Janssen reports positive results in Phase III combination trial to treat HIV
Janssen Sciences Ireland (Janssen) has reported positive results in the first of the two Phase III studies that evaluate the safety and efficacy of switching virologically suppressed patients from a three or four drug anti-retroviral regimen to the two drug regimen of rilpivirine and dolutegravir in HIV-1-infected adults.
The result of the study, known as Sword, has met the primary endpoint of non-inferiority at week 48 of the trial.
Secondary endpoints of the study include evaluation of the development of viral resistance, measurements of safety and tolerability, as well as changes in renal, bone and cardiovascular biomarkers.
The study also features exploratory measures to evaluate change in health-related quality of life, willingness to switch, and adherence to treatment regimens.
Janssen Sciences Ireland infectious diseases and vaccines global R&D head Lawrence Blatt said: "HIV has become a chronic, long-term condition in many parts of the world thanks to the availability of more than 20 approved medicines.
“As physicians, and those living with HIV considering lifelong treatment, they must balance efficacy and the side effects of treatment.
"We are committed to exploring new combination therapies to improve the lives of those facing lifelong HIV treatment and these important results for a two-drug regimen support those efforts."
During the clinical trials of SWORD Phase III programme, dolutegravir and rilpivirine have been provided as individual tablets.
Both the stages of the trial, SWORD-1 and Sword-2, are replicate 148-week, randomised, open-label, non-inferiority studies that aim to assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir and rilpivirine compared with current anti-retroviral therapy.
Janssen expects to submit regulatory application to make the two-drug regimen of rilpivirine and dolutegravir as a single tablet by next year.