A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV

Prior treatment

• Within 6 months prior to Screening, any plasma HIV-1 RNA measurement ≥50 copies/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement \>200 copies/mL, or 2 or more plasma HIV-1 RNA measurements ≥50 copies/mL.
• Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month.
• Present or past evidence of viral resistance to agents of the NNRTI or INI class or prior treatment failure with agents of NNRTI or INSTI class
• Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:
  • Participants positive for HBsAg are excluded.
  • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded.
  • Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
  • Participants treated with entecavir are not excluded.
• Current use of concomitant treatment with prohibited medication

Other illness

• Any condition that does not recommend intramuscular injections in the gluteal muscle.

Other

• Any contraindication for CAB LA, RPV LA, oral Cabotegravir or Rilpivirine (see EU SmPC).
• Pregnancy or breastfeeding women, or with the desire to become pregnant soon.

• Aged 18 years or older at the time of signing the informed consent.
• Virologically suppressed (HIV-1 RNA \<50 copies/mL) on a stable antiretroviral regimen
• Documented evidence of plasma HIV-1 RNA measurements \<50 copies/mL in the 6 months prior to Screening (1x blip is allowed).
• Ability to understand informed consent form (ICF) and other relevant regulatory documents.
• Prior to starting CAB LA + RPV LA injections, HIV physicians should have carefully selected patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses.
• A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine hCG test ) and not lactating. Females of childbearing potential will be required to use a highly effective method of contraception.