PK and Safety Studies

Dolutegravir-based regimens are now recommended by the World Health Organization as alternative first-line antiretroviral regimens (ARVs) for people living with HIV, and several countries with high HIV prevalence have adopted the new regimens.

A small drug-drug interaction study of Dolutegravir and Rifapentine + isoniazid (3HP) among healthy volunteers reported hypersensitivity reactions in two of four participants [CROI 2017, poster 409A].  

This safety concern led to our execution of a small study aimed to assess the safety and evaluate the pharmacokinetics of administering 3HP to people living with HIV on a dolutegravir-based regimen.

During the first phase, we enrolled the first group of 13 participants and reviewed preliminary safety data.

  • On May 9, 2018, the Safety Monitoring Committee reviewed the data and based on the absence of a safety signal recommended that the study proceed as designed.
  • From the PK  review in Phase 1 it has been determined we do not need to double the dose of  dolutegravir required with 3HP.
  • Final safety data will be disseminated by February 2019.