Core Concepts
Concerns about lymphocyte levels in HIV patients led to adjustments in the islatravir antiretroviral trial, with promising outcomes.
Abstract
The content discusses the impact of concerns regarding lower lymphocyte levels in HIV patients during the islatravir antiretroviral trial. It covers the changes made to the trial, the results presented at the International AIDS Society Conference, and the implications of the study's findings. Key highlights include:
- FDA hold on islatravir trial due to lymphocyte decreases
- Phase 3 trial results comparing islatravir with doravirine vs. B/F/TAF
- Virologic outcomes and treatment resistance
- Impact on CD4+ T cell counts and total lymphocytes
- New lower dose trial with islatravir and doravirine
- Weight gain comparison between treatment arms
- Need for alternative HIV treatment strategies
Stats
"Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks."
"At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL."
"Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group compared with 234 cells/mL in the B/F/TAF group."
Quotes
"These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events."