South Africa has one of (if not the) highest incidence of HIV in the population, so it makes sense to test it there. If you test it in a country where the incidence is 0.01 of the population, it's very hard to see statistical significance.
Edit: to add to my comment, it's also a phase 3 trial, so the safety has already been proven before.
They probably will, since they've extensively shared patents for their previous HIV drugs through the Medicines Patent Pool. It seems like you've fallen victim to some misinformation on Gilead or the pharmaceutical industry more generally.
Drugs in general are not tested on people in africa ("african people" is probably not the right term). More likely drugs are tested less in africa vs other places.
If you are talking about drugs for diseases that are a much more serious problem in africa than in the rest of the world - well doesnt that make sense? You dont test a new malaria drug in canada where there is no malaria. You test them where there is the biggest problem.
Globally, women and adolescent girls bear the highest burden of HIV, highlighting the critical need for effective HIV prevention options. In Sub-Saharan Africa, women and adolescent girls make up almost 60% of all new HIV infections. Stigma, marginalization, poverty, gender-based violence, and social inequities are some of the factors that have made women and adolescent girls especially vulnerable to HIV. PURPOSE 1, which enrolled cisgender women, will evaluate an investigational drug, lenacapavir, and an FDA-approved PrEP drug for people assigned male at birth, emtricitabine/ tenofovir alafenamide, also known as F/TAF or DESCOVY®, for PrEP. This trial is taking place in South Africa and Uganda and has completed enrollment.
I wonder what the existing breakdown is. If, hypothetically, all males had HIV already, then the new HIV infections would be 100% female. Obviously that isn't the case, just directionally this stat in isolation doesn't really show whether HIV is disproportionately affecting women.
Subsaharan Africa has the largest epidemic of HIV, that is why. Because you need a control group and compare the frequency of new infections.
It would make no sense to study HIV drugs in, say, Egypt, where the sexual mores are rather strict due to the conservative Islamic character of the society, and thus infection rates remain very low.
(Note that Egypt is also Africa, but probably the "wrong kind of"... at least as far as the fashionable racial classifications go.)
That's a legit question: drugs are now day tested in Europe on a relatively small and strictly controlled cohort and in China/India/Africa on much larger cohorts with much different rules.
It's easier and cheaper to test new drugs outside the us/eu because laxer regulations.
> It's easier and cheaper to test new drugs outside the us/eu because laxer regulations.
Given your comments elsewhere I suspect you're claiming this with no evidence.
For other readers, this isn't true / it's drug dependent. Amongst other things: difficulty sourcing the correct patients; difficulty importing drugs, particularly because they're not yet approved; difficulty getting high quality or reliable labs; etc. As any ctm could have told you.
As for this drug: the US/EU don't have rampant hiv, esp with the use of PrEP.
Or rather (due to obvious reasons) you just couldn't get a meaningful sample and would just be wasting resources/money if you conducted this test in US/EU.
Not really. When performing clinical trials, if you'd like to use the results of the studies in chinese/indian populations you'll need to prove bioequivalence in many cases, so you're going to need to collect a meaningful sample in the first place.
The reality is that most clinical trials aren't successes. If you can get a huge cohort of people for relatively cheap elsewhere, you can screen a lot of promising but doomed tests at a cheaper price point, then only re-create similar testing on the most promising candidates in your lucrative markets.
What the grandparent post was referring to as "obvious reasons" must be the high prevalence of HIV in the study countries[0]. Why wouldn't they test in countries with the highest infection risk?
There may be common reasons to trial there like it being cheaper or less regulated. But there is a good reason for this specific medication to be tested in those specific countries. Criticizing the study authors for being "cheap" is uncalled for in this case.
I'm not sure developed countries are the most lucrative market for HIV vaccines. How many people would even get them and why? This is a product almost entirely developed for Sub-Saharan Africa so it only makes sense that they focus on testing it there?
Hard to say, maybe it's not inconceivable that ~1% of potential patients in the US/EU/etc. might end up paying more than > 50%-90% of the people living Sub-Saharan Africa for whom getting the vaccine would make a lot of sense.
