ViiV Healthcare reveals positive results from phase three programme assessing two-drug regimen for HIV.
M2 PHARMA-February 16, 2017-ViiV Healthcare reveals positive results from phase three programme assessing two-drug regimen for HIV
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United Kingdom-based ViiV Healthcare has revealed positive results from its phase three programme evaluating the safety and efficacy of switching virologically suppressed patients from a three- or four-drug antiretroviral regimen to a two-drug regimen of dolutegravir and rilpivirine, it was reported yesterday.
Use of dolutegravir and rilpivirine as a two-drug regimen for HIV-1 maintenance therapy is investigational and not approved anywhere in the world. The dolutegravir and rilpivirine regimen achieved non-inferior viral suppression at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD 1 and SWORD 2 studies (current antiretroviral therapy (CAR) 485/511 (95%), dolutegravir + rilpivirine 486/513 (95%) [adjusted difference -0.2% (95% CI: -3.0%, 2.5%], pooled analysis]).
The programme included two studies with more than 1000 patients who earlier achieved viral suppression on a three- or four-drug (integrase strand transfer inhibitor [INSTI]-, non-nucleoside reverse transcriptase inhibitor [NNRTI]-, or protease inhibitor [PI]-based) antiretroviral regimen. These patients were randomised to either stay on their three- or four-drug regimen or switch to a dolutegravir and rilpivirine regimen.
The safety profiles for dolutegravir and rilpivirine in these studies were consistent with the product labelling for each medicine.
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|Date:||Feb 16, 2017|
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