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Brand Name: Ziagen

Common Name: abacavir sulfate (ABC)

Class: nucleoside analog (also called nucleoside reverse transcriptase inhibitor, NRTI, or nuke)

Standard Dose: Two 300 mg tablets once-a-day (or one 300 mg tablet twice-a-day), no food restrictions (may be taken with or without food). A strawberry/banana flavored liquid is available. Take missed dose as soon as possible, but do not double up on your next dose.

AWP: $472.14 / month

Manufacturer contact: GlaxoSmithKline,
www.treathiv.com, 1 (888) 825–5249

AIDSInfo:1 (800) HIV–0440 (448–0440), www.aidsinfo.nih.gov

Potential side effects and toxicity:

Approximately 8% of people taking abacavir experienced hypersensitivity reaction (HSR, an allergic-like reaction) during clinical trials. People who think they are experiencing HSR must be evaluated by an experienced HIV provider as soon as possible before they stop taking abacavir. Be very careful, especially in the first two months of treatment. Symptoms worsen with every dose, but very slowly. If treatment is stopped because of this serious reaction, they can never take abacavir, Epzicom or Trizivir again (called “re-challenging”) because of life-threatening and potentially 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 reaction usually occurs during the second week of treatment, but may take as long as six weeks to appear, but can occur anytime during treatment. It 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. Symptoms are listed on the patient information sheet and warning card that you receive each time you fill your prescription. Always keep the warning card with you. HSR might be confused with flu during flu season, but remember that it worsens with every dose. See Epzicom tips. Check with your doctor if you have any side effects after taking this medicine—don’t just stop! More common side effects include nausea, vomiting, diarrhea, fatigue, headache, fever, rash, anorexia (loss of appetite), and potentially high blood sugar and high triglyceride levels (fat in the blood). Rare but potentially fatal toxicity with all NRTIs is hepatomegaly (enlarged liver) with steatosis and lactic acidosis (accumulation of lactate in the blood and abnormal acid-base balance). Lactic acidosis has been seen in patients taking NRTIs but is more severe in women, people who are obese and people who have been taking nukes for a long time; and more common in people with liver disease, but can occur in people without a history of liver damage. Symptoms include persistent fatigue, abdominal pain or distension, nausea/vomiting, and difficulty breathing or shortness of breath; and enlarged, fatty liver (called hepatomegaly with steatosis).

Potential drug interactions:
Excessive alcohol increases abacavir levels and may increase side effects. People with moderate to severe cirrhosis should use abacavir with caution.
Tips:

This is a potent NRTI, but the potential hypersensitivity reaction (HSR) does warrant the U.S. HIV treatment guidelines not recommending Ziagen as first-line treatment. It is important to remember that HSR occurs in 5–8% of people and is not fatal unless ignored, and to communicate any and all symptoms to your healthcare provider. Do not stop Ziagen until you have discussed this with your healthcare provider. You don’t want to burn through a potent and tolerable HIV drug. The manufacturer recommends that people with symptoms of acute respiratory disease consider HSR even if other diagnosis such as pneumonia, bronchitis or flu is possible. An analysis of 8,000 patients found a reduced risk of HSR in blacks and in men.

Doctor
Abacavir (ABC) is a generally well tolerated drug with the exception of persons genetically at risk for a hypersensitivity reaction (HSR)—characterized by varying combinations of fever, rash, malaise, sore throat, and gastrointestinal and pulmonary symptoms. ABC HSRs generally intensify over a several day period, so careful education and access to expert advice is important if symptoms develop particularly during the first eight weeks of use. The risk may be higher in Caucasians than in African Americans, and may be partly predicted by the presence of the HLA-B5701 haplotype. Prospective screening for HLA B5701 and avoiding use of ABC if positive may be a clinically useful way to decrease (but not eliminate) the HSR. Patch testing is also being studied as a technique to further manage suspected HSRs. If a HSR is suspected, then ABC should be discontinued and not restarted. I often prefer to keep the components separate during the first eight weeks of treatment in order to be able to respond in an individual manner to a suspected serious drug toxicity before simplifying regimens. When started at the same time as other ARVs that can cause a rash (e.g., efavirenz) it can be challenging to properly manage a rash plus other symptoms. I thus often add ABC for eight weeks on top of an existing regimen when I want to alter non-failing regimens in order to clearly assess whether there is any sign of a HSR before making a switch (such as from Combivir or Truvada to Epzicom). Alcohol increases ABC levels. ABC appears to have minimal effect on fat distribution, lipid levels. ABC is also available in several co-formulations (Epzicom and Trizivir).—Keith Henry, MD
Activist
This drug exemplifies a pretty good drug that will always struggle to shed its “bad rap” legacy. Ziagen is a potent nuke that carries the unfortunate burden of a very rare hypersensitivity reaction (HSR). The fear on behalf of many doctors and patients has limited its use in many situations, even though it may be a great option. The HSR only occurs in a tiny number of patients, usually happens during the early weeks of treatment, and is problematic only when the drug is re-started after stopping. Good communication between the medical provider, and close monitoring when starting this drug is crucial. If you take this med and experience a rash or flu-like symptoms, call your doctor right away (you should have their cell number or pager)—if not, you should carry the package insert with you to show to a medical professional who may otherwise be unfamiliar with the drug and its side effects. Ziagen might be a good option for you if you are looking for a drug that has a decent side effect profile, but remember the key word is monitoring. If you are not able to get to a knowledgeable medical provider in a short amount of time when starting this drug (should you develop symptoms of a HSR), you may want to discuss with your doctor whether or not this drug is a good option at this time. Many people I know take this drug and are doing just fine.—Cathy Olufs
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