Examining the Durability of HIV Regimens
MARCH 02, 2017
At CROI 2017, Katia Boven, MD, Head of Clinical Development and Global Medical Affairs, Infectious Diseases, Janssen, discussed results and impact of the SWORD clinical trial involving the investigational two-drug combination being as effective as the three or four regimens as maintenance therapy in HIV patients who have already achieved viral suppression.
Boven explained that in the study, her team saw one subject who had a mutation, but later admitted she hadn't taken the drugs for three weeks, so her viral loads went up. But, once the team identified the problem, she restarted her dual regimen and the levels came down despite having the mutation. "In either of the studies we saw no integrase inhibitor-associated mutation, so that was very good," said Boven.
According to Boven, "The trial goes out to 148 weeks, [but] we want to also look at the durability of this regimen, because 48 weeks is already good (it's a bout a year), so we want to make sure the longer term is as durable. We have one correlate where we can look at the durability of a similar regimen also in development, which is a long-acting injectable."
In answering how the study results would impact patient care, Boven remarked, "Currently, most patients are in a triple or quadruple regimen and every drug carries some safety or tolerability issues - maybe not in the short term, but in the longer term after 5,10, or 15 years of having to take the drugs. So, it's better to have to only take two drugs. Most of the these combo regiments are already in a single tablet, so the patient only has to take one pill."