But unfortunately for Gilead, lenacapavir was so effective, that the outside ethical review panel stopped the clinical trial early.
There wasn't enough statistical power to support expanding Descovy's approval to women and it would be unethical to continue to give women either Descovy or Truvada
It made me remember the bar graph in the last post. Why did Gilead do 3 arms, comparing lenacapavir to both Truvada and Descovy, already approved drugs with similar effectiveness?
It's because they could take advantage of the high incidence in Africa to get the restriction on Descovy removed
Bar graph of HIV+ case rate comparing lenacapavir, truvada, and descovy
A few days ago I attended a physician's dinner hosted by Gilead to promote Descovy. The presenter pointed out that the drug is only approved for cis men and trans women. When the drug was first approved, they talked about it being too expensive to run clinical trials in women, DT low incidence
14.11.2024 23:36 — 👍 1 🔁 0 💬 1 📌 0
As long as we take our ARVs, resistance shouldn’t emerge spontaneously.
In the pipeline we have more new ways to stop HIV replication, so the future looks good
❤️
Today, an INSTI-based regimen (like TLD) can be given immediately, before the patient’s first labs are ordered.
The main way we see resistance is when it happens immediately, like when someone is infected with a resistant strain of HIV. The first VL won’t show a decline.
INSTIs are in a new class (stopping integration) there was no preexisting resistance.
In wealthy countries, it is a standard practice to order a test that looks at resistance before prescribing.
That way, the doctor’s know what is still effective before prescribing a particular medication.
Overall, ARV drug resistance is ⬇️. In the early days it was much more common. We were prescribed 1 then 2 drug ARVs that would work for a short while.
The virus wasn’t totally suppressed so HIV could mutate and resistance would emerge.
With the advent of INSTIs, HIV has a more difficult barrier.
In my newly diagnosed HIV+ peer support group there were plenty of guys who knew about PrEP but never got around to getting it.
Also working as a PrEP navigator I had patients stop PrEP when they were in a relationship then came back a year later being HIV+.
Us humans are bad at estimating risk
