D/C/F/TAF Tablet Effective Rapid-Initiation HIV Treatment

By Will Boggs MD

January 21, 2020

NEW YORK (Reuters Health) - The single-tablet combination of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is effective for treating newly diagnosed HIV-1 infection before baseline laboratory results are available, according to results from the DIAMOND phase-3 study.

"In a rapid-initiation setting, D/C/F/TAF, now Food and Drug Administration (FDA) approved as SYMTUZA, may help patients get their viral loads decreased quickly and achieve an undetectable viral load of less than 50 copies/mL within 48 weeks," Dr. Gregory D. Huhn from The Ruth M. Rothstein CORE Center, in Chicago, told Reuters Health by email.

Guidelines from the U.S. Department of Health and Human Services recommend that laboratory testing be performed to help guide initial treatment selection in patients diagnosed with HIV-1 infection. The World Health Organization and International Antiviral Society-USA, on the other hand, urge rapid initiation, where therapy is started prior to the availability of baseline laboratory assessments, for most newly diagnosed patients.

Dr. Huhn and colleagues from 16 study sites assessed the efficacy and safety of D/C/F/TAF in a rapid-initiation scenario in an open-label, single-arm, 48-week study of 109 treatment-naive patients with newly diagnosed HIV.

At week 48, 84% of the participants achieved the primary endpoint of virologic response, defined as HIV-1 RNA <50 copies/mL (FDA snapshot), the researchers report in Clinical Infectious Diseases.

In the per-protocol analysis, 92 of 96 participants achieved HIV-1 RNA <50 copies/mL at week 48, and the other four participants had HIV-1 RNA <200 copies/mL.

The mean CD4-cell count increased from 413 cells/uL at baseline to 628 cells/uL at week 48.

None of the participants discontinued due to lack of efficacy or developed protocol-defined viral failure, and none discontinued due to baseline-resistance stopping criteria.

There were no serious adverse events that were considered to be study-drug related, and there were no deaths.

Body weight increased from baseline through week 48 by a median 2.9 kg.

At week 48, 97% of participants said they were satisfied with their treatment, and 98% said they would recommend the treatment to someone else with HIV.

"These are important data for physicians, as it is common not to have CD4-cell counts or viral loads when rapidly starting patients on treatment," Dr. Huhn said. "Some treatments are not recommended in patients with high viral loads, or who require other laboratory testing prior to starting treatment. In my practice, getting patients to an HIV-1 RNA <200 copies/mL is important because it is the threshold recognized as the level at which patients are unable to transmit HIV to uninfected sexual partners."

"Beyond the clinical benefits demonstrated in DIAMOND, recent data also has been published documenting that rapid initiation of ART may be associated with lower total accumulated and per-patient per-month costs when compared to those patients who delay initiation of ART, representing a potential cost savings for payers," he added.

Dr. Jared Baeten, who directs the University of Washington/Fred Hutch Center for AIDS Research, in Seattle, told Reuters Health by email, "These are really exciting results. It is incredibly important to see examples like this of rapid initiation of antiretroviral therapy and how successful and safe they can be."

"There should be very few instances when persons newly diagnosed with HIV cannot be instantly linked to care and started on life-saving treatment," said Dr. Baeten, who was not involved in the study.

Dr. Martin Hoenigl of the University of California, San Diego, who earlier reported rapid HIV suppression in patients initiating antiretroviral therapy (ART) at their first visit after HIV diagnosis, told Reuters Health by email, "Rapid if not immediate start of ART should be standard of care, as it helps control transmission to HIV uninfected partners and benefits the infected individual, including preservation of immune functioning and reduced accumulated exposure to chronic immune inflammation."

"The study shows again that single-pill regimens are associated with high treatment satisfaction," added Dr. Hoenigl, who also was not part og the study.

Janssen Scientific Affairs, LLC funded the study, employed five of the authors, and had financial ties to several others, including Dr. Huhn.

SOURCE: https://bit.ly/2TlYtYm Clinical Infectious Diseases, online December 27, 2019.