BICSTAR - Observational HIV-1 adult patients receiving B/F/TAF

• Research type

  Research Study

• Full title

  Multi-country, non-interventional, cohort study of the effectiveness, safety, adherence, and health-related quality of life in HIV-1 infected adult patients receiving Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF)

• IRAS ID

  256686

• Contact name

  Suzanne Todd

• Contact email

  suzanne.todd@belfasttrust.hscni.net

• Sponsor organisation

  Gilead Sciences Europe Ltd

• Duration of Study in the UK

  3 years, 3 months, 30 days

• Research summary

  Research Summary:

  This study aims to review the safety and effectiveness of a licensed anti-retroviral therapy (B/F/TAF) in adult HIV-1 patients. The study will look at two groups (cohorts) of patients who have taken previous anti-HIV treatment and patients who have not taken any previous anti-HIV treatment. The study will also look at how well patients follow the treatment schedule, how their quality of life and health status is affected, and how satisfied they are with their treatment.

  Summary of Results:

  Study Centers: 82 sites overall including 24 in France, 20 in Germany, 4 in Ireland, 10 in Italy, 5 in the Netherlands, 8 in Spain, 7 in Turkey, and 4 in the United Kingdom (UK).
  Number of participants: 1 492
  Age groups:
  • Adult and elderly population (≥18 years)
  o Adults (18 to < 65 years)
   Adults (18 to < 46 years)
   Adults (46 to < 65 years)
  o Elderly (≥ 65 years)
   Adults (65 to < 75 years)
   Adults (75 to < 85 years)
   Adults (85 years and over)

  Study Period:
  27 June 2018 (first participant enrolled)
  21 July 2022 (last participant last visit for the primary end point)
  24 June 2024 (last participant last visit for this report)

  Scope of the study: Effectiveness study (incl. comparative); Safety study (incl. comparative)

  SUMMARY OF RESULTS:
  Participant Disposition and Demographics:
  The study was conducted on data collected from 27 June 2018 (first participant enrolled) to 12 September 2024 (database lock) by 82 physicians. A total of 1,492 participants were enrolled in the study (written informed consent obtained). Among them, 4 participants who had important protocol deviations were excluded from the dataset due to erroneous data collection after the important protocol deviation (3 participants no longer met the inclusion criteria as they were not treated with B/F/TAF in accordance with the SmPC, and 1 had been enrolled in an interventional trial, all since study enrollment). In total, 1,488 participants comprised the enrolled population included in this report. Among them, 1,435 were included in the Analysis population (enrolled participants who met all inclusion/exclusion criteria, received at least one dose of B/F/TAF and had at least one post-baseline visit completed): 381 participants (26.6%) were ART-naïve participants (never treated with ART before enrollment in the study and treated with B/F/TAF for the first time) and 1,054 participants (73.4%) were ART-experienced participants (treated with ART before enrollment and switched to B/F/TAF).
  A total of 628 participants were included in the Analysis population (enrolled participants who met all inclusion/exclusion criteria, received at least one dose of B/F/TAF and had at least one post-baseline visit completed) in France and Germany and 498 of them (79.3%) were eligible to the extension phase i.e., (no discontinuation of B/F/TAF and no premature study discontinuation during the main phase of the study). Of these, 366 (73.5%) reconsented to the extension phase (73 [70.2%] in the ART-naïve group and 293 [74.4%] in the ART-experienced group). Note that 368 participants are recorded as enrolled in the electronic data capture system, but one of these was subsequently excluded from the dataset due to erroneous data collection after the important protocol deviation, and another one did not meet the criteria to be included in the analysis population.
  The median age at B/F/TAF initiation was 36.0 (Q1: 29.0, Q3: 45.0) years in the ART-naïve group and 49.0 (Q1: 39.0, Q3: 56.0) years in the ART-experienced group. The proportion of participants ≥50 years was 19.9% in the ART-naïve group and 47.2% in the ART-experienced group. The proportion of males was 90.0% in the ART-naïve group and 83.7% in the ART experienced group.
  Overall, participants were characterized by a high prevalence of comorbidities at baseline. Medical history or comorbidities/co-infections at B/F/TAF initiation were reported in 46.7% of participants in the ART-naïve group (most frequently reported conditions: neuropsychiatric disorders [8.7%], hypertension [6.1%], and cardiovascular disorders [5.3%]) and in 78.2% in the ART-experienced group (most frequently reported conditions: neuropsychiatric disorders [25.8%], hyperlipidemia [24.9%], and hypertension [18.6%]).
  The median age at HIV diagnosis was 35.0 (Q1: 27.0, Q3: 45.0) years in the ART-naïve group and 34.0 (Q1: 28.0, Q3: 42.0) years in the ART-experienced group.
  In the ART-experienced group, the most frequent combinations of ART taken immediately prior to B/F/TAF were EVG_COBI_FTC_TAF (Genvoya, 30.9%), DTG+FTC_TAF (Dolutegravir + Descovy, 8.8%), and ABC_DTG_3TC (Triumeq, 6.2%). History of virologic failure was reported in 11.8% of ART-experienced participants (unknown in 6.9% of participants). Current or prior resistance-associated mutations were reported in 281 participants (26.7% of participants). Mutations were associated with NNRTI (12.2%), PI (19.6%), NRTI (9.2%) and INI (1.7%). No information on resistance status was available in 49.6% of participants.
  The majority of participants had a Centers for Disease Control and Prevention (CDC) stage A at B/F/TAF initiation (75.2% in the ART-naïve group and 66.8% in the ART-experienced group); 14.8% of participants in the ART-naïve group and 16.4% of participants in the ART experienced group had a CDC stage B, and 10.0% of participants in the ART-naïve group and 16.7% of participants in the ART-Experienced group had a CDC stage C.
  In the ART-naïve group, 111 participants (29.9%) were late presenters (CD4 <200 cells/µL and/or at least one AIDS defining event at baseline defined as any C stage). At baseline, there were 3 participants with HIV-1 RNA viral load <50 copies/mL in the ARTnaïve group, the median CD4 cell count was 344.9 (Q1: 169.0, Q3: 501.0) cells/µL and median CD4/CD8 ratio was 0.33 (Q1: 0.20, Q3: 0.60). In the ART-experienced group, 80 participants (8.6 %) had a viral load ≥50 copies/mL, the median CD4 cell count was 701.0 (Q1: 480.0, Q3: 909.0) cells/µL and the median CD4/CD8 ratio at baseline was 0.89 (Q1: 0.60, Q3: 1.23). Among French and German participants, demographics (age at B/F/TAF initiation, sex) and disease characteristics were comparable between participants who reconsented to the extension phase and participants who did not reconsent. However, the proportion of White participants was higher in participants who reconsented to the extension phase than in participants who did not reconsent (90.4% vs. 74.2%).

  Effectiveness Results:
  • Primary Outcome
  The primary objective of this study was to evaluate HIV-1 RNA suppression, defined as HIV1 RNA <50 copies/mL, at 12 months after initiating or switching to B/F/TAF. At baseline, the medianHIV-1 RNA viral load was 5.11 (Q1: 4.44, Q3: 5.64) log10 copies/mL in the ART-naïve group and 1.28 (Q1: 1.28, Q3: 1.28) log10 copies/mL in the ARTexperienced group. Baseline viral load was >100,000 copies/mL in 196 participants (52.5%) in the ART-naïve group and 7 participants (0.8%) in the ART-experienced group. A total of 3 participants (0.8%) in the ART-naïve group and 845 participants (91.4%) in the ARTexperienced group had a viral load <50 copies/mL. In France and Germany, the median HIV-1 RNA viral load at baseline was 4.78 (Q1: 4.00, Q3: 5.28) log10 copies/mL in the ART-naïve group and 1.28 (Q1: 1.28, Q3: 1.28) log10 copies/mL in the ART-experienced group. Baseline viral load was >100,000 copies/mL in 46 participants (38.7%) in the ART-naïve group and 4 participants (0.9%) in the ART-experienced group. No participants had a viral load <50 copies/mL in the ART-naïve group and 414 participants (90.8%) in the ART-experienced group had a viral load <50 copies/mL. HIV-1 RNA suppression at 12 months after initiating or switching to B/F/TAF was achieved in 90.6% of participants (95% CI: 86.7%, 93.6%) in the ART-naïve group and was maintained in 96.8% of participants (95% CI: 95.4%, 97.9%) in the ART-experienced group. In France and Germany, HIV-1 RNA suppression at 12 months was achieved in 96.2% of participants (95% CI: 90.6%, 99.0%) in the ART-naïve group and in 95.9% of participants (95% CI: 93.5%, 97.6%) in the ART-experienced group. The sensitivity analysis (treatment discontinuation/interruption >1 month considered as treatment failure) showed similar results: HIV-1 RNA suppression was achieved in 87.1% of participants (95% CI: 83.0%, 90.6%) in the ART-naïve group and was maintained in 90.5% of participants (95% CI: 88.4%, 92.3%) in the ART-experienced group. In France and Germany, HIV-1 RNA suppression was achieved in 92.7% of participants (95% CI: 86.2%, 96.8%) in the ART-naïve group and 88.5% of participants (95% CI: 85.2%, 91.3%) in the ARTexperienced group.

  • Secondary outcomes
  o HIV-1 RNA Suppression at 3, 6, 24, 36, 48, and 60 Months

  Main phase (3, 6, and 24 months)
  In the ART-naïve group, HIV-1 RNA suppression was achieved in 74.1% of participants (95% CI: 69.0%, 78.7%) at 3 months, 85.8% of participants (95% CI: 81.5%, 89.5%) at 6 months, and 94.3% of participants (95% CI: 91.0%, 96.7%) at 24 months.
  In the ART-experienced group, HIV-1 RNA suppression was maintained in 96.0% of participants (95% CI: 94.4%, 97.3%) at 3 months, 94.6% of participants (95% CI: 92.8%,
  96.0%) at 6 months, and 95.7% of participants (95% CI: 94.0%, 97.0%) at 24 months.

  The sensitivity analysis (treatment discontinuation considered as treatment failure) showed comparable results. In the ART-naïve group, HIV-1 RNA suppression was achieved in 73.2% of participants (95% CI: 68.1%, 77.9%) at 3 months, 84.0% of participants (95% CI: 79.5%, 87.8%) at 6 months, and 88.1% of participants (95% CI: 83.9%, 91.5%) at 24 months. In the ART-experienced group, HIV-1 RNA suppression was achieved in 94.4% of participants (95% CI: 92.6%, 95.9%) at 3 months, 90.9% of participants (95% CI: 88.7%, 92.7%) at
  6 months, and 84.1% of participants (95% CI: 81.5%, 86.4%) at 24 months. France and Germany (3, 6, 24, 36, 48, and 60 months). In the ART-naïve group in France and Germany, HIV-1 RNA suppression was achieved in 85.0% of participants (95% CI: 76.9%, 91.2%) at 3 months, 89.4% of participants
  (95% CI: 81.9%, 94.6%) at 6 months, 96.9% of participants (95% CI: 91.3%, 99.4%) at 24 months. During the extension phase, HIV-1 RNA suppression was maintained in 98.4% of participants (95% CI: 91.2%, 100%) at 36 months, 100% of participants (95% CI: 92.7%, 100%) at 48 months, and 100% of participants (95% CI: 92.0%, 100%) at 60 months.
  In the ART-experienced group in France and Germany, HIV-1 RNA suppression was maintained in 95.8% of participants (95% CI: 93.3%, 97.5%) at 3 months, 94.0% of participants (95% CI: 91.3%, 96.1%) at 6 months, and in 94.2% of participants (95% CI: 91.4%, 96.3%) at 24 months. During the extension phase, HIV-1 RNA suppression was maintained in 97.1% of participants (95% CI: 94.4%, 98.7%) at 36 months, 97.3% of participants (95% CI: 94.5%, 98.9%) at 48 months, and in 97.4% of participants (95% CI: 94.4%, 99.0%) at 60 months.
  The sensitivity analysis (treatment discontinuation considered as treatment failure) in France and German participants showed comparable results up to 24 months. After 24 months, results are less meaningful. Results are available in Table 19.
  o CD4 Cell Count at 24 and 60 Months

  Main phase (24 months)
  In ART-naïve participants, the median CD4 cell count increased during the treatment period from 344.9 (Q1: 169.0, Q3: 501.0) cells/µL at baseline to 651.0 (Q1: 430.0, Q3: 890.0) cells/µL at 24 months. The median absolute change from baseline in CD4 cell count was +258.5 cells/µL (Q1: +106.0, Q3: +485.5, p<0.001) at 24 months.
  In ART-experienced participants, the median CD4 cell count increased slightly during the treatment period from 701.0 (Q1: 480.0, Q3: 909.0) cells/µL at baseline to 734.0 (Q1: 533.0,
  Q3: 960.5) cells/µL at 24 months. The median absolute change from baseline in CD4 cell count was +39.0 cells/µL (Q1: -75.0, +151.0; p<0.001) at 24 months. France and Germany (24 and 60 months).
  In ART-naïve participants in France and Germany, the median CD4 cell count increased during the treatment period from 424.5 (Q1: 220.0, Q3: 543.0) cells/µL at baseline, to 659.5
  (Q1: 482.5, Q3: 865.0) cells/µL at 24 months, and to 830.5 (Q1: 661.0, Q3: 1113.0) cells/µL at 60 months in the extension phase. The median absolute change from baseline in CD4 cell count was +363.5 cells/µL (Q1: +229.0, Q3: +555.5, p<0.001) at 60 months.

  In ART-experienced participants in France and Germany, the median CD4 cell count globally increased during the treatment period from 678.0 (Q1: 458.5, Q3: 914.5) cells/µL at baseline, to 723.5 (Q1: 532.0, Q3: 956.0) cells/µL at 24 months, and to 779.0 (Q1: 558.0, Q3: 1007.0) cells/µL at 60 months in the extension phase. The median absolute change from baseline in
  CD4 cell count was +87.0 cells/µL (Q1: -84.0, Q3: +220.0, p<0.001) at 60 months.
  o CD4/CD8 Ratio at 24 and 60 Months

  Main phase (24 months)
  In the ART-naïve group, the median CD4/CD8 ratio increased during the treatment period from 0.33 (Q1: 0.20, Q3: 0.60) at baseline, to 0.84 (Q1: 0.57, Q3: 1.20) at 24 months. The median absolute change from baseline in CD4/CD8 ratio was +0.40 (Q1: +0.24, Q3: +0.65) at 24 months (p<0.001).
  In the ART-experienced group, the median CD4/CD8 ratio increased during the treatment period from 0.89 (Q1: 0.60, Q3: 1.23) at baseline, to 0.99 (Q1: 0.68, Q3: 1.30) at 24 months.
  The median absolute change from baseline in CD4/CD8 ratio was +0.06 (Q1: -0.08, Q3: +0.20) at 24 months (p<0.001).
  France and Germany (24 and 60 months).
  In the ART-naïve participants in France and Germany, the median CD4/CD8 ratio increased during the treatment period from 0.32 (Q1: 0.20, Q3: 0.55) at baseline, to 0.86 (Q1: 0.58,
  Q3: 1.19) at 24 months, and 0.99 (Q1: 0.70, Q3: 1.33) at 60 months. The median absolute change from baseline in CD4/CD8 ratio was +0.51 (Q1: +0.26, Q3: +0.86) at 60 months (p<0.001).
  In the ART-experienced participants in France and Germany, the median CD4/CD8 ratio increased during the treatment period from 0.84 (Q1: 0.59, Q3: 1.20) at baseline, to 1.00
  (Q1: 0.69, Q3: 1.30) at 24 months, and 1.00 (Q1: 0.70, Q3: 1.31) at 60 months. The median absolute change from baseline in CD4/CD8 ratio was +0.10 (Q1: -0.03, Q3: +0.26) at
  60 months (p<0.001).
  • Exploratory Outcomes
  o Persistence

  Persistence on B/F/TAF was assessed by the duration of treatment with B/F/TAF (time from treatment initiation to treatment discontinuation / B/F/TAF interruption >1 month or to the end of the follow-up period, whichever occurred first) and as a categorical parameter.

  Main phase
  In the ART-naïve group, the median duration of B/F/TAF treatment was 23.8 (Q1: 21.9, Q3: 25.6) months. A total of 36 participants (9.5%) discontinued B/F/TAF treatment within
  60 months following treatment initiation. The main reasons for B/F/TAF discontinuation were related AEs leading to drug withdrawn (n=14), participant decision (n=5), and investigator's discretion (n=9). Among the ART-naïve participants who discontinued B/F/TAF during the study, the median duration of B/F/TAF treatment was 19.9 (Q1: 8.5, Q3: 36.4) months.
  B/F/TAF persistence was 97.5% at 12 months and 95.4% at 24 months.

  In the ART-experienced group, the median duration of B/F/TAF treatment was 24.0 (Q1: 22.1, Q3: 44.0) months. A total of 163 participants (15.5%) discontinued B/F/TAF treatment within
  60 months following treatment initiation. The main reasons for B/F/TAF discontinuation were related adverse event leading to drug withdrawn (n=74), participant decision (n=23), and investigator’s discretion (n=22). Among participants who discontinued B/F/TAF during the study, the median duration of B/F/TAF treatment was 12.5 (Q1: 5.8, Q3: 22.0) months.
  B/F/TAF persistence was 94.3% at 12 months and 89.1% at 24 months.

  France and Germany
  In ART-naïve participants in France and Germany, the median duration of B/F/TAF treatment was 36.0 (Q1: 23.3, Q3: 58.6) months. A total of 23 participants (19.0%) discontinued B/F/TAF treatment within 60 months following treatment initiation. The main reasons for B/F/TAF discontinuation were related AEs leading to drug withdrawn (n=7), investigator’s discretion (n=6), and participant decision (n=4). Among participants who discontinued B/F/TAF during the study, the median duration of B/F/TAF treatment was 29.4 (Q1: 17.1,
  Q3: 41.2) months. B/F/TAF persistence was 98.3% at 12 months, 94.7% at 24 months, and 70.4% at 60 months.
  In ART-experienced participants in France and Germany, the median duration of B/F/TAF treatment was 48.6 (Q1: 22.9, Q3: 59.1) months. A total of 109 participants (21.5 %) discontinued B/F/TAF treatment within 60 months following treatment initiation. The main reasons for B/F/TAF discontinuation was related adverse event leading to drug withdrawn (n=48), investigator’s discretion (n=18) and participant decision (n=14). Among participants who discontinued B/F/TAF during the study, the median duration of B/F/TAF treatment was 14.5 (Q1: 6.4, Q3: 37.0) months. B/F/TAF persistence was 92.9% at 12 months, 86.2% at
  24 months, and 70.1% at 60 months.

  Pharmacokinetic Results:
  No pharmacokinetic analyses were performed for this study.

  Safety Results:
  In the Analysis population, 873 participants (60.8%) experienced a total of 3,207 AEs;
  (incidence: 0.49 per patient-year [95% CI: 0.45, 0.52]; 0.61 per patient-year [95% CI: 0.55, 0.67] in France and Germany over the 60 month period). The median time from B/F/TAF initiation to the first AE was 96.0 (Q1: 6.0, Q3: 231.0) days in the ART-naïve group and 128.5 (Q1: 42.0, Q3: 320.0) days in the ART-experienced group. The most common AEs were
  COVID-19 (101 participants [7.0%]), weight increased (85 participants [5.9%]), nasopharyngitis (67 participants [4.7%]), and syphilis (67 participants [4.7%]). Overall, 188 participants (13.1%) experienced a total of 265 AEs considered by the investigators to be related to B/F/TAF; (incidence: 0.06 per patient-year [95% CI: 0.06, 0.08]; 0.05 per patient-year [95% CI: 0.04, 0.07] in France and Germany). The most common AEs related to B/F/TAF were weight increased (54 participants [3.8%]), nausea (14 participants [1.0%]), depression (14 participants [1.0%]), headache (12 participants [0.8%]), and fatigue (11 participants [0.8%]).

  Overall, 126 participants (8.8%) experienced a total of 208 SAEs (incidence: 0.04 per patient year [95% CI: 0.03, 0.05]; 0.05 per patient-year [95% CI: 0.04, 0.06] in France and Germany).
  In the ART-naïve group, 24 participants (6.3%) experienced a total of 34 SAEs (incidence: 0.03 per patient-year [95%
  CI: 0.02, 0.05]; 0.05 per patient-year (95% CI: 0.03, 0.08) in France and Germany). In the ART-experienced group, 102 participants (9.7%) experienced a total of 174 SAEs (incidence:
  0.04 per patient-year [95% CI: 0.03, 0.05]; 0.04 per patient-year [95% CI: 0.03, 0.06] in France and Germany).
  Most SAEs were reported as 1 or 2 events in a single participant. The most frequent SAEs were depression (0.5%), acute kidney injury (0.3%), pneumonia (0.2%), metastases to central nervous system (0.2%), and cardiac failure (0.2%). Overall, one participant (0.1%) from the ART-experienced group experienced one SAE of depression considered by the investigator to be related to B/F/TAF. Depression duration was
  72 days and B/F/TAF was withdrawn as a result of the event. Other SAEs were considered unrelated to B/F/TAF.
  A total of 14 deaths were reported during the study: 3 in the ART-naïve group and 11 in the ART-experienced group. No deaths were related to B/F/TAF. Overall, 4 pregnancies were reported during the study in the ART-experienced group; for 2 of them, B/F/TAF was stopped during pregnancy. Changes significantly different from zero were observed at 24 months for the following chemistry parameters:

  • The median change from baseline in total cholesterol was +0.50 mmol/L (Q1: -0.03, Q3: +1.01; p<0.001) in the ART-naïve group, and -0.10 mmol/L (Q1: -0.67, Q3: +0.50; p=0.050) in the ART-experienced group.
  • The median change from baseline in LDL was +0.36 mmol/L (Q1: -0.13, Q3: +0.67; p<0.001) in the ART-naïve group, and -0.06 mmol/L (Q1: -0.60, Q3: +0.39; p=0.001) in the ART-experienced group.
  • The median change from baseline in eGFR was -9.79 mL/min (Q1: -21.75, Q3: +1.31; p<0.001) in the ART-naïve group and -4.94 mL/min (Q1: -14.23, Q3: +3.75; p<0.001) in the ART-experienced group.
  • The median change from baseline in creatinine was +11.00 µmol/L (Q1: +4.00, Q3: +17.68; p<0.001) in the ART-naïve group and 3.00 µmol/L (Q1: -4.42, Q3: 10.61; p<0.001) in the ART-experienced group.
  • The median change from baseline in total bilirubin was +1.20 µmol/L (Q1: -1.88, Q3: +3.80; p=0.021) in the ART-naïve group and +1.54 µmol/L (Q1: -1.54, Q3: +3.76; p<0.001) in the ART-experienced group.

  Some changes significantly different from zero were observed at 24 months for the following chemistry parameters in ART-naïve participants only:
  • The median change from baseline in HDL was +0.13 mmol/L (Q1: -0.03, Q3: +0.27; p<0.001).

  • The median change from baseline in TC/HDL ratio was -0.16 (Q1: -0.72, Q3: +0.34; p=0.040).
  • The median change from baseline in alanine aminotransferase was -3.00 U/L (Q1: -15.00, Q3: +5.99; p=0.023).
  • The median change from baseline in aspartate Aminotransferase was -1.75 U/L (Q1: -9.00, Q3: +3.00; p=0.001).
  • The median change from baseline in albumin was +0.95 g/L (Q1: -1.00, Q3: +4.00; =0.039).
  • The median change from baseline in phosphorus was +0.06 mmol/L (Q1: -0.05, Q3: +0.17; p=0.002).
  Changes significantly different from zero were observed at 24 months for the following parameters in ART-experienced participants only:
  • The median change from baseline in triglycerides was -0.07 mmol/L (Q1: -0.50,
  Q3: +0.32; p=0.005).
  • The median change from baseline in glucose was +0.11 mmol/L (Q1: -0.44, Q3: +0.67; p=0.005).
  • The median change from baseline in direct bilirubin was +0.17 µmol/L (Q1: -0.68, Q3: +1.03; p=0.043).

  In France and Germany, some changes were significantly different from zero at 60 months for the following chemistry parameters:
  • The median change from baseline in creatinine was +11.00 µmol/L (Q1: +1.77, Q3: +17.68 ; p<0.001) in the ART-naïve group and +3.54 µmol/L (Q1: -6.19, Q3: +10.61 ;
  p=0.001) in the ART-experienced group. In France and Germany, some changes were significantly different from zero at 60 months for the following chemistry parameters in the ART-experienced group only:
  • The median change from baseline in eGFR was -4.89 mL/min (Q1: -13.79, Q3: +4.04; p<0.001).
  • The median change from baseline in glucose was +0.30 mmol/L (Q1: -0.22, Q3: +0.78; <0.001).
  • The median change from baseline in aspartate aminotransferase was +2.00 U/L (Q1: -3.00, Q3: +7.00; p=0.006).
  • The median change from baseline in total bilirubin was +0.90 µmol/L (Q1: -1.80, Q3: +3.65; p=0.013).
  For urinary parameters, the median change from baseline to 24 months in UPCR was -4.17 mg/mmol (Q1: -8.70, Q3: -0.11) in the ART-naïve group and was statically different from zero (p=0.008). No major findings were observed in France and Germany.

  In addition, weight increased during the treatment period: at 24 months the median change in weight from baseline was +4.0 kg (Q1: +0.2, Q3: +8.6; p<0.001) in the ART-naïve group and was +1.0 kg (Q1: -1.4, Q3: +4.0; p<0.001) in the ART-experienced group; at 60 months in France and Germany (extension phase), the median change in weight from baseline was +5.5 kg (Q1: +2.0, Q3: +12.0; p=0.001) in the ART-naïve group and +2.0 kg (Q1: -1.0, Q3: +5.0; p<0.001) in the ART-experienced group. Overall, the safety results were consistent with the known safety profile of B/F/TAF. No new safety concerns associated with B/F/TAF were identified for the treatment of HIV-1 infected participants in Europe.

  CONCLUSIONS:
  In conclusion, this study provided insights into the effectiveness and safety, as well as patterns of use of B/F/TAF in HIV-1 infected participants in routine clinical care in Europe over a period of 24 months and up to 60 months in France and Germany. The results of this study confirmed that treatment with B/F/TAF used in a real-world cohort, including ART-naïve and ART-experienced participants, is associated with rapid achievement and maintenance of high rates of virologic suppression. This study also confirmed that the safety of B/F/TAF in real-world settings in participants with HIV-1 in Europe does not differ from the previously established B/F/TAF safety profile.
  No new safety concerns were identified.

  We thank all participants and investigators involved in the BICSTaR programme
  

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  19/WM/0156

• Date of REC Opinion

  24 May 2019

• REC opinion

  Further Information Favourable Opinion