Positive Results From First Phase III Studies of Investigational Two-Drug HIV Treatment Regimen

– Investigational Two-Drug Regimen of Rilpivirine and Dolutegravir Shows Efficacy As Maintenance Therapy in Patients Who Have Already Achieved Viral Suppression –

Janssen Sciences Ireland UC (Janssen) announced on December 20th 2016, that two Phase III studies to evaluate the safety and efficacy of switching virologically suppressed patients from a three or four drug (integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based) antiretroviral regimen to the two drug regimen of rilpivirine (Janssen) and dolutegravir (ViiV Healthcare) met the primary endpoint of non inferiority at week 48.

The primary endpoint in both studies was evaluated as the proportion of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48. Detailed study results will be presented at an upcoming scientific meeting.  The safety profile for rilpivirine and dolutegravir in the two studies was consistent with the product labelling for each medicine.

“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, consider life-long treatment they must balance efficacy and the side effects of treatment,” says Lawrence M. Blatt, Global R&D Head, Infectious Diseases & Vaccines, Janssen.  “We are committed to exploring new combination therapies to improve the lives of those facing life-long HIV treatment and these important results for a two-drug regimen support those efforts.”

It is anticipated that regulatory submissions for the investigational two-drug regimen of rilpivirine and dolutegravir as a single tablet will be made in 2017.

About the SWORD Phase III Program for dolutegravir (Tivicay®) and rilpivirine (Edurant®)

The Phase III program evaluates the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four drug regimen.  In the clinical trials, dolutegravir and rilpivirine are provided as individual tablets. SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomised, open-label, non-inferiority studies to assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy.

The primary endpoint is proportion of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48. Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The study also includes exploratory measures to assess change in health-related quality of life, willingness to switch, and adherence to treatment regimens.

For more information on the trials please visit: www.clinicaltrials.gov

 

EDURANT® (Rilpivirine)
Product Information

 

TIVICAY® (dolutegravir) tablets

Product information

 

SOURCE Janssen Sciences Ireland UC

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