I really hate blogging on non-published information, but for the second time in as many weeks, we have had interesting information come out of CROI. This bit of news isnt as exciting. It pretty much confirms my annoyed Debbie Downer stance on using antiretrovirals in non-infected individuals as a means to prevent HIV infection (thats not entirely accurate– my position is more ‘concerned’, ‘baffled’, ‘distressed’ about the obvious route of an increase in drug-resistant transmittable HIV).
This is a BIG OL Debbie Downer post.
VOICE, or Vaginal and Oral Interventions to Control the Epidemic, set up a trial where women were divided into five groups– One group got oral meds that contained two drugs, one group got oral meds that contained one drug, and one group got a vaginal gel that contained the drug, placebo gel, and placebo pill groups.
Based on previous trials like this, I would have anticipated mediocre results, at best, again (repeating clinical trials after similar clinical trials were stopped due to lack of efficacy? *slowclap* why not? theres lots of cash in science right now to be tossing around!). And clinical trials are a ‘best-case’ scenario. Participants are being educated, guided, monitored in a way they would not be in The Real World. Whats more, participants want to please the scientists and physicians involved in the study. Thats why we double blind things. Thats why we have placebo groups. Thats why we have ethical guidelines that prevent scientists from using their position of power to influence study subjects. (among many other reasons for those things)
Yes, well, okay, ‘Maybe this time it will be different! Maybe THIS time it will work!’
Even though patients were 90% compliant.
Except they werent.
According to patient reporting, the patients were 90% compliant with the antiretroviral therapy.
According to testing of their serum, the patients were 29% compliant with the antiretroviral therapy, at best (the gel group was down to 23%, segregate the data by age groups and the % goes down even further). And how it is worded in the news releases, this is the percentage of participants who had detectable drug in their system. They did not mention how many of this <30% of patients had *therapeutic levels* of drugs in their system. They also dont know which of the >70% patients were taking the drugs even more sporadically, and had periods of time when they had sub-therapeutic levels of the antiretrovirals.
Why am I bringing this up?
Do you want to know how we develop antiretroviral resistant strains of HIV in the lab? Why, we passage viruses in increasing concentrations of antiretrovirals. Start out with subtherapeutic doses, and then escalate.
And unless the >70% were never taking the drugs, we had thousands of women in Africa walking around with cyclical, sometimes sub-therapeutic levels of antiretroviral drugs in their system, getting infected with HIV.
But here in the US, taking antiretrovirals to prevent HIV infection is not in the ‘clinical trials’ stage. The FDA already approved it. And we are supposed to believe that Average Jane in the setting of a clinical trial would only be <30% compliant, but Average Jane in The Real World will who pays out-of-pocket or insurance co-pays (no one splits their life-saving pills or skips doses due to cost these days!) totally do better and this wont be a problem so it was a great idea for the FDA to approve use of antiretroviral therapy in non-infected individuals and this is not a ticking time-bomb waiting to blow up in our faces.
I do not get it.