ViiV Healthcare starts Phase III program with dolutegravir/rilpivirine combination to treat HIV

The program includes two replicate studies evaluating 48 week viral suppression with a two drug regimen combining dolutegravir and rilpivirine in HIV patients who have already achieved viral suppression with a three drug regimen.

Dolutegravir is an integrase inhibitor, while rilpivirine is a non-nucleoside reverse transcriptase inhibitor.

ViiV Healthcare chief scientific and medical officer Dr John Pottage said: "As HIV care becomes an increasingly long term consideration, patients and clinicians are seeking to balance efficacy and side effects of treatment.

"We are able to attain initial viral suppression with a standard three drug regimen and the question is whether we can maintain viral suppression with two drugs instead of three.

"An interesting part of this Phase III programme is the inclusion of measures of the patient experience — we’re looking at health-related quality of life and adherence to treatment, in addition to the primary efficacy and safety endpoints."

The Phase III program is designed to evaluate the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-,NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed.

In these trials, dolutegravir and rilpivirine will be provided as individual tablets; development of the single-tablet formulation will be concurrent with conduct of the trials.

In June 2014, ViiV Healthcare and Janssen Sciences Ireland entered into a partnership to investigate the potential of combining dolutegravir and rilpivirine in a single-tablet in order to expand the treatment options available to people living with HIV.