ViiV Healthcare, the HIV specialty firm of GlaxoSmithKline, presented 100-week results from its phase 3 clinical trials on a 2-drug regimen called Juluca (dolutegravir and rilpivirine) at the 22nd International AIDS Conference held in Amsterdam in July.
SWORD 1 and SWORD 2 studies proved the efficacy and safety of the 2-drug regimen comprised of dolutegravir, known as Tivicay and developed by ViiV Healthcare, and rilpivirine, known as Edurant developed by Janssen Sciences Ireland UC.
The phase 3 trial evaluated the safety and efficacy of switching HIV patients who were virologically suppressed from a three or four-drug antiretroviral regimen to a 2-drug regimen of Juluca.
Pooled data from the two studies showed that nearly 90 percent of participants taking the dolutegravir/rilpivirine combination for 100 weeks maintained viral suppression with a viral load of fewer than 50 copies per milliliter.
Virologic non-response was low with only 3 percent of patients falling into the category. Six participants met the confirmed virologic withdrawal criterion. A total of 34 participants experienced adverse events that led to withdrawal.
In the “late switch” arm, where 477 participants continued on their existing antiretroviral regimen until week 52 before switching to the two-drug combo, 93 percent of participants maintained viral suppression until week 100. Two participants met the confirmed virologic withdrawal criterion. The safety profile of the late switch group was comparable to the early switch group. A total of 30 participants experienced severe adverse events, and 15 participants withdrew from the trial because of them.
“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,” said Dr. John C. Pottage, chief scientific and medical officer of ViiV Healthcare said. “This 100-week data should provide physicians with further confidence that they may be able to reduce the number of antiretroviral drugs required to maintain virologic suppression in their patient’s HIV effectively.”
HIV, which stands for the Human Immunodeficiency Virus, has no cure but effective treatment can control the virus so patients can enjoy healthy and productive lives, making it a chronic treatable disease. The World Health Organization estimates about 36.7 million people are living with HIV, with 160,000 new patients diagnosed in the European region in 2016 alone.