Once-a-day pill as switch option receives thumbs up across multiple HIV populations

Switching to the once-a-day, fixed-dose pill that contains bictegravir, emtricitabine, and tenofovir (BIC/FTC/TAF) appears to be safe and effective in older HIV patients and in people living with HIV (PLHIV) with pretreatment or treatment-acquired resistance, in addition to yielding metabolic benefits, according to studies presented at HIV Glasgow 2022.

In the multicentric, prospective, single-arm BICOLDER study, switching to BIC/FTC/TAF from a booster antiretroviral kept HIV suppressed (50 copies/mL) in virologically controlled PLHIV aged ≥65 years. The virological response rate at week 24 was 91.7 percent (95 percent confidence interval [CI], 73.0–99.0). [HIV Glasgow 2022, abstract P038]

The analysis included 24 older PLHIV (median age 68.5 years, 79.2 percent male, median body mass index [BMI] 25.3 kg/m²). These patients had a long history of HIV infection (median 26 years), multiple comorbidities (hypertension, dyslipidaemia, chronic renal disease, diabetes; median Charlson Comorbidity Index score 3), and a high number of medication use (median 6).

Six patients (25 percent) developed drug-related adverse events (AEs), which included two grade 3 events in one participant that led to discontinuation of BIC/FTC/TAF (mood disorders and nightmare) at week 4. There were no serious AEs documented.

According to presenting author Dr Clotilde Allavena of Hotel Dieu University Hospital of Nantes, Nantes, France, the results of BICOLDER may have important clinical implications, given that ageing PLHIV have a greater burden of comorbidities and polymedication and, as a result, are at higher risk of AEs and pharmacological interactions.

PIBIK

Meanwhile, in the phase IV randomized, open-label pilot study PIBIK, the presence of limited nucleoside reverse transcriptase inhibitors (NRTI) resistance mutations did not compromise the virologic efficacy of BIC/FTC/TAF among virologically suppressed patients who had switched from boosted protease inhibitor-based (bPI) regimens.

PIBIK included 72 PLHIV with any of the following drug resistance mutations: M184V/I with or without any NRTI-associated mutation (eg, L74I/V, Y115F, K70E/G/Q/T/N/S), or up to two thymidine analogue mutations (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) with or without M184V/I. They were randomized to either continue with their current bPI regimen (n=39) or switch to BIC/FTC/TAF (n=33) for 24 weeks.

At week 24, all 33 patients in the BIC/FTC/TAF arm remained virologically suppressed (HIV-1 RNA 50 copies/mL) as opposed to 38 out of 39 in the bPI arm (difference, 2.6 percent, 95 percent CI, –2.4 to 7.5). [HIV Glasgow 2022, abstract P089]

The switch was tolerated well. Twelve (36.4 percent) patients on BIC/FTC/TAF experienced drug-related AEs, which were mild or moderate in severity and did not lead to treatment discontinuation.

Furthermore, the BIC/FTC/TAF arm saw marked improvements in lipid parameters, except for a slight decrease in high-density lipoprotein cholesterol (HDL-C). HBA1c, BMI, and weight increased following the switch.

The findings of PIBIK provide evidence that “it is feasible [for] carefully selected PLWH with drug resistance, virologically suppressed on a bPI, [to] maintain virologic efficacy on BIC/FTC/TAF fixed-dose combination,” said presenting investigator Dr Collins Iwuji of Brighton & Sussex Medical School, University of Sussex, UK.

METABIC

Finally, in the METABIC study, switching to BIC/FTC/TAF from tenofovir-sparing antiretroviral regimens improved total cholesterol at both 6 and 12 months, with the levels of the rest of the metabolic parameters remaining neutral throughout 1 year of follow-up. [HIV Glasgow 2022, abstract P161]

METABIC included a cohort of 147 PLHIV (median age 55 years, 81 percent male, 89 percent Caucasian, 79.6 percent virologically suppressed). At baseline, 30 percent of patients had hypertension, 49 percent had dyslipidaemia, 16 percent had diabetes, and 46 percent had obesity or overweight. More than half of the patients (66 percent) switched from integrase inhibitor-based triple therapy with dolutegravir or raltegravir.

Following the switch to BIC/FTC/TAF, total cholesterol decreased by –9.45 mg/dl at 6 months (p=0.004) and by –7.54 mg/dl at 12 months (p=0.034). There were additional significant improvements seen in the TyG ratio (for hepatic steatosis) at 6 months (–0.147; p=0.0023), as well as in glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration) at both 6 months (–1.87 ml/min; p=0.0319) and 12 months (–2.73ml/min; p<0.001).

The results of METABIC may be a boon for PLHIV who have a twofold greater risk of developing cardiovascular disease than their counterparts who do not have the infection, according to presenting study author Dr Jose Bernardino of Hospital La Paz Institute for Health Research in Madrid, Spain.