May 13, 2019
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Baseline genotype testing at HIV diagnosis not cost-effective

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Baseline genotype testing at HIV diagnosis provides minimal clinical benefit and is not cost-effective with integrase strand inhibitor-based first-line regimens in the United States, according to study findings.

Writing in Clinical Infectious Diseases, Emily P. Hyle, MD, MSc, an infectious disease physician at Massachusetts General Hospital, and colleagues noted that guidelines recommend standard genotype resistance testing in newly diagnosed patients with HIV, which can guide selection of ART and establish baseline resistance profiles.

The results are used to evaluate resistance to nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors and protease inhibitors, whereas resistance to integrase strand inhibitors (INSTIs) is evaluated with a separate test not routinely recommended prior to ART and not cost-effective for routine screening, they said.

“Current U.S. treatment guidelines recommend an INSTI with an NRTI pair as first-line ART for most people with HIV. Therefore, at ART initiation, baseline genotype now guides only the initial choice of NRTI pair given transmitted NRTI resistance. This choice may not be critical, as limited data suggest that regimens including an NRTI pair and a later generation INSTI, such as dolutegravir or bictegravir, remain effective in the setting of most transmitted NRTI-R mutations,” they wrote.

“With the evolution of HIV treatment, uncertainty surrounding the role of baseline genotype has grown. We examined the clinical and economic impact of baseline genotype for people newly diagnosed with HIV in the U.S.”

To do this, they used a model that simulates patients’ lifetimes, tracking health outcomes and care costs, to compare baseline genotype testing with no baseline genotype testing for people starting ART with dolutegravir and an NRTI pair, according to the study.

Results showed that baseline genotype testing would result in less than 1 additional undiscounted quality-adjusted life day and cost $500 more per person. Additionally, Hyle and colleagues found that the clinical benefits of baseline genotype testing never exceeded 5 quality-adjusted life days.

“In this modeling analysis of the current INSTI treatment era, we found that obtaining a standard genotype at the time of HIV diagnosis had minimal clinical impact and was not cost-effective,” the authors concluded. “A baseline genotype offered no clinical benefit to most people newly diagnosed with HIV ... We projected an average population benefit of [less than 1 quality-adjusted life day]. This benefit is far less than other HIV interventions in the U.S., such as expanded HIV testing, improved engagement in care, or pre-exposure prophylaxis.” – by Caitlyn Stulpin

Disclosures: Hyle reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.