2-Drug Regimen Shows Comparable Effectiveness With 3-Drug Regimen to Treat HIV-1

New study findings from ViiV Healthcare announced that dolutegravir and lamivudine (DTG/3TC, Dovato; ViiV Healthcare) displayed non-inferior efficacy in maintaining viral suppression among individuals with HIV, compared with bictegravir, emtricitabine, and tenofovir alafenamide fumarate (BIC/FTC/TAF, Biktarvy; Gilead Sciences, Inc).¹

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HIV-1 is the most common form of HIV, which is a virus that infects cells in the immune system. When an individual is infected with HIV-1, the virus taints the CD4 immune cell that aids the body’s immune response. Study authors noted that the virus can continue to infect the CD4 cells if the individual is not treated with antiretroviral drugs. The longer an individual goes without treatment, the harder the immune system must work to fight infections and types of cancers.²

The study authors noted that DTG/3TC is designed to treat individuals with HIV-1 infection with no antiretroviral (ARV) treatment history, as well as to replace current ARV regimen among those who are virologically suppressed.¹ In April of this year, the FDA approved dolutegravir/lamivudine for the treatment of HIV-1 infection in adolescents who are 12 years of age or older.³

The results are from a randomized, phase 4, open-label, multicenter clinical trial called PASO DOBLE, that assessed the efficacy of DTG/3TC compared with BIC/FTC/TAF to maintain virologic suppression among individuals with HIV-1. The study was conducted across 30 sites in Spain and included 553 individuals who were on therapies that could be enhanced. The individuals were then randomly assigned to receive treatment with either DTG/3TC (n=277) or BIC/FTC/TAF (n=276).¹

Presented at the AIDS 2024 Conference, the results showed that at 48 weeks, DTG/3TC was non-inferior to BIC/FTC/TAF, meeting the study’s primary end point. The secondary end point found significant weight increase among individuals who switched to BIC/FTC/TAF, compared with individuals who switched to DTG/3TC, according to study authors.¹

“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,” said Harmony P. Garges, MD, MPH, Chief Medical Officer at ViiV Healthcare, in a news release. “This is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV. 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.”¹

Additional results displayed that the weight change among individuals on DTG/3TC did not vary between men and women based on regimens they were previously taking. However, individuals who experienced greater than 5% weight gain on BIC/FTC/TAF were reported to be 45% higher compared with those on DTG/3TC, when switching from a regimen with abacavir, and 2-folds higher with tenofovir disoproxil fumarate.¹

The study authors noted that the safety of DTG/3TC was comparable and consistent through 48 weeks to previously known safety profiles.¹

“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. 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,” said Esteban Martínez, MD, PhD, Chief Executive Investigator of the PASO DOBLE study and Senior Consultant in Infectious Diseases at Hospital Clínic of Barcelona, Spain, in a news release.¹

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. ViiV Healthcare. News release. July 23, 2024. Accessed July 31, 2024. https://viivhealthcare.com/en-us/media-center/news/press-releases/2024/july/viiv-healthcare-announces-positive-data-demonstrating/.

2. Understanding HIV-1 and How It May Affect You. Healthline. News release. March 24, 2021. Accessed July 31, 2024. https://www.healthline.com/health/hiv-aids/hiv-1.

3. McGovern G. FDA Approves Dolutegravir/Lamivudine for Treatment of Adolescents With HIV-1 Infection. Pharmacy Times. News release. April 8, 2024. Accessed July 31, 2024. https://www.pharmacytimes.com/view/fda-approves-dolutegravir-lamivudine-for-treatment-of-adolescents-with-hiv-1-infection.