By Alex Keown
In April, Dr. Robert Redfield, the new head of the U.S. Centers for Disease Control and Prevention, boldly predicted that the AIDS epidemic can be defeated by 2025. This morning Merck, Janssen and Gilead Sciences all released clinical data for HIV treatments that could make Redfield’s prediction a reality.
Janssen released 96-week data for Symtuza, a triple-combination medication for HIV-1 that showed patients who are virologically suppressed and switched to Symtuza, maintained high virologic suppression for up to 96 weeks. Data showed that 91 percent of Symtuza patients were able to maintain that suppression. Only 1 percent of patients experienced low virologic failure at 96 weeks, Janssen reported. The positive 96-week data followed earlier reports that showed the single-pill treatment was effective at suppressing the virus for 24 and 48 weeks.
Joseph Eron, a professor of AIDS research at the University of North Carolina at Chapel Hill and a trial investigator, said the results from the Phase III study shows Symtuza “can offer clinically appropriate people living with HIV a single-tablet option that may help them maintain high rates of virologic suppression over time.”
Symtuza was well tolerated by patients, with only 2 percent of subjects experiencing an adverse event of Grade 3 or Grade 4.
Symtuza was approved by the U.S. Food and Drug Administration (FDA) in July for HIV-1 based on the 48-week data. Trial data showed that up to 95 percent of participating patients achieved or maintained virologic suppression.
Not to be outdone, Gilead Sciences released 96-week data from its Phase III study of Biktarvy that showed the medication was not inferior to a regimen of abacavir/dolutegravir/lamivudine. The patients in this late-stage trial were treatment-naïve adults. Data showed that at 96 weeks, 87.9 percent of patients taking Biktarvy showed non-inferiority against 89.8 percent of patients on the abacavir/dolutegravir/lamivudine arm. Biktarvy was well tolerated through Week 96, Gilead said. The company added that the study, known as 1489, will remain randomized and blinded through 144 weeks.
Biktarvy, a once-per-day treatment, was approved by the FDA in February as a complete regimen to treat HIV-1 in adults who haven’t been treated with antiretrovirals or to replace the current antiretroviral regimen in patients who are virologically suppressed on a stable antiretroviral regimen for at least three months.
UNC scientist David Wohl, the lead author of the study, said the Phase III data “underscores the role of Biktarvy as a first-line treatment option for appropriate adults living with HIV who are new to therapy. In addition, Biktarvy was shown to have less nausea with a similar bone and renal safety profile to the comparator through 96 weeks.”
Merck also showcased data from its study of HIV patients who switched to Delstrigo, its once-per-day triple combination treatment. The Phase III DRIVE SHIFT trial included HIV-1 adults who demonstrated virological suppression for at least six months on a stable antiretroviral treatment regimen. Merck said the study met its primary endpoint of non-inferiority as measured by the number of patients who switched to Delstrigo compared to those who remained on the baseline treatment.
Princy Kumar head of Georgetown University School of Medicines’ Division of Infectious Diseases, said the Phase III data builds on the existing profile of Delstrigo as a therapy for treatment-naïve patients. Kumar said the data suggests that Delstrigo has the potential to address a broader population of HIV-1 patients.
The FDA approved Delstrigo in August, alongside another HIV treatment, Pifeltro. Clinical data showed that patients who took Delstrigo, which is a combination of doravirine, lamivudine and tenofovir disoproxil fumarate, demonstrated sustained viral suppression through 48 weeks. Data showed that 84 percent of the patients on Delstrigo achieved viral suppression.