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CATIE - www.catie.ca

HIV diagnosis followed by initiation of treatment on the same day

8 December 2016 - Clinical trials have found that the initiation of HIV treatment (ART) very early in the course of infection can significantly improve a person's health and greatly reduce their risk for developing serious infections. Early initiation of ART helps to reduce the amount of HIV in the blood and continued use of ART helps to drive HIV down to undetectable levels.

Once the amount of HIV in a person's blood falls to an undetectable level and stays there through continued use of ART, his or her risk of transmitting HIV falls to a negligible level. Therefore, it is vital to increase the number of people who are aware of their HIV status through confidential HIV testing. This should be followed by counselling and swift referral to care (when the test is positive) where an offer of initiating ART can be made. Furthermore, it is essential that people taking ART have regular checkups and blood tests to ensure that their viral load continues to remain undetectable. All of these steps are important to improve the health of HIV-positive people and also to reduce the spread of HIV in a city, region or country.

For the past several years a research team at San Francisco General Hospital has been seeking ways to overcome the barriers that can arise when trying to implement programs associated with rapid initiation of HIV treatment. They note that HIV testing can often occur at a location that is different from where care is provided and treatment dispensed. Newly diagnosed people may require help finding stable housing and health insurance coverage and managing issues related to mental health and substance use. These issues can all prolong the time between an HIV diagnosis and the start of ART.

The San Francisco team has developed a program called RAPID that overcomes these common barriers. An evaluation of RAPID has found that 95% of participants who entered the program were able to initiate ART within 24 hours of a positive HIV test result. Furthermore, participants were able to achieve a very low viral load in a relatively short period after initiating and continuing to take ART. Only 5% of participants developed side effects. The researchers concluded: “Treatment of HIV infection can be started on the day of diagnosis without impacting safety or acceptability of ART.”

About RAPID

In 2013 a team at San Francisco General Hospital launched an intervention called the Rapid ART Program for Individuals with an HIV Diagnosis (RAPID). The program provided the following:

  • When participants received a positive HIV diagnosis at a testing site in the city, they were offered an appointment with an HIV specialist on the same day. Taxi vouchers were given to participants for immediate transportation from the testing site to the clinic.
  • At the clinic a visit usually lasted between three and four hours. During this time the ART prescriber educated participants about HIV transmission risks, sexual health and the benefits of early initiation of ART. Any possible reasons for not starting ART that day were discussed; researchers said that participants “were given the option to decline treatment.” Blood was drawn for a wide range of tests, including CD4+ count and HIV viral load, assessments of kidney and liver health, and screening for hepatitis-causing viruses. Blood tests were also done to find out if participants had HIV that had some degree of resistance to treatment and if they had hypersensitivity to a commonly used anti-HIV drug called abacavir (Ziagen, and in Kivexa, Triumeq and Trizivir). Importantly, the research team noted that the results of all of these tests were not usually available prior to the initiation of ART.
  • If necessary, expedited access to health care insurance was facilitated.
  • An expert committee recommended the use of the following combination of anti-HIV drugs: the integrase inhibitor dolutegravir (Tivicay) together with two nucleoside analogues, tenofovir + FTC. They based their recommendation on research results that showed that HIV in the San Francisco area was generally susceptible to these drugs. Furthermore, in the observation of hospital staff, this combination was generally well tolerated. This or alternative combinations were dispensed in starter packs so that treatment could begin shortly.
  • Participants who agreed to initiate ART were offered the opportunity to take their first dose in the clinic in the presence of a healthcare provider.
  • Over the next seven days, nurses in the program contacted participants via telephone. According to the research team, this call allowed nurses to “review lab results and enquire about adherence, pharmacy/prescription issues and possible side effects.”

Focus on the participants

For their evaluation of RAPID, researchers reviewed health-related data collected between July 1, 2013 and December 31, 2014 from 39 people who entered RAPID and 47 other people who received the standard approach to HIV care at the hospital's HIV clinic. In the standard approach, a multidisciplinary team addressed symptoms that patients might be experiencing and provided help for social (housing, insurance, food, immigration status) and psychological (counselling, mental health, substance use) issues.

According to researchers, the average profile of participants was as follows:

  • more than 95% were male
  • more than 50% were people of colour
  • 42% had “major mental disorders”
  • 42% used street drugs
  • 28% reported being homeless
  • CD4+ cell count – 450 cells/mm 3
  • HIV viral load – 50,000 copies/mL

Results

In the case of the typical person enrolled in RAPID, their first visit to the hospital's clinic occurred on the same day that they were diagnosed and also on the same day that they received their first prescription for ART.

Among all participants enrolled in RAPID, 90% took their first dose of ART in the clinic. Furthermore, 95% of participants in RAPID who were offered immediate initiation of ART took their first dose within 24 hours of their first clinic visit.

In contrast, among participants who did not enter the RAPID program, their first clinic visit occurred 10 days after they received their positive HIV test result and they received their first prescription for ART 22 days after their first clinic visit.

Safety

According to the researchers, “most participants (90%) in RAPID received integrase inhibitor–based ART.” Furthermore, they stated that the following regimen was the most commonly prescribed (to 67% of participants) in RAPID:

  • dolutegravir + tenofovir + FTC

Changes to regimens were more common in RAPID participants. Such changes were usually made for the following reasons:

  • rash – two people
  • simplification to one pill once daily (Triumeq: dolutegravir + abacavir + 3TC) after doctors had received the results of abacavir hypersensitivity testing – 10 people

No details were released on similar changes in people who were not in the RAPID program.

Changing clinics and other issues

Similar proportions of participants in RAPID (21%) and non-RAPID care (23%) subsequently chose to receive care at a different clinic.

Clinic staff lost contact with a broadly similar proportion of participants in RAPID (10%) and non-RAPID care (15%).

Viral load

For the purposes of this analysis, the research team chose to use a viral load level of 200 copies/mL as a goal of therapy in the short term. They found that, on average, participants in RAPID achieved a target viral load of 200 copies/mL faster (56 days) after their first clinic visit than non-RAPID participants who took nearly 80 days after their first clinic visit to reach the same level.

A combined effort

The research team noted that “starting ART immediately [after diagnosis] required additional time from all members of our multidisciplinary team.” This issue arose because the researchers found that “our new patients lacked health insurance and often had immediate housing, substance use or mental health treatment needs. The addition of same-day ART into the first clinic visit therefore increased the urgency of arranging health insurance and also compressed the time available for social workers to begin the process of psychological and social stabilization.”

Summing it up

Based on their results, the researchers made the following statement:

“We found that a health system intervention to initiate ART on the same day as an HIV diagnosis was highly feasible in a real-world public health clinic in San Francisco. Same-day, observed initiation of ART was well accepted, was well tolerated by patients and did not appear to interfere with subsequent engagement in care.”

It is likely that in the future more cities, regions and countries will prioritize programs such as RAPID to help improve the health of HIV-positive people and stem the spread of new infections.

Not just in San Francisco

Researchers in Vancouver have also published their preliminary results with HIV diagnosis followed by the offer of initiating ART on the same day. Also, researchers in London, England, have reported their experience with a relatively early initiation of ART in people with very early HIV infection.

Resources

Negligible Risk: Updated results from two studies continue to show that antiretroviral treatment and an undetectable viral load is a highly effective HIV prevention strategy – CATIE News

Starting ART on the same day as an HIV diagnosis in British Columbia – TreatmentUpdate 210

Study heralds an important shift in care and treatment – TreatmentUpdate 210                                

Detailed results from the START study – TreatmentUpdate 210

CATIE statement on the use of antiretroviral treatment (ART) and an undetectable viral load to prevent the sexual transmission of HIV

—Sean R. Hosein

REFERENCES:

  1. Rodger AJ, Cambiano V, Bruun T, et al. Sexual activity without condoms and risk of HIV transmission in serodifferent couples when the HIV-positive partner is using suppressive antiretroviral therapy. JAMA . Jul 12;316(2):171-81.
  2. Daar ES, Corado K. Condomless sex with virologically suppressed HIV-infected individuals: How safe is it? JAMA. 2016 Jul 12;316(2):149-51.
  3. Cohen MS, Chen YQ, McCauley M, et al. Antiretroviral therapy for the prevention of HIV-1 transmission. New England Journal of Medicine . 2016 Sep 1;375(9):830-9.
  4. Mayer KH, Krakower DS. Antiretrovirals for HIV treatment and prevention: The challenges of success. JAMA . 2016 Jul 12;316(2):151-3.
  5. Pilcher CD, Ospina-Norvell C, Dasgupta A, et al. The effect of same-day observed initiation of antiretroviral therapy on HIV viral load and treatment outcomes in a U.S. public health setting. Journal of Acquired Immune Deficiency Syndromes . 2017; in press .
  6. Ryom L, Boesecke C, Gisler V, et al. Essentials from the 2015 European AIDS Clinical Society (EACS) guidelines for the treatment of adult HIV-positive persons. HIV Medicine . 2016 Feb;17(2):83-8.
  7. INSIGHT START Study Group, Lundgren JD, Babiker AG, Gordin F, et al. Initiation of antiretroviral therapy in early asymptomatic HIV infection. New England Journal of Medicine. 2015 Aug 27;373(9):795-807.

From Canadian AIDS Treatment Information Exchange (CATIE). For more information visit CATIE's Information Network at http://www.catie.ca

Source: CATIE: CANADIAN AIDS TREATMENT INFORMATION EXCHANGE


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