An ongoing dialogue on HIV/AIDS, infectious diseases,
May 26th, 2011
Surprise! It’s Generic Combivir!
After last week’s unveiling of the new NNRTI rilpivirine, now we have a different kind of drug approval from the FDA:
FDA granted approval for a generic formulation fixed dose combination of lamivudine and zidovudine tablets, 150 mg/300 mg, two nucleoside analogue reverse transcriptase inhibitors, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection … FDA has determined that the generic formulation is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Combivir Tablets…
Now that’s a surprise — most HIV providers thought that the next generic antiviral would be lamivudine (3TC) on its own. Some were even expecting it last year. After all, 3TC is incredibly safe and effective, has been used in literally millions of patients both here and abroad since its approval in 1995, and already is available as a generic all over the world.
Adding the zidovudine (AZT) part to 3TC definitely makes this generic much less appealing. Zidovudine hasn’t been a “preferred” or “recommended” part of first-line regimens for several years due to its association with GI side effects, anemia, lipoatrophy, and the requirement for twice-daily dosing.
So why generic “Combivir” (it won’t be called that anymore) and not 3TC alone? Some thoughts:
- Coformulation magic. All of us have had patients who didn’t tolerate individual drugs — efavirenz, for example — who later went on to be quite happy taking that same drug as part of a combination pill (e.g., Atripla, which has efavirenz in it). The same thing happened when branded Combivir was approved. Suddenly, AZT was fine. Go figure.
- There are a lot of pregnant women with HIV out there. Yes, most of the pregnant women with HIV are treated with Combivir. But if the rest of the country is practicing the way we do, they are switched to something safer and better tolerated when the pregnancy ends. So I doubt this is it.
- Studies suggest that everyone already on TDF/FTC, TDF/FTC/EFV, and ABC/3TC will stay on them. Our patients love these coformulated drugs (see #1 above). Perhaps a survey of patients, providers, payors, and other interested parties found little appetite for breaking these combinations up, which is what would be required to get generic 3TC prescribed.
- Some “business plan” we don’t understand. My next door neighbor is a smart guy who went to business school. He’s not a doctor. And he says that everyone he works with knows that doctors are lousy with money issues, negotiate poorly, and are easily duped into paying top dollar for things that aren’t worth very much (electronic medical records and billing systems are his favorite examples). So maybe we just don’t understand the finances of selling combination AZT/3TC vs 3TC alone. Right.
- A deal involving companies and lawyers and back room deals. It goes something like this: The makers of branded HIV drugs have made an elaborate deal with the generic companies involving the transfer of huge sums of cash (preferably to an off-shore bank account) in exchange for not making generic 3TC. The exploitation of an obscure legal loophole would undoubtedly have been required. If it can happen with potassium … Something for the conspiracy theorists to mull over.
In sum, the real reason there’s no generic 3TC remains a mystery.
Of course the FDA could announce its availability next week, in which case this whole post is irrelevant.
Comments are closed.
Paul E. Sax, MD
Learn more about HIV and ID Observations.
Follow HIV and ID Observations Posts via Email
- Endless Recertification in Medicine — Some Thoughts About the Tests We Take
- My Vote for the Weirdest Antibiotic on the Planet
- Long-Acting Cabotegravir-Rilpivirine for People Not Taking Oral Therapy — Time to Modify Treatment Guidelines?
- Learning the Names of HIV Drugs Is Horribly Difficult — Here’s Why
- Really Rapid Review — Brisbane IAS 2023
- ID Cartoon Caption Contest (125)
- ID Cartoon Caption Contest #2 Winner — and a New Contest for the Holidays (92)
- Dear Nation — A Series of Apologies on COVID-19 (80)
- How to Induce Rage in a Doctor (77)
- IDSA’s COVID-19 Treatment Guidelines Highlight Difficulty of “Don’t Just Do Something, Stand There” (74)
- Missed Chances for Screening in Persons Newly Diagnosed with HIV: New York City, 2018–2022
- Arboviral Disease Surveillance in the U.S.
- Observations from ID and Beyond: Long-Acting Cabotegravir-Rilpivirine for People Not Taking Oral Therapy — Time to Change Treatment Guidelines?
- Risk for C. difficile Infection Varies Widely with Choice of Antibiotic
- Mpox in Persons with Previous Infection or Vaccination
- Abacavir AIDS antibiotics antiretroviral therapy ART atazanavir baseball Brush with Greatness CDC C diff COVID-19 CROI darunavir dolutegravir elvitegravir etravirine FDA HCV hepatitis C HIV HIV cure HIV testing ID fellowship ID Learning Unit Infectious Diseases influenza Link-o-Rama lyme disease MRSA PEP Policy PrEP prevention primary care raltegravir Really Rapid Review resistance Retrovirus Conference rilpivirine sofosbuvir TDF/FTC tenofovir Thanksgiving vaccines zoster