Epzicom (lamivudine/3TC + abacavir)

August 2007     View PDF     En español
Reprinted from www.aidsmeds.com, US

What is Epzicom?
Epzicom is an HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Epzicom prevents HIV from altering the genetic material of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.

Epzicom is marketed by GlaxoSmithKline. It was approved by the US Food and Drug Administration (FDA) for use by people living with HIV in August 2004.

Epzicom is a combination of two drugs: 600mg of Ziagen (abacavir) and 300mg of Epivir (lamivudine). Epzicom should be prescribed by a healthcare provider for patients who need both of these drugs. Both of these drugs can still be purchased individually for use in combination with other HIV drugs.

In the European Union, the single-tablet combination of Ziagen and Epivir is sold under the brand name Kivexa.

Epzicom must be combined with at least one other HIV drug, usually a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI).

GlaxoSmithKline has established a patient assistance program (PAP) for people living with HIV who do not have private or public health insurance and are unable to afford Epzicom. To learn more about the PAP for Epzicom, call 888-825-5249 or refer to GSK's website for more information. For those with private health insurance, GSK has established a program to help cover each Epzicom co-payment, up to $100 every month. To learn more about this co-pay program, check out mysupportcard.com.

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What is known about Epzicom?
Epzicom is a tablet taken once a day. It can be taken with or without food.

Epzicom should not be any more or less effective than Ziagen and Epivir taken as separate pills together. However, it is considered to be a much more convenient way of taking these two anti-HIV drugs.

For HIV-positive adults beginning HIV drug therapy for the first time, Epzicom is listed as an "alternative" NRTI option — used in combination with either a protease inhibitor or non-nucleoside reverse transcriptase inhibitor — by the United States Department of Health and Human Services in its treatment guidelines. Tenofovir and emtricitabine, used together as Truvada or as a part of Atripla (efavirenz, tenofovir and emtricitabine), is listed as the "preferred" dual-NRTI option.

See the "What is known about ... " sections of Ziagen and Epivir for information about possible drug resistance.

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What about drug interactions?
It is believed that Epzicom can be safely taken at the same time as most drugs used to treat HIV and AIDS-related complications.

Epzicom should not be taken at the same time as Emtriva or Truvada (containing Viread and Emtriva). This is because the Epivir in Epzicom is very similar to Emtriva, and it is not believed that combining these two HIV drugs will make a regimen any more effective against the virus. Similarly, Epzicom should not be taken at the same time as Ziagen, Epivir, or Trizivir (containing Ziagen, Epivir and Retrovir).

See the "What about drug interactions?" sections of Ziagen and Epivir to learn about possible drug interactions.

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What about side effects?
An important side effect that doctors and patients need to be aware of is "hypersensitivity." Approximately 5 percent of people who take Ziagen (abacavir), one of the two medications in Epzicom, are allergic to it. This can be serious and generally requires that Epzicom be stopped, and that Epzicom or Ziagen should not be taken again. A hypersensitivity reaction usually appears during the second week of therapy, but it can take as long as six weeks to notice any symptoms. The most common symptoms are fever and rash, followed by headaches, stomach upset, feeling sick or tired, sore throat, cough, and shortness of breath. These symptoms usually get worse over time and it is important that you report them to your doctor immediately. If you need to stop Epzicom because of this hypersensitivity reaction, you will still be able to take Epivir, the other drug in Epzicom.

An inexpensive laboratory test is available to look for an inherited gene, called HLA-B*5701, that has been linked to the hypersensitivity reaction in HIV-positive people taking Epzicom. While not all people with this gene experience an allergic reaction while taking Epzicom, most do. In turn, if you are tested and found to have this gene, Epzicom (or other medications containing abacavir) should either be avoided or used with caution. If you and your doctor are thinking about starting Epzicom or another abacavir-containing medication for the first time, be sure to discuss this genetic test.

Lactic acidosis, which can be fatal, and severe liver problems have been reported in people taking nucleoside reverse transcriptase inhibitors (NRTIs), including Ziagen and Epivir, the two active drugs in Epzicom. Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area.

HIV drug regimens containing nucleoside reverse transcriptase inhibitors (NRTIs), including Epzicom, can cause increased fat levels (cholesterol and triglycerides) in the blood, abnormal body-shape changes (lipodystrophy; including increased fat around the abdomen, breasts, and back of the neck, as well as decreased fat in the face, arms, and legs), and diabetes.

Taking medications like Epzicom that contain Ziagen may increase the risk of a heart attack. The reason for the increased risk associated with Ziagen, compared with other NRTIs, has not been established. The risk of a heart attack is highest among people living with HIV taking Ziagen who have other cardiovascular disease (CVD) factors, including high blood pressure, high lipids, diabetes, cigarette smoking, family history of CVD.

If you have hepatitis B and HIV and plan to stop taking Epzicom, your doctor might want to frequently check your liver enzymes after stopping treatment. This is because the Epivir in Epzicom is also active against the hepatitis B virus (HBV). If Epivir is stopped abruptly, it can cause liver disease to "flare" and damage the liver.

See the "What about side effects?" sections of Ziagen and Epivir for additional possible side effects.

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Can pregnant women take Epzicom?
Epzicom is classified by the FDA as a pregnancy category C drug. Pregnancy category C means that animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. HIV-positive women who become pregnant should discuss the benefits and possible side effects of anti-HIV treatment to help protect their babies from HIV.

It is not known whether Epzicom passes into breast milk and what effect they may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.

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What should I tell my doctor before taking Epzicom?
Before taking this medication, tell your doctor if you have: kidney disease or liver disease.

Be sure to tell your doctor if you've ever taken Epzicom, Trizivir, or Ziagen in the past. If you stopped these medications in the past because of an allergic reaction, you should not take Epzicom or any medication that contains Ziagen.

Tell your doctors and pharmacists about all medicines you take. This includes prescription medications, over-the-counter products, or herbal/natural remedies.

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Where can I learn more about clinical trials involving Truvada?
If you would like to find out if you are eligible for any clinical trials that include Epzicom, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.

Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the US National Institutes of Health. They have "health information specialists" you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).

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