Sunlenca® (lenacapavir)

Use in Heavily Treatment-Experienced Individuals

This document is in response to your request for information regarding the use of Sunlenca® (lenacapavir [LEN]) in people with HIV-1 (PWH) who are heavily treatment-experienced (HTE), including those with baseline (BL) resistance.

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/sunlenca/sunlenca_pi.

Summary

Product Labeling1

LEN, an HIV-1 CAI, in combination with other ARV(s), is indicated for the treatment of HIV-1 infection in HTE adults with multidrug resistant HIV-1 whose current ARV regimen is failing due to resistance, intolerance, or safety considerations.

Clinical Studies on LEN Use in HTE Individuals

In the ongoing phase 2/3 CAPELLA study that is evaluating LEN as an add-on therapy to a failing regimen in HTE PWH with multidrug resistance, significantly more participants in the LEN group than in the PBO group met the primary endpoint of a ≥0.5‑log10 reduction in HIV‑1 RNA at the end of the 14-day functional monotherapy phase (88% vs 17%, respectively; P<0.001).2,3

• At Week 156, 61.4% and 84.6% of participants achieved virologic suppression per FDA Snapshot and M=E analyses, respectively.4
• Subgroup analyses at Week 52 showed that LEN + OBR was associated with high rates of virologic suppression across various demographics and BL characteristics.3,5
• At Week 104, 27 participants met the criteria for resistance testing; 14 of these participants developed CAI resistance.6 There were no new cases of LEN resistance between Weeks 104 and 156.4
• Grade 3 TRAEs were reported in 6 participants (8.3%) and no Grade >4 or serious TRAEs occurred during follow-up through a median (IQR) of 165 (146–178) weeks. Two participants discontinued due to Grade 1 injection site nodules.4
• Through Week 52, the mean CfB in SF-36, EQ-5D-5L, and NPRS scores did not reach the MIC thresholds, and most symptoms were reported as bothersome by fewer participants at Week 52 than at BL.7

Real-World Data on LEN Use in HTE Individuals

In an analysis of HTE PWH in the French Compassionate Use Program who received LEN SUBQ + OBR (N=33), 12/14 patients (86%) with HIV-1 RNA <50 c/mL at BL and 10/19 patients (53%) with HIV-1 RNA ≥50 c/mL at BL achieved virologic suppression at Week 26. From BL to Week 26, 6 patients experienced virologic failure; 1 of those patients had the Q67H mutation that confers resistance to LEN. There were no Grade 3 or 4 TRAEs. ISRs were reported in 11/33 patients (33%); none led to treatment discontinuation.8

Clinical Studies on LEN Use in HTE Individuals

CAPELLA: LEN in HTE PWH

Study design and demographics

CAPELLA (NCT04150068) is an ongoing, phase 2/3, double-blinded, PBO‑controlled clinical study designed to evaluate LEN as add-on therapy to a failing regimen in HTE PWH with multidrug resistance. According to the change in the HIV-1 RNA level between the screening and cohort selection visits, participants were enrolled in either the randomized or non-randomized cohorts. Participants in the randomized cohort were assigned to receive oral LEN or PBO in a 2:1 ratio for 14 days, in addition to continuing their failing regimen. The non-randomized cohort started LEN (2-week oral initiation then SUBQ) with an OBR (Figure 1). Both cohorts are part of the maintenance phase evaluating the safety and efficacy of SUBQ LEN administered every 6 months in combination with an OBR.2,3,9

Figure 1. CAPELLA: Study Design2,4,10

Abbreviations: ATV/r=atazanavir/ritonavir; EFV=efavirenz; ETR=etravirine; NVP=nevirapine; TPV=tipranavir.

aParticipants with a <0.5 log10 decline in HIV-1 RNA and HIV-1 RNA ≥400 c/mL were enrolled in the randomized cohort; participants were enrolled in the non-randomized cohort if they had a ≥0.5 log10 decline in HIV-1 RNA and/or had HIV-1 RNA <400 c/mL or were enrolled after the randomized cohort was fully recruited.

bOral LEN dosing schedule: Day 1, 600 mg; Day 2, 600 mg; and Day 8, 300 mg.

cSUBQ LEN dosing schedule: 927 mg (2 × 1.5 mL) on Day 15 and then every 6 months.

Note: ATV, ATV/COBI, ATV/r, EFV, ETR, NVP, and TPV were not permitted for use in OBR.

The primary endpoint was the proportion of participants who achieved a ≥0.5‑log10 c/mL reduction in HIV‑1 RNA from BL to the end of the functional monotherapy phase in the randomized cohort. Secondary endpoints included the percentage of participants in the randomized cohort with HIV-1 RNA <50 c/mL and <200 c/mL at Week 26.2 Twenty‑two percent of all participants (16/72) did not have changes in their OBR before they entered the open-label maintenance phase; the ARV classes and agents that comprised the failing regimen and OBR are shown in Table 2.11

Table 1. CAPELLA Study: BL Demographics and Disease Characteristics2,3,9,12

aPercentages may not equal 100 due to rounding.

bRace was reported by the participants. Collection of race or ethnicity data was prohibited by local regulators for 1 participant in the PBO group and was excluded from the denominator of the percentage calculation.

cTwo participants in the non-randomized cohort had HIV-1 RNA >400 c/mL at screening but <50 c/mL at enrollment.

Table 2. CAPELLA Study: Composition of Failing Regimens and OBR13

aOSSs were calculated with a proprietary algorithm (Monogram Biosciences Inc.), and investigators provided data for scoring from historical resistance reports. An OSS of 1 indicated full susceptibility; 0.5 indicated partial susceptibility; and 0 indicated no susceptibility. The OSS of the OBR was the sum of the individual scores.

BL resistance analyses14

The study enrolled participants who had resistance to ≥2 ARVs in ≥3 of the four main ARV classes (NRTIs, NNRTIs, PIs, and INSTIs; Table 3 and Table 4). BL resistance in these participants was assessed using genotypic and phenotypic assays (Monogram Biosciences, Inc.) at screening or historical data provided by the investigators. BL HIV‑1 capsid genotypic and phenotypic analyses were also performed. At BL, no RAMs associated with LEN resistance (eg, L56I, M66I, Q67H, K70N, K74D/S, and T107N) were found in the 62 participants for whom these data were available.

Table 3. CAPELLA Study: RAMs per ARV Class at BL14

Table 4. CAPELLA Study: BL Resistance to NRTI, NNRTI, PI, and INSTI Classes by Cohort and in the Overall Population14,15

aResistance to ≥2 ARVs in the class. To be eligible for the study, participants had to have resistance to ≥2 ARVs from ≥3 of the four classes noted above.

bFor this study, M184V/I alone was not sufficient to fulfill the NRTI resistance criteria.

cThis participant had three-class resistance in the presence of NRTI mutation M184V/I only, which was not sufficient to fulfill the NRTI resistance criteria in this study.

Efficacy results

Day 15: randomized cohort results

From BL to Day 15 in this study, LEN showed potent antiviral activity when added to a failing regimen. Significantly more participants in the LEN group than in the PBO group met the primary endpoint of a ≥0.5-log10 reduction in HIV-1 RNA at the end of the 14-day functional monotherapy phase (88% [21/24] vs 17% [2/12], respectively; P<0.001) and had a greater mean change in HIV-1 RNA (-2.1 vs 0.07 log10 c/mL, respectively; P<0.001).2

Week 26: subgroup analysis by BL HIV entry inhibitor resistance16

At Week 26 in both cohorts, treatment response to LEN + OBR was unaffected by BL entry inhibitor susceptibility, as no significant difference in susceptibility was observed between participants with viral suppression (HIV-1 RNA <50 c/mL) and those with treatment failure (HIV-1 RNA ≥50 c/mL or no virologic data; P>0.1).

Week 52: subgroup analysis by BL characteristics3

Among all participants (n=72), HIV-1 RNA <50 c/mL was achieved at a rate of 78%. Several prespecified, post hoc subgroup analyses of all participants (n=72) were conducted to determine the efficacy of LEN at Week 52 according to selected BL demographics (ie, age, sex at birth, and race) as well as BL CD4 and HIV‑1 RNA values, BL number of fully active agents in OBR and BL resistance to INSTI, and BL use of ARV agents (eg, DTG, DRV, IBA, or FTR). There were no statistically significant differences between the subgroups.

Week 104: subgroup analysis in participants whose OBR had no fully active ARVs17

Twelve participants had no fully active ARVs in their OBR (OSS of 0, n=5; OSS of 0.5, n=6; OSS of 1, n=1). At Week 104, the mean (95% CI) changes in HIV-1 RNA and CD4 cell count were ‑2.34 (‑3.25, ‑1.44) log10 c/mL and +105 (-10, +220) cells/mcL, respectively. No participants developed resistance to their OBR or discontinued LEN.

Ten participants had HIV-1 RNA <50 c/mL at ≥1 of the predefined visits at Weeks 26, 52, or 104, and 8 had virologic suppression at all three visits. Of the 4 participants who did not have virologic suppression at those timepoints or had emergent LEN resistance, 3 developed LEN RAMs (M66I at Week 10, M66I at Week 4, and M66M/I at Week 4) that were associated with LEN functional monotherapy (no agents in the OBR were fully active). Two of these participants had an OBR change at Week 21 and Week 25, respectively, and were later suppressed, and another had HIV-1 RNA levels ≥50 c/mL throughout the study. The fourth participant also had HIV-1 RNA ≥50 c/mL throughout the study despite an OBR change at Week 30; no emergent LEN resistance was noted.

Week 156: maintenance phase results4

At Week 156, 52 out of 72 participants (72%) continued the study. Overall, 98% of the SUBQ doses were within ±14 days of the scheduled time. At Week 156, 61.4% and 84.6% of participants achieved virologic suppression per FDA Snapshot and M=E analyses, respectively (Figure 2).

Figure 2. CAPELLA Study: Virologic Outcomes Through Week 1564

aTwo participants who had missing HIV-1 RNA at Week 56 and had completed the study before reaching the upper limit of the analysis window for Week 156 were excluded.

bThe denominator was the number of participants with non-missing HIV-1 RNA values at each time point.

CD4 changes through Week 1564

Overall, CD4 count increased from BL by a mean (95% CI) of 164 cells/mcL at Week 156. At Week 156, the proportion of participants with CD4 counts <50 cells/mcL decreased from 24% of participants at BL to 2%, and the proportion of participants with CD4 counts <200 cells/mcL decreased from 64% to 22% (Figure 3).

Figure 3. CAPELLA Study: Changes in CD4 Counts at Week 1564

Abbreviation: D1=the first day SUBQ LEN was administered.

Post-BL resistance analyses

Post-BL resistance analyses were conducted in participants with suboptimal virologic response (HIV-1 RNA ≥50 c/mL and <1‑log10 decrease in HIV RNA from LEN initiation; assessed at Week 4), virologic rebound (after suppression, HIV RNA ≥50 c/mL or >1‑log10 increase from nadir), or viremia at their last visit.3

Week 156: post-BL resistance analysis

Through Week 52, 22 participants were included in the post-BL resistance analysis population; of these participants, 9 developed CAI resistance.3,18 An additional 5 participants had emergent LEN resistance from Week 52 to 104 (Table 5). This totaled 14 participants with emergent LEN resistance during the study, and all were at high risk of developing emergent LEN resistance due to inadequate OBR adherence (n=10) or a lack of fully active drugs in the OBR (n=4).4,9

Table 5. CAPELLA Study: Emergent LEN Resistance Through Week 1046

There were no new cases of LEN resistance between Weeks 104 and 156. Two participants who had previously detected resistance developed additional mutations: 1 participant had emergence of K70R+T107N with existing Q67H (reduction in LEN susceptibility from 4.5- to 85-fold of wild-type), and 1 participant had emergence of T107T/N with existing K70N+N74K (no LEN susceptibility data for triple mutant).4

Despite the emergence of LEN resistance, 5 participants were resuppressed while continuing LEN treatment (OBR was changed in 2 participants and unchanged in 3 participants). Six of the 9 participants who were not resuppressed continued study treatment (2 participants returned to their BL VL; mean log reduction for the 4 participants who did not return to BL VL: -1.64), and 3 participants discontinued the study (death, investigator’s discretion due to non‑compliance, and lost to follow-up, n=1 each).4

Safety results4

The median (IQR) duration of follow-up on LEN was 165 (146–178) weeks. Safety results through Week 156 are reported in Table 6.

Table 6. CAPELLA Study: Safety Results Through Week 1564

Abbreviation: TEAE=treatment-emergent adverse event.

aISRs and COVID-19 were excluded. bISR, n=4; immune reconstitution inflammatory syndrome, n=1; abdominal abscess, n=1; rash, n=1. cGrade 1 injection site nodule, n=2. dMalignant neoplasm, n=1; acute respiratory failure, n=1; unknown, n=1.

Note: TEAEs occurring in ≥10% of participants: constipation (13.9%), headache (13.9%), pyrexia (13.9%), abdominal distention (11.1%), arthralgia (11.1%), back pain (11.1%).

ISR results: Week 1564

Most ISRs (97.2%) reported through Week 156 were Grade 1 or 2, and the frequency reduced over time (Figure 4). Grade 1 ISRs of injection site nodules led to study discontinuation in 2 participants. The median (IQR) duration of swelling, erythema, pain, nodules, and induration was 8 (4–15), 5 (3–8), 3 (2–5), 288 (155–548), and 190 (67–410) days, respectively.

Figure 4. CAPELLA Study: ISRs Related to SUBQ LEN Through Week 1564

PROs7

Design

At Week 52, PROs were evaluated to assess CfB in HIV symptoms (using the SF‑36 [scale: 0–100; higher scores are associated with better physical health, mental health, and function] and HIV-SI scales [scale: 0–4; higher scores indicate more bothersome HIV symptoms]), overall HRQoL (using the EQ-5D-5L [0- to 1-point index score and a 0- to 100‑point VAS score; higher numbers indicate better health and how a patient’s health condition may limit or worsen the patient’s daily activities]), and injection pain (using the NPRS scale; [scale: 0–10; higher score indicates more intense pain]) during the most recently received injection.

Results

At BL, the mean SF-36 physical and mental component scores were 48.5 and 48.4, respectively; normal SF-36 scores in the US are 50 for both components. Through 52 weeks, the SF-36 component summary scores remained stable (Week 52 mean CfB: physical component, 1; mental component, -0.9), and the score changes did not reach the MIC values at any time (2 and 3, respectively).  

At Week 52, the proportion of participants who reported symptoms as bothersome decreased by 1% to 15% in most symptom categories (Figure 5). The three symptoms with the greatest decrease on the HIV-SI were fatigue or loss of energy (-15%), feeling nervous or anxious (-‍14%), and muscle aches or joint pain (-‍10%). At least 5% more participants reported the following symptoms as bothersome at Week 52 than at BL: headache and pain, numbness, or tingling in the hands or feet.

Figure 5. Proportion of Participants Who Reported Each Symptom as at Least a Little Bothersome (HIV-SI ≥2)7a

aAmong all participants; percentages based on participants who responded 2 (“it bothers me a little”), 3 (“it bothers me”), and 4 (“it bothers me a lot”) on the HIV-SI response scale.

bA ≥5% decrease at Week 52 vs BL.

cA ≥5% increase at Week 52 vs BL.

At BL, the mean EQ-5D-5L index and VAS scores were 0.87 and 80.4, respectively; normal EQ-5D-5L index and VAS scores in adults in the US are 0.851 and 80.4, respectively. Through 52 weeks, the EQ-5D-5L scores remained stable (Week 52 mean CfB: index, -‍0.06; VAS, 3), and the score changes did not reach the MIC values at any time (0.063 and 7, respectively).

The individual NPRS scores for all participants were highly variable over 52 weeks (range: 3.9–5.1), with no clear trend; however, the mean score remained stable, and the mean CfB was less than the MIC threshold of 2.

Real-World Data on LEN Use in HTE Individuals

French Compassionate Use Program8

Study design and demographics

An analysis was conducted among PWH with a history of multidrug failure in the French Compassionate Use Program who were enrolled between January 2021 and December 2023 to assess the effectiveness and safety of LEN SUBQ + OBR (N=33). Patients received a 2-week oral loading dose of LEN followed by LEN SUBQ once every 26 weeks in combination with an OBR. The primary endpoint was the proportion of patients with HIV-1 RNA <50 c/mL at Week 26. Secondary endpoints included virologic status at the end of follow‑up, emergence of LEN resistance in cases of virologic failure (defined as confirmed HIV-1 RNA >50 c/mL at Week 26 or at the last visit prior to discontinuation or virologic rebound after achieving HIV-1 RNA <50 c/mL), and tolerance of treatment.

The most frequently used ARVs in the OBR were DRV/r (n=13), FTR (n=12), DTG (n=11), CAB (n=10), MVC (n=8), IBA (n=7), and T20 (n=4). Additional BL characteristics are presented in Table 7.

Table 7. BL Demographics and Disease Characteristics (Delaugerre et al)8

aGenotypic susceptibility scores were determined by using the ANRS French algorithm V35 to interpret cumulative historical resistance reports. The OSS of the OBR was the sum of the individual scores.

Results

Overall, 24/33 patients (73%) received 3 doses of LEN SUBQ. At Week 26, LEN SUBQ + OBR resulted in high levels of virologic suppression (Figure 6). At the last follow-up visit (median, 12.2 months), 13/14 patients (93%) with HIV-1 RNA <50 c/mL at BL and 14/19 (74%) with HIV-1 RNA ≥50 c/mL at BL maintained or achieved virologic suppression.

Figure 6. Effectiveness Outcomes at Week 26 Overall and by BL HIV-1 RNA
(FDA Snapshot; Delaugerre et al)8

The mean CD4 cell count increased by +86 cells/mcL from BL to Week 26 and by +51 cell/mcL from BL to the last follow-up visit. At the last follow-up visit, 81% of patients had a CD4 count >200 cells/mcL. The proportion of patients with CD4 count >200 cells/mcL increased from 60% at BL to 68% at Week 26 and 81% at LVFU.

From BL to Week 26, 6 patients experienced virologic failure and underwent HIV-1 capsid sequencing. One patient had the Q67H mutation that confers resistance to LEN.

There were no Grade 3 or 4 TRAEs. There were 2 deaths: 1 death occurred at Week 4 secondary to acute hepatitis with hepatocellular insufficiency that led to multiorgan failure, and 1 death occurred at Week 15 secondary to septic shock. ISRs were reported in 11/33 patients (33%); none led to treatment discontinuation.

References

1. SUNLENCA, Gilead Sciences Inc. SUNLENCA® (lenacapavir) tablets, for oral use. SUNLENCA® (lenacapavir) injection, for subcutaneous use. U. S. Prescribing Information. Foster City, CA.

2. Segal-Maurer S, DeJesus E, Stellbrink HJ, et al. Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2022;386(19):1793-1803.

3. Ogbuagu O, Segal-Maurer S, Ratanasuwan W, et al. Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial. Lancet HIV. 2023;10(8):e497-e505.

4. Ogbuagu O, McGowan JP, Stapleton A, et al. Long-Acting Subcutaneous Lenacapavir in People With Multi-Drug-Resistant HIV-1: 3-Year Results of the CAPELLA Study.[Presentation #155]. Paper presented at: IDWeek 2024; October 16-19, 2024; Los Angles, CA.

5. Ogbuagu O, Segal-Maurer S, Castagna A, et al. Week 52 Subgroup Efficacy of Lenacapavir in Heavily Treatment-Experienced PWH [Poster 523]. Paper presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 19-22 February, 2023; Seattle, WA.

6. Margot N, Jogiraju V, VanderVeen L, et al. Resistance Analysis of Long Acting Lenacapavir in Heavily Treatment Experienced People with HIV after 104 Weeks of Treatment. [Oral Presentation: PS8 O4]. Paper presented at: The 19th European AIDS Conference; October,18-21, 2023; Warsaw, Poland.

7. Ramgopal M, Mezzio DJ, Dunn K, et al. Participant-Reported Outcomes With Long-Acting Lenacapavir-Based Regimens Among Heavily Treatment-Experienced People Living With HIV in the CAPELLA Clinical Trial [Poster EPB0216]. Paper presented at: International AIDS Society (IAS) 2023, the 12th IAS Conference on HIV Science; July 23-26, 2023; Brisbane, Australia.

8. Delaugerre C, Mafi S, Zenuni A, et al. Capsid Inhibition with Lenacapavir in HIV-1 Infection: Real-life Results from the French Compassionate Use Program. [Poster #EP0195]. Paper presented at: 13th International AIDS Society (IAS) Conference on HIV Science; July 13–17, 2025; Kigali, Rwanda.

9. Ogbuagu O, DeJesus E, Berhe M, et al. Efficacy and safety of long-acting subcutaneous lenacapavir in heavily treatment experienced people with multi drug resistant HIV: Week 104 results [Poster 1596]. Paper presented at: ID Week 2023; October 11-15, 2023; Boston, MA.

10. Segal-Maurer S, DeJesus E, Stellbrink HJ, et al. Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection [Supplement]. N Engl J Med. 2022;386(19):1793-1803.

11. Castagna A, Blanco JL, Hung C, et al. Week 52 Subgroup Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People With Multidrug-Resistant HIV (CAPELLA Study) [Poster P026]. Paper presented at: HIV Glasgow 23-26 October, 2022; Glasgow, UK.

12. Ogbuagu O, Segal-Maurer S, Brinson C, et al. Long-Acting Lenacapavir in People With Multidrug-Resistant HIV-1: Week 52 Results [Poster 1047]. Paper presented at: Virtual Conference on Retroviruses and Opportunistic Infections (CROI) 2022; 12-16 February, 2022.

13. Stellbrink H, DeJesus E, Segal-Maurer S, et al. Subgroup Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People With HIV in the Phase 2/3 CAPELLA Study [Poster]. Paper presented at: 18th European AIDS Conference (EACS); October 27-30, 2021; London, UK.

14. USE DN, Margot NA, Naik V, et al. USE ENDNOTE 75466 Resistance analyses in Highly Treatment-Experienced People with HIV Treated with the Novel Capsid HIV Inhibitor Lenacapavir. J Infect Dis. 2022:1-7.

15. Margot N, VanderVeen L, Naik V, et al. Resistance Analysis of Long-Acting Lenacapavir in Highly Treatment-Experienced People with HIV after 26 Weeks of Treatment [Presentation]. Paper presented at: 18th European AIDS Conference (EACS); October 27-30 2021; London, UK.

16. Margot N, Naik V, Rhee MS, Callebaut C. Absence of Cross-Resistance to Lenacapavir in HIV Entry Inhibitor-Resistant Isolates [Poster 508]. Paper presented at: Virtual Conference on Retroviruses and Opportunistic Infections (CROI) 2022; 12-16 February, 2022.

17. Ogbuagu O, Ratanasuwan W, Avihingsanon A, et al. Lenacapavir Efficacy in CAPELLA Patients with No Fully Active Agents in Optimized Background Regimen [Poster 000940]. Paper presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2024; Denver, CO.

18. Ogbuagu O, Segal-Maurer S, Ratanasuwan W. Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial.[Supplementary Appendix]. Lancet HIV. 2023;10(8):e497-e505.

Abbreviations

ANRS=Agence Nationale de Recherche sur le Sida et les Hepatites
ARV=antiretroviral ATV=atazanavir
BL=baseline
c/mL=copies/mL
CAB=cabotegravir
CAI=capsid protein inhibitor
CD4=cluster of differentiation 4
CfB=change from baseline
COBI=cobicistat
DRV=darunavir
DRV/r=darunavir/ritonavir
DTG=dolutegravir
FTR=fostemsavir
HIV-SI=HIV symptom index
HRQoL=health-related quality of life
HTE=heavily treatment‑experienced
IBA=ibalizumab
INSTI=integrase strand transfer inhibitor
ISR=injection site reaction
LEN=lenacapavir
M=E=missing equals excluded
MIC=minimal important change
MVC=maraviroc
NNRTI=non-nucleos(t)ide reverse transcriptase inhibitor
NPRS=numeric pain rating scale
NRTI=nucleos(t)ide reverse transcriptase inhibitor


OBR=optimized background regimen
OSS=overall susceptibility score
PBO=placebo
PI=protease inhibitor
PWH=people with HIV
PRO=patient-reported outcomes
RAM=resistance-associated mutation
SF-36=36-item Short Form Survey
SUBQ=subcutaneous
T20=enfuvirtide
TRAE=treatment-related adverse event
VAS=visual analogue scale
VL=viral load
 

Product Label

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