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Brand Name: Zerit
Common Name: stavudine or d4T
Class: nucleoside analog (also called nucleoside reverse transcriptase inhibitor, NRTI or nuke)
Standard dose: One 40 mg capsule twice-a-day for people weighing 132 pounds (60 kg) or more, or one 30 mg capsule twice-a-day for people weighing less; no food restrictions (may be taken with or without food). Zerit is also available in 15 mg, 20 mg, 30 mg and 40 mg capsules and a powder for oral solution; check for food restrictions. An approved extended-release (XR) formulation has yet to be manufactured. Take missed dose as soon as possible, but do not double up on your next dose.
AWP: $385.88 / month for 40 mg
Manufacturer contact: Bristol-Myers Squibb, www.bmsvirology.com, 1 (800) 272–4878
AIDS Treatment Information Service: 1 (800) HIV–0440 (448–0440)
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Potential side effects and toxicity: Peripheral neuropathy (tingling, burning, numbness or pain in the hands or feet) may go away once Zerit is stopped, but can be painful and permanently debilitating if not treated in time. Additive lipoatrophy (facial wasting) and mitochondrial toxicities when combined with Videx or Hivid. Caregivers of young children should be instructed regarding noticing and reporting peripheral neuropathy. Adverse reactions and serious laboratory abnormalities in children were similar in type and frequency to those seen in adults. Other side effects include headache, chills/fever, malaise (general ill feeling), insomnia, anxiety, depression, rash, upset stomach (nausea and vomiting), diarrhea and abdominal pain. Rare but potentially fatal toxicity with all NRTIs is pancreatitis (inflammation of the pancreas), hepatomegaly with steatosis (enlarged, fatty liver) 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 common and 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. Pregnant women should particularly avoid the combination of Zerit and Videx due to the risk of lactic acidosis. People with lactic acidosis may experience persistent fatigue, abdominal pain or distension, nausea/vomiting, and difficulty breathing or shortness of breath; and enlarged, fatty liver. People with a history of peripheral neuropathy, pancreatitis or heavy alcohol use should avoid Zerit. Pancreatitis can be life-threatening and may cause pain in the stomach and back, along with nausea, vomiting and blood in the urine. Stop taking Zerit immediately if exeriencing symptoms of pancreatitis and seek immediate medical attention. Your physician will check for pancreatitis by checking for increased levels of amylase and lipase in the blood. Risks for pancreatitis include: higher than recommended doses of NRTIs, advanced HIV, and alcohol use. Lipoatrophy (fat loss) in the face and limbs (arms and legs) and, to a lesser degree, lipohypertrophy (such as “buffalo hump” and increase in abdominal girth) has been associated with Zerit. Zerit and AZT are the HIV drugs (the thymidine analogs) most implicated by studies as causing lipoatrophy. Zerit also seems to be implicated in blood lipid (fat) increases, particularly triglycerides.
Potential drug interactions: When used in combination with Zerit, drugs such as Fungizone (amphotericin B), Foscavir (foscarnet), dapsone, and some drugs used to treat HIV may increase the risk of developing peripheral neuropathy. Cytovene and Vitrasert (ganciclovir), valganciclovir (Valcyte), intravenous Pentam (pentamidine), and Videx (ddI) may increase the risk of pancreatitis. Should be used with caution by people with pre-existing bone marrow suppression, renal insufficiency or peripheral neuropathy. AZT and Zerit should not be used together due to evidence that one limits the other’s effectiveness. Because of additive neurotoxicity, if possible, Zerit should not be combined with zalcitabine (Hivid) or ddI.
Tips: In 2004, Zerit was moved from the list of “preferred” drugs to “alternate” drugs, according to U.S. HIV treatment guidelines, “due to increasing reports of stavudine-associated toxicities.” Contact your healthcare provider immediately if peripheral neuropathy is suspected, but do not stop taking medication unless directed to do so by your healthcare provider. Studies show that Zerit crosses the blood-brain barrier to a useful degree, which may be beneficial for patients at risk for neurological damage (such as dementia) from HIV. Zerit is increasingly associated with facial wasting and many leading HIV advocates are adamant that it should be avoided for this reason.
Doctor
Stavudine (D4T) was once the tried-and-true work-horse of the nucleoside backbones. Initially it was better tolerated than its counterpart, AZT, and was therefore used with great frequency. However, its long-term toxicities and side effects gradually emerged and now d4T is being used with more caution. It has long been known for its association with peripheral neuropathy, and rarely with fatty liver, pancreatitis, and potentially fatal lactic acidosis. Now, it is better known for its association with lipoatrophy (fatty wasting) and hyperlipidemia (high levels of “bad” cholesterol in the blood). Due to its pharmacokinetics, it must be dosed twice daily. It cannot be used in combination with AZT.—Chad J. Zawitz, MD
Activist
Zerit (d4T) has fallen out of grace after years of reports of lipoatrophy, neuropathy and higher lipids due to toxic effects on the cells’ mitochondria (energy factories of our cells). It was dropped from a “preferred drug” to an “alternate” one by the DHHS guidelines committee for the treatment of naïve patients. I just wish that they had done it sooner, since this fact has been known well since 2001. Unfortunately, Zerit is becoming one of the most commonly used drugs in the developing world. I feel horrible for people in countries like mine (Venezuela) who will endure these side effects even after we have learned so much in the developed world. Zerit is still a valuable drug in salvage therapy, when the benefits outweigh the risks. Some studies seem to indicate that lower-dose Zerit may work as well without as many side effects, but I do not think doctors are totally buying that concept.—Nelson Vergel
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