Brand name: Epivir

Generic name: lamivudine, or 3TC

Class: Nucleoside reverse transcriptase inhibitor (nucleoside, NRTI, or nuke)

Manufacturer: ViiV Healthcare, www.viivhealthcare.com, (877) 844-8872

AWP: $498.90/month for 300 mg tablets; $429.66 for generic; $122.14/month for 240 mL solution (10 mg/mL)

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 closer to the time of your next dose. Do not double up on your next dose. Generic is available.

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, and cough. See chart for potential drug class side effects.

Potential drug interactions: No significant drug interactions. Do not take Epivir with Atripla, Combivir, Complera, 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 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 (Epivir-HBV is used only in people without HIV), but if you have HIV and HBV, you will need to take full-dose Epivir along with a complete regimen to treat HIV and HBV. If you have HIV and HBV and your hep B needs treatment but your HIV doesn't, you should be treated for both. You should never be treated only for HBV without treatment for HIV. Epivir and Viread both work against HBV and HIV and can be used together as the NRTI backbone to increase activity and avoid HBV resistance, but there are other HBV treatments available that can be combined with HIV meds. Make sure you are taking Epivir at HIV doses -- always ask your doctor or pharmacist. If you are co-infected with HIV and HBV and you stop Epivir, your HBV may reactivate and you may experience signs and symptoms of acute HBV. You should be closely monitored by your physician. If your HIV develops resistance to Epivir, it doesn't mean that your HBV is also resistant to it. Epivir is also available in three combination products: Combivir, with zidovudine, taken one tablet twice a day; Epzicom, with abacavir, taken one tablet once daily; and Trizivir with zidovudine and abacavir, 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 (Epivir) 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 in your virus that you got from taking AZT or d4T [stavudine]) or partially reverse the resistance that they caused. 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. 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, M.D., M.P.H.

Activist's Comments

The earlier (and weaker) version of a nucleoside with a kick, this drug along with AZT made for a reduction in the number of pills and helped as a backbone for many combinations in the '90s. This drug still has a useful purpose, especially in financially limited settings as generics came to market, so it keeps its place on the list of drugs we can use to combat HIV.

-- Joey Wynn

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