Rapid HIV care cuts time to viral suppression in half

Photo of Jason Halperin
Jason Halperin

With the help of his local health department in New Orleans, Jason Halperin, MD, and colleagues are starting patients on ART within 72 hours of their HIV diagnosis — most of them within 24 hours. A recent study showed that the intervention cut the median time to viral suppression by more than half, and he believes its success can be replicated in other clinics around the country.

“I want to demonstrate to people that this can be done in the resource-poor areas of this country, like the South,” Halperin told Infectious Disease News.

The Southern United States is disproportionately affected by the HIV epidemic, and New Orleans ranks among the top three cities in the country with the highest incidence of disease — just behind Baton Rouge and Miami, according to the CDC.

“We really are on the frontlines of the HIV epidemic in the United States,” Halperin said.

Halperin oversees HIV services at CrescentCare, federally qualified health center that runs a large pre-exposure prophylaxis clinic in the city with almost 900 active patients. They conduct approximately 10,000 HIV tests in the community each year. The disease predominantly affects young black men who have sex with men, and the core of their work is committed to this population, he said.

Before the intervention, patients with an HIV diagnosis had to wait 4 to 5 weeks before starting ART, which Halperin suggested is “better than average,” but the lapse still increases the risk for HIV transmission. There are several reasons for the delay, he said. First, it can take up to 2 weeks or more to sort out patients’ insurance, which is often provided through the Ryan White HIV/AIDS program. Second, providers frequently choose to postpone treatment until they know the status of their kidney and liver functions and their CD4 cell counts. HIV drug-resistance testing is also recommended for patients with HIV before selecting an ART regimen, tacking on even more time. Finally, the price of the medication and whether payers will even cover the expense is yet another challenge.

“I really had to lay out all these barriers to start dismantling them,” Halperin said.

With the expansion of Medicaid in Louisiana in 2016 — “a gift from the heavens,” according to Halperin — the clinic could enroll patients in Medicaid services on the same day as their HIV diagnosis. In December of that year, they started a test-and-start strategy called the CrescentCare Start Initiative (CCSI), which links newly diagnosed patients with a treating provider and starts them on ART within 72 hours, ideally within 24. But first, they needed help from the city’s health department.

“So, I got in touch with the Office of Public Health (OPH), and I said, ‘This is our plan: I guarantee that we are going to have a higher rate of linkage and an impact on our time to viral suppression and hopefully 2-year data that show retention and sustained viral repression,’” Halperin said. “‘What I need from you is that when I fax you the form for Ryan White services, you fax it back within an hour. I don’t care how you figure it out, but if you can do it, I can see these patients [within 24 hours].’”

CrescentCare proposed to use Ryan White funds to cover the first 30 days of patients’ medication, giving them 4 weeks to figure out how to refill the prescriptions. The OPH agreed.

“So now, within an hour of a diagnosis I can get patients Ryan White services,” he said. “I can get them signed up for Medicaid if they meet criteria, and 4 weeks of medication are provided.”

Halperin argued that knowing the genotype was unnecessary before starting patients on ART because evidence suggests there is a low risk for resistance to the integrase inhibitor Tivicay (dolutegravir, ViiV Healthcare), which is used in combination with Descovy (tenofovir alafenamide/emtricitabine, Gilead Sciences). In addition, if lab work comes back within 24 hours and indicates that a patient has kidney damage, they can be switched to a new regimen.

In a paper published in AIDS Patient Care and STDs, Halperin and colleagues compared outcomes of patients who were referred to CCSI (n = 77) with an historical cohort of patients (n = 29) from the previous year. Results showed that the median time to linkage was 1.3 days (95% CI, 1.09-1.51) in CCSI, compared with 30 days (95% CI, 25.1-43.6) in the historical cohort (P < .0001). Additionally, the median time to viral suppression — defined as less than 200 copies/mm2 — was 30 days (95% CI, 27-34) in CCSI vs. 68 days (95% CI, 60-92) in the historical cohort (P < .0001).

“There is a public health benefit ... as we know, patients can’t transmit the virus,” said Halperin, who also presented findings from CCSI at IDWeek 2017.

CCSI is modeled after the University of California, San Francisco’s RAPID program, which began offering immediate ART in 2013. Of 39 UCSF patients who participated in a pilot study, 95% started ART within 24 hours. The median time to viral suppression was 1.8 months among those in the RAPID program, compared with 4.3 months in an historical cohort and 7.2 months among patients who were given ART based on their CD4 cell count (P = .0001). Additionally, researchers said retention in care was high. Since the pilot study, immediate ART has become standard clinical practice as part of the city’s “Getting to Zero” initiative.

A similar study examined a rapid-entry program at a large Ryan White-funded clinic in Atlanta — the Infectious Disease Program (IDP) of the Grady Health System. Unlike Louisiana, however, Georgia has not expanded Medicaid, so for uninsured patients the program relies on the Ryan White program for medications, according to Jonathan Colasanti, MD, MSPH, assistant professor of medicine at Emory University School of Medicine and associate medical director of the Grady IDP. For those patients without all the necessary documentation to enroll fully in Ryan White, medications were obtained through a manual pharmaceutical assistance program application, Colasanti said. Patients without all the required documents to fully enroll in Ryan White were still able to see a primary care provider and given a grace period of 30 days to obtain missing documentation.

The study, presented at this year’s Conference on Retroviruses and Opportunistic Infections, included all patients new to the IDP clinic who were not virologically suppressed — both newly and previously diagnosed with HIV — at the time of enrollment. Findings showed that the median time from entry to the clinic to viral suppression decreased from more than 67 days to about 41 days (P = .0001). However, the overall proportion of patients achieving viral suppression in the 6-month follow-up did not significantly change, according to Colasanti.

“Our hypothesis as to why more patients in rapid entry didn’t achieve viral suppression is that by removing barriers to entry into the clinic, patients with social challenges who were previously unable to enroll were now included in our denominator. The same social challenges that would influence ability to enroll likely influence retention and ability to achieve viral suppression as well,” Colasanti told Infectious Disease News. “Going forward, it will be very important to determine which populations will benefit the most from rapid entry into care and to make sure that we continue to build up our programs to retain patients in care.”

According to Halperin, more than 95% of patients in CCSI said they wanted to be treated the same day they were diagnosed with HIV, and most of the remaining 5% were seen within the week. The program has fast-tracked more than 115 patients so far, representing more than a third of all newly diagnosed patients in New Orleans.

In addition to its public health benefit, immediate ART has had a meaningful impact on individual patients as they process the news that they are HIV positive.

“I get to see patients on the day they are diagnosed and look them in the eye and say, ‘One, I am starting you on medication, and this medication is going to allow you to have the same life expectancy as you would have without HIV, and two, when you’re virally suppressed, you cannot transmit the virus,’” Halperin said. “And this is happening on the day that they are being told they have this life-threatening infection, and that relationship, because it happens that day, is so profound.”

Halperin and colleagues are now collecting and analyzing 2-year data from the CCSI program, and they hope to show improved retention rates and the cost-effectiveness of the intervention, along with mathematical models demonstrating how many infections could potentially be averted if the median time to viral suppression is reduced by 38 days.

“That’s going to have, I think, a really nice effect of ensuring that this intervention is supported at a federal level and beyond,” he said. – by John Schoen and Gerard Gallagher

References:

CDC. HIV Surveillance Report. Diagnoses of HIV Infection in the United States and Dependent Areas, 2015. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf. Accessed March 16, 2018.

Colasanti J, et al. Abstract 1109. Presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston.

Halperin J, et al. AIDS Patient Care STDS. 2018;doi:10.1089/apc.2017.0309.

Halperin J, et al. Abstract 1421. Presented at: IDWeek; Oct. 4-8, 2017; San Diego.

Disclosures: Colasanti and Halperin report no relevant financial disclosures.

Photo of Jason Halperin
Jason Halperin

With the help of his local health department in New Orleans, Jason Halperin, MD, and colleagues are starting patients on ART within 72 hours of their HIV diagnosis — most of them within 24 hours. A recent study showed that the intervention cut the median time to viral suppression by more than half, and he believes its success can be replicated in other clinics around the country.

“I want to demonstrate to people that this can be done in the resource-poor areas of this country, like the South,” Halperin told Infectious Disease News.

The Southern United States is disproportionately affected by the HIV epidemic, and New Orleans ranks among the top three cities in the country with the highest incidence of disease — just behind Baton Rouge and Miami, according to the CDC.

“We really are on the frontlines of the HIV epidemic in the United States,” Halperin said.

Halperin oversees HIV services at CrescentCare, federally qualified health center that runs a large pre-exposure prophylaxis clinic in the city with almost 900 active patients. They conduct approximately 10,000 HIV tests in the community each year. The disease predominantly affects young black men who have sex with men, and the core of their work is committed to this population, he said.

Before the intervention, patients with an HIV diagnosis had to wait 4 to 5 weeks before starting ART, which Halperin suggested is “better than average,” but the lapse still increases the risk for HIV transmission. There are several reasons for the delay, he said. First, it can take up to 2 weeks or more to sort out patients’ insurance, which is often provided through the Ryan White HIV/AIDS program. Second, providers frequently choose to postpone treatment until they know the status of their kidney and liver functions and their CD4 cell counts. HIV drug-resistance testing is also recommended for patients with HIV before selecting an ART regimen, tacking on even more time. Finally, the price of the medication and whether payers will even cover the expense is yet another challenge.

“I really had to lay out all these barriers to start dismantling them,” Halperin said.

With the expansion of Medicaid in Louisiana in 2016 — “a gift from the heavens,” according to Halperin — the clinic could enroll patients in Medicaid services on the same day as their HIV diagnosis. In December of that year, they started a test-and-start strategy called the CrescentCare Start Initiative (CCSI), which links newly diagnosed patients with a treating provider and starts them on ART within 72 hours, ideally within 24. But first, they needed help from the city’s health department.

“So, I got in touch with the Office of Public Health (OPH), and I said, ‘This is our plan: I guarantee that we are going to have a higher rate of linkage and an impact on our time to viral suppression and hopefully 2-year data that show retention and sustained viral repression,’” Halperin said. “‘What I need from you is that when I fax you the form for Ryan White services, you fax it back within an hour. I don’t care how you figure it out, but if you can do it, I can see these patients [within 24 hours].’”

CrescentCare proposed to use Ryan White funds to cover the first 30 days of patients’ medication, giving them 4 weeks to figure out how to refill the prescriptions. The OPH agreed.

“So now, within an hour of a diagnosis I can get patients Ryan White services,” he said. “I can get them signed up for Medicaid if they meet criteria, and 4 weeks of medication are provided.”

Halperin argued that knowing the genotype was unnecessary before starting patients on ART because evidence suggests there is a low risk for resistance to the integrase inhibitor Tivicay (dolutegravir, ViiV Healthcare), which is used in combination with Descovy (tenofovir alafenamide/emtricitabine, Gilead Sciences). In addition, if lab work comes back within 24 hours and indicates that a patient has kidney damage, they can be switched to a new regimen.

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In a paper published in AIDS Patient Care and STDs, Halperin and colleagues compared outcomes of patients who were referred to CCSI (n = 77) with an historical cohort of patients (n = 29) from the previous year. Results showed that the median time to linkage was 1.3 days (95% CI, 1.09-1.51) in CCSI, compared with 30 days (95% CI, 25.1-43.6) in the historical cohort (P < .0001). Additionally, the median time to viral suppression — defined as less than 200 copies/mm2 — was 30 days (95% CI, 27-34) in CCSI vs. 68 days (95% CI, 60-92) in the historical cohort (P < .0001).

“There is a public health benefit ... as we know, patients can’t transmit the virus,” said Halperin, who also presented findings from CCSI at IDWeek 2017.

CCSI is modeled after the University of California, San Francisco’s RAPID program, which began offering immediate ART in 2013. Of 39 UCSF patients who participated in a pilot study, 95% started ART within 24 hours. The median time to viral suppression was 1.8 months among those in the RAPID program, compared with 4.3 months in an historical cohort and 7.2 months among patients who were given ART based on their CD4 cell count (P = .0001). Additionally, researchers said retention in care was high. Since the pilot study, immediate ART has become standard clinical practice as part of the city’s “Getting to Zero” initiative.

A similar study examined a rapid-entry program at a large Ryan White-funded clinic in Atlanta — the Infectious Disease Program (IDP) of the Grady Health System. Unlike Louisiana, however, Georgia has not expanded Medicaid, so for uninsured patients the program relies on the Ryan White program for medications, according to Jonathan Colasanti, MD, MSPH, assistant professor of medicine at Emory University School of Medicine and associate medical director of the Grady IDP. For those patients without all the necessary documentation to enroll fully in Ryan White, medications were obtained through a manual pharmaceutical assistance program application, Colasanti said. Patients without all the required documents to fully enroll in Ryan White were still able to see a primary care provider and given a grace period of 30 days to obtain missing documentation.

The study, presented at this year’s Conference on Retroviruses and Opportunistic Infections, included all patients new to the IDP clinic who were not virologically suppressed — both newly and previously diagnosed with HIV — at the time of enrollment. Findings showed that the median time from entry to the clinic to viral suppression decreased from more than 67 days to about 41 days (P = .0001). However, the overall proportion of patients achieving viral suppression in the 6-month follow-up did not significantly change, according to Colasanti.

“Our hypothesis as to why more patients in rapid entry didn’t achieve viral suppression is that by removing barriers to entry into the clinic, patients with social challenges who were previously unable to enroll were now included in our denominator. The same social challenges that would influence ability to enroll likely influence retention and ability to achieve viral suppression as well,” Colasanti told Infectious Disease News. “Going forward, it will be very important to determine which populations will benefit the most from rapid entry into care and to make sure that we continue to build up our programs to retain patients in care.”

According to Halperin, more than 95% of patients in CCSI said they wanted to be treated the same day they were diagnosed with HIV, and most of the remaining 5% were seen within the week. The program has fast-tracked more than 115 patients so far, representing more than a third of all newly diagnosed patients in New Orleans.

In addition to its public health benefit, immediate ART has had a meaningful impact on individual patients as they process the news that they are HIV positive.

“I get to see patients on the day they are diagnosed and look them in the eye and say, ‘One, I am starting you on medication, and this medication is going to allow you to have the same life expectancy as you would have without HIV, and two, when you’re virally suppressed, you cannot transmit the virus,’” Halperin said. “And this is happening on the day that they are being told they have this life-threatening infection, and that relationship, because it happens that day, is so profound.”

Halperin and colleagues are now collecting and analyzing 2-year data from the CCSI program, and they hope to show improved retention rates and the cost-effectiveness of the intervention, along with mathematical models demonstrating how many infections could potentially be averted if the median time to viral suppression is reduced by 38 days.

“That’s going to have, I think, a really nice effect of ensuring that this intervention is supported at a federal level and beyond,” he said. – by John Schoen and Gerard Gallagher

References:

CDC. HIV Surveillance Report. Diagnoses of HIV Infection in the United States and Dependent Areas, 2015. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf. Accessed March 16, 2018.

Colasanti J, et al. Abstract 1109. Presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston.

Halperin J, et al. AIDS Patient Care STDS. 2018;doi:10.1089/apc.2017.0309.

Halperin J, et al. Abstract 1421. Presented at: IDWeek; Oct. 4-8, 2017; San Diego.

Disclosures: Colasanti and Halperin report no relevant financial disclosures.