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Epzicom and Ziagen

600 mg abacavir, 300 mg lamivudine ABC and 3TC (two NRTIs) 300 mg abacavir ABC (NRTI)
HHS recommended for certain clinical situations
Standard Dose
One Epzicom tablet once daily, with or without food. Two Ziagen tablets once daily (or one 300 mg tablet twice daily), with or without food. Both must be taken in combination with another antiretroviral(s) from a different drug class.

Epzicom is approved for adults and children weighing 55 pounds (25 kg) or more. Ziagen is for adults and children at least 3 months of age and older. In children, Ziagen is dosed based on body weight. See package insert for weight-based dosing. Tablets may be crushed or split and added to a small amount of semi-solid food or liquid. Ziagen is also available as an oral solution (20 mg/mL) (strawberry-banana flavor) for children and adults who are not able to swallow the tablets.

Take missed dose as soon as possible, as long as it is at least 12 hours before your next dose. Do not double up on your next dose. According to the drug label, Epzicom is not recommended for people with decreased kidney function (creatinine clearance less than 30 mL/min) due to lamivudine component, or those with moderate or severe liver impairment due to abacavir component. Alternative doses may be obtained by using the individual components of this medication as needed. Ziagen dose adjustment is not needed for people with kidney impairment. Dose adjustment is needed for people with mild liver impairment (200 mg twice daily). Ziagen should not be used in people with moderate or severe liver disease.
  • Generic is available.
  • See the individual drugs contained in Epzicom: Epivir and Ziagen.
  • See package insert for more complete information on potential side effects and interactions. 
Manufacturer
ViiV Healthcare
viivhealthcare.com; epzicom.com
(877) 844-8872
AWP
Epzicom: $1,550.05/month
generic: $1,395.05/month
Ziagen 300 mg, 60 tablets: $670.37/month
generic: abacavir 300 mg, 60 tablets: $602.71/month
Activist Comments

JUAN MICHAEL PORTER II:

I’m going to quote one of my doctor friends here: “Absolutely no one should be prescribed these drugs, because the only drug that was found to be associated with cardiovascular events was abacavir.” That should give you cause for alarm, especially if you are on a statin.

Doctor Comments

JO-ANN JOSE, MD, MPH:

A positive test result for HLA-B*5701 doesn’t mean you will have the allergy, but you have a higher risk than someone with a negative test result. Epzicom and Ziagen cannot be used without having this test done first; there’s an association between abacavir (a component in both drugs) and cardiovascular risk, so for that reason, we don’t use these medications often.

Potential Drug Interactions

Alcohol can increase levels of abacavir, and therefore can increase the possibility of side effects. May be used with the hepatitis C drugs Epclusa, Harvoni or Zepatier, depending on the third drug in the HIV regimen. Avoid use of sorbitol-containing medicines with lamivudine; there are many, such as acetaminophen liquid (Tylenol liquid and others). Tell your provider or pharmacist about all medications, herbals and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions not listed here.

Potential Side Effects and Toxicity

Common side effects may include headache, nausea, fatigue, depressed mood, dizziness, diarrhea, rash or insomnia. Of note is the hypersensitivity reaction (HSR, an allergic-like reaction) warning on abacavir; see warning card that comes with Epzicom and Ziagen. To minimize the risk for HSR, a simple blood test for HLA-B*5701 (a genetic marker) should be done before starting an HIV regimen containing abacavir to identify people at higher risk for this reaction. This test is covered by most insurance and also by LabCorp/ViiV (see company contact on co-pay chart). A warning card should be included with this medication when dispensed from the pharmacy and kept with you. Symptoms of HSR usually include some combination of the following: fever, skin rash, malaise (general ill feeling), severe nausea, headache, muscle ache, chills, diarrhea, vomiting, abdominal pain, respiratory symptoms (cough, difficulty breathing, sore throat) and/or joint pain. HSR might be confused with flu, but symptoms of HSR usually worsen, very slowly, and with every dose.

Some large observational studies suggest abacavir may increase the risk of cardiovascular events, including myocardial infarction (MI, or heart attack), in people with risk factors such as smoking, diabetes, uncontrolled high blood pressure, older age, high cholesterol, family history of heart disease and drug use. Other studies have found no increased risk. To date, no absolute consensus has been reached on the association with cardiac risk, although theoretical contributing mechanisms have been described. People who have high risk for heart disease should discuss risks with their provider, and they should be monitored more closely.

Prior to initiation, people should be tested for hepatitis B virus (HBV). Epzicom and Ziagen by themselves are not enough to treat HBV and must be taken with an additional HBV medication. Severe exacerbations of hepatitis B have been reported by people co-infected with HBV who have discontinued Epzicom (due to elimination of the lamivudine component). Monitor liver enzymes closely in people co-infected with HBV and, if appropriate, initiation of anti-hepatitis B therapy may be warranted upon Epzicom discontinuation. Call your health care provider right away if you develop any of the following signs or symptoms of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite or pain, aching or tenderness on the right side below the ribs.

More Information

The guidelines recommend Descovy or Truvada over Epzicom as the backbone NRTI component of an HIV drug combination for first-time therapy. Recommended as part of a preferred initial regimen in pregnancy (Tivicay plus Descovy or Epzicom or Truvada; Triumeq is also a preferred initial regimen). Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO apregistry.com