Question

Can my boyfriend take Truvada only with biscuits?

11 December 2008. Related: All topics, Side effects.

My partner is on HAART. He has started 3 days ago-Sustiva and Truvada. He is having no side effects from the Truvada, however the Sustiva is making him feel really giddy.

It says to take Truvada with or after food. He takes his dose in the morning at 10am, due to shift work. He is normally in bed or at work and can’t eat.

Would it be acceptable to have maybe a couple of biscuits or a packet of crisps with this medication? Would this be classed as having food?

Also I have read that in the USA you can take Truvada with or without food. Sorry for such a long winded question, we have had such a lot to take in during tha last month, both recently diagnosed, but things do seem to be getting easier day by day. Many, many thanks.

Answer

Answer: Simon Collins

Things will be getting better and better, I am sure.

Although in the US you can take Truvada with or without food, in Europe the recommendation is still to take with food. This difference comes because the food interaction (food increases tenofovir levels by about 30%) was only discovered after the main trials were well underway. US and European regulatory agencies interpreted the results differently.

This is probably most important in the first months of therapy until your viral load is reduced to undetectable, or if you have drug resistance and need the extra potency.

These difference were highlighted again with Atripla, which is the 3 compounds in one pill. This makes it impossible to divide them and have food with one and not the other.

So, in the US, patients can start with Atripla, with or without food (but not with a high fat meal which increases efavirenz levels too high). In Europe, patients are advised to take Truvada and efavirenz separately at first so that the tenofovir can be taken with food, and then only switch to the combined Atripla formulation after their viral load is suppressed.

The amount and type of food is even more complicated. Although the leaflet that comes with Truvada should say ‘take with food’ the food interaction studies showed that a light meal had no effect and that the dose increase only came form a high fat meal. **

As for the side effects from efavirenz and how to deal with them, there is more information here.

** From the Summary of Products Characteristics for tenofovir/Truvada:

“Administration of tenofovir disoproxil fumarate with a high fat meal enhanced the oral bioavailability, with an increase in tenofovir AUC by approximately 40% and Cmax by approximately 14%. Following the first dose of tenofovir disoproxil fumarate in fed patients, the median Cmax in serum ranged from 213 to 375 ng/ml. However, administration of tenofovir disoproxil fumarate with a light meal did not have a significant effect on the pharmacokinetics of tenofovir. ”

AUC=Area Under the Curve – ie total exposure over the whole dose period

Cmax=Maximum drug level

Cmin=Minuimum drug level (at the end of the dose period)