The US Food and Drug Administration announced that Gilead Sciences’ Biktarvy can be used by PLWH struggling with M184V/I resistance, a common form of treatment resistance.
Biktarvy, a once-daily HIV treatment pill, can now be used by people who are virally suppressed but also resistant to M184/I. The M184V/I resistance mutation has been identified in a number of PLHIV with previous resistance to nucleoside reverse transcriptase inhibitors.
“Clinical data has confirmed that Biktarvy is a long-term HIV treatment option for a wide range of PLHIV. With this label update, healthcare providers better understand the effectiveness of Biktarvy in an underserved segment of PLHIV,” said Jared Bethen, MD, vice president of clinical development Gilead Sciences HIV, in a statement: “Thanks to decades of therapeutic improvements, PLHIV can live longer and healthier lives, but treatment needs remain. Treatment resistance is one such problem. We are committed to a people-centered approach to HIV treatment research that not only promotes ongoing scientific innovation to meet public health needs, but also maximizes long-term outcomes for PLHIV.”
Treatment resistance is a serious problem; Once a person with HIV develops such resistance, it becomes permanent and irreversible. Drug resistance can result in a treatment regimen failing to stop the virus from replication, and can also potentially lead to transmission of HIV to others if resistance causes a person’s viral load to no longer be suppressed.
“Treatment of HIV infection must avoid failure whenever possible, so a high barrier to resistance should be the standard of care to maximize the chances of long-term virologic suppression,” said Paul E. Sachs, MD, clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital. professor of medicine at Harvard Medical School. “This label update builds on Biktarvy’s established high resistance barrier by showing that it is effective in PLHIV who may have certain forms of previous resistance or a history of past treatment failure.”