Single-tablet D/C/F/TAF regimen measures up even in HIV+ people with NPCs

The once-daily single-tablet combination therapy comprising darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) yields high virologic response rates over 96 weeks in patients with HIV-1, regardless of the presence of neurologic and/or psychiatric comorbidities (NPCs), a subgroup analysis presented at the AIDS 2020 virtual conference has shown.

“Patients living with HIV are more likely than the general population to be affected by NPCs,” said the researchers. 

“Patients with HIV-1 and NPCs face unique challenges including suboptimal adherence and possible exacerbation of NPCs, requiring individualized treatment approaches for optimal health outcomes,” they added.

To address the issue of suboptimal adherence to antiretroviral therapy (ART), a subgroup analysis of two phase III trials (AMBER and EMERALD) was conducted to compare patients with vs without NPCs who had been randomized to receive D/C/F/TAF. [AIDS 2020, abstract PDB0202]

The AMBER involved 362 treatment-naïve patients (of which 88 had NPCs) in the D/C/F/TAF arm while EMERALD included 763 treatment-experienced, virologically suppressed patients (of which 294 had NPCs) randomized to switch to D/C/F/TAF. At baseline, psychiatric comorbidities were more common than neurologic issues in these patients.

Across both studies, the presence of NPCs did not preclude high virologic response rates with the D/C/F/TAF regimen. A virologic response is defined as HIV-1 RNA of <50 copies/mL.

In AMBER, virologic response rates to D/C/F/TAF were similarly high at 96 weeks, regardless of whether patients had NPCs or no NPCs (80 percent vs 87 percent). Likewise, high virologic response rates of 91 percent were seen for both subgroups of patients with or without NPCs in the EMERALD study.

Only 2 percent with NPCs and 1 percent without NPCs discontinued early due to a HIV-1 viral load of ≥50 copies/mL at 96 weeks in AMBER. In comparison, no patients in EMERALD discontinued early due to a HIV-1 viral load >50 copies/mL.

“Patients with and without NPCs receiving D/C/F/TAF over 96 weeks had high virologic response rates and low D/C/F/TAF-related discontinuation rates,” the researchers summed up.

“No treatment-emergent resistance was detected among patients with NPCs in either studies,” they observed.

Importantly, patients with baseline NPCs did not have higher rates of neurologic or psychiatric adverse events (AEs) related to D/C/F/TAF compared with those without baseline NPCs. The rates of any AEs related to D/C/F/TAF were similar between patients with and without NPCs in both the AMBER (44 percent vs 38 percent) and EMERALD studies (18 percent vs 24 percent).

In both studies, most AEs up till 96 weeks were mild and of grade 1. Also, the rates of discontinuation due to any drug-related AEs were low in both AMBER (2 percent each) and EMERALD (1 percent vs 2 percent), regardless of NPCs.

There were no drug-related serious AEs that were neurologic or psychiatric in nature.

“Patients with NPCs tolerated D/C/F/TAF well without additional central nervous system-related burden, indicating that D/C/F/TAF may be a suitable option for these patients,” the researchers concluded.