At a glance
- Through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), CDC is making significant strides in addressing the global health threat of HIV drug resistance (HIVDR) by developing innovative and cost-effective testing methods.
- CDC is revolutionizing HIVDR monitoring in 75 countries, ensuring millions of people living with HIV receive effective and lifesaving treatment.
- Proactively monitoring drug resistance trends overseas provides an early warning system against the emergence of new, harder-to-treat forms of drug-resistant HIV that could spread to the U.S.
Background
As HIV medicine use has increased globally over the past decade, so too has the emergence and steady rise of drug resistance. With over 30 million people on antiretroviral therapy (ART), the possibility of HIVDR remains high. For many, the inability to access reliable HIVDR testing can mean the difference between life and death.
As drug resistance increases, the effectiveness of ART diminishes, leading to treatment failure and increased transmission risk, endangering Americans, U.S. investments, and global progress made against HIV. Proactively monitoring drug resistance trends overseas provides an early warning system against the emergence of new, harder-to-treat forms of drug-resistant HIV that could spread to the U.S.
Challenges in monitoring HIV drug resistance
HIVDR monitoring faces substantial barriers, including limited laboratory infrastructure, a shortage of trained personnel, and the high costs of testing kits. These challenges threaten the progress made by CDC and PEPFAR in reducing HIV-related cases and deaths. Recognizing the critical need for effective drug resistance monitoring, CDC develops and evaluates innovative solutions that can be implemented and sustained in resource-limited settings.
- Dr. Heather Alexander, CDC's International Laboratory Branch Chief
Transforming innovations in HIV drug resistance testing
To ensure consistent, high-quality results, developing and validating tests capable of analyzing the genetic makeup of HIV-1 viruses to identify specific mutations that may make them resistant to antiretroviral drugs is critical. Through public-private partnerships, CDC makes this advanced HIV testing technology accessible and quality-assured. These partnerships allow the production of standardized and cost-effective HIV-1 genotyping test kits, making it feasible to monitor the global emergence of HIV drug resistance on a large scale.
CDC also pioneered the use of dried blood spots (DBS) as a practical alternative to traditional plasma samples for HIVDR testing. DBS collection is simple, requiring only a finger prick, and the samples remain stable at room temperature, eliminating the logistical challenge of cold chain transport and storage. This innovation, combined with the development of low-cost HIV genotyping assays, has enabled over 30 countries to conduct effective population-level HIVDR monitoring.
To overcome the high cost and complexity of HIV drug resistance testing, CDC developed and validated three versions of low-cost, broadly sensitive sequencing assays. Through this work, the test was made commercially available, and the cost per test was dramatically reduced by over 85% from $150 to just $20, making drug resistance testing more affordable for low- and middle-income countries.
Currently, 75 countries use this assay for HIVDR testing. For a country that tests 1,000 samples annually, $130,000 is saved by using the CDC-developed assay. This translates to approximately $4 million saved each year across PEPFAR-supported countries thanks to CDC’s innovations.
Through PEPFAR, CDC is a leader in detecting and preventing the spread of drug-resistant HIV.
Global implications: Strengthening health security
The establishment of a robust network of HIVDR genotyping laboratories in more than 30 countries has provided critical data that informs national treatment guidelines and prevention strategies. This network enhances the effectiveness of currently available ART regimens and significantly reduces the risk of resistant strains spreading across borders, ultimately protecting the U.S. and the global community.
The capacity and network of genotyping laboratories established through HIVDR monitoring and surveys by CDC and PEPFAR are extensively used to detect and respond to outbreaks of emerging and high-consequence pathogens, including Ebola, influenza, and hepatitis. As countries work together to monitor and respond to HIVDR, they contribute to a global effort that protects their populations from a wide range of diseases and helps mitigate global pandemics from reaching the U.S.
A vision for the future: Ensuring effective HIV treatment
CDC's innovations in HIVDR monitoring exemplify the power of collaboration and scientific advancement in public health. By developing cost-effective technologies, supporting the use of quality-assured tests, and strengthening laboratory capacities, CDC ensures that individuals living with HIV receive the lifesaving treatment they need while preserving the effectiveness of first-line medicines used to treat and control HIV in the U.S.
By investing in laboratory infrastructure, quality management systems, training, and innovative testing solutions, CDC is safeguarding the health of millions and improving the U.S.'s ability to detect and respond effectively to current and emerging health threats. The commitment to addressing HIV drug resistance protects patients and strengthens global health security, ultimately benefiting communities in the U.S. and around the world.