Patients with HIV achieve virologic suppression with rapid initiation Symtuza treatment
Treatment-naive adults with newly diagnosed HIV-1 infection achieved virologic suppression at week 24 when treated with the single-tablet treatment Symtuza in a rapid initiation model of care, according to research presented at the International AIDS Conference.
“This is the first known phase 3 clinical trial to examine an ART regimen in the rapid initiation model of care,” Gregory Huhn, MD, MPHTM, attending physician at the John H. Stroger Jr. Hospital of Cook County and the Ruth M. Rothstein CORE Center, told Infectious Disease News.
Huhn, who is also an associate professor at Rush University Medical Center, presented research on two studies of Symtuza, Janssen’s once-daily, single-tablet regimen containing darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) for treatment-naive and certain virologically suppressed adults. D/C/F/TAF was approved by the FDA in June.
The ongoing, 48-week phase 3 DIAMOND study included 109 patients with a median time of HIV-1 diagnosis of 5 days, with 29% of patients enrolled within 48 hours of diagnosis. Data was presented for interim analysis conducted at 24 weeks.
The researchers noted that WHO recommends rapid initiation of treatment for all patients diagnosed with HIV-1.
The primary endpoint was the percentage of patients with virologic suppression at week 48, which was defined as HIV-1 RNA less than 50 copies/mL. In the interim analysis, virologic response was measured at 24 weeks in the study.
Treatment with D/C/F/TAF began at the initial visit without any known viral load.
Researchers presented data on retention, virologic suppression, safety, drug resistance, and patient satisfaction. The retention rate was high, with 91% of patients continuing in the study, Huhn said.
At week 24, 88 patients (81% of the 109 patients) achieved the primary endpoint of a virologic response. Of the patients who continued through the study at week 24, 90% were virologically suppressed.
No participants stopped therapy due to drug resistance, and patient satisfaction was very high overall, the researchers said. One patient discontinued use because of adverse events.
“Health care providers have less clinical information available in a rapid initiation model of care, so it is important to consider a regimen’s effectiveness in the setting of possible transmitted drug resistance, the safety profile and the patient’s ability to adhere to the regimen,” Huhn said. “These results are encouraging as we await primary endpoint 48-week data.”
The second phase 3 study (EMERALD) involved adults with HIV-1 who switched from boosted protease-inhibitor (bPI)-based regimens to D/C/F/TAF and experienced similar virologic response rates and rates of virologic rebound compared with the continued previous treatment.
In the study, 1,141 treatment-experienced, virologically suppressed adults with HIV-1 who were on a bPI regimen plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) regimen were randomly assigned 2:1 to switch to D/C/F/TAF or to continue their current treatment regimen.
The endpoint at 48 weeks was the proportion of patients with virologic rebound or those that continued to have virologic suppression. The virologic rebound rate in the C.C/F/TAF arm was 2.5%, and it was 2.1% in the control arm.
“This was not inferior among the 1,141 treatment-experienced patients that were enrolled,” Huhn said.
Seventy percent of patients were on a darunavir-based regimen at baseline, 22% were on atazanavir and 8% were on lopinavir/ritonavir.
“There were no statistically significant differences in virologic rebound at baseline bPI through 48 weeks,” no matter which treatment the patients were on at the beginning of the study, Huhn said.
He added that no resistance to darunavir or any other study drug was observed.
“Together with previously recorded results, findings from EMERALD have shown that in patients who are virologically suppressed, switching to Symtuza was highly effective regardless of demographic characteristics, prior treatment experience, and pre-switched bPI or boosting agents,” Huhn said. “Despite significant progress in the field of HIV therapy, clinical challenges remain with patients with diverse backgrounds who may have had problems with adherence in the past, or who are at risk for drug resistance.”
In summarizing the two studies, Huhn said, “overall, these results demonstrate effectiveness in patients entering into care upon initial diagnoses, and patients who may have been highly treatment experienced and now can be successfully treated with a single-tablet regimen, even with past protease inhibitor nondarunavir failures.” – by Bruce Thiel
Girard PM, et al. Abstract THPEB056. Presented at: International AIDS Conference; July 23-27, 2018; Amsterdam.
Huhn G, et al. Abstract WEPEC200. Presented at: International AIDS Conference; July 23-27, 2018; Amsterdam.
Disclosure: Huhn reports receiving research funding for his institution from Janssen, Gilead Sciences, ViiV Healthcare, Proteus and the NIH.