Meeting NewsPerspective

DIAMOND study: 48-week results show long-term efficacy of Symtuza

Moti Ramgopal, MD
Moti Ramgopal

A high proportion of patients with newly diagnosed HIV-1 infection achieved an undetectable viral load through 48 weeks after rapidly initiating Symtuza, according to phase 3 data presented at the American Conference for the Treatment of HIV.

The DIAMOND study measured the efficacy and safety of Symtuza, Janssen’s once-daily, single-tablet regimen containing darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-naive adults who were enrolled within 14 days after receiving an HIV diagnosis and started D/C/F/TAF before laboratory or baseline resistance test results were available, according to a news release.

Symtuza was approved by the FDA in July 2018 for treating HIV-1 infection in treatment-naive and certain virologically suppressed adults.

“Rapid initiation of antiretroviral therapy is emerging as the standard of HIV care, with global guidelines starting to recommend that all people living with HIV be treated as soon as possible once a diagnosis is confirmed,” Moti Ramgopal, MD, infectious disease director at Midway Immunology and Research Center in Fort Pierce, Florida, told Infectious Disease News. “It could be an additional strategy in our quest to achieve the 90/90/90 prevention and treatment goals as outlined by UNAIDS.”

Ramgopal added that “the DIAMOND study further reinforces the concept of rapid initiation as it is the first phase 3 trial studying the rapid initiation of a single-tablet regimen and reflects the real clinical scenarios that physicians face today.”

Janssen previously presented 24-week results from the DIAMOND study at the 2018 International AIDS Conference, which confirmed the safety, efficacy and tolerability of starting D/C/F/TAF as treatment for ART-naive adults with HIV-1.

In the current analysis, researchers reported that that 97 of 109 patients (90%) completed the study through 48 weeks. According to the primary intent-to-treat analysis, they found that 84% of the 109 patients achieved undetectable viral loads, less than 50 copies/mL, and 8% experienced virologic failure, or a viral load of greater than 50 copies/mL.

When excluding participants with missing data, the researchers found that 96% of patients achieved undetectable viral loads and 100% of patients achieved viral loads of less than 200 copies/mL at week 48. No patients discontinued D/C/F/TAF because of lack of efficacy.

For a secondary endpoint of the study, the researchers measured patient-reported satisfaction with the regimen. Ninety-seven percent of patients reported they were satisfied with the treatment.

“The 48-week data presented at ACTHIV showed that in a rapid initiation setting, Symtuza was well-tolerated and may help patients get their viral loads decreased quickly with a high proportion of patients achieving an undetectable viral load of less than 50 copies/mL after 48 weeks,” Ramgopal said. – by Bruce Thiel

Reference:

Huhn GS, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide rapid initiation for HIV-1 infection. Primary analysis of the DIAMOND study. Presented at: American Conference for the Treatment of HIV; April 11-13, 2019. Miami.

Disclosures: Ramgopal reports receiving research support from Janssen and has served as a paid consultant to the company.

Moti Ramgopal, MD
Moti Ramgopal

A high proportion of patients with newly diagnosed HIV-1 infection achieved an undetectable viral load through 48 weeks after rapidly initiating Symtuza, according to phase 3 data presented at the American Conference for the Treatment of HIV.

The DIAMOND study measured the efficacy and safety of Symtuza, Janssen’s once-daily, single-tablet regimen containing darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-naive adults who were enrolled within 14 days after receiving an HIV diagnosis and started D/C/F/TAF before laboratory or baseline resistance test results were available, according to a news release.

Symtuza was approved by the FDA in July 2018 for treating HIV-1 infection in treatment-naive and certain virologically suppressed adults.

“Rapid initiation of antiretroviral therapy is emerging as the standard of HIV care, with global guidelines starting to recommend that all people living with HIV be treated as soon as possible once a diagnosis is confirmed,” Moti Ramgopal, MD, infectious disease director at Midway Immunology and Research Center in Fort Pierce, Florida, told Infectious Disease News. “It could be an additional strategy in our quest to achieve the 90/90/90 prevention and treatment goals as outlined by UNAIDS.”

Ramgopal added that “the DIAMOND study further reinforces the concept of rapid initiation as it is the first phase 3 trial studying the rapid initiation of a single-tablet regimen and reflects the real clinical scenarios that physicians face today.”

Janssen previously presented 24-week results from the DIAMOND study at the 2018 International AIDS Conference, which confirmed the safety, efficacy and tolerability of starting D/C/F/TAF as treatment for ART-naive adults with HIV-1.

In the current analysis, researchers reported that that 97 of 109 patients (90%) completed the study through 48 weeks. According to the primary intent-to-treat analysis, they found that 84% of the 109 patients achieved undetectable viral loads, less than 50 copies/mL, and 8% experienced virologic failure, or a viral load of greater than 50 copies/mL.

When excluding participants with missing data, the researchers found that 96% of patients achieved undetectable viral loads and 100% of patients achieved viral loads of less than 200 copies/mL at week 48. No patients discontinued D/C/F/TAF because of lack of efficacy.

For a secondary endpoint of the study, the researchers measured patient-reported satisfaction with the regimen. Ninety-seven percent of patients reported they were satisfied with the treatment.

“The 48-week data presented at ACTHIV showed that in a rapid initiation setting, Symtuza was well-tolerated and may help patients get their viral loads decreased quickly with a high proportion of patients achieving an undetectable viral load of less than 50 copies/mL after 48 weeks,” Ramgopal said. – by Bruce Thiel

Reference:

Huhn GS, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide rapid initiation for HIV-1 infection. Primary analysis of the DIAMOND study. Presented at: American Conference for the Treatment of HIV; April 11-13, 2019. Miami.

Disclosures: Ramgopal reports receiving research support from Janssen and has served as a paid consultant to the company.

    Perspective
    Paul A. Volberding

    Paul A. Volberding

    We continue to see real progress in treating HIV infection, and this trial reflects two important trends in care.

    The standard of care increasingly allows the use of an entire two- to four-drug ART regimen in a single pill taken just once daily. In this trial, that regimen includes the newer TAF version of tenofovir and the potent protease inhibitor darunavir, boosted with cobicistat and emtricitabine. Unsurprisingly, this treatment was potent and safe, and enrolled subjects gave it favorable satisfaction ratings.

    The second treatment trend included in the study design was to begin therapy very soon after HIV infection was diagnosed (less than 14 days) and before baseline laboratory results were returned. Rapid treatment initiation, even on the same day as diagnosis, has been shown to increase care retention and shorten time to full viral suppression, and this trial adds to that experience. That strategy does require vigilance, of course, to be certain that contraindications to any of the drugs in the regimen found at baseline are addressed by treatment modifications, but those are expected to be infrequent. The rapid treatment of HIV, along with potent single pill regimens, is another advance in the remarkable record of success since combinations of antiretrovirals were first introduced just over 20 years ago.

    • Paul A. Volberding, MD
    • Infectious Disease News Chief Medical Editor
      Professor of medicine and director of the AIDS Research Institute,
      University of California, San Francisco

    Disclosures: Volberding reports no relevant financial disclosures.