A dual-drug regimen to treat HIV could soon be a reality, according to results presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI), February 13-16, in Seattle.
Janssen Sciences Ireland UC (Janssen) announced positive results from two phase 3 studies evaluating the safety and efficacy of switching virologically suppressed patients from a 3- or 4-drug antiretroviral regimen to the 2-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen).
If approved by FDA, the treatment could be the first 2-drug regimen for HIV and could offer those living with HIV who are virally suppressed the option to switch to a regimen which does not include a nucleotide reverse transcriptase inhibitor (NRTI), Janssen said.
“This is the first large-trial program that has been conducted, looking specifically at the combination of dolutegravir and rilpivirine as a complete, two-drug antiretroviral therapy,” Brian Woodfall, MD, global head of late development, Infectious Diseases and Vaccines for Janssen, told FormularyWatch. “We are proud to partner with ViiV Healthcare to develop this new 2-drug regimen that couples 2 drugs already proven to be highly efficacious with, together, a high barrier to resistance and a safety and tolerability profile that could be beneficial to a diverse HIV patient population.”
In the SWORD 1 and SWORD 2 studies, the dolutegravir and rilpivirine regimen achieved non-inferior viral suppression at 48 weeks, compared with a 3- or 4-drug regimen in both pooled and individual analyses. Virologic suppression rates were similar between treatment arms. The median duration of antiretroviral treatment was just over 4 years at the time of entry into the studies.
The clinical trial results are significant because, “Today, HIV is increasingly treated as a long-long condition. It is important to identify and provide treatment options that control the virus, combat the risk of resistance, and also improve the lives of patients through simplified dosing, reduced pill burden and side effects,” Woodfall said.
ViiV Healthcare and Janssen are preparing regulatory in the coming months, Woodfall said. “Based on regulatory review timelines, if approved, the combination would likely be available for patients around 12 months after filing. This will, however, vary from country to country.”