GlobalData analysed the number of infectious disease clinical trials with start dates ranging between 1 January 2018 and 31 December 2018. Of all the indications within the infectious diseases therapeutic area, human immunodeficiency virus (HIV) was the most frequently investigated, accounting for 12.8% of trials initiated within this time period.
The majority of HIV clinical trials were in the early stages, with 61.6% in either Phase I (30.1%) or Phase II (31.5%), followed by Phase IV (25.5%) and Phase III (13.0%).
Single-country trials significantly outnumbered multinational trials at 88.3% and 11.7%, respectively. A significant proportion of clinical trials was carried out in the US (26.1%) followed by China (9.9%). Institution-led clinical trials (64.4%) considerably outnumbered industry led clinical trials (32.9%) with a difference of 31.5%.
The top sponsor was the National Institute of Allergy and Infectious Diseases, a branch of the National Institute of Health, accounting for 7.9% of clinical trials, followed by ViiV Healthcare (4.2%), a joint venture between GlaxoSmithKline, Pfizer, and Shionogi.
The most frequently researched agents had reverse transcriptase inhibiting mechanisms of action (MOA), which were largely used as part of combination therapy with HIV integrase-inhibiting agents, the second most researched MOA.
This can be attributed to the FDA approving Gilead’s Biktarvy, a fixed-dose combination of an HIV integrase inhibitor (bictegravir) and two reverse transcriptase inhibitors (emtricitabine and tenofovir alafenamide). Biktarvy was the top drug utilised in HIV clinical trials initiated in 2018. Because Biktarvy demonstrates a dual MOA functionality in a single tablet, this prevents the need for patients to take multiple tablets, which is regularly the case in combination antiretroviral therapies. Consequently, this increases treatment adherence and allows for improved patient outcomes.