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Brand Name: Epzicom
Common Name: abacavir sulfate and lamivudine
Class: fixed dose combination—nucleoside analogs (also called nucleoside reverse transcriptase inhibitors, NRTIs or nukes)
Standard Dose: One tablet (600 mg Ziagen/abacavir sulfate and 300 mg Epivir /3TC/ lamivudine), once a day, no food restrictions (may be taken with or without food). Take missed dose as soon as possible, but do not double up on your next dose.
AWP: $823.50 / month
Manufacturer contact: GlaxoSmithKline,
www.epzicom.com, 1 (888) 825–5249
AIDSInfo:1 (800) HIV–0440 (448–0440), www.aidsinfo.nih.gov
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| Potential side effects and toxicity: |
The most common side effects of Epzicom are the same as Epivir and Ziagen. See those pages for more information.
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| Potential drug interactions: |
| See also Epivir and Ziagen for more information. Do not take Epivir or Ziagen while taking Epzicom since these medications are already in Epzicom. The hypersensitivity reaction (HSR, an allergic-like reaction) warning on abacavir (Ziagen) bears repeating here. Approximately 8% of people taking abacavir experienced hypersensitivity during clinical trials. People who think they are experiencing hypersensitivity must be evaluated by an experienced HIV provider as soon as possible before they stop taking abacavir. If treatment is stopped because of this serious reaction, they can never take abacavir or Trizivir or Epzicom again (called “re-challenging”) because of life-threatening and in a few instances fatal reaction. (This does not apply to missed doses, when there’s no HSR, but watch for symptoms if you’ve stopped the drug for at least a few days). This hypersensitivity usually occurs during the second week of treatment, but may take as long as six weeks to appear, gets progressively worse and resolves quickly (24–48 hours) after permanent discontinuation. Symptoms usually, but not always, include some combination of sudden fever, muscle ache, severe nausea, vomiting or abdominal pain, severe tiredness, respiratory symptoms (cough, difficulty breathing and sore throat) and possibly mild rash. These symptoms are listed on the patient information sheet and warning card that you receive each time you fill your prescription. You should always keep the warning card with you. Hypersensitivity might be confused with flu during flu season, but remember that HSR worsens with every dose. See tips. |
| Tips: |
| Remember, Epzicom is two drugs in one pill, so see the pages for those drugs, Epivir and Ziagen. Ziagen by itself is FDA approved for either once-a-day or twice-a-day dosing. The once-daily formula in Epzicom was found to have the same amount in the blood over 24 hours (bioequivalency) as Ziagen twice-a-day. Currently, U.S. HIV treatment guidelines recommend Truvada over Epzicom as a preferred agent for NRTI component of a treatment regimen. Epzicom is not on the preferred list due to the risk of hypersensitivity reactions even though it has demonstrated potency when compared to Combivir. The combination of Viread with either Epivir or Emtriva has shown potent virologic suppression with Sustiva and was not worse than Combivir. The Ziagen in Epzicom unfortunately has a hypersensitivity reaction (HSR) in about 8% of people taking it. The incidence of HSR was the same between Epzicom and Ziagen twice-a-day (8% vs. 9%), but the incidence of severe reactions was higher with Epzicom (5% vs. 2%). Remember that the HSR cited may have been suspected, not definitely diagnosed. Check with your doctor if you have any side effects after taking this medicine—don’t just stop! |
| Doctor |
| Little data is available comparing use of Epzicom (abacavir plus 3TC) to either Combivir (GSK has generally not compared their two NRTI backbone combinations against each other in their own studies) or Truvada. Considerable data is available from mostly GSK studies reporting reasonable success and efficacy for regimens using Epzicom as the NRTI backbone in a variety of regimens. That lack of comparative data and concern about the risk for the abacavir hypersensitivity reaction contributes to Epzicom being relegated to a recommended alternative backbone NRTI regimen. Advantages of Epzicom include once-a-day dosing, a relatively clean metabolic profile, no interaction with atazanavir, and no concern about renal toxicity. The risk for the abacavir hypersensitivity reaction appears to be higher in Caucasians (averaging 6–7%) compared to African American or African populations (averaging 2%) and may be lowered through use of genetic testing (such as screening for HLA-B5701). Results from ACTG 5202 (the large trial comparing Truvada to Epzicom) won’t be available for several years but will be eagerly awaited. I am often hesitant to start patients on both efavirenz and abacavir at the same time since a rash plus other symptoms is seen fairly often and it can be a challenge to ascertain whether the patient is experiencing an abacavir hypersensitity reaction. Only 3TC is active against hepatitis B, which is germane to co-infected patients where hepatitis B monotherapy is often avoided.—Keith Henry, MD |
| Activist |
| Another of GSK’s efforts at making treatment simpler, Epzicom combines another two of GSK’s drugs into one pill. For people who can tolerate the Ziagen and are sensitive to the 3TC, this is a viable way to make taking pills easier. It is once-a-day dosing, so like other QD drugs, you definitely don’t want to forget that one dose…or resistance can start to creep in.—Cathy Olufs |
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