East Bay Getting to Zero
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Data, PEP, PrEP, Prevention, Research, STIs

The CROI 2024 conference covering the latest scientific research in HIV, STIs, mpox, hepatitis and Covid, took place on March 3-6, 2024. Below are some of the highlights from the conference that we think are most relevant for care and prevention teams in the East Bay. Lots of great data on injectables.

Jump to updates on: injectable ART, cardiometabolic risk reduction, PrEP and PEP, STI prevention, more CROI resources

Injectable ART updates

  • Injectable ART: More evidence that injectable ART is effective for people with adherence challenges and viremia; longer intervals between viral load monitoring might be ok.
    • The LATITUDE trial found that CAB/RPV was superior to oral ART for PLWH with adherence challenges. This trial included people who have adherence challenges who were first given oral ART and economic incentives. Those who achieved viral suppression (VL<200c/mL) were then randomized to CAB/RPV q4wks or continuing oral ART. At week 48, so many more people taking oral ART had virologic failure (25.4%) compared to those on CAB/RPV (7.2%) that the trial was stopped early because the data had already demonstrated superiority of the CAB/RPV arm.
    • The Ward 86 team presented updated data for their cohort of PLWH starting with viremia and adherence challenges: at week 48, 81% of 59 patients remained on CAB/RPV and suppressed (<50c/mL), 93% of people on CAB/RPV or alternative ART (such as CAB+LEN) were suppressed. 3 people (5%) were lost-to-follow-up, and 3 people (5%) had virologic failure with emergent resistance.
    •  CAB/RPV virologic failure in clinical practice was low (similar to clinical trials):
      • The OPERA cohort of 1,362 diverse people on CAB/RPV found a 2% CAB/RPV virologic failure rate compared to 3% for oral ART. All started with VL<50 and virologic suppression rates were similar between the CAB/RPV and oral ART groups.
      • A smaller cohort of 75 people on CAB/RPV at Rush U in Chicago found a 4% virologic failure rate (3 patients), including 2/10 of the people receiving injections at an infusion clinic, all of whom had injections with 1.5” needles, including for a person with a BMI of 35, raising concerns about “irregular injection techniques.” This is a good reminder for monitoring the training
    • High CAB/RPV uptake in an urban academic clinic in Southside Chicago: The U. Chicago Ryan White clinic shared data from their pharmacist and nurse-led CAB/RPV program. Viral suppression was requirement before switching to CAB/RPV. Of the 114 people referred for CAB/RPV start (85% Black, 35% cisfemale, 31% mental illness, 8% substance use, 53% permanent housing), 71% who were virally suppression at referral started CAB/RPV and 86% remained on CAB/RPV and suppressed at 8 months. However, only 1 of the 12 people not suppressed at baseline (9%) subsequently suppressed on oral ART and started CAB/RPV, leading to the study authors to state: “More work is needed to support providers, patients, and clinic systems to deliver LAI-CAB/RPV to this group.” The U Chicago team is planning low-barrier care teams with intensive case management.
    • The CARES trial with CAB/RPV Q8wk injections and Q24wk viral loads in Uganda, Kenya and South Africa compared outcomes for 512 people starting out virally suppressed and no history of treatment failure, though with high levels of NNRTI use/resistance, who were randomized to CAB/RPV Q8wks to standard-of-care oral ART. Outcomes at week 48 include:
      • Viral suppression rates: 96.9% with CAB/RPV vs. 97.3% with oral ART at week 48.
      • 12-15% had baseline CAB or RPV resistance mutations on archived genotypes.
      • CAB/RPV was highly effective for people with HIV subtype A1.
      • Participants had a very high adherence to the injection schedule and higher treatment satisfaction with CAB/RPV at week 48.
      • Q8 week injections and Q24 week viral load monitoring worked in this group.
    • The IMPAACT/MOCHA trial of CAB/RPV in 144 adolescents (ages 12+ and 35+ kg) with viral suppression in 18 international sites found that after 24 weeks, CAB/RPV was safe and well-tolerated, 96.5% had viral suppression, and there were no confirmed virologic failures. 99% preferred long-acting injections over oral medications, citing convenience and “reduced burden” (reduction in anxiety, treatment fatigue and adherence; increase in privacy) as the main reasons.
    • LEN+CAB: A case series of 34 patients with adherence challenges to oral ART and most with RPV resistance were given lenacapavir and cabotegravir (LEN+CAB). Viral suppression rates doubled from 47% at to 94% after starting LEN.   

Cardiometabolic risk reduction

  • Data from the REPRIEVE trial found that CV risk-prediction tools (ASCVD, pooled equation) overestimated cardiovascular event risk in low-to-middle income countries and underestimated risk in high-income regions, especially among women (2.5x or 250% more events than predicted) and Black/Af Am participants (50% more events than predicted).
  • The REPRIEVE trial previously found that pitavastatin 4mg taken for ~5 years reduced major cardiovascular events by 35% vs. placebo in PLWH with low-to-moderate cardiovascular risk.
  • Moderate intensity statins are now recommended for most PLWH 40+ yo; strongest evidence for ASCVD ≥5%; if <5% decide on a case by case basis. Recommended options include:
    •   Pitavastatin 4 mg once daily
    •   Atorvastatin 20 mg once daily
    •   Rosuvastatin 10 mg once daily
  • A study on INSTIs during menopause found that women who switched to INSTI regimens during menopause experienced early increases in waist circumference and BMI. 
  • MASLD = metabolic dysfunction-associated steatotic liver disease, a condition formerly known as NAFLD, including NASH and NAFL.
  • The SLIM LIVER study found that 53% of PLWH have MASLD with unique characteristics: less steatosis on histology but higher fibrotic stage.
  • The SLIM LIVER study also found that low-dose once-weekly semaglutide for 24 weeks in PLWH with MASLD lowered weight (ave. 17 lbs lost), triglycerides, glucose, and HbA1C.
    • 29% had complete resolution of MASLD.
    • 58% had a 30+% reduction in intrahepatic triglycerides.
    • Sarcopenia: psoas muscle volume declined (more in ages 50+) but muscle fat content and physical function was preserved.
  • MASLD diagnosis in the study was done by liver MRI.
    • MASLD diagnosis in our network: clinicians are using mostly ultrasound-based elastography (such as FibroScan). Other diagnostic options include liver MRI, and if imaging is not available/accessible, serologic tests, such as the FIB-4 index.
    • Consider getting imaging and/or calculating a FIB-4 score for people with unexplained elevations in ALT or AST, and/or two or more metabolic risks (such as metabolic syndrome, dyslipidemia, obesity, pre-diabetes, diabetes), or a first-degree relative with MASLD cirrhosis.

PrEP and PEP updates

Viral loads likely not needed in oral PrEP and may still be useful in CAB-LA PrEP; injectable PrEP uptake is slow but offering options increases PrEP coverage.

  • A CDC study evaluated a large cohort of PrEP users, including 439 people on CAB-LA, and found no conclusive LEVI cases.
  • The HPTN083 study group found that getting viral loads for people on CAB-LA would have detected some cases earlier.
  • These data combined suggest that viral loads are likely not needed in oral PrEP and may be useful in CAB-LA PrEP if you can get them.
  • Another CDC study found that only 0.5% of PrEP users were prescribed CAB-LA as of September 2022, with insurance coverage and staffing major challenges.
  • A PrEP dynamic choice study in East Africa found that offering multiple options including CAB-LA increased overall PrEP coverage.

More data supporting BIC/TAF/FTC (Biktarvy) for PEP: A prospective study using Biktarvy as PEP in 119 people found high tolerability, high adherence, and no seroconversions, which matches previously published data on Biktarvy for PEP.  

STI prevention

Doxy-PEP works; the 4CMenB vaccine not so much.

  • The DOXY-PEP and DOXYVAC studies continue to show that doxycycline PEP reduced gonorrhea, chlamydia and syphilis infections among men who have sex with men and transgender women.
  • Public health data from SF also showed that community STIs were reduced after doxy-PEP was introduced.
  • The DOXYVAC study conducted further analysis and found that the 4CMenB vaccine did not significantly reduce the cumulative incidence of culture-positive gonorrhea infection, though the data does not rule out small benefit for symptomatic gonorrhea.

More CROI 2024 resources