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Federal HIV Initiative Could Offer Increased Opportunities for Decentralized Testing

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NEW YORK – A new impetus from US federal officials could result in better ways to detect and treat HIV, while simultaneously providing a boost to new ways of diagnosing the disease, including decentralized methods.

More than 150,000 Americans have HIV but don't know it, according to new estimates, and getting these people diagnosed so that they can get on treatment — and prevent further transmission — is a key part of a new federal plan to end HIV in the US by 2030. Recent data from the US Centers for Disease Control and Prevention highlight specific populations that may need more access to testing under the federal plan, including self-testing options targeting hard-to-reach at-risk groups.

This increased attention on more diagnostic testing, particularly self-testing, is likely to favor the only HIV test approved for home use by the US Food and Drug Administration, the OraQuick test from OraSure Technologies.

Called "Ending the HIV Epidemic: A Plan for America," the ambitious federal plan aims to reduce new HIV infections in the US by 75 percent in 2025, and 90 percent by 2030, and brings together a vast array of agencies: CDC, the Health Resources and Service Administration, Indian Health Service, the National Institutes of Health, and the Substance Abuse and Mental Health Services Administration. Its four-pronged attack — emphasizing diagnosis, treatment, prevention, and response to outbreaks — will be focused on the 48 US counties where HIV rates are the highest, as well as seven states with high rates in rural areas.

The initial budget for the Ending HIV plan is $291 million, and it cleared a major hurdle toward being funded this week when it passed the House, with provisions reortedly including $140 million for CDC, $70 million for the Ryan White HIV/AIDS Program that supports HIV interventions for low-income people, and $50 million for the HRSA.

Diagnostics are a lynchpin of the Ending HIV plan. The CDC is emphasizing the importance of diagnosing all people with HIV as early as possible, with a target of diagnosing at least 95 percent of all HIV infections. Once a person is diagnosed, he or she would be treated quickly, and the plan's goal is to increase the number of patients achieving viral suppression within six months of diagnosis. Increasing HIV prevention by improving access to preventative therapies like pre-exposure prophylaxis (PrEP) among the at-risk people, and improving responses to localized HIV outbreaks, are also key parts of the plan.

The need for a new, large-scale approach to HIV was highlighted earlier this month in a Morbidity and Mortality Weekly Report, which suggested that status quo strategies may have reached the limit of their effectiveness. According to Jay Butler, deputy director for infectious diseases at CDC, the report "shows that HIV testing, treatment, and prevention have not reached enough Americans."

The US made a lot of progress in the late '90s and into the early part of the 21st century in reducing the number of new cases of HIV, Butler said during a teleconference to discuss the report, but HIV prevention progress has stalled in America since 2013, and rates of undiagnosed HIV infections have hovered around 15 percent between 2013 and 2017, the most recent years for which complete data is available.

"This stalling underscores the need to increase resources, deploy new technologies, and build expertise, particularly in areas where they're needed most," Butler said. He also acknowledged that the MMWR data show "there are inequities in the HIV epidemic" in the US.

To whit, HIV infection rates have fallen among certain demographics ­­­­­­­­— new infections are down 21 percent among African American women, about 32 percent among young people ages 13 to 24, and about 16 percent among white gay and bisexual men, for example — but this has been offset by stabilization of rates or even large increases among other groups.

Specifically, rates of new HIV infections among gay and bisexual Latino and African American men between the ages of 25 and 34 skyrocketed over the five years evaluated — up 68 percent and 65 percent, respectively. And, rates of new infections among injection drug users that had previously been on the decline have stayed flat recently unchanged.

The overall stasis can be attributed in part to undiagnosed infections, since undiagnosed people are by definition unaware that they may be infected, are not being treated to reduce their viral load, and can be unwittingly spreading the infection.

In order to estimate the number of people who are infected but not diagnosed, a CDC spokesperson explained in an email that researchers used a model to estimate total HIV prevalence. The model incorporates routinely collected data on each HIV-positive person's first CD4 count after diagnosis. That value can to be used to approximate how long a person likely had the infection before getting tested.

Based on the estimated time from infection to diagnosis, researchers can then estimate what is called a diagnosis delay distribution, which in turn is extrapolated to account for individuals who are infected but not yet diagnosed.

Using these methods, CDC researchers estimated there were 1,140,400 people ages 13 years and older in the US living with HIV in 2016, including both diagnosed and undiagnosed infections. And, subtracting the number of known diagnosed cases reported to heath departments reveals that each year between 2013 and 2017 approximately 154,000 Americans have had undiagnosed HIV. In the MMWR report, CDC also estimated that there were 38,000 new HIV infections each year and that this number has also remained stable in that five-year period.

A role for self-testing

Ongoing research is attempting to determine why some groups are less likely to get tested, and how to better reach them. Overcoming the mistrust and fear that prevents people in some at-risk groups from seeking out testing will be critical in getting people diagnosed.

Self-testing is an important option in some situations, as "it saves time, offers privacy, and reaches people who may not be able to or willing to access existing testing services," a CDC spokesperson said in an email.

Indeed, a recent study by researchers at CDC and Emory University attempted to see whether self-testing could improve the rate of diagnosis among men who have sex with men, a group considered to be particularly at higher risk.

Participants in the Evaluation of Rapid HIV Self-testing Among MSM Project (eSTAMP) were mailed self-tests every three months. Specifically, they were initially mailed a "welcome kit" containing instructions, support materials, two OraQuick In-Home HIV test and two Sure Check HIV 1/2 assay.

The former is an oral fluid test from OraSure Technologies and the latter is a fingerstick whole-blood HIV self-test from Chembio Diagnostics. The participants were provided the tests for free and they were also paid for their participation. Every three months they were asked to fill out a survey and were mailed extra tests to replace those that they either used or gave away.

At the end of one year, 96 percent of people who were provided frequent, free self-tests reported having been tested at least once for HIV in the past year, according to the eSTAMP results published last month in the Journal of the American Medical Association Internal Medicine. In contrast, only 63 percent of the control group that was not provided with tests had been tested in that same timeframe.

However, this study did not specifically focus on young African American and Latino MSMs. Most of the study participants were white, and retention rates among non-white groups were lower, but overall the study authors recommended a strategy of distributing self-tests be considered for incorporation in other prevention programs.

Potential boon for OraSure

A CDC spokesperson could not comment on whether the federal plan will include more self-test use, per se, but noted that the agencies' funds are dispersed to health departments and can be used "to purchase tests, support systems that implement testing efforts, and support testing activities and events."

If the federal Ending the HIV Epidemic is funded, "CDC will work in collaboration with communities and other agencies to increase capacity to expand HIV testing according to CDC guidelines," the spokesperson said.

CDC also encourages and collaborates with the public sector in efforts to make HIV testing more accessible. "There are a growing number of health departments [that] have initiated programs to overcome the HIV self-test cost barrier, including offering free HIV self-tests via the Internet," the spokesperson said.

Currently, the only HIV self test that is cleared by the US Food and Drug Administration for home use is the saliva-based OraQuick test. A fingerstick blood-based HIV test from Chembio has been CE marked and is CLIA waived for professional use only, although it's incorporation into the eSTAMP study for research-use could suggest it has some utility for at-home testing.

The self-testing market is also a crucial growth driver for both OraSure and Chembio, as recently reported, and blood-based home use tests are also available internationally from Atomo Diagnostics, BioSure, and Biolytical Laboratories.

There are also direct-to-consumer testing options in which people collect sample at home and mail it to a lab, but no at-home sample self-collection methods have been evaluated or cleared by FDA to date. The CDC spokesperson emphasized that, "If consumers buy any HIV home-use or self-test online, they should make sure it is FDA-approved."

Stephen Tang, CEO of OraSure said in an interview that the firm is encouraged by the new US plan, in part because the company has already seen great success internationally when its HIV tests have been used specifically to target hard-to-reach demographics.

For example, low- and middle-income countries with sparse healthcare infrastructure, particularly in sub-Saharan Africa, have incorporated OraQuick into initiatives that have reached previously untestable people by bringing the tests to them in their homes.

Indeed, Tang said the firm started out in the US market, but clearing the high hurdle of FDA approval for the home use test gave international groups the confidence to include it in their efforts, and now the global efforts and experiences can boomerang and benefit patients in the US as well.

Some of the "untestable" people in the US are intravenous drug users, Tang said, or are otherwise fearful of the stigma of getting tested in a clinic, and they are generally not seeking out healthcare. "You literally have to go find these folks, in the same way that we had to find them in other places around the world," Tang said.

Studies like eSTAMP, meanwhile, serve as "validation of what we have known for a while, which is that the use of self-tests is going to help people that are at risk," he said.

Tang also reiterated sentiments he expressed in the firm's third quarter earnings call. "We remain optimistic that the Ending the HIV Epidemic program will be beneficial to our overall business," he said.