Monoclonal Antibody-Based Assays for Real-Time Monitoring of HIV Medication Adherence

What is the Problem?

Adherence to antiretroviral medications is critical for both HIV treatment and prevention, yet many patients struggle to maintain consistent use. The most common option remains a daily oral pill, but ~30% of users fail to achieve protective drug levels because they take medication fewer than five days per week. These individuals are candidates for long-acting injectable (LAI) drugs, which are more expensive but effective when adherence to oral therapy is poor. However, there are currently no simple, objective tools to identify patients with oral pill adherence challenges who should be switched to LAIs. Since both oral and injectable drugs are equally effective when taken as directed, and given the substantially higher cost of LAIs, insurers typically require prior authorization, oral-first “step therapy,” or documented failure of oral regimens before approving injectable alternatives. Despite the availability of LAIs, only 1.4% of PrEP users currently receive them. Drug companies face adoption challenges and aim to expand use among the 30% of patients with adherence issues. Insurers want to avoid overprescribing costly LAIs to patients who succeed with inexpensive oral pills, while providers seek to optimize adherence, improve outcomes, and match treatments to patient lifestyles. Clinicians often struggle to justify LAI prescriptions without objective adherence data, and patients need access to regimens that align with their daily routines while ensuring reliable protection.

What is the Solution?

The solution is a rapid, point-of-care (POC) test that measures tenofovir, a key drug used in daily oral HIV treatment and prevention regimens. This test provides objective, clinical evidence to identify individuals who may benefit from switching from daily oral pills to LAI regimens. By enabling data-driven decisions, providers can strengthen pre-authorization requests for LAIs by presenting measurable drug levels that confirm adherence challenges. Patients gain access to therapies that better fit their lifestyle, insurers avoid unnecessary costs by reserving expensive LAIs for those with demonstrated need, and manufacturers of long-acting drugs can expand adoption among the 30% of patients with oral pill adherence issues.

This technology introduces novel monoclonal antibody-based immunoassays that detect tenofovir (TFV) and its active metabolite, tenofovir diphosphate (TFV-DP), in small blood or urine samples. The assays are designed for point-of-care use and deliver results within minutes. The antibodies selectively bind to TFV or TFV-DP, ensuring accurate detection of recent drug intake. The platform supports both lateral flow formats (similar to pregnancy tests) and laboratory-based ELISA formats. By enabling real-time adherence monitoring, the technology supports immediate feedback and tailored adherence support, particularly in PrEP programs and HIV treatment adherence initiatives.

What is the Competitive Advantage?

-Provides real-time adherence data without the need for complex laboratory infrastructure.

-Provides objective measurement vs unreliable and not practical alternative methods to access adherence.

-Compatible with low-resource settings and adaptable to both clinical and community-based programs.

-Uses highly specific monoclonal antibodies that distinguish between recent and cumulative drug exposure.

-Supports both lateral flow formats and laboratory-based ELISA formats, offering flexibility for diverse clinical and field settings.