Hiv
Conditions
Keywords
Adherence, Case Management, Biktarvy
Brief summary
COMEBACK is an investigator-initiated, 48-week study. The study will be conducted in 100 persons living with HIV (PLWH) who have been off ART for two or more weeks. All enrolled participants will be prescribed Biktarvy, if determined appropriate upon review of past historical resistance tests, for use throughout the study period. Participants will also complete a series of Patient Reported Outcomes (PROs) at screening and be assigned one of three tiers of case management intervention (Piggyback, Got Your Back, Backbone), with each tier increasing in intensity regarding intervention techniques and options provided. Participants will be assessed for virologic suppression, retention in care, and PROS throughout study follow up and at study end.
Detailed description
In most settings in the US when patients out of care and off of ART reengage with clinical providers routine labs are collected, including CMP, CD4, VL, and HIV resistance testing when indicated, healthcare benefits are reassessed, and the most recent ART regimen is restarted if the patient agrees to treatment. There may be characteristics of these regimens that may present barriers to sufficient adherence, or perform suboptimally in patients with certain immunologic and/or viral factors, which may impact virologic suppression, including multiple pills, drug-drug interactions, variable tolerability, low CD4, high VL, or low thresholds for resistance. Biktarvy is a Single Tablet Regimen (STR) with high potency and good tolerability that can be safely used in multiple patient groups, with features, including activity in patients with a history of multi-class resistance, that may facilitate immediate ART reinitiation among a broad population of patients reengaging in care in order to promote rapid virologic suppression. Addressing this important patient population with poor retention with support mechanisms to reengage in care and reinitiate effective ART immediately may improve retention in care and accelerate virologic suppression as likewise derived in immediate ART models in treatment-naïve patients, and represent a touchstone to drive sustainability in preventing new HIV transmissions in a high burden area to meet the goals of reducing HIV as a public health threat over the next 10 years.
Interventions
BEHAVIORALCase Management
Each tier will have a different level of case management and support, all with the goal of increasing adherence to Biktarvy for HIV management.
Sponsors
Gilead Sciences
Gregory Huhn
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. HIV-infected 2. Not on ART for \>2 weeks 3. History of estimated eGFR \> 30 ml3/min 4. Baseline labs (CBC, CMP, CD4+, HIV-1 RNA) and resistance genotype test collected \<2 weeks or on day of Biktarvy ART reinitiation 5. 18 years or older
Exclusion criteria
1. No history of primary integrase inhibitor mutations, \>3 TAMs, K70E, Q151M, T69 insertion, or K65R + M184V/I on prior resistance testing 2. Drug-drug interactions with Biktarvy 3. Pregnancy 4. Unable or unwilling to provide consent for study participation 5. Any condition that, in the opinion of the Investigator of Record (IoR), would make participation in the study unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the study objective. 6. Current participation in another ART adherence study 7. Allergy to bictegravir, emtricitabine or tenofovir alafenamide 8. Signs or symptoms of opportunistic infection with cryptococcal meningitis, tuberculosis or other infection that requires delay of reinitiation of antiretroviral therapy 9. Concomitant use of medications that are contraindicated with bictegravir, emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine, dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin, rifabutin, rifapentine, St. John's Wort, tipranavir
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virologic Suppression Rates | 1 year | Number of patients with virologic suppression, defined as HIV RNA \<200 copies/ml at week 48 RNA. |
| Retention in Care | 1 year | Number of patients retained in study, defined as at least 2 visits or 2 HIV-1 RNA viral load reports occurring at least 3 months apart within the 12-month study time period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes concerning social and health related barriers | 1 year | Favorable outcomes concerning health and and social related determinants as assessed by responses to a series of Patient Reported Outcomes at 6 and 12 months. See full list in attached documents. |
Countries
United States
Outcome results
None listed