ViiV Healthcare today presented 100-week results from its phase III programme evaluating the safety and efficacy of switching virologically-suppressed people living with HIV (PLHIV) from a three or four-drug antiretroviral regimen to a 2-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson.)1 These results were presented at the 22nd International AIDS Conference taking place 23-27 July 2018 in Amsterdam.
John C. Pottage, Jr., MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “As we progress further into a new era of HIV treatment, these 100-week data from the SWORD studies add to the growing evidence base for Juluca and 2-drug regimens. The results confirm the ability of Juluca to maintain efficacy over a 100-week period and importantly support that the long-term safety profile of this regimen is consistent with the respective labels of the component medicines. This 100-week data should provide physicians with further confidence that they may be able to reduce the number of antiretroviral drugs required to effectively maintain virologic suppression in their patient’s HIV.”
In pooled data from the SWORD 1 and SWORD 2 studies, 89% (456/513) of participants on the 2-drug regimen of dolutegravir and rilpivirine for 100 weeks (n=513) maintained viral suppression, with a viral load of less than 50 copies/mL. A low rate of snapshot virologic non-response was observed (n=13; 3%) and 6 participants met the confirmed virologic withdrawal criterion. Three participants failed with NNRTI mutations, one that had pre-existing NNRTI mutations at baseline developed resistance to rilpivirine and was withdrawn; no participants developed integrase inhibitor resistance. There were no new safety findings in the second year of the study. A total 34 participants (7%) experienced adverse events that led to withdrawal through week 100.1
In the ‘late switch’ arm (n=477), where participants continued on their current antiretroviral regimen until week 52 before switching to the 2-drug regimen of dolutegravir and rilpivirine, 93% (n=444) of participants maintained viral suppression through week 100. Two participants (<1%) met the confirmed virologic withdrawal criterion, and the safety profile of the late switch group was comparable to the early switch group (dolutegravir and rilpivirine from day 1 to week 100). 30 participants (6%) experienced serious adverse events and 15 participants (3%) experienced adverse events that led to withdrawal.1
The SWORD clinical programme is part of ViiV Healthcare’s ongoing commitment to lessening the burden of HIV treatment on PLHIV through research into 2-drug regimens. The 48-week results from the SWORD studies were presented at CROI 2017 and later published in The Lancet.2 Data from the SWORD studies as well as a pivotal bioequivalence study3 has led to successful regulatory approval of the 2-drug regimen in the United States, European Union, Canada and Australia, marketed under the trade name Juluca.4,5,6,7