Janssen Announces Two-drug Combination of Dolutegravir and Rilpivirine Demonstrates Efficacy in Maintaining Viral Suppression in Phase III Clinical Studies

SEATTLE, February 13, 2017 /PRNewswire/ --

- First Detailed Results from SWORD Clinical Trial Program Show Investigational Two-drug Combination as Effective as Three- or Four-drug Regimens as Maintenance Therapy

in Patients who have Already Achieved Viral Suppression  

Janssen Sciences Ireland UC (Janssen) announced positive results from the full data read out for two Phase III studies evaluating the safety and efficacy of switching virologically suppressed patients from a three- or four-drug antiretroviral regimen to the two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen). Full results were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, WA.

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If approved, this treatment could be the first two-drug regimen for HIV and could offer those living with HIV who are virally suppressed the option to switch to a regimen which does not include a nucleotide reverse transcriptase inhibitor (NRTI).

The dolutegravir and rilpivirine regimen achieved non-inferior viral suppression (HIV-1 RNA 5%) adverse events in the dolutegravir and rilpivirine arm were nasopharyngitis, headache, diarrhea and upper respiratory tract infection. For the CAR arm, the most commonly reported adverse events were nasopharyngitis, upper respiratory tract infection, back pain, headache and diarrhea. The studies are ongoing for 148 weeks.

"The SWORD Phase III results represent an important step forward in our efforts to deliver a two-drug regimen that may help simplify dosing regimens and reduce pill burden for people living with HIV," says Lawrence M. Blatt, Global R&D Head, Infectious Diseases & Vaccines, Janssen.  "As HIV is increasingly treated as a life-long condition, we remain committed to ongoing research and development of further medicines to treat HIV more simply and to help all those living with HIV to achieve an undetectable viral load and have an improved quality of life."

Virologic failure rates were

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