CAN CABENUVA

KEEP ME UNDETECTABLE?

At Week 48 in all studies:

  • 9 out of 10 people remained undetectable, whether they were on daily HIV pills or CABENUVA
  • Less than 2% of people did not remain undetectable (primary endpoint)

*Undetectable means the amount of HIV in the blood is below the level that can be measured by a lab test. Results may vary.

†Daily pill regimens contained dolutegravir and 2 nucleoside reverse transcriptase inhibitors (NRTIs) or 2 NRTIs plus a protease inhibitor (PI), non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).

Results were consistent:

  • After 96 weeks
  • With both once-monthly and every-other-month regimens
  • Whether or not people took starter pills before beginning injections
  • Across a diverse range of ages, races and genders, including transgender people

CABENUVA was also tested in people 12 years and older who weigh at least 77 lbs (35 kg).

SIDE

EFFECTS

Injection-site reactions were reported less often the longer people were on treatment.§

Aside from injection-site reactions, the most common side effects to occur in less than 9% of people were:

  • Fever
  • Tiredness
  • Headache
  • Muscle or bone pain
  • Nausea
  • Sleep problems
  • Dizziness
  • Rash

Less than 4% of people on CABENUVA stopped treatment due to any side effect.||

These are not the only side effects of CABENUVA. For more information, see the Risks & Side Effects page. Always tell your doctor if you experience any side effects.

Results may vary.

‡Injection-site reactions include pain, tenderness, hardened mass or lump, swelling, redness, itching, bruising and warmth at the injection site.

§The true rate of injection-site reactions over time may be underestimated, as symptoms that occurred may not have been reported during the study.

||4% of people on once-monthly CABENUVA; 2% of people on every-other-month CABENUVA.

DID PEOPLE

PREFER LONG-ACTING TREATMENT?

PMUS-CBRWCNT250041

HOW’S CABENUVA

IN THE REAL WORLD?

To help understand the impact of CABENUVA on people outside clinical trials, BEYOND—an ongoing, 2-year, real-world study—analyzed data collected from routine medical care delivered in a realistic, everyday setting with adult participants who switched to CABENUVA

Who participated?:

  • Adults 18 years or older, living with HIV-1
  • With no prior experience on long-acting CABENUVA
  • [233] people who met the criteria to be enrolled and switched to long-acting CABENUVA treatment 

All participants had:

  • Undetectable status (HIV-1 RNA <50 copies/mL)
  • No history of treatment failure(s) while on other HIV treatments
  • No documented resistance to cabotegravir or rilpilvirine—the 2 medicines in CABENUVA

The BEYOND study revealed relevant results in 4 categories: efficacy, side effects, preference, [and commitment].

EFFICACY

Same proven efficacy from clinical trials, now shown with patients in the real world

In the BEYOND study, 98% of people who began CABENUVA treatment remained undetectable at 24 months*

*Achieved by a group of participants who, when initiating CABENUVA, were virally suppressed with no reported virologic failures or documented resistance to either of the medicines in CABENUVA. Of participants (24%) who began receiving CABENUVA without meeting all the criteria the original clinical trial had required, 90% were undetectable at 12 months.

SAFETY & SIDE EFFECTS

Consistent with clinical trials, real world evidence showed that very few patients discontinued due to injection site reactions.

Only 2% of people on CABENUVA stopped the treatment due to injection-site reactions.*§

*The BEYOND study was not designed to collect safety data, however, some safety information was sent to reviewers from site staff, or seen in medical records or from patient preference surveys.

§The true rate of injection-site reactions over time may be underestimated, as symptoms that occurred may not have been reported during the study.

PREFERENCE

In the real world, 98% of people living with HIV who switched to CABENUVA preferred long-acting injectable over their previous daily oral pills.

At month 12, the BEYOND study showed that switching to CABENUVA was associated with improvements in psychological challenges related to HIV treatment. The #1 reason that participants gave for preferring long-acting injections over daily pills was not having to remember to take HIV medicines every day.

COMMITMENT

Real world evidence showed CABENUVA can fit well with people’s routines.

88% of people received their CABENUVA injection on their Target Treatment Day or within the Flexible Treatment Window throughout 2 years. The other 12% of people received their injections early or late. If you cannot attend your scheduled appointment, be sure to contact your doctor right away.