ARV Compliance Assay
July 21, 2022
Our partner in the medical device industry developed a simple point of care assay that detects the presence of tenofovir in a urine sample, providing instant results. Our go-to-market strategy helped to integrate a simple and cost-effective point of care tool to improve HIV treatment compliance.
Our partner in the medical device industry developed a simple point of care assay that detects the presence of tenofovir in a urine sample, providing instant results. This tool has the potential to bring greater value to the comprehensive care package already available for those living with HIV.
For people living with HIV, compliance to antiretroviral therapy has been a persistent challenge. In response to this, first line therapy is now available as a user-friendly, one tablet, once-a-day combination, often containing tenofovir. Similarly, the medication’s side-effects have greatly improved over the last few decades. However, the course of HIV treatment is a life-long affair, which can make compliance a challenge. This increases the risk of viral mutation and drug resistance, requiring patients to change therapy. Failure to comply with daily treatment regimens can lead to an increased viral load and the increased likelihood of transmission. In addition, a decreased CD4+ count increases susceptibility to opportunistic infections.
Antiretroviral therapy adherence is vital for multiple reasons. It leads to a suppression of the viral load and reduces the likelihood of a person developing AIDS. A viral load count reveals the efficacy of antiretroviral therapy. However, this test is often conducted every six months and this process can be expensive and results can take several days.
Tools that monitor patients’ drug levels to confirm treatment compliance are not available at the point of care. Although innovative tools do exist, they can be costly and slow in giving a result.
The challenge of monitoring treatment compliance can be addressed with a simple and cheap point of care diagnostic tool.
We were commissioned by our partner to (i) validate the established use cases for their point of care tool, (ii) develop a comprehensive go-to-market strategy, (iii) provide a pre-exposure prophylaxis landscape report, and (iv) to identify study protocols for future studies they may wish to commission.
We identified five potential use cases for the product based on interviews with relevant local and regional stakeholders. Based on a quantitative and qualitative assessment of more than 20 countries, combined with deep insights from our network of country associates, we prioritized five African countries for market entry. The readiness by the countries to adopt this new product was assessed by conducting a thorough review of factors including policy landscape, uptake and ease of regulations, and the level of financing available.
Our in-depth analyses of country and regulatory requirements led us to propose three future studies that would generate the evidence and data required to gain a deeper understanding of the use of the assay and to build advocacy for the product in a local context. This helped our partner to confidently embark on their next steps in integrating this point of care tool into already existing suite of comprehensive HIV care packages.
