Healthcare on Track
ViiV Healthcare Releases Promising Data from Two Drug Studies
by Hank Trout
On July 17, 2021, ViiV Healthcare announced promising findings in two recent drug trials, reported at the International AIDS Society Conference 2021 (IAS 2021).
The first of these presentations outlined 48-week data from the Phase III SALSA study, demonstrating comparable safety for two-drug regimen Dovato versus continuing an antiviral regiment of at least three drugs, reinforcing Dovato’s efficacy for use in a switch of drug regimens.
The two-drug regimen (2DR) Dovato (dolutegravir/lamivudine) demonstrated non-inferior efficacy compared to continuation of a current antiretroviral regimen (CAR) of at least three drugs, with zero cases of virologic failure and no development of resistance, in a diverse population of virologically suppressed adults with HIV-1 who have not experienced prior virologic failure. The diverse SALSA study population presents a broad representation of people living with HIV on a variety of different regimens of at least three drugs.
The study drew participants to more than 120 study sites across North America, Europe, Asia Pacific, South America, and Africa. A significant proportion of participants were female (39%), aged fifty or over (39%), and represented varied racial backgrounds (59% white; 19% black; 14% Asian). Study participants were HIV-1 positive adults on a CAR with an undetectable viral load for at least six months, with no historical NRTI or integrase strand transfer inhibitor (INSTI) resistance mutation, and no evidence of hepatitis B infection. Dovato is approved in the U.S., Europe, Japan and other countries worldwide.
Kimberly Smith, MD, Head of Research & Development at ViiV Healthcare, said: “SALSA is the second switch study to demonstrate Dovato’s non-inferior efficacy and high barrier to resistance, with no participants experiencing virologic failure in the Dovato arm of the study. These findings demonstrate its versatility for participants who had previously been on a broad range of different regimens, cementing its place in the HIV treatment paradigm.”
The second ViiV Healthcare study demonstrated that their new long-acting HIV regimen consisting of cabotegravir and rilpivirine, administered once a month via injection, can be successfully implemented in a broad range of U.S. healthcare practices, even during COVID-19. The once-monthly long-acting regimen of cabotegravir and rilpivirine was authorized by the U.S. Food and Drug Administration (FDA) in January 2021 under the brand name Cabenuva.
Positive twelve-month data from the CUSTOMIZE (Cabotegravir plus Rilpivirine long acting in the US to Optimize and Measure Implementation and Experience) trial, which included people living with HIV and healthcare teams, and overlapped with the COVID-19 pandemic, demonstrated that Cabenuva (a co-pack with two injectable medicines including ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine) can be successfully implemented across a range of healthcare settings in the U.S.
This study, begun in 2019, included a variety of clinic types, from private practices, university clinics and federally qualified health centers, to integrated health care systems. The majority of healthcare staff (96%) agreed that the long-acting regimen was feasible to implement in their clinic, and most (78%) felt that optimal implementation was achieved within one-to-three months, with only minor adjustments to clinic logistics required.
Patients too seemed pleased with the new monthly injectable regimen. The people who participated in the trial agreed that the long-acting regimen was acceptable and appropriate to implement, with the majority (97%) expressing interest in continuing to receive the long-acting regimen over daily oral therapy after the study ended at twelve months.
The CUSTOMIZE trial also assessed the safety and efficacy of the regimen. Over the course of the study, findings showed that 100% of participants with available viral load results maintained viral suppression, and there were no virologic failures. Injection site reactions were the most common overall adverse event, reported in 72% of participants who received one or more injections through the twelfth month.
Other patient-reported results: 74% reported that nothing interfered with their ability to receive the monthly injection; 87% found monthly clinic visits very or extremely acceptable; 92% reported that they preferred the long-acting regimen over their previous daily oral regimen; 97% reported they would continue with the long-acting regimen of cabotegravir and rilpivirine after the study; and 93% found the time spent in clinic to receive the injections to be very or extremely acceptable.
Maggie Czarnogorski, MD, MPH, Head of Innovation and Implementation Science at ViiV Healthcare said, “Administering monthly injections for the treatment of HIV is a new experience for healthcare providers and some anticipated that there would be barriers to implementation. Over the course of a year, even with the added challenges of COVID-19, the barriers that providers and patients thought they would face turned out not to be as concerning as originally thought. What’s more, the risk of failure with this therapy has always been low, and this is reflected in the data showing that all the people living with HIV who participated in the trial maintained viral suppression, and many found that monthly visits with their healthcare professional were valuable and had a positive impact on their overall HIV care.”
For more information on both of these studies and other ViiV Healthcare initiatives, please log on to: www.viivhealthcare.com.
Hank Trout, Senior Editor, edited Drummer, Malebox, and Folsom magazines in the early 1980s. A long-term survivor of HIV/AIDS (diagnosed in 1989), he is a forty-one-year resident of San Francisco, where he lives with his husband Rick.