New Data Support Switch to Single-Tablet Darunavir-Based Regimen for HIV Treatment

New research demonstrates continued virologic control in patients with HIV-1 following a switch to Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg [D/C/F/TAF]) regardless of prior treatment regimen, according to a press release.

On July 17, 2018, the FDA approved Symtuza as the first and only complete darunavir-based single tablet regimen for the treatment of HIV-1 in treatment naïve and certain virologically suppressed adults.

At the 22^nd International AIDS Conference, Janssen presented new data from its phase 3 EMERALD study reinforcing the safety and efficacy of switching to D/C/F/TAF from boosted protease inhibitor-based (bPI) regimens in treatment-experienced adults. The primary endpoint of the study is the proportion of patients with virologic rebound cumulative through week 48.

In the study, a total of 1141 patients were randomized and treated. At screening, use of darunavir (70%) was more common than atazanavir or lopinavir (30% combined). Boosting with ritonavir (85%) was more common than cobicistat (15%).

According to the data, results demonstrated similar virologic response rates at week 48 with D/C/F/TAF compared with the continuation of previous treatment in the overall population. Results were consistent across subgroups based on bPI regimens used at screening. No patients developed resistance to the study drugs.

Interim results from the phase 3 DIAMOND study also provided evidence to support a darunavir-based regimen when rapidly initiating treatment in individuals who are newly diagnosed with HIV-1, according to Janssen.

The DIAMOND trial is an ongoing study to assess the efficacy and safety of D/C/F/TAF in a test-to-treat model over a 48-week period. It is the first phase 3 trial for a single-tablet regimen conducted in a rapid initiation scenario, according to the press release.

In the trial, adults diagnosed with HIV-1 infection within 14 days were immediately enrolled and started D/C/F/TAF without screening/baseline laboratory or HIV genotype resistance information. Screening/baseline laboratory and resistance findings were reviewed by investigators as results became available.

No patients met predefined resistance stopping rules and 81% of patients achieved virologic suppression <50 copies/mL at week 24 in an intent-to-treat analysis. Ninety percent of patients achieved virologic suppression <50 copies/mL at week 24 based on as-observed analysis.

“HIV drug resistance and rapid initiation of treatment are key issues in today’s HIV care landscape,” Brian Woodfall, MD, vice president, global head, Late Development, Infectious Diseases & Vaccines, Janssen Pharmaceutica NV, said in a press release. “We are committed to developing treatments for HIV that address key real-world challenges such as these. Symtuza provides an important new option for people living with HIV.”

Reference

Janssen Presents Switch Data for New HIV-1 Treatment Symtuza (D/C/F/TAF) and Second Study Supporting its Use in a Rapid Initiation Scenario [news release]. Janssen’s website. https://www.janssen.com/janssen-presents-switch-data-new-hiv-1-treatment-symtuzatm-dcftaf-and-second-study-supporting-its. Accessed July 24, 2018.