Monoclonal Antibodies for the Detection of Antiretroviral Integrase Inhibitors
Pre-exposure prophylaxis (PrEP) is a critical component in the fight against HIV but is only effective if persons prescribed PrEP are adhering to the regimens to maintain appropriate drug levels. As PrEP regimens have moved from daily pills to longer lasting injections, the ability to quickly measure and monitor the circulating drug levels of PrEP drugs has increased importance.
The CDC designed and developed the first monoclonal antibodies (clones 3H9E4 and 6E6F1) that have cross-reactivity to the key HIV integrase inhibitors cabotegravir, dolutegravir and bictegravir. These are key inhibitors in highly active HIV treatment and prevention. The monoclonal antibodies can be used for specific and sensitive detection of cabotegravir, dolutegravir and bictegravir integrase inhibitors and allow for both rapid, low-complexity point-of-care with finger-stick blood and high-throughput enzyme immunoassay (EIA) testing to determine if protective levels of the inhibitors are present.
- Clinical monitoring of HIV integrase inhibitor concentrations following delays in long-acting pre-exposure prophylaxis (PrEP) visits; may avoid the need to re-initiate the need to restart taking oral pills before resuming injections.
- Self-testing for assurances of protective levels by persons taking integrase inhibitor PrEP regimens.
- HIV integrase inhibitor detection for treatment adherence evaluation and national adherence surveillance.
- Help clinicians determine if the presence of HIV integrase inhibitors are affecting HIV diagnostic test results as HIV diagnostic tests were not validated and approved with persons receiving antiretroviral drugs.
- The sensitivity exceeds that of mass spectrometry to allow for flexible assay use-cases, including rapid point of care and self-testing using fingerstick whole blood.