Switching to B/F/TAF combo maintains viral suppression in elderly with HIV

Switching to a single-tablet triple-drug combination comprising bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is well tolerated while continuing to provide virologic suppression through to 48 weeks in elderly people (aged ≥65 years) living with HIV (PLWH), shows a pooled analysis presented during the AIDS 2020 virtual conference.

“As life expectancy for people with HIV increases, optimizing antiretroviral therapy to fit the needs of older adults, including those with comorbidities and multiple medications, is paramount,” said presenting author Dr Moti Ramgopal from Midway Research Center in Fort Pierce, Florida, US.

Almost 50 percent of PLWH are >50 years. As Ramgopal noted, older PLWH are at an increased risk of comorbidities and often have higher levels of polypharmacy, so ensuring the safety and convenience of antiretroviral therapy in this population is critical. 

“B/F/TAF is a small single-tablet regimen with few drug-drug interactions, a high barrier to resistance and may provide a beneficial option for older patients,” he highlighted.

To evaluate the efficacy and safety of B/F/TAF in older PLWH, the researchers pooled data of 140 treatment-experienced, virologically suppressed patients aged ≥65 years (median 68 years, 14 percent female) from four international trials (Studies 4030, 4449, 1844, and 1878). All four studies explored the effects of switching from prior baseline regimen to B/F/TAF (with or without another arm which continued on prior treatment). [AIDS 2020, abstract OAB0403]

Forty-eight weeks after switching to B/F/TAF, the rate of virologic suppression (defined as HIV RNA <50 copies/mL) remained high at 92 percent. The remaining participants (8 percent) had no virologic data available.

Among those with virologic data, none had virologic failure or developed treatment-emergent resistance.

“[In terms of safety,] there were no renal, bone, or hepatic adverse events [AEs] leading to discontinuations,” reported Ramgopal.

For changes in renal biomarker, eGFR declined by a median of 2.9 mL/min from baseline at week 12 and remained stable with a decline of 2.7 mL/min at week 48.

“This is consistent with the known inhibition of OCT2 creatinine transporter,” explained Ramgopal. “No proximal renal tubulopathy was reported.”

The most common AEs were nasopharyngitis and arthralgia, each occurring in 7 percent of the participants. AEs leading to study discontinuation were reported in four participants, involving one case each of abdominal discomfort, device-related infection, drug withdrawal syndrome, and alcohol withdrawal syndrome.

AEs that were considered to be related to the study drug occurred in eleven participants (8 percent) — all of which were grade 1 or 2. There was only one drug-related AE that led to discontinuation.

“There were no drug-related AEs that were serious or of grade 3 or 4,” Ramgopal stated.

Overall, there was an increase in body weight by a median of 1 kg, which plateaued at week 36 and was consistent with observed trends in the general population over time, he reported.

Improvements in fasting lipid parameters were modest: total fasting cholesterol decreased by 7 mg/dL, LDL by 2 mg/dL, triglycerides by 15 mg/dL, and total cholesterol:HDL ratio dropped by 0.1.

“These data support the use of B/F/TAF for treatment of adults ≥65 years who could benefit from a small tablet with few drug-drug interactions and an established safety profile,” said Ramgopal.