May 31, 2023

Categories:: Clinical Guides, Data, HIV treatment, PrEP, Prevention

Injectable resources

Clinical guides, protocols and EHR tools
- EBGTZ Injectable PrEP Quick Guide
- Pacific AETC Injectables Toolkit, including clinical protocols, checklists and patient education
- SFDPH Injectable PrEP Pocket Card PDF; also on this webpage
- Ward 86 Long-acting Injectable Antiretroviral Protocol
- LifeLong Long-acting Injectable ARV Protocol
- Epic SmartPhrases for Cabenuva and Apretude from LifeLong
Training videos
- Apretude clinical training video from Viiv: click to watch here or watch on the Viiv website
- Cabenuva implementation video from AETC: medication storage (at 11:02 mins), administration (at 12:59 mins)
- Ventrogluteal injection site training video
- Thigh injection (vastus lateralis) site training video
Infographics for community members
- Injectable ART and PrEP graphics from NLAAD, some are posted below in English and Spanish
- Options for PrEP Chart (includes pill & injectable options) – Denver PTC (also posted below in English and Spanish)

Latest HIV injectable updates

We currently have 3 long-acting injectable HIV medications (Cabenuva and Sunlenca) and 1 long-acting injectable HIV PrEP medication (Apretude) that are FDA-approved and available.
Clinical/prescribing updates:
- Sunlenca (lenacapavir, or LEN) is a long-acting injectable HIV medication in a new class called capsid inhibitors taken every 6 months in combination with other active HIV medications for people who have drug-resistance.
- Cabenuva (cabotegravir/rilpivirine, or CAB/RPV) is a combination of 2 long-acting injectable HIV medications taken every 1 to 2 months. Cabenuva no longer requires an oral lead-in prior to injection. Study data shows long-term virologic suppression and safety to ~3 years.
  - Check carefully for resistance: Remember to check genotype and ART history carefully, including evaluating baseline transmitted resistance. Since CAB/RPV is a 2-drug regimen, we want to avoid using it alone in people with RPV or CAB resistance. Check for the key CAB/RPV resistance mutations listed at the bottom of page 2 of the W86 protocol. You can also analyze the impact of resistance mutations on the Stanford database.
  - For people starting injections with viremia:
    - Check viral load every 1-2 months after you start CAB/RPV.
    - We recommend staying with q4-week dosing for 3-6 months and wait for sustained viral load suppression before switching to q8-week dosing.
    - CAB/RPV is effective even for people with viremia and adherence challenges and is non-inferior to bictegravir regimens (Biktarvy), but baseline viremia and NNRTI or INSTI resistance are associated with CAB/RPV failures so watch those starting with viremia closely and avoid using it alone with any baseline resistance.
  - For people with chronic hepatitis B: CAB/RPV is not active against hep B. If CAB/RPV is still the best HIV ART option for them, add oral hep B treatment.
  - Consider injection site options: New data presented at CROI 2023 found that CAB/RPV thigh injections have drug levels equivalent to ventrogluteal and dorsogluteal injections.
  - For people with BMI>30 on CAB/RPV:
    - Data presented at CROI 2023 found lower cabotegravir and rilpivirine concentrations were associated with people with high BMI and people who did not use an oral lead-in.
    - The ATLAS 2M study also found lower drug concentrations with q8-week dosing compared to Q4-week dosing, though still above the necessary concentration.
    - Here are strategies to consider for people with BMI>30, based on discussion with SF and East Bay HIV clinicians and pharmacists and the updated Ward 86 LAI Protocol:
      - Use an oral ART regimen overlapping with the first CAB/RPV injection for the first 2 weeks.
      - Use a 2-inch needle or longer to inject the medication into muscle.
      - Consider using injection sites where you can best reach muscle, e.g. thigh vs. ventrogluteal vs. dorsogluteal injection sites.
      - Stay on a q4-week dosing schedule for at least 3-6 months with consistent viral load suppression before switching to q8-week dosing.
      - Be even more cautious in people with BMIs>40 since we do not have data yet for people with BMIs>40 and already know that drug levels are lower for people with BMIs 30-40. Consider not using CAB/RPV if you have good alternatives, or consider using 900/600 mg RPV/CAB dosing q4-weeks, pending further data.

East Bay access and coverage updates
- Sunlenca (lenacapavir) has been a Medi-Cal pharmacy benefit since March 1, 2023, and on the ADAP formulary starting April 25, 2023. Prior authorization is required for ADAP coverage due to its high cost. Sunlenca is available through CVS Specialty Pharmacy.
- Apretude and Cabenuva is covered by Medi-Cal without a prior authorization, and Cabenuva is covered by ADAP without prior authorization. Walgreens Community, AHF, CVS Specialty and Walgreens Alliance pharmacies have Cabenuva ART and Apretude PrEP available.