January 22nd, 2012

Generic Lamivudine Has Arrived

An e-mail from a patient last week:

Just got refills. Epivir is now generic???  Refill is simply labeled Lamivudine Tablets by Aurobindo Pharma USA, Inc …but made in India.  Should I be concerned about that???

I told John (not his real name) not to be concerned — he is merely substituting the generic for the branded version, not switching from a fixed-dose combination or from a different drug (that drug being emtricitabine, or FTC).

With all the hoo-ha about generic atorvastatin, this one is much more under the radar. And the process to approval has not been smooth, as I wrote about here and here.

But generic lamivudine for HIV treatment is a watershed moment nonetheless, since it’s really the first time there’s a generic antiretroviral that we might actually consider prescribing. (Zidovudine and didanosine have been generic for years.)

It will be fascinating to see how this plays out, both here in the US and in other developed countries.

2 Responses to “Generic Lamivudine Has Arrived”

  1. Dr Sax, what are your thoughts on managed care systems potentially looking at substituting generic lamivudine for emtricitabine, (including splitting out combination meds that include emtricitabine) particularly with regards to any published data regarding differences of time to virologic failure, resistance, side effects between the two medications as the DHHS guidelines still indicate they are “interchangable”. I know that adherance is important, and patient-nurse-provider education on this matter if undertaken would be very important to make sure that the patient is on the right regimen and that he/she is taking it if switched over.

    • Paul Sax says:

      Matthew, it’s an excellent question. The bottom line is that we just don’t know yet if this is safe, especially since there are decent data that FTC is a better drug (more potent, longer half life, less resistance) than 3TC, and patients truly love coformulated meds. My hunch is that it wouldn’t make a difference for highly-adherent patients with long-term virologic suppression, but that in borderline cases it could lead to more treatment failure.

      For now, I’m comfortable substituting generic 3TC for branded — it’s probably the most widely used generic HIV medication in the world.


HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

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NEJM Journal Watch
Infectious Diseases

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