External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA

Epividian

Status: Completed

Conditions: HIV-1-infection

Treatments: Drug: Ibalizumab

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05495204

COL2022-001

Details and patient eligibility

About

Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.

Full description

The US Department of Health and Human Services (DHHS) HIV treatment guideline suggest that ibalizumab may be considered in the context of multidrug resistance without fully active ART options. However, clinical trials assessing ibalizumab efficacy did not include an active comparison arm in which participants did not receive ibalizumab. The use of external controls can provide valuable information and context to interpret the results of clinical trials when randomization to a control arm cannot be performed.

The OPERA (Observational Pharmaco-Epidemiology Research & Analysis) cohort, a large US electronic health record database, is well suited for this as the OPERA and trials populations arose from the same geographic location (i.e., US). An external comparison of ibalizumab + optimized background regimen from trials vs. non-ibalizumab containing regimens in routine clinical care in the OPERA cohort may confirm results from prior studies suggesting viral control benefits of ibalizumab.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Trial IBA+OBR group):

• Participant in TMB-202 or TMB-301/311
• Received 800 mg IBA every 2 weeks, with or without a loading dose

Inclusion Criteria (OPERA non-IBA OBR group):

• HIV-1 infection
• 18 years or older
• Heavily treatment experienced (i.e., ever on a regimen containing either DTG BID or DRV BID)
• Documented resistance to ≥1 ARV from each of three ARV classes
• Genotype information available for all the relevant gene regions (see Table 2)
• Viral load > 200 copies/mL at index regimen initiation
• Not pregnant at index
• No new AIDS defining event within 3 months before/on index (except cutaneous Kaposi's sarcoma or HIVAW)
• No new cancer diagnosis within 12 weeks before/on index
• No IBA prescribed prior to/with the index regimen
• Index regimen does not include cabotegravir, fostemsavir, investigational drugs
• Viral sensitivity/susceptibility to at least one ARV in the index regimen
• Baseline VL available (within 6 months before/at index)
• Baseline CD4 available (within 6 months before/at index)
• ≥1 VL measurement at any time after index

Trial design

141 participants in 2 patient groups

IBA+OBR (trials)

Description:

Participants in TMB-202 or TMB-301/311 trials who received 800 mg ibalizumab every 2 weeks, with or without a loading dose

Treatment:

Drug: Ibalizumab

Non-IBA+OBR (OPERA)

Description:

Heavily treatment experienced adults living with HIV in care in OPERA, with documented resistance to ≥1 ARV from each of three ARV classes switching to a new regimen that does not include ibalizumab