INFECTIOUS DISEASE
CONFERENCE UPDATE

B/F/TAF maintains HIV-1 and c suppression after switch from DTG + F/TDF: 48-week results from ALLIANCE OLE

30 May 2025

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STUDY DESIGN

Approximately 3.1 million people worldwide live with concomitant human immunodeficiency virus-1 (HIV-1) and hepatitis B virus (HBV) infection.1 Current guidelines recommend tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF)-based antiretroviral therapies for most adults and adolescents with HIV-1 and HBV co-infection.1 The ALLIANCE study previously demonstrated that bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) was noninferior to dolutegravir (DTG) + F/TDF for HIV-1 ribonucleic acid (RNA) suppression and superior for HBV DNA suppression at week 48 in treatment-naïve adults.1 These suppression rates were sustained through week 96.1 Following this, participants in the DTG + F/TDF arm had the option to switch to B/F/TAF for an additional 48 weeks of open-label extension (OLE).1 The captioned analysis evaluated the efficacy and safety of B/F/TAF in treatment-experienced adults who transitioned from DTG + F/TDF during the OLE phase.1

ALLIANCE was a phase 3, randomized, double-blind, active-controlled clinical trial comparing B/F/TAF to DTG + F/TDF in adults with HIV-1 and HBV.1 The captioned analysis focuses on 89 participants who switched to B/F/TAF after completing at least 96 weeks of the randomized phase, reporting outcomes from OLE baseline to week 48.1 At OLE baseline, 98% of participants were male at birth, and 94% were Asian.1 The median age was 34 years (interquartile range [IQR]: 28-39 years).1 Elevated alanine aminotransferase (ALT) levels were observed in 30% of participants, and 58% were HBeAg-positive.1 At the time of switching, 96.6% had HIV-1 RNA suppressed to less than 50 copies (c)/mL, while 83.1% had HBV DNA levels below 29IU/mL.1 By week 48 of the OLE phase, 98.9% of participants (n=88) who switched to B/F/TAF successfully completed treatment.1 The key outcomes assessed included HIV-1 RNA and HBV DNA suppression, ALT normalization based on American Association for the Study of Liver Diseases (AASLD) 2018 criteria, HBeAg and HBsAg loss or seroconversion, and safety assessments.1

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FINDINGS

Efficacy outcomes:
  • The key efficacy outcomes assessed in the analysis included HIV-1 RNA and HBV DNA suppression, ALT normalization, HBeAg and HBsAg loss or seroconversion at OLE week 481
  • At OLE week 48, 95.4% of participants had HIV-1 RNA <50c/mL and 86.6% had HBV DNA <29IU/mL1
  • ALT normalization exceeded 50% by week 12 and remained stable, reaching 52% at week 481
  • In patients who were HBeAg-positive at OLE baseline, HBeAg loss/seroconversion was 17.0%/12.8%, and HBsAg loss/seroconversion was 4.3%/0% at week 481
Safety:
  • B/F/TAF was well-tolerated, with no study drug discontinuations due to treatment-emergent adverse events (TEAEs)1
  • Up to OLE week 48, 17 (19%) participants experienced a study drug-related TEAE, of which 3 (3%) were grade 3 or 41
  • Over the 48 weeks, no participants experienced TEAEs that led to discontinuation and none died1
  • The most common drug-related TEAEs were weight gain (9%) and increased low-density lipoprotein (LDL) cholesterol (3%)1
  • eGFR showed a slight increase, suggesting potential renal health benefits following the switch1
  • Fasting glucose, lipid parameters, and weight remained stable, except for a small increase in total and LDL cholesterol levels1

 

“Through 48 weeks of the OLE phase, B/F/TAF maintained high rates of HIV-1 and HBV virologic suppression following switch from DTG + F/TDF”

Dr. Anchalee Avihingsanon

HIV-NAT,

Thai Red Cross AIDS and Infectious Disease Research Centre,

Bangkok, Thailand

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References

1. Avihingsanon A, et al. ALLIANCE Open-Label Extension: Switch to B/F/TAF in People with Both HIV-1 and HBV. Presented at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI); March 9-12, 2025

B/F/TAF
HIV-1
HBV
DTG + F/TDF
ALLIANCE OLE

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