According to IMS, the global market for HIV antiviral drugs was $24.4 billion in 2015. Over the past three decades, drug companies have registered an average of one new molecular entity HIV ARV per year. This is a lot of money to spend on HIV drugs to induce just one new drug per year.
Today I took a look at data from the NIH clinicaltrials.gov database, to see what the industry was reporting in terms of trials.
Using the search term “HIV” there were 882 “intervention Studies” reported from January 1, 2010 to December 31, 2015, where “industry” was listed as having funded a trial. Of those 882 trials, 340 trials were co-funded with the NIH, other federal agencies, or “other” funders. Of the remaining trials I narrowed the search to trials that had as an intervention either “Drug” or “Biological”, and excluded trials for conditions that did not include HIV. Among the excluded trials were those for conditions such as HCV, HBV, cancer or diabetes, which did not list HIV co-infection as a condition.
That left 357 trials testing the intervention of a drug or biological for HIV/AIDS, including those specifically listing co-infections with HIV with other diseases. (Data here [1])
The 357 trials had an enrollment of 46,704 patients, including the 44,542 patients enrolled in Phase 1 through Phase 3 trials.
I used the March 2015 PhRMA/Battelle estimates of phase specific trial costs for infectious diseases, for trials done in the United States, which generally are higher cost than trials done in other countries, to estimate a price tag of $792.8 million for all 357 trials that were frist reported over the six year period. Note that this includes trials that occurred before 2010, but where not reported to the NIH clinicaltrails.gov database until 2010 or later.
I will take a deeper dive into the data, and also look at the HIV drug and biologics trials co-funded by industry, and trials that industry did not fund.