Epzicom and Ziagen
600 mg abacavir, 300 mg lamivudine ABC and 3TC (two NRTIs), 300 mg abacavir ABC (NRTI)
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, unless it is closer to the time of 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 Healthcareviivhealthcare.com; epzicom.com
(877) 844-8872
AWP
Epzicom: $1,550.05/monthgeneric: $1,395.05/month
Ziagen 300 mg, 60 tablets: $670.37/month
generic: abacavir 300 mg, 60 tablets: $602.71/month
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 Epizom 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) infection. Severe exacerbations of hepatitis B have been reported in 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.
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.
More Information
Triumeq, a single-tablet regimen (STR) containing Epzicom, is a DHHS recommended initial therapy for most people. Otherwise, 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.
Doctor Comments
Dr. Melanie Thompson:
Brand name Epzicom and Ziagen tablets have been discontinued by ViiV due to the availability of generic abacavir and abacavir/3TC. Abacavir and 3TC also are coformulated with dolutegravir as Truimeq (see Triumeq.) Abacavir was once an important medication for HIV treatment, but it always has been problematic because of the risk of life-threatening abacavir hypersensitivity. Results of the genetic marker HLA-B*5701 are required before dosing with abacavir to decrease this risk. Anyone with prior abacavir hypersensitivity should never take even one dose of abacavir again and should ensure that their medical chart is marked as “allergic to abacavir” (although this reaction is not a true allergy). Observational studies have found conflicting evidence on whether abacavir is associated with cardiovascular disease. The FDA says the evidence is “inconclusive,” however, guidelines panels acknowledge a potential risk. In early clinical trials, the most common side effects with abacavir were nausea, headache, malaise and fatigue, vomiting and dream/sleep disorders. At present, abacavir is mainly used for people who can’t take tenofovir-containing regimens, especially because of kidney disease. Dovato or nuke-sparing regimens like Juluca or Cabenuva are also options for some people.
Activist Comments
Activist Joey Wynn:
Epzicom and Ziagen have not aged well. With the shadow of cardiovascular issues still lurking in the lexicon of advocates, the allergic hypersensitivity and the required lab tests needed, abacavir is simply too complicated to compete with so many easier to tolerate, simplified regimens around today. Definitely ill advised to take if you have hepatitis B. Epzicom is recommended by DHHS as one of the preferred NRTI combination components of HIV treatment in pregnancy. As for Ziagen, I personally do not believe this is a viable option in today’s choices. But maybe for a select few in certain circumstances. Some studies have found increased rates of heart disease among people on Ziagen. Even though Ziagen is a component of an ART regimen that is recommended by current guidelines, there are a number of other options that are just better for you.