Dovato Demonstrates Non-Inferior Efficacy to Biktarvy in Head-to-Head Phase IV Trial
Dovato regimen met its primary endpoint at 48 weeks for the treatment of HIV-1 in people who are virologically suppressed.
ViiV Healthcare has shared initial results from the 48-week Phase IV PASO DOBLE clinical trial (NCT04884139) investigating the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/[3TC]) compared to the 3-drug regimen Biktarvy (bictegravir/emtricitabine]/tenofovir alafenamide fumarate [BIC/FTC/TAF]) for the treatment of HIV-1 in people who are virologically suppressed and who could benefit from treatment optimization.1
According to ViiV, findings from the trial show that switching to DTG/3TC demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF. Additionally, those treated with the DTG/3TC regimen had significantly less weight gain compared to those randomized to BIC/FTC/TAF. Viiv will be presenting these data at the 25th International AIDS Conference (AIDS 2024) held in Munich, Germany.
PASO DOBLE is an open-label, randomized, multicenter study conducted at 30 sites across Spain which evaluated the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virologic suppression in people living with HIV-1. The primary endpoint was the proportion of people living with HIV with RNA ≥50 copies/mL at 48 weeks (FDA snapshot, 4% non-inferiority margin) in the intention-to-treat exposed population. Secondary endpoints included absolute weight gain, BMI change, and the proportion of participants with weight change greater than 5%.
“The results from PASO DOBLE show that Dovato demonstrated non-inferior efficacy compared to Biktarvy, and that the average weight gain for trial participants taking DTG/3TC was significantly lower than those taking BIC/FTC/FTC over the course of the year. This is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV,” Harmony P. Garges, MD, MPH, chief medical officer at ViiV said in a press release. “At ViiV Healthcare we're dedicated to bringing innovative HIV treatments to people living with HIV that are not only safe and effective, but also address their specific needs beyond viral suppression.”
According to the Centers for Disease Control and Prevention, an estimated 1.2 million people in the United States had HIV at the end of 2021. In the same year, 36,136 people received an HIV diagnosis in the United States. However, the annual number of new diagnoses decreased by 7% from 2017 to 2021.2
“The HIV treatment regimens that are commonly prescribed today are all highly effective, which makes it critical that we study the impact of these therapies beyond just viral suppression,” Esteban Martínez, MD, PhD, chief executive investigator of the PASO DOBLE study and senior consultant in infectious diseases at Hospital Clínic of Barcelona, Spain said in the press release. “The results from PASO DOBLE show Dovato, a 2-drug regimen, not just demonstrated the same efficacy as a 3-drug regimen, but also showed less weight gain compared to BIC/FTC/TAF through 48 weeks.”
Earlier in April, the FDA approved the Dovato regimen for the treatment of HIV-1 in adolescents 12 years of age and older and weighing at least 25 kilograms with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.3
It became the first and only oral, two-drug, single-tablet regimen available for people aged 12 and older living with HIV.
References
1. ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING 2-DRUG REGIMEN DOVATO IS AS EFFECTIVE AS 3-DRUG REGIMEN BIKTARVY FOR MAINTENANCE THERAPY OF HIV-1. News release. ViiV Healthcare. July 23, 2024. Accessed July 23, 2024. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/july/viiv-healthcare-announces-positive-data-demonstrating/
2. HIV Basics. Centers for Disease Control and Prevention. May 22, 2023. Accessed July 23, 2024. https://www.cdc.gov/hiv/basics/statistics.html.
3. ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV. News release. ViiV Healthcare. April 8, 2024. Accessed July 23, 2024. https://www.businesswire.com/news/home/20240319579558/en/ViiV-Healthcare-announces-U.S.-FDA-approval-of-Dovato-dolutegravirlamivudine-for-adolescents-living-with-HIV
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