Sunlenca® (lenacapavir)

Investigational Use for HIV-1 Pre‑Exposure Prophylaxis

This document is in response to your request for information regarding Sunlenca® (lenacapavir [LEN]) and its investigational use for HIV-1 pre-exposure prophylaxis (PrEP).

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.

LEN is not indicated for use as PrEP to reduce the risk of sexually acquired HIV-1. The use of LEN for HIV-1 PrEP and the use of FTC/TAF for prevention of HIV in cisgender women are investigational and have not been approved by any regulatory authority. The full indication, important safety information, and boxed warnings are available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/sunlenca/sunlenca_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/truvada/truvada_pi.

Summary

Clinical Data on Use of Twice-Yearly SUBQ LEN for HIV-1 PrEP

Gilead is studying LEN for the prevention of HIV-1 across multiple ongoing PURPOSE studies. Please see Table 1 for an overview of these studies.1-5

PURPOSE 1 is an ongoing, phase 3, double-blind, randomized study evaluating the efficacy and safety of twice-yearly SUBQ LEN (n=2134) and once-daily oral FTC/TAF (n=2136) or FTC/TDF (active control; n=1068) for HIV-1 PrEP in 5338 cisgender women and adolescent girls (16–25 years old) across South Africa and Uganda.1

• A total of 55 incident HIV cases occurred; no participants in the LEN group acquired HIV, 39 HIV cases occurred in the FTC/TAF group, and 16 occurred in the FTC/TDF group.
• LEN significantly reduced the incidence rate of HIV by 100% compared with both bHIV (IRR, 0; 95% CI: 0–0.04; P<0.001) and FTC/TDF (IRR, 0; 95% CI: 0–0.1; P<0.001). The incidence rate of HIV in the FTC/TAF group was not significantly different from bHIV (IRR, 0.84; 95% CI: 0.55–1.28; P=0.21), and there was no evidence of a meaningful difference in HIV incidence from FTC/TDF (IRR, 1.2; 95% CI: 0.67–2.14).
• LEN, FTC/TAF, and FTC/TDF were all generally well tolerated, with few discontinuations due to study drug–related AEs. ISRs were the most common AE in all groups and occurred at a higher rate with LEN than with placebo injections.

PURPOSE 2 is an ongoing, phase 3, double-blind, randomized study evaluating the efficacy and safety of twice-yearly SUBQ LEN or once-daily oral FTC/TDF for HIV-1 PrEP in cisgender gay, bisexual, and other men, TGW, TGM, and GNB individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the US who have condomless receptive anal sex with partners assigned male at birth (N=3265).2

• At the prespecified interim analysis, there were 2 incident HIV cases in the LEN group and 9 in the FTC/TDF group.
• PURPOSE 2 met its key efficacy endpoints, demonstrating superiority of twice‑yearly SUBQ LEN over bHIV (incidence expected in the absence of PrEP) and daily oral FTC/TDF. LEN reduced HIV incidence by 96% compared with bHIV incidence (primary endpoint; IRR, 0.04; 95% CI: 0.01–0.18; P<0.001) and by 89% compared with daily oral FTC/TDF (secondary endpoint; IRR, 0.11; 95% CI: 0.02–‍0.51; P=0.002).
• Overall, the frequencies of non-ISR AEs and laboratory abnormalities were similar between groups, with the exception of changes in eGFR.

Background: PURPOSE Studies Overview

The PURPOSE program is evaluating the efficacy and safety of LEN for PrEP given twice yearly as a SUBQ injection. LEN for PrEP is being studied in two large phase 3 clinical studies, PURPOSE 1 and PURPOSE 2, and in three smaller phase 2 studies, PURPOSE 3, 4, and 5.1-5 See Table 1 for an overview of each study design.

Table 1. PURPOSE Studies Overview1-6

Clinical Data on Use of Twice-Yearly SUBQ LEN for HIV-1 PrEP

PURPOSE 1 Study

Study design and demographics1

PURPOSE 1 is an ongoing, phase 3, double-blind, randomized, active-controlled study evaluating the efficacy and safety of twice-yearly SUBQ LEN and once-daily oral FTC/TAF for HIV-1 PrEP in cisgender women and adolescent girls across South Africa and Uganda. In addition, a third group was assigned once-daily oral FTC/TDF, which served as the active control. Eligible women and adolescent girls were tested for HIV at screening, and those who tested negative were randomly assigned in a 2:2:1 ratio to receive LEN 927 mg SUBQ every 26 weeks, FTC/TAF 200/25 mg orally daily, or FTC/TDF 200/300 mg orally daily (Figure 1). Those who tested positive for HIV at screening were referred for care at a local center and their samples underwent additional testing to determine the recency of HIV; these data were used to estimate the bHIV that would be expected without PrEP. Participants who discontinued blinded study drug were given the option to take open-label FTC/TDF. Testing for HIV in the randomized cohort was conducted at Weeks 4, 8, and 13 and every 13 weeks thereafter.

Figure 1. PURPOSE 1: Study Design1

aThe bHIV was determined based on a cross-sectional incidence estimate derived from rates of recent HIV in 8094 screened participants; these participants were not followed longitudinally.

bAll participants randomly assigned to receive LEN received an initial loading dose of LEN, which consisted of 600 mg (two 300-mg tablets) administered on Days 1 and 2.

cParticipants in the LEN SUBQ group also received placebo FTC/TAF or placebo FTC/TDF (2:1), and participants in the FTC/TAF and FTC/TDF groups also received placebo LEN oral loading doses and placebo LEN SUBQ.

A total of 5345 participants were randomly assigned and received ≥1 dose of study drug; 7 participants were subsequently determined to have had HIV at baseline, thus 5338 participants were included in the mITT efficacy analysis. Baseline (at randomization) characteristics among the three treatment groups were similar. Overall retention in the study was high and similar across treatment groups, with 4855/5020 participants (96.7%) completing 26 weeks of follow-up, 2439/2612 participants (93.4%) completing 52 weeks, and 39/43 participants (91%) completing 104 weeks.

An independent committee determined that the planned interim efficacy analysis (when 50% of participants had completed ≥52 weeks of follow-up; data cutoff for clinical data, May 28, 2024, and data cutoff for laboratory data, May 29, 2024) met the prespecified criteria for stopping the randomized, blinded portion of the trial. According to the study protocol, the interim analysis became the primary efficacy and safety analysis. Starting July 8, 2024, all participants were offered open-label LEN.

Table 2. PURPOSE 1: Baseline Demographics and Disease Characteristics1

Results of primary and secondary efficacy analyses1

A total of 55 incident HIV cases occurred in the randomized cohort; no participants in the LEN group acquired HIV (1939 PY; incidence rate: 0 per 100 PY; 95% CI: 0–0.91); 39 HIV cases occurred in the FTC/TAF group (1932 PY; incidence rate: 2.02 per 100 PY; 95% CI: 1.44–‍2.76); and 16 occurred in the FTC/TDF group (949 PY; incidence rate: 1.69 per 100 PY; 95% CI: 0.96–2.74). The bHIV in the screened population was 2.41 per 100 PY (Figure 2).

LEN significantly reduced the incidence rate of HIV by 100% compared with both the background incidence rate (IRR, 0; 95% CI: 0–0.04; P<0.001) and the rate with FTC/TDF (IRR, 0; 95% CI: 0–0.1; P<0.001). The incidence rate of HIV in the FTC/TAF group did not significantly differ from the bHIV rate (IRR, 0.84; 95% CI: 0.55–‍1.28; P=0.21), and there was no evidence of difference in the incidence of HIV with FTC/TDF (IRR, 1.2; 95% CI: 0.67–2.14).

Figure 2. PURPOSE 1: Incidence of HIV1

Figure 3. PURPOSE 1: Primary and Secondary Analyses1

Adherence results1

Adherence to LEN was defined as on-time injections (within 28 weeks after the last injection). Most participants received their injections (LEN and placebo LEN) on time at Weeks 26 (91.5%; 4545/4967) and 52 (92.8%; 2025/2181), and adherence to injections was similar across the groups.

Adherence to FTC/TAF and FTC/TDF was evaluated at study visits using DBS analysis of TDF levels in 10% of participants who were randomly preselected from each group. Adherence in the 10% sample of participants in the FTC/TAF and FTC/TDF groups was low and decreased over time. At Week 8, in the FTC/TAF and FTC/TDF groups, adherence was low (<2 doses/week) in 34% and 50% of participants, respectively; at Week 52, adherence was low in 84% and 93%. Among participants who acquired HIV and had data available, 34/37 participants in the FTC/TAF group and 13/14 participants in the FTC/TDF group had low or undetectable levels of TDF. In a matched case‑control analysis to assess the association between adherence and efficacy in the FTC/TAF group, participants with medium (2 or 3 doses/week) or high (≥4 doses/week) adherence had lower odds of acquiring HIV than those with low adherence (odds ratio, 0.11; 95% CI: 0.01–0.49).

Persistence results7

Persistence to LEN was defined as on-time injections (within 28 weeks after the last injection) at Week 26 and Week 52. Persistence was evaluated in 10% of participants, who were randomly preselected from each group and limited to those who had ≥1 year of study follow‑up at time of interim analysis. Most participants demonstrated high persistence to LEN and placebo LEN, with 79.5% on LEN (n=112), 81.8% on FTC/TAF with placebo LEN (n=99), and 75.9% on FTC/TDF with placebo LEN (n=54) with on-time injections at Week 26 and Week 52.

Persistence to daily oral FTC/TAF or FTC/TDF was assessed by TFV-DP concentration in DBS at Weeks 13, 26, 39, and 52. Compared with LEN injections, persistence to daily oral FTC/TAF or FTC/TDF was significantly lower, with 5.2% of participants (n=153) having DBS TFV-DP concentrations consistent with ≥4 doses/week through Week 52 (P<0.0001).  

Safety results

LEN, FTC/TAF, and FTC/TDF were generally well tolerated, with fewer gastrointestinal AEs in the LEN group than in either the FTC/TAF or FTC/TDF groups (Table 3). LEN ISRs were relatively common, and most were Grade 1 or 2. Six deaths occurred, all in the FTC/TAF group; none of these were considered by the investigator to be related to study drug.1

The most common AEs were ISRs. A total of 25,329 injections were administered, with 10,154 administered to 2138 participants in the LEN group and 15,175 administered to 3206 participants receiving placebo injection in the FTC/TAF and FTC/TDF groups. SUBQ nodules, injection site pain, and swelling were the most common ISRs; these events occurred in 63.8%, 31.2%, and 4.4% of participants, respectively, who received LEN injections and in 16.6%, 23.7%, and 5.4% of participants, respectively, who received placebo injections.8 No Grade 4 ISRs occurred, and the frequency of ISRs decreased over time (Figure 4). Four ISRs (0.2%) that led to premature discontinuation occurred in the LEN group; all were reported as SUBQ nodules, including 1 that was also reported as injection site pain. No participants who received a placebo injection discontinued due to an ISR. No keloid scars were reported in any treatment group.1

Table 3. PURPOSE 1: Safety Summary1

aAEs that led to discontinuation of LEN were nausea (n=1), decreased CrCl (n=1), increased liver enzyme levels (n=1), spontaneous abortion (n=1), and suicide attempt with major depression (n=1); in the FTC/TAF group, AEs that led to discontinuation were suicide attempt, depressive symptoms, and drug overdose (n=1, all in the same participant) and angioedema (n=1).

bPercentages shown are based on the number of participants who had ≥1 postbaseline laboratory result (LEN, n=2126; FTC/TAF, n=2113; FTC/TDF, n=1054).

cReactions to trial-related injections only; percentages shown are based on the number of participants who received ≥1 placebo or LEN injection (LEN, n=2138; FTC/TAF, n=2136; FTC/TDF, n=1070).

dGrade 3 ISRs consisted of injection site ulcer (LEN, n=3; FTC/TAF, n=2; FTC/TDF, n=1), nodule (LEN, n=1), and pain (FTC/TDF, n=1).

Figure 4. PURPOSE 1: Occurrence or Absence of Common Grade ≤2 ISRs Over Time9

Pregnancies occurred in 487 participants (for a total of 510 pregnancies; LEN, n=193; FTC/TAF, n=219; FTC/TDF, n=98). A total of 277 pregnancies were completed at the time of the interim analysis; 121 (23.7% of all pregnancies) resulted in births, 66 (12.9%) resulted in spontaneous abortions, and 90 (17.6%) resulted in induced abortions. One congenital abnormality of polydactyly, which was not considered related to study drug, was observed in a participant in the LEN group who had a strong family history of the condition. Among pregnant participants, HIV occurred in no participants in the LEN group, in 4 participants in the FTC/TAF group, and in 1 participant in the FTC/TDF group.1

PURPOSE 2 Study

Study design and demographics2

PURPOSE 2 (NCT04925752) is an ongoing, phase 3, double-blind, randomized study evaluating the efficacy and safety of twice-yearly SUBQ LEN and once-daily oral FTC/TDF for HIV-1 PrEP in cisgender gay, bisexual, and other men, TGW, TGM, and GNB individuals aged ≥16 years in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the US who have condomless receptive anal sex with partners assigned male at birth (N=3265). Eligible participants were tested for HIV at screening, and those who tested negative were randomly assigned in a 2:1 ratio to SUBQ LEN every 26 weeks plus daily oral FTC/TDF placebo (n=2179) or SUBQ LEN placebo every 26 weeks plus daily oral FTC/TDF (n=1086;
Figure 5). Additional testing was performed with samples from participants who tested positive for HIV at screening to determine the recency of the HIV infection, and these data were used to estimate the bHIV that would be expected without PrEP.

The primary efficacy endpoint was the incidence of HIV among randomized participants.

Figure 5. PURPOSE 2: Study Design2,3  

aIncluded oral PrEP use within the last 12 weeks or any prior use of long-acting injectable forms of PrEP.

bCondomless receptive anal sex with ≥1 partner in the previous 12 months and met ≥1 of the following criteria: condomless receptive anal sex with ≥2 partners in the previous 12 weeks; history of syphilis, rectal gonorrhea, or rectal chlamydia in the previous 24 weeks; self-reported use of stimulants with sex in the previous 12 weeks.

cThe bHIV was the incidence of HIV expected without PrEP that would be anticipated in a placebo group. A total of 45 participants (11.9%) were classified as recently acquiring HIV.

dAll participants received an oral initiation dose of LEN (600 mg) or matching oral placebo on Days 1 and 2. Participants randomly assigned to the SUBQ LEN group received oral placebo FTC/TDF, and participants in the FTC/TDF group received SUBQ LEN placebo.

A total of 3271 participants were randomly assigned and received ≥1 dose of study drug; 6 participants were diagnosed with HIV on Day 1 and were excluded from the ITT efficacy analysis (mITT, n=3265). Baseline demographics are presented in Table 4.

Table 4. PURPOSE 2: Select Baseline Demographics and Disease Characteristics2

aIncluded all participants who identified as Black/of Black ancestry: Black, Back/White, Black/Pardo (a specific racial category in Brazil), Black/Brown (Brazil), Black/Colored (a specific racial category in South Africa), Black/American Indian or Alaskan Native, Black/Asian, and Black/Native Hawaiian or Pacific Islander.

bIncluded all participants who identified as American Indian or Alaskan Native, Native Hawaiian or Pacific Islander, Asian/Native Hawaiian or Pacific Islander, White/Native Hawaiian or Pacific Islander, and White/American Indian or Alaskan Native.

cIncluded all participants who identified as Asian/White, Colored (South Africa), Pardo (Brazil), White/Brown (Brazil), multiracial any other, and not multiracial other.

dIncluded 122 participants (89.7%) in the LEN group and 53 participants (84.1%)in the FTC/TDF group assigned male at birth.

eIncluded individuals who identified as Travesti (LEN, n=3; FTC/TDF, n=3) or as an “Other” gender (LEN, n=3; FTC/TDF, n=1).

fChlamydia trachomatis and Neisseria gonorrhea were diagnosed based on testing pharyngeal, rectal, and urethral (urine) samples by central and local laboratories. Syphilis was diagnosed by testing blood and was performed locally by local testing protocols.

Results of primary and secondary efficacy analyses2

In total, 3220 participants had ≥1 post-randomization HIV-1 test, resulting in 2905 PY of follow-up for calculations of incident HIV. The overall study retention rate was high and similar between treatment groups: 94.4% (2834/3001) at Week 26, 93.3% (1191/1277) at Week 52, and 91.3% (63/69) at Week 104.

The prespecified interim analysis was conducted when 50% of participants had completed ≥52 weeks of follow-up. Adherence was high, and injections were administered on time (ie, within 28 weeks of prior injection) in 91% of participants (2606/2864) at Week 26 and in 92.8% of participants (1016/1095) at Week 52. In the FTC/TDF group, TFV-DP concentrations in dried blood stains consistent with high adherence (≥4 pills per week) was seen in 82% at Week 8, 67% at Week 26, and in 62% at Week 52.

The bHIV in the screened population was 2.37 per 100 PY (95% CI: 1.65–3.42; Figure 6). In the LEN group, there were 2 incident HIV cases (0.1 per 100 PY; 95% CI: 0.01–0.37) 13 and 26 weeks after the first dose. Both participants had LEN concentrations above the IQ4 (15.5 ng/mL) at the time of diagnosis; no delayed diagnosis was revealed by retrospective HIV-1 RNA viral load testing, and both participants developed the N74D capsid resistance mutation. There were 9 incident HIV cases (0.93 per 100 PY; 95% CI: 0.43–1.77) in the FTC/TDF group; these participants had low/no adherence (determined through measurements of TFV-DP levels in dried blood stains) or had documented discontinuation of FTC/TDF >10 days prior to diagnosis, and 1 participant was found to have an M184V resistance mutation.

PURPOSE 2 met its key efficacy endpoints, demonstrating superiority of twice‑yearly SUBQ LEN over bHIV and daily oral FTC/TDF. LEN reduced HIV incidence by 96% compared with bHIV incidence (primary endpoint; IRR, 0.04; 95% CI: 0.01–0.18; P<0.001), and by 89% compared with daily oral FTC/TDF (secondary endpoint; IRR, 0.11; 95% CI: 0.02–‍0.51; P=0.002; Figure 7).

Figure 6. PURPOSE 2: Incidence of HIV-1 (mITT Population)2

Figure 7. PURPOSE 2: Primary and Secondary Analyses (mITT Population)2

Safety results2

Overall, the frequencies of non-ISR AEs and laboratory abnormalities were similar between groups (Table 5), except for changes in eGFR, with a median (IQR) change from baseline to Week 26 of +1.2 (-8 to +10.9) mL/min in the LEN group and ‑3 (-12.4 to +6.5) mL/min in the FTC/TDF group (P<0.001) and a median (IQR) change from baseline to Week 52 of +0.6 (‑10.3 to +10.8) mL/min in the LEN group and -2.9 (-13.8 to +7.4) mL/min in the FTC/TDF group (P=0.002). There were 4 deaths (0.2%) in the LEN group (each, n=1: cerebrovascular accident and pulmonary thromboembolism, car collision, sudden death with an undetermined cause, and suicide) and 2 (0.2%) in the FTC/TDF group (each, n=1: intracranial hemorrhage and undetermined cause); none were deemed related to study drug by investigator.

Table 5. PURPOSE 2: Safety Summary of Non-ISR AEs and Laboratory Abnormalities2

aDecreased renal CrCl was the only non-ISR AE that led to study drug discontinuation in >1 participant in either group (FTC/TDF, n=2 [0.2%]).

bIncluded participants with ≥1 post-baseline result.

Overall, 10,094 SUBQ LEN and 5145 SUBQ LEN placebo injections were administered, and ISRs were reported in 1816 participants (83.2%) who received LEN and 756 participants (69.5%) in the FTC/TDF group who received placebo injections. Most ISRs were mild to moderate in severity, and nodules, pain, and erythema were the most common ISRs. Nodules were reported more frequently in the LEN group than in the placebo injection group (63.4% vs 39.2%, respectively), with a median (IQR) duration of 183 (89–274) days in the SUBQ LEN group and 64 (19–98) days in the placebo injection group. The median (IQR) duration of induration was 84 (8–190) days in the SUBQ LEN group and 8 (5–57) days in the placebo injection group. The incidence of pain was similar between groups (SUBQ LEN, 56.4%; placebo injection, 53.4%). There were no reports of keloid formation. Overall, the frequency and severity of ISRs decreased over time. AEs of ISRs led to study drug discontinuation in 29 participants (LEN, n=26 [1.2%]; FTC/TDF, n=3 [0.3%]).

PURPOSE 3, 4, and 5: Phase 2 Study Designs

PURPOSE 3 is evaluating LEN for PrEP among cisgender women in the US, and PURPOSE 4 is studying LEN for PrEP among PWID in the US.4,10 

Figure 8. PURPOSE 3 and PURPOSE 4: Study Designs4,10

aParticipants in the LEN group will switch to oral FTC/TDF, and participants in the FTC/TDF group will continue to receive FTC/TDF in the PK tail phase for 78 weeks.

PURPOSE 5 will assess persistence, defined as sustained and consistent use of LEN compared with FTC/TDF, among individuals who need or want PrEP and who are not currently taking PrEP. The study is recruiting participants from France and the UK.5

Figure 9. PURPOSE 5: Study Design5

aIf LEN is safe and effective in the PURPOSE 1 and 2 studies, all participants will be offered LEN at Week 52.

References

1. Bekker LG, Das M, Abdool Karim Q, et al. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024;391(13):1179-1192.

2. Kelley CF, Acevedo-Quinones M, Agwu AL, et al. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. N Engl J Med. 2024.

3. ClinicalTrials.gov. Study to Assess the Effectiveness and Safety of Lenacapavir for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PURPOSE 2). ClinicalTrials.gov Identifier: NCT04925752. Available at: https://clinicaltrials.gov/ct2/show/NCT04925752?term=purpose-2&draw=2&rank=1. Accessed: 22 December. Last Updated: 21 December. 2022.

4. Gilead Sciences. Study of Lenacapavir and Emtricitabine/​Tenofovir Disoproxil Fumarate (F/​TDF) for Prevention of HIV in People Who Inject Drugs (HPTN-103) (PURPOSE-4) Available at: https://clinicaltrials.gov/study/NCT06101342?intr=lenacapavir&rank=5 Accessed: 07 November 2023. 2023.

5. Molina J-M, University of Paris Cite and Department of Infectious Diseases, St-Louis and Larilboisiere Hospitals. Going Beyond HIV and STls with PrEP and PEP. Paper presented at: 19th European AIDS Conference (EACS) October 18-21, 2023; Warsaw, Poland.

6. Clinicaltrials.gov. Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis(PrEP) (PURPOSE 5). Available at: https://clinicaltrials.gov/study/NCT06513312?term=lenacapavir, persistence&rank=1. Accessed: 11 November 2024. Last Updated: 21 October. 2024.

7. Bekker LG, Kiwanuka N, Selepe P, et al. Annual Persistence in Use of Twice-Yearly LenacapavirVersus Daily Oral PrEPin the PURPOSE 1 Phase 3 Trial [Presentation]. Paper presented at: HIV Drug Therapy Glasgow; November 10-13, 2024; Glasgow, UK.

8. Bekker LG, Das M, Abdool Karim Q, et al. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women [Supplementary Appendix]. N Engl J Med. 2024:1-69.

9. Bekker LG, Das M, Abdool Karim Q, et al. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women [Protocol]. N Engl J Med. 2024:1-672.

10. Gilead Sciences. Study of Lenacapavir and Emtricitabine/​Tenofovir Disoproxil Fumarate (F/​TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN-102) (PURPOSE 3) Available at: https://clinicaltrials.gov/study/NCT06101329?term=lenacapavir%20purpose&rank=1 Accessed: 13 November 2023. 2023.

Abbreviations

Ab=antibody
AE=adverse event Ag=antigen
bHIV=background HIV incidence
CGM=cisgender men
DBS=dried blood spot
FTC=emtricitabine
GNB=gender non-binary
IQ4=inhibitory quotient 4
IRR=incidence rate ratio
ISR=injection site reaction
LEN=lenacapavir
mITT=modified intent-to-treat
PEP=post-exposure prophylaxis
PK=pharmacokinetic(s)
PrEP=pre-exposure prophylaxis
PWID=people who inject drugs
PY=person-years
SUBQ=subcutaneous
TAF=tenofovir alafenamide
TDF=tenofovir disoproxil fumarate
TFV-DP=tenofovir diphosphate
TGM=transgender men
TGW=transgender women

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Sunlenca, Descovy, and Truvada US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/sunlenca/sunlenca_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi;
www.gilead.com/-/media/files/pdfs/medicines/hiv/truvada/truvada_pi.

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