Monday, July 14, 2014

Grinding my gears - Truvada marketing

I don't know whether you watch Family Guy, but if you do you will recall Peter going on to become a minor TV celebrity in an episode where he goes on rants about whatever it is that's grinding his gears, as he puts it so succinctly.

Take this commentary in that spirit - I may have missed relevant information (aka Peter …). I know that HIV prevention/Tx folks check on this blog every now and then. Consider yourselves invited to enlighten me if I missed a beat.

So, Truvada marketing by WHO and other assorted HIV prevention folks is grinding my gears in a big way these days. WHO reportedly advises that sexually active HIV negative gay men in sero-discordant relationships should go on Truvada. What grinds my gears is that to date there is not a single documented case of HIV transmission from an HIV positive guy on HAART whose viral load is undetectable, courtesy of that medication, to his sex partner. For the sake of the argument, assume that there are in fact a (very) small number of such transmissions happening. How can that be a good reason for advising every HIV negative gay man in such a relationship to initiate a regime of - frankly - fairly toxic drugs for ever (i.e. while he is sexually active)? Unlike Gilead's information on its Truvada website, the UK NHS provides a clearer picture of what you HIV negative gay guys can expect if you choose to join the Truvada train. These ain't sugar pills.

What grinds my gears it that we have zero clinical evidence that folks who take Truvada prophylactically, and say, successfully, throughout their sexually active lives, fare any better than those who wait with going on HAART until they sero-convert. What one would want to know, obviously, is whether folks who wait for a possible infection and then get treated, fare any worse in terms of mortality/morbidity than those who have boarded the Truvada train at gigantic cost to the health care system or their insurance company or to themselves. The truth is, we don't know that. This hasn't stopped WHO from marketing Truvada busily on behalf of Gilead, the drug's manufacturer.

Some have argued that folks would typically only need to use Truvada for a few weeks prior to an unsafe sexual encounter and then possibly use post-exposure prophylaxis afterwards. So, the argument continues, they'd be better off than those who'd sero-convert and have to take HAART for the rest of their biological lives. I'm sure Gilead's sales executives quietly laugh at this logic, because none of us plan for an unsafe sexual encounter (you know, in the real world nobody will say, hey, I'm going to have unsafe sex in six weeks time, lemme go on Truvada now, when unsafe sex done, I'll stop it again - sex doesn't quite work like that). In any case, post-exposure prophylaxis works in around 92-95% of cases, so why not stick to such a regime if you had unsafe sex with someone who's HIV positive and doesn't have an undetectable viral load.

Now, this was what I consider the strongest rationale for advising sexually active men to go on Truvada as a means of HIV prevention. Apparently, WHO hasn't quite left it there and went all out, it recommends that all 'men who have sex with men consider taking antiretroviral medicines as an additional method of preventing HIV infection'. This quote is from WHO's own press statement on the release of its report.

Talking about grinding my gears, this definitely does. For starters, the majority of sexually active gay men do not become HIV infected. And yet, WHO thinks they all should go permanently on highly expensive  - prices admittedly vary, in Canada they're at 1100 $ p/month, in South Africa at a more palatable 9$/month - and fairly toxic drugs. At this point in time we do not even know what the impact on their health would be 20 years down the track. As mentioned earlier, even for those who might become infected we do not know whether they might not be better off beginning treatment after they got infected than using comparable drugs throughout their lives to prevent an infection.

Let me cut thru the chase here: If WHO was an honest organization, it would concede that the only sound motive for advising all sexually active gay men to begin taking Truvada is a public health rationale, and not the health of those who take those drugs. Incidentally, that makes sense, WHO does mostly public health stuff anyway. If all or most sexually active gay men would take Truvada, we'd probably be able to get rid of the bug over a generation or two. This would come at a medium to potentially high price paid by the majority of gay men who would take this drug even though they'd not have caught the bug anyway.

That being said, I'm not trying to persuade anyone not to go on Truvada, I don't know whether it's a good or a bad idea, what grinds my gears is that in the absence of crucial clinical questions being settled, sweeping recommendations are made by WHO with a view to putting perfectly healthy gay men throughout their sexually active lives on seriously heavy medication with a side-effects list as long as your weekend shopping list. This is dangerous, because the absence of vital clinical evidence suggests there ought not to be consensus advice of this sort.

I can't wait for NICE to step in here and call this nonsense for what it is, a marketing exercise.

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