Janssen, Gilead Showcase HIV Data at Glasgow Conference

HIV virus in blood animation

Janssen and Gilead Sciences continue to showcase the potential treatment abilities of their respective HIV treatments. This morning the two companies released 96-week data demonstrating their efficacy and safety that was presented during an HIV conference in the United Kingdom.

The news shared by both companies comes less than a month after they both released data showcasing the efficacy of their HIV medications.

California-based Gilead announced 96-week results from a Phase III study of its HIV drug Biktarvy for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing Phase III study, Gilead said Biktarvy was found to be statistically non-inferior to a triple-combination regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) through 96 weeks of therapy. The new data were presented during a late-breaking abstract session at the 2018 HIV Glasgow conference in Glasgow, Scotland.

In the study, treatment-naïve adults were randomized to receive either the Gilead medication or the triple combination. At week 96, non-inferiority was maintained from the primary endpoint measurement at Week 48, with 84.1 percent of patients taking Biktarvy and 86.5 percent taking the triple combination achieving HIV-1 RNA levels less than 50 copies/mL. In the resistance analysis population, none of the study participants randomized to Biktarvy developed treatment-emergent resistance, Gilead said.

That follows data released earlier this month that showed 87.9 percent of patients taking Biktarvy showed non-inferiority against 89.8 percent of patients taking a different triple combination medication of abacavir/dolutegravir/lamivudine.

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.

John McHutchison, Gilead’s chief scientific officer, said the latest data continues to demonstrate the efficacy and safety profile of Biktarvy. McHutchison added that the data also supports use of the single-tablet regimen in a “broad range of adults living with HIV who are new to HIV therapy.”

“Gilead is working to advance access to Biktarvy to appropriate patients around the world as we continue our clinical and research efforts focusing on novel mechanisms of action for next-generation HIV treatments and, ultimately, a cure,” McHutchison said in a statement.

Janssen, a division of Johnson & Johnson, also showed off data from its HIV treatment Symtuza at the Scotland conference. Janssen also presented 96-week data that showed positive, long-term efficacy of the medication in treatment-naïve adults with HIV-1. Results from the 96-week study showed that a high proportion of antiretroviral treatment (ART)-naïve adults with HIV-1, 85 percent, achieved virologic suppression at 96 weeks when treated with Symtuza.

Symtuza was approved by the U.S. Food and Drug Administration in July for HIV-1. Trial data that supported approval of the drug showed that up to 95 percent of participating patients achieved or maintained virologic suppression. The latest data announced in Scotland builds off the data that was used for approval.

Richard Nettles, head of medical affairs for Janssen, said the long-term results build on the “growing clinical data set” that continues to provide support for Symtuza as a potential treatment option for HIV-1 patients who are just starting their therapy.

“At Janssen, we are building on our 25-year heritage in HIV and remain committed to the research and development of transformational medicines and solutions that span the continuum of HIV care to address real-world clinical challenges, combat HIV drug resistance and meet the diverse needs of those living with HIV,” Nettles said in a statement.

Earlier this month, Janssen released data 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.

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