Biktarvy® (BIC/FTC/TAF)

BICSTaR Study

This document is in response to your request for information regarding Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]) and available data from the BICSTaR real‑world cohort study.

Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.

The full indication, important safety information, and boxed warnings are available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.

Summary

BICSTaR: Real-World Data on BIC/FTC/TAF in PWH

BICSTaR is an ongoing, real-world, multicountry, observational cohort study of BIC/FTC/TAF in ARV-naïve and TE participants that has demonstrated high rates of virologic suppression (including in subgroup analyses of females, older adults, and late presenters), 85% treatment persistence, and low rates of D/C due to DRAEs through 4 years of treatment in clinical practice.1-4 PRO assessments were also evaluated at 12 months, 24 months, and 4 years.4-6

BICSTaR: Real-World Data on BIC/FTC/TAF in PWH

Study Design and Demographics

BICSTaR is a large, ongoing, multicountry, prospective, observational cohort study in PWH that is evaluating the efficacy, safety, and tolerability of BIC/FTC/TAF in clinical practice. The study includes ARV-naïve and TE participants from across Europe, Canada, Israel, Japan, Taiwan, South Korea, and Singapore.1,7 The study outcomes include virologic suppression (HIV‑1 RNA <50 c/mL), treatment persistence (ie, the percentage of participants still receiving BIC/FTC/TAF at 12, 24, or 36 months), resistance status, DRAEs, and changes in weight, BMI, lipid levels, and renal function.1,3

Twelve-Month Pooled Analysis

Pooled Month 12 data for France, Germany, Ireland, Italy, the Netherlands, Spain, the UK, Canada, and Israel are presented below. This is an analysis of data from 1135 participants who started BIC/FTC/TAF between June 2018 and September 2020, with a data cutoff date of February 22, 2021. The analysis included ARV-naïve (n=180) and TE (n=955) participants who had BL and Month 12 data available and participants who had discontinued the study at the time of data cutoff.7 The most frequent reason for initiating BIC/FTC/TAF in ARV-naïve participants was early treatment according to guidelines (77%), and a majority of TE participants switched to BIC/FTC/TAF to simplify their treatment regimen (59%).1,7 

Table 1. BL Demographics and Disease Characteristics (Mallolas et al)1,7

an=177. bn=849. cn=945. dn=178.

Efficacy, persistence, and resistance

Using the M=E population at Month 12, 97% (95% CI: 93–99%) of ARV-naïve participants and 96% (95% CI: 95–98%) of TE participants were virologically suppressed (HIV-1 RNA <50 c/mL). At Month 12, BIC/FTC/TAF demonstrated high rates of efficacy in subgroup analyses of females, older adults, and adults who presented late for HIV care.1

Treatment persistence was high: 95% of all ARV-naïve participants and 90% of all TE participants continued to receive BIC/FTC/TAF treatment at Month 12.1

No treatment-emergent resistance to the components of BIC/FTC/TAF was reported. M184V/I was detected in 44 participants in the TE group at BL, and 43 of these participants continued to have undetectable viral loads (HIV-1 RNA <50 c/mL) through Month 12. One participant had a viral load of 78 c/mL at Month 12 but was resuppressed to <50 c/mL at Month 24.7

PROs

The PRO analysis population was similar to the overall study population in age, gender, and ethnicity and was composed of ARV-naïve and TE participants who completed PRO questionnaires at BL and/or Month 12.5

The PRO measures included adherence (VAS), physical and mental health (SF-36 PCS and MCS scores), bothersome symptoms (HIV-SI), treatment satisfaction (HIVTSQ), and healthcare utilization (physician visits). In ARV-naïve participants, median SF-36 PCS scores increased from 53.7 at BL to 58 at Month 12 (P=0.001), and MCS scores increased from 45.3 to 52.9 (P<0.001). In TE participants, median SF‑36 PCS and MCS scores remained stable at Month 12.5

At Month 12, significant decreases from BL in the overall median bothersome symptom count and in the frequency of several bothersome symptoms were observed in ARV‑naïve participants (Figure 1); the bothersome symptom count observed in TE participants remained stable. A significant improvement in treatment satisfaction was reported at Month 12 following the switch to BIC/FTC/TAF (Table 2).5,8

Figure 1. Frequency of Several Bothersome Symptoms in ARV-Naïve Participants (Brunetta et al)5,8

Note: P-values were calculated by the McNemar test with Bonferroni correction to account for multiple testing.

Table 2. HIV Treatment Satisfaction in TE Participants (Brunetta et al)5,8

aThe HIVTSQ status score ranges from 1 to 100, with higher scores indicating greater satisfaction with treatment.

bThe HIVTSQ change score ranges from -30 to +30, with positive total scores indicating improvement in treatment satisfaction.

cThe P-value was calculated using the Wilcoxon signed-rank test.

Subanalysis: TE participants with preexisting PRMs9

The efficacy and tolerability of 12 months of BIC/FTC/TAF treatment were assessed in TE participants with preexisting PRMs. Of the 996 participants who were virologically suppressed, 555 had no available genotype data and were considered not to have PRMs. Of the 441 participants with available genotype data at BL, 105 (24%) had preexisting PRMs (NRTI, n=66, 15%; NNRTI, n=56, 13%; PI, n=28, 6%; INSTI, n=1, 0.2%). Efficacy results at Month 12 are reported in Table 3.

Table 3. Month 12 Virologic Suppression by BL Status and Preexisting PRMs
(M=E Analysis; Trottier et al)9

aHIV-1 RNA <50 c/mL. bHIV-1 RNA ≥50 c/mL.

Of the 20 participants with a detectable viral load at Month 12, 19 had no preexisting PRMs, and 1 participant with preexisting PRMs experienced an isolated blip (HIV-1 RNA, 78 c/mL) before becoming resuppressed by the next visit. A total of 130/996 participants (13%) experienced ≥1 DRAE, and 115 participants (12%) discontinued, with 56 D/Cs (6%) due to DRAEs through Month 12. No treatment-emergent PRMs to BIC/FTC/TAF were reported.

24-Month Pooled Analysis

The efficacy and safety of BIC/FTC/TAF in ARV-naïve (n=135) or TE (n=703) PWH were evaluated in a 24-month pooled analysis of data from clinical sites in Canada, France, Germany, Ireland, Israel, Italy, Spain, the Netherlands, and the UK (data cutoff date of August 4, 2021).2

Table 4. BL Demographics and Disease Characteristics of Participants Treated With BIC/FTC/TAF for 24 Months (Trottier et al)2

an=121.
bA participant may be included in more than one drug class.

Efficacy, resistance, and persistence

According to the results of an M=E analysis, most participants in both groups maintained virologic suppression (HIV-1 RNA <50 c/mL) at Month 24 (ARV-naïve participants, 97% [104/107]; TE participants, 95% [497/521]). In the TE cohort, treatment with BIC/FTC/TAF demonstrated high rates of virologic suppression at 24 months in subgroup analyses according to sex (females, 97%; males, 95%), age (<50 years, 95%; ≥50 years, 96%), race (Black, 94%; other [predominantly White], 96%), and adherence (<95% adherence, 93%; ≥95% adherence, 96%). At 24 months in the ARV-naïve cohort, high rates of virologic suppression were observed in participants with and without late diagnosis (96% vs 98%). The median change from BL to 24 months in CD4 cell count was +228 cells/mcL in the ARV‑naïve group (n=94; P<0.001) and +48 cells/mcL in the TE group (n=424; P<0.001).2

No treatment-emergent resistance to the components of BIC/FTC/TAF was detected.10 At 24 months, 89% of all ARV-naïve participants (120/135) and 85% of all TE participants (600/703) continued to receive BIC/FTC/TAF (overall population, 86%).2

Subanalysis: adherence patterns among TE participants11

A subanalysis was conducted among 1496 TE participants with any VAS/missed doses data through 24 months to identify patterns of treatment adherence in TE people switching to BIC/FTC/TAF, to identify significant associations between each treatment pattern and BL characteristics, and to determine effectiveness outcomes according to adherence pattern. Self-reported adherence data were collected at BL, 6 months, 12 months, and 24 months using a VAS adherence questionnaire and a report of missed doses in the last 4 and 30 days.

Patterns of adherence identified with GBTM are described in Table 5.

Table 5. BIC/FTC/TAF Adherence Patterns Identified With GBTM (Boffito et al)11

In an M=E analysis at 24 months, virologic suppression was high (92–100%) among all groups, regardless of adherence pattern. Among participants who reported missing ≥4 doses of BIC/FTC/TAF in the last month at 6 months (n=25), 12 months (n=31), and 24 months (n=34), virologic suppression was maintained through 24 months in 92%, 100%, and 94% of participants, respectively.

With Group 1 (near-perfect adherence) as a reference group, participants <65 years of age were more likely to be associated with Group 3 (moderate adherence) than participants aged ≥65 years (aOR, 3.6; 95% CI: 1.5–8.6); participants <50 years of age were more likely to be associated with Group 4 (decreasing adherence) than participants aged ≥50 years (aOR, 2.7; 95% CI: 1.5–4.6); and participants with Black race or CD4 count <350 cells/mcL were more likely to be associated with Group 5 (increasing adherence) than participants of other races (aOR, 6.3; 95% CI: 2.2–18) or those with CD4 counts ≥350 cells/mcL (aOR, 3.39; 95% CI: 1.35–8.5).

Key safety parameters2

In the overall population, DRAEs were reported in 15% of participants (ARV naïve, 18% [24/135]; TE, 15% [104/703]), and serious DRAEs were reported in <1% (2/838; both events occurred in participants in the TE cohort). A total of 7% of participants discontinued BIC/FTC/TAF due to DRAEs (ARV naïve, 6% [8/135]; TE, 8% [54/703]). The most common AEs that led to study drug D/C were weight increase (3%) and depression (1%).

In participants with weight and BMI data available at BL and Month 24, increases in body weight from BL were observed in both cohorts (ARV naïve [n=75], +4.3 kg, P<0.05; TE [n=376], +1.2 kg; P<0.05). In the ARV-naïve cohort, a greater increase in body weight from BL to Month 24 was observed in participants with a CD4 count of <350 cells/mcL (n=33; +6.6 kg; P<0.05) than in those with a CD4 count of ≥350 cells/mcL (n=39; +4 kg; P<0.05). Weight changes observed in key subgroups of the TE cohort (sex, age, race, and prior TDF use) are reported in Table 6.

Table 6. Body Weight Changes in Key Subgroups of TE Participants at 24 Months (Trottier et al)2a

aParticipants with available weight and BMI data at BL and Month 24 were included in the analysis.

bPeople of other races, of whom the majority were White.

PROs6

A pooled analysis was conducted among TE participants with preexisting depression, anxiety, and/or insomnia at the time of the switch to BIC/FTC/TAF in the BICSTaR Europe, Canada, and Israel cohorts to determine outcomes through 24 months of treatment. BL characteristics of participants in this analysis were similar to those in the overall study population. Of the 123 participants taking ≥1 medication for ongoing depression/anxiety/insomnia at BL, 16 participants added a new medication, 8 participants changed medication, and 4 participants discontinued BIC/FTC/TAF due to a depression/anxiety/insomnia–related DRAE through 24 months. Switching to BIC/FTC/TAF resulted in small improvements in mental well-being and treatment satisfaction. HIV symptom scores remained stable.

36-Month Pooled Analysis3

A total of 67 ARV-naïve and 382 TE PWH in Germany, France, and Canada who completed 24 months of BIC/FTC/TAF participated in the extension phase, with a 36-month data cutoff date of August 12, 2022.

Table 7. BL Demographics and Disease Characteristics of Participants Treated With BIC/FTC/TAF for 36 Months (Sabranski et al)3

Efficacy, resistance, and persistence

According to the results of an M=E analysis, 97% of participants overall maintained virologic suppression at Month 36. In the TE group (n=367), treatment with BIC/FTC/TAF demonstrated high rates of virologic suppression at 36 months in subgroup analyses, including any preexisting PRM at BL (yes, 100%; no, 98%), eGFR at BL (<60 mL/min/1.73 m2, 100%; ≥60 mL/min/1.73 m2, 96%), and prior ART regimens (any DTG‑based regimen, 97%; EVG/COBI/FTC/TAF, 95%; RPV/FTC/TAF, 100%). In the ARV group (n=60), high rates of virologic suppression were observed in participants with late diagnosis and CD4 count <200 cells/mcL and/or ≥1 AIDS‑defining event at BL (yes, 91%; no, 98%), late diagnosis and CD4 count <350 cells/mcL and/or ≥1 AIDS-defining event at BL (yes, 95%; no, 97%), and eGFR ≥60 mL/min/1.73 m2 (96%). For patients with data available at both BL and Month 36, the median change from BL to 36 months in CD4 cell count was +232 cells/mcL in the ARV‑naïve group (n=52; P<0.001) and +44 cells/mcL in the TE group (n=302; P<0.001). The median change from BL to 36 months in CD4/CD8 ratio was +0.5 in the ARV-naïve group (n=51; P<0.001) and +0.06 in the TE group (n=268; P<0.001).

No treatment-emergent resistance to the components of BIC/FTC/TAF was reported. At 36 months, 86% of all ARV-naïve participants (105/122) and 84% of all TE participants (557/659) continued to receive BIC/FTC/TAF (overall population, 85%).

Key safety parameters

Over 36 months, DRAEs were reported in 14% of participants in the overall population (ARV-naïve, 16% [19/122]; TE, 14% [89/659]), with 7% of ARV-naïve participants and 10% of TE participants experiencing a DRAE in the first 6 months of BIC/FTC/TAF initiation. DRAEs led to BIC/FTC/TAF D/C in 7% (n=54) of the overall population (ARV‑naïve, 5% [6/122]; TE, 7% [48/659]), with weight increase (ARV naïve, 3% [4/122]; TE, 2% [15/659]) and depression (ARV naïve, 0; TE, 1% [7/659]) being the most frequently reported DRAEs that led to D/C.

Among participants with available weight at BL and Month 36, the median (Q1, Q3) weight changes from BL were 4.3 (-0.5, 7.3) kg (P=0.003) in the ARV-naïve group and 1.7 (‑1, 4.3) kg (P<0.001) in the TE group. Among participants with available BMI data at BL and Month 36, the median (Q1, Q3) change was 1.5 (-0.1, 2.5) kg/m2 (P=0.003) in the ARV‑naïve group and 0.5 (-0.3, 1.5) kg/m2 (P<0.001) in the TE group. At 36 months, 48% of ARV-naïve participants had a normal BMI. The median TC:HDL ratio was stable over 3 years, with a median TC:HDL ratio among ARV-naïve participants of 4.18 at BL (n=67) and 4.11 at Year 3 (n=47). Among TE participants, the median TC:HDL ratio was 3.91 at BL (n=366) and 3.99 at Year 3 (n=255).

4-Year Analysis4

An analysis was conducted among participants from Canada, France, and Germany with ≥4 years of follow-up data (2 years in the main BICSTaR study plus 2 years in the extension phase) to assess the effectiveness and safety outcomes, QoL, and HIV symptom measures (data cutoff, September 1, 2023). The analysis population (N=800) included the 415 participants who had a 4-year visit or discontinued the study having initiated treatment ≥42 months prior to the data cutoff date (lower bound of the 4-year visit window).

Efficacy, resistance, and immunologic outcomes

According to the results of an M=E analysis at 48 months, 98% of the 51 ARV-naïve participants and 97% of the 352 TE participants with available data were virologically suppressed (HIV-1 RNA <50 c/mL). No treatment-emergent resistance to the components of BIC/FTC/TAF was reported through 4 years of treatment.

CD4 cell counts and CD4/CD8 ratios improved significantly among all participants with available data through 4 years. The median (IQR) change from BL to 4 years in CD4 cell count was +350 (195–480) cells/mcL in the ARV-naïve group (n=45; P<0.001) and +96 (‑49 to +217) cells/mcL in the TE group (n=274; P<0.001). The median (IQR) change in CD4/CD8 ratio among ARV-naïve (n=44) and TE participants (n=243) was +0.54 (0.33–‍0.81) and +0.1 (-0.02 to +0.23), respectively (each, P<0.001).

Key safety parameters

A summary of key safety data through 4 years of BIC/FTC/TAF treatment is presented in Table 8.

Table 8. Key Safety Results Through 4 Years of BIC/FTC/TAF Treatment
(Analysis Population; Wong et al)4

aThe most common DRAEs that led to BIC/FTC/TAF D/C were weight increased (n=21), depression (n=7), fatigue (n=6), and sleep disorder (n=5).

The median change in weight at 4 years among ARV-naïve participants (n=30) was +4.4 kg from a BL median weight of 70 kg (P=0.019); the median change in weight among TE participants (n=295) was +1.6 kg from a BL median weight of 77 kg (P<0.001). BMI increased over 4 years in both groups, with a median change of +1.6 kg/m2 from a BL BMI of 22.9 kg/m2 among ARV-naïve participants (n=29; P=0.022) and +0.5 kg/m2 from a BL of 24.7 kg/m2 among TE participants (n=284; P<0.001).

PROs

From BL to 4 years, the median change in HIV-SI overall bothersome symptom count was ‑3 from a BL of 6.5 among ARV-naïve participants (n=44; P=0.053) and remained stable at the BL median overall bothersome symptom count of 4 among TE participants (n=292; P=0.798). Among ARV-naïve participants, the incidence of the following symptoms most relevant to the safety profile of BIC/FTC/TAF decreased from BL to 4 years: fatigue or loss of energy (from 69% to 52%), feeling sad/down/depressed (46% to 30%), diarrhea or loose bowel movements (35% to 21%), feeling dizzy or lightheaded (34% to 12%), headache (28% to 26%), and nausea or vomiting (19% to 5%).

QoL scores for the physical and mental health components of the SF-36 remained stable or increased from BL to 4 years among all participants with available data. In ARV‑naïve participants (n=38), the median PCS increased from 53 to 57 (P=1), and the median MCS increased significantly from 46 to 53 (P=0.03); in TE participants (n=251), the median physical score remained stable at 56 (P=0.569), and the median mental score increased from 48 to 51 (P=0.225).

References

1. Mallolas J, Esposito V, Hocqueloux L, et al. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for the treatment of people living with HIV: 12-month effectiveness, persistence, and safety in a multi-country cohort study [Poster PE2/57]. Paper presented at: 18th European AIDS Conference; October 27-30, 2021; Online & London, UK.

2. Trottier B, Antinori A, De Wet J, et al. Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for the Treatment of People Living With HIV: 24-Month Analyses by Age, Race, Sex, Adherence and Late Diagnosis in a Multi-Country Cohort Study [Poster P067]. Paper presented at: HIV Glasgow 23-26 October, 2022; Glasgow, UK.

3. Sabranski M, Vassallo M, Wet J, et al. Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Antiretroviral Treatment Naïve (TN) and Experienced (TE) People With HIV (PWH): 3 Year Effectiveness and Safety Outcomes in the BICST a R Observational Cohort. [Poster eP.A.081]. Paper presented at: The 19th European AIDS Conference; October,18–21, 2023; Warsaw, Poland.

4. Wong A, Beer D, Duvivier C, et al. Four-Year Outcomes From the BICSTaR Study: Observational Analysis of B/F/TAF in Treatment-Naïve and Treatment-Experienced People With HIVin Canada, France, and Germany [Poster P063]. Paper presented at: HIV Glasgow; November 10–13, 2024; Glasgow, UK.

5. Brunetta J, Monforte AD, Elbirt D, et al. Patient-reported outcome (PRO) measures at 12 months in a real-world cohort of people living with HIV with a high prevalence of comorbidities receiving bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in Europe, Canada, and Israel [Poster PE2/50]. Paper presented at: 18th European AIDS Conference; October 27–30, 2021; Online & London, UK.

6. Esser S, Trottier B, Antinori A, et al. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment- Experienced People With HIV (PWH) With Baseline Symptoms of Depression/Anxiety and/or Insomnia in the Observational BICSTaR Study.[Poster eP.B2.073]. Paper presented at: The 19th European AIDS Conference; October,18–21, 2023; Warsaw, Poland.

7. Mallolas J, Esposito V, Hocqueloux L, et al. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for the treatment of people living with HIV (PLWH): 12-month effectiveness, persistence, and safety in a multi-country cohort study [Supplement]. Paper presented at: 18th European AIDS Conference; October 27-30, 2021; Online & London, UK.

8. Brunetta J, Monforte AD, Elbirt D, et al. Patient-reported outcome (PRO) measures at 12 months in a real-world cohort of people living with HIV with a high prevalence of comorbidities receiving bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in Europe, Canada, and Israel [Supplement]. Paper presented at: 18th European AIDS Conference; October 27–30, 2021; Online & London, UK.

9. Trottier B, Bonnet F, García-Deltoro MG, et al. Real World Effectiveness and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Treatment Experienced People With HIV and a History of Antiretroviral Drug Resistance Mutations [Poster 1628848]. Paper presented at: ID Week 2023; October 11-15, 2023; Boston, MA.

10. Trottier B, Antinori A, De Wet J, et al. Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for the Treatment of People Living With HIV: 24-Month Analyses by Age, Race, Sex, Adherence and Late Diagnosis in a Multi-Country Cohort Study [Poster P067 Supplementary Information]. Paper presented at: HIV Glasgow 23-26 October, 2022; Glasgow, UK.

11. Boffito M, Brunetta J, Levy I, et al. Real-World Effectiveness in Treatment-Experienced People With HIV Switching to B/F/TAF With Distinct Patterns of Self-Reported Adherence [Poster P068]. Paper presented at: HIV Glasgow; November 10-13, 2024; Glasgow, UK.

Abbreviations

ABC=abacavir
AE=adverse event
aOR=adjusted odds ratio
ART=antiretroviral therapy
ARV=antiretroviral
BIC=bictegravir
BICSTaR=BIC single-tablet regimen
BL=baseline
c/mL=copies per mL
CD4/8=clusters of differentiation 4/8
COBI=cobicistat
D/C=discontinuation
DRAE=drug-related adverse event
EVG=elvitegravir
FTC=emtricitabine
GBTM=group-based joint trajectory modeling
HIV-SI=HIV Symptom Index
HIVTSQ=HIV Treatment Satisfaction Questionnaire
INSTI=integrase strand transfer inhibitor
M=E=missing=excluded MCS=mental component summary
NRTI=nucleos(t)ide reverse transcriptase inhibitor
NNRTI=non-nucleos(t)ide reverse transcriptase inhibitor
PCS=physical component summary
PI=protease inhibitor
PRM=primary resistance mutation
PRO=patient‑reported outcome
PWH-people with HIV
Q=quartile
QoL=quality of life
RPV=rilpivirine
SF-36=36‑item short form
TAF=tenofovir alafenamide
TC=total cholesterol
TDF=tenofovir disoproxil fumarate
TE=treatment-experienced
VAS=visual analog scale
 

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For the full indication, important safety information, and boxed warning(s), please refer to the Biktarvy US Prescribing Information available at:
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