POSITIVELY AWARE MARCH/APRIL 2011
brand name: Epivir
common name: lamivudine or 3TC
class: Nucleoside analog reverse transcriptase inhibitor
(nucleoside analog, NRTI, or nuke)
manufacturer: ViiV Healthcare | www.viivhealthcare.com, (877) 844-8872
Standard dose: One 300 mg tablet once a day (or one 150 mg tablet twice daily), with or without food, with no dietary restrictions. Dose is lowered for people with kidney impairment. Dose for children 3 months to 16 years of age is 4 mg per 2.2 pounds twice daily to a maximum of 150 mg twice daily. A strawberry/banana-flavored liquid (10 mg/1 mL) is available. Take missed dose as soon as possible, unless it is almost time for your next dose. Do not double up on your next dose.
AWP: $457.97 / month for 300 mg tablets, $122.14 / month for 240 ml solution (10 mg/ml)
Potential side effects and toxicity
Very tolerable. Side effects (though rarely seen) may include headache, nausea, vomiting, diarrhea, fever, fatigue, hair loss, insomnia, malaise (general ill feeling), nasal symptoms, cough, peripheral neuropathy, low white blood cells, and anemia. Rare but potentially serious toxicity with all NRTIs: enlarged, fatty liver (hepatomegaly with steatosis) and lactic acidosis (accumulation of lactate in the blood and abnormal acid-base balance). Lactic acidosis may cause persistent fatigue, abdominal pain or distension, nausea/vomiting, difficulty breathing or shortness of breath, and enlarged liver.
Potential drug interactions
No significant drug interactions. Do not take Epivir with Atripla, Combivir, Emtriva, Epivir-HBV, Epzicom, Trizivir, or Truvada, since they contain Epivir or medication equivalent to Epivir.
More information
One benefit is that the drug resistance the virus develops against Epivir, the M184V mutation, makes the virus less fit to replicate and has even been shown to keep T-cells from dropping during a treatment interruption as much as they would have otherwise. The mutation also slightly improves the antiviral activity of Retrovir (zidovudine) and Viread, and for that reason, some doctors keep Epivir onboard in combination with those drugs after M184V resistance develops. Epivir is also approved for the treatment of hepatitis B virus (HBV), under the brand name Epivir-HBV, which has a lower dose than Epivir for HIV. Patients co-infected with HIV and HBV who also need to take HIV medications, need to treat both HBV and HIV. Epivir and Viread both work against HBV and HIV and should be used together as the NRTI backbone to increase activity and avoid HBV resistance. Make sure you are taking Epivir at HIV doses—always ask your doctor or pharmacist. Worsening of hepatitis B (HBV) in people co-infected with HIV/HBV has occurred when Epivir was discontinued. These patients should be closely monitored by their physician. Epivir is also available in three combination products: Combivir (Epivir and Retrovir [zidovudine]), taken one tablet twice a day; Epzicom (Epivir and Ziagen), taken one tablet once daily; and Trizivir (Epivir, Retrovir, and Ziagen), taken one tablet twice a day. See package insert for more complete information on potential side effects and interactions.
Doctor’s comments
In the early ‘90s the approval of 3TC was a big shot in the arm to the tired nucleoside class. Adding it to other nucleoside analogs after they’d stopped working seemed to revive them for awhile, and if you started 3TC and AZT together, resistance was delayed. We later learned that the 3TC mutation, M184V, could delay the emergence of thymidine analog mutations (TAMs, the mutations you got from taking AZT or d4T). M184V could also partially reverse the resistance caused by TAMs. During the early years of the HAART era, 3TC became a component of virtually every antiretroviral regimen, and even today, most people taking either AZT or abacavir are also taking 3TC using a co-formulation (see Combivir, page 21; Epzicom, page 24; and Trizivir, page 26). 3TC is extremely well tolerated and very safe with long-term use. Resistance to 3TC occurs quickly if the viral load isn’t completely suppressed, and while there are some resistance advantages to having an M184V mutation, it’s still better not to have it, allowing 3TC to retain its full antiviral activity. —Joel Gallant, MD, MPH
Activist’s comments
The father of Emtriva (FTC), ViiV’s Epivir is a convenient drug that they used in their early fixed dose combos like Combivir (AZT and 3TC), Epzicom (Ziagen and 3TC), and Trizivir (AZT, Ziagen, and 3TC). It has the same potential advantages as FTC in salvage regimens, and the same caveats for those with hepatitis B. —Jeff Taylor
