It starts with proven efficacy and safety

SOLAR: Efficacy

CABENUVA phase 3b, head-to-head, clinical trial efficacy:

Every-2-month CABENUVA was noninferior to daily oral BIKTARVY1,2

SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with daily oral BIKTARVY1,2

  • SOLAR Study Design

    SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY1,2

    A large phase 3b, open-label, noninferiority study of virologically suppressed* adults (≥18 years) with HIV-1

    CABENUVA vs BIKTARVY SOLAR study with virologically suppressed patients
    SOLAR study design efficacy endpoints graphic
    • Efficacy analyses, baseline questionnaire, and preference calculation were based on the mITT-E (N=670) population. After consultation with a blinded external expert, 11 participants at a single study site were excluded from the ITT-E population due to critical findings related to significant and persistent noncompliance to protocol requirements
    • Safety analyses were based on ITT-E (N=681) population
    1. Suppression defined as plasma HIV-1 RNA <50 copies/mL. A single prior INSTI-based regimen was allowed for reasons other than treatment failure.
    2. 39% (n=173) started with oral lead-in (OLI) and 61% (n=274) of patients in the CABENUVA arm started with injections (SWI) without OLI. OLI regimen consisted of 30-mg cabotegravir and 25-mg rilpivirine once daily given for 1 month; on last day of the OLI period, patients received 2 sets of initiation CABENUVA injections 1 month apart followed by every-2-month injections thereafter.
    3. Month 12 (OLI and BIKTARVY) and Month 11 (SWI).
    Primary endpoint, secondary efficacy endpoint, and exclusion criteria for SOLAR study patients

  • SOLAR Baseline Characteristics

    SOLAR included a broad range of patients (mITT-E)1,2

    • 61% (n=274) of patients in the CABENUVA arm started with injections without oral lead-in (OLI) and 39% (n=173) started with OLI
    SOLAR study baseline characteristics table

SOLAR primary endpoint

The SOLAR primary endpoint was met (mITT-E; HIV-1 RNA ≥50 copies/mL):
Every-2-month CABENUVA was noninferior* to BIKTARVY at Month 12 analysis (1% [5/447] vs <1% [1/223], respectively, adjusted difference = 0.7% [95% CI -0.7 to 2.0]).

SOLAR study secondary endpoint chart SOLAR study secondary endpoint chart

Hear from Dr. Ramgopal about key elements of SOLAR

The power of peer-proven CABENUVA results

Moti Ramgopal, MD

Explore key CABENUVA data with Dr. Ramgopal, including challenges with taking daily oral HIV therapy, proven noninferiority of CABENUVA vs daily oral therapy with BIKTARVY, and patient preference for CABENUVA.

Speaker has been compensated by ViiV Healthcare.

  • BMI Subset Efficacy

    CABENUVA was as effective in patients with higher BMI at 12 months (subset analysis)2,3

    BMI ≥30 kg/m2: HIV-1 RNA ≥50 copies/mL: 1% (1/93) of participants treated with CABENUVA vs 0/52 treated with BIKTARVY (difference=1.1, 95% CI -6.5, 6.1)

    SOLAR BMI subset efficacy chart

    Longer needle lengths may be required for patients with higher BMI.

  1. Noninferiority shown if the upper bound of the 95% CI for the treatment difference was <4%.
  2. Noninferiority shown if the lower bound of the 95% CI for the treatment difference was > -12%.

SOLAR confirmed virologic failure

Confirmed virologic failure (CVF) breakdown

SOLAR confirmed virologic failure graphic
  • Key differences in ATLAS-2M: all patients had previously received an NNRTI-, PI-, or INSTI-based regimen. Through Week 152, there were 12 (2%) CVFs in the every-2-month arm and 2 (<1%) in the once-monthly arm4
  • Of the two CVFs on CABENUVA, both patients had rilpivirine and INSTI RAMs observed

Patients who met CVF re-suppressed on alternative, highly suppressive antiretroviral therapies

  1. An additional patient on CABENUVA in the ITT-E population met CVF at Month 3 with RPV RAMs.

SOLAR: Safety

Drug-related adverse events through Month 121,2

SOLAR common adverse events table SOLAR common adverse events table

Most common adverse events ≥1%

  • Most drug-related AEs were Grade 1 or 2 in CABENUVA patients; all were Grade 1 or 2 in BIKTARVY patients
  • 2% of CABENUVA patients (event level) discontinued treatment due to injection-related reasons, and 2% discontinued due to non-ISR, drug-related AEs
  1. Defined as “treatment-related” as assessed by the investigator. Only maximum-graded report per adverse reaction contributes to table.
  2. Pyrexia: includes pyrexia, feeling hot, chills, influenza-like illness, body temperature increased.
  3. Fatigue: includes fatigue, malaise, asthenia.
  4. Musculoskeletal pain: includes musculoskeletal pain, musculoskeletal discomfort, back pain, myalgia, pain in extremity.
  5. Sleep disorders: includes insomnia, poor quality sleep, somnolence.
SOLAR injection site reactions table SOLAR injection site reactions table

Injection site reactions (ISRs)1,2

  • The median duration (IQR) of ISRs was 3 days (2-5)
  • 2% of CABENUVA patients (event level) discontinued treatment due to injection-related reasons

Patient-reported ISRs decreased over time1,2*

Majority of ISR events (event-level: 98% [1885/1915]) were Grades 1-2.

Self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the course of the study.

SOLAR injection site reactions over time table

Majority of ISR events (event-level: 98% [1885/1915]) were Grades 1-2.

Self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the course of the study.

*Participants’ injection schedule during the maintenance phase: oral lead-in—Month 1, 2, 4, 6, 8, 10, 12; direct to injections—Day 1, Month 1, 3, 5, 7, 9, 11.
Data for the 2 arms have been combined.

SOLAR: Patient preference

It starts with a regimen that some patients prefer

In SOLAR, every-2-month CABENUVA was preferred by 9 out of 10 survey respondents vs daily oral therapy with BIKTARVY1

At Month 12 analysis or study withdrawal (secondary endpoint), all CABENUVA-treated patients in SOLAR (mITT-E; n=447) were asked to respond to a question about which regimen they preferred. 22 patients did not respond. Of the 425 survey respondents:

Patient Ambassador Miranda on long-acting CABENUVA

90%

reported a preference for CABENUVA

  • Patients were asked to compare their experience using CABENUVA versus BIKTARVY, to select the treatment they preferred, and then select from a list of provided statements to support their preference
  • 5% (n=21/425) preferred BIKTARVY and 5% (n=22/425) had no preference

These results are descriptive in nature and should not be used to infer clinical significance.

  • Why did patients prefer CABENUVA?

    The most commonly chosen responses were3*:

    85%“I do not have to worry as much about remembering to take HIV medication every day.”

    83%“It is more convenient for me to receive injections every 2 months.”

    74%“I do not have to carry my HIV medication with me.”

    61%“I do not have to think about my HIV status every day.”

    59%“I do not have to worry about others seeing or finding my HIV pills.”

    Respondents could choose one or more reasons for their preference.

    1. Patients who preferred CABENUVA were given a list of 11 reasons to choose from; more than one reason could be chosen.

CABENUVA real-world results
reinforce SOLAR

Explore real-world studies

AE=adverse event; BMI=body mass index; CI=confidence interval; HBV=hepatitis B virus; INSTI=integrase strand transfer inhibitor; ITT-E=intent-to-treat exposed; IQR=interquartile range; mITT-E=modified intent-to-treat exposed; M=Month; NA=not applicable; NNRTI=non-nucleoside reverse transcriptase inhibitor; PI=protease inhibitor; RAM=resistance-associated mutations; RPV=rilpivirine

References:

  1. Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023;10(9):E566-E577.  doi.org/10.1016/S2352-3018(23)00136-4
  2. Data on file. ViiV Healthcare group of companies. Durham, NC.
  3. Eu B, Oka S, Sims J, et al. Cabotegravir + rilpivirine long-acting outcomes by sex at birth, age, race, and body mass index: a subgroup analysis of the phase 3b SOLAR study. Presented at: 
IAS Conference on HIV Science; July 23-26, 2023; Virtual and Brisbane, Australia.
  4. Overton E, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with human immunodeficiency virus 1 type 1 infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b, noninferiority study. Clin Infect Dis. 2023;76:1646-1654. doi: 10.1093/cid/ciad020

PMUS-CBRWCNT240093