphilis.[Ref]

References

1. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC). NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Available from: URL: http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf." ([2011 Oct 14]):

2. "Product Information. Combivir (lamivudine-zidovudine)" Glaxo Wellcome, Research Triangle PK, NC.

3. Brinkman K, terHofstede HJM, Burger DM, Smeitinkt JAM, Koopmans PP "Adverse effects of reverse transcriptase inhibitors: mitochondrial toxicity as common pathway." AIDS 12 (1998): 1735-44

4. Toerner JG, Cvetkovich T "Kawasaki-like Syndrome: Abacavir Hypersensitivity?" Clin Infect Dis 34 (2002): 131-2

5. "Product Information. Trizivir (abacavir / lamivudine / zidovudine)" Glaxo Wellcome, Research Triangle Pk, NC.

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