Generic Truvada

[BootmanLA]

16 hours ago, R86 said:

Why is nobody doing a full study on the effectiveness of TDF/3TC as PrEP? Clinical trials are expensive. Truvada was under patent by Gilead when they paid for the study proving efficacy as PrEP. The payout was coming at the completion of the study. With generics, there’s no financial incentive for a company to investigate a novel prophylaxis treatment with an existing generic drug; there is no exclusivity period for the drug once efficacy has been proven. Short answer? Money!

This is undoubtedly a big part of it, perhaps the main reason by far. But it's important to note as well that this is a 2-pill treatment; either a manufacturer would have to propose and fund a study using a combined pill (which doesn't yet exist) or the study would really have to account for situations where someone takes only one of the two pills (either periodically, or regularly), because otherwise you're assuming one more thing that could vary in actuality.

One thing I vaguely remember as a concern with the original 3-drug cocktails that required three separate pills is that things would get wonky for patients at times; one of the pills would be unavailable at refill time, for instance, and though it was fairly quickly in stock, the patients still had varying levels of the three drugs at times. Or someone would lose a few pills from one of the three, and until there was a refill, he was using 2 instead of 3 drugs. And some of those original medications required two or more doses per 24 hour period, so it was complex for people to take, and there was even more opportunity to get "out of sync" with the 3 drugs in the "cocktail". The single-pill regimens solved all of that, but it also means that you have to actually be prepared to produce a single pill combining the two drugs you want to test together as PrEP, if the study works out. 

[Guest]

I was in the 3 year clinical trial for Descovy.  The primary benefits as I understand it are liver/kidney function (short term side effect causing some not to use it), but also bone density issues (long term side effect no one thinks about).  I actually read SOME of the technical stuff when I first got it back in 2014. 

Descovy just changed the make up of the active ingredients to lower the bone density issue (as well as the liver/kidney issue).  So I believe both brand name Truvada and Generic Truvada would both be inferior regarding the longer term bone density problem.   All along I thought it was suspicious that the new and improved formula would be coming out almost exactly when Truvada was going Generic.  Even my clinical trial doctor stated it will be interesting to see if Descovy is actually covered by insurance due to generic Truvada.  I'm not currently on anything at all, but if I were paying with my own money I would use generic regardless of the Descovy benefits at the present time.  Our whole medical system is profit driven.  It's unsustainable for so many young healthy guys to be paying maybe $500 per month for insurance and taking a $1500 per month prescription.  That person is a guaranteed loss every single month....even before the other std visits (LOL) and other routine stuff everyone has.  I don't really blame the insurance companies for requiring generic - our system is messed up, but until that changes a private company needs to make a profit and is gonna require generic if it's available.

[BootmanLA]

12 hours ago, justsexnowatl said:

t's unsustainable for so many young healthy guys to be paying maybe $500 per month for insurance and taking a $1500 per month prescription.  That person is a guaranteed loss every single month....even before the other std visits (LOL) and other routine stuff everyone has.  I don't really blame the insurance companies for requiring generic - our system is messed up, but until that changes a private company needs to make a profit and is gonna require generic if it's available.

Here's the thing, though. While not arguing against requiring generics when they're efficacious, sometimes it's more cost-effective for an insurer to run a small loss on a given patient to avoid much bigger losses down the road, especially when it comes to group insurance. Keeping the guy from becoming positive and the thousands of additional dollars that will be required annually for his treatment may be worth not making any profit along the way - because once he's positive, you can be pretty sure he's going to hang onto that policy if at all possible for the rest of his life.

Additionally, the group insurer's PBM may have negotiated a much, much cheaper rate on the medication in exchange for having all that business, so what would cost you or me $1,500 a month may cost the PBM $500. It may still not make the particular patient profitable, but it can reduce the loss considerably. 

And realistically, in any particular group plan or population of individual plans, there are going to be a handful of patients who cost the insurer a lot of money and a lot who make them money that, added together, makes them profitable. It's how insurance works, as I'm sure you know.