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Empower your patients to initiate treatment ASAP

There are several benefits to beginning treatment as quickly as possible after an initial diagnosis. Guidelines have changed in recent years to reflect the importance of early treatment initiation, which has allowed patients to start treatment at the time of diagnosis, regardless of CD4 count.1

Benefits of early initiation logo.

  • Shortens the time between diagnosis and viral suppression
  • Lowers the risk of transmission sooner
  • Improves retention in care

Starting ART and achieving viral suppression earlier in the course of disease may also1,5:

  • Reduce inflammation and immune activation1
  • Restore and preserve normal immune function (immune system damage may occur early)1,5
  • Decrease future risk of AIDS events and non-AIDS-related health complications1

Are you considering treatment regimens that allow for early initiation?

The importance of laboratory monitoring

IAS-USA recommends laboratory monitoring in order to characterize6:

  • The stage of HIV (using HIV RNA level and CD4 count)
  • Overall health (kidney and liver function, lipid levels, complete blood cell count, blood glucose level, and pregnancy)
  • Any co-infections, including viral hepatitis A, hepatitis B, hepatitis C, tuberculosis, and STIs
  • These tests should not delay the start of ART unless preexisting kidney or liver damage is present or there is a high likelihood of drug resistance
  • Quickly perform follow-up tests for all measures to ensure proper safety

Evidence-based benefits of early initiation

START (Strategic Timing of Antiretroviral Therapy) and TEMPRANO (Trial of Early
Antiretrovirals and Isoniazid Preventive Therapy in Africa) were two large
randomized controlled trials that1,7:

  • Evaluated the optimal time to initiate ART
  • Demonstrated a reduction in morbidity and mortality
  • Influenced the DHHS recommendation for the earliest possible treatment initiation

View START Study Design

START was a large, multinational, randomized controlled clinical trial of 4685 treatment-naïve adults that evaluated the role of immediate ART in asymptomatic HIV-infected patients. The primary clinical endpoint was a composite outcome that included any serious AIDS-related event, whether death from AIDS or any AIDS-defining illnesses, as well as any serious non-AIDS events, including death.1,7

View TEMPRANO Study Design

TEMPRANO was a multicenter, randomized controlled trial of more than 2000 participants to assess the benefits of early ART, 6-month isoniazid preventive therapy (IPT), or both. The primary composite endpoint was AIDS diseases, non-AIDS malignancies, non-AIDS invasive bacterial diseases, and death from any cause.1,8

Rapid ART start at the Detroit STD clinic further supported the importance of early initiation

Among newly diagnosed patients, 93% (n=40/43) of patients were virally suppressed with at least one month of follow-up, and 81% (n=35/43) of patients were retained in care.9

View RAPID Start ART Detroit Study Design

The objective of the study was to evaluate the rate of viral suppression and retention in care with a Rapid Start ART Protocol implemented in a municipal clinic for STDs with a high rate of new HIV diagnoses. The Rapid Start ART protocol was performed specifically in a municipal STD clinic (n=43) that experienced a high rate of new HIV diagnoses. The Rapid Start ART protocol was initiated for all patients on either the same day as HIV diagnosis or the day of initial presentation at the clinic. Patients were scheduled for follow-up with the same provider at both 1 week and up to 1 month to reinforce adherence and to perform lab testing.9

Rapid ART and its effect on virologic suppression rates performed in San Francisco

95.8% of patients (P = 0.84) with HIV achieved viral suppression down to <200 cells/μL at least once by 1 year after intake. During a median follow-up time of 1.09 years, only 14.7% of patients had a viral rebound and 78% of patients were resuppressed. The RAPID program sought to demonstrate the feasibility of rapid initiation of ART in a diverse population with the goal of reducing barriers to treatment and linkage to care. The city-wide program included patients with a history of substance abuse (51.4%), mental illness (48.1%), or unstable housing (30.6%).10


View RAPID ART San Francisco Study Design

This study presents a retrospective analysis of sociodemographic characteristics and virologic outcomes in 225 patients who were referred to the Ward 86 RAPID clinical program within 6 months of HIV diagnosis.10

For illustrative purposes only. Not actual patient or physician.

HCP communicating with another person.
Do the guidelines agree on the importance of early initiation?

DHHS guidelines1

  • ART should be initiated as soon as possible in all people living with HIV, regardless of CD4 count
  • In people with acute or recent (early) HIV infection, in pregnant people with HIV, or in people who will initiate ART on the day of or soon after HIV diagnosis, ART initiation should not be delayed while awaiting resistance testing results; the regimen can be modified once results are reported
  • When initiating treatment, it is important to educate patients on the benefits and considerations of ART and adherence

IAS-USA6

  • ART should be initiated as soon as possible after diagnosis, including immediately after diagnosis, unless patient is not ready to commit to starting therapy
  • Studies demonstrate that implementing rapid treatment protocols can lead to increased retention and population-level viral suppression

WHO11 

  • Rapid ART initiation, defined as within seven days of diagnosis, should be offered to all patients with HIV following confirmed diagnosis and clinical assessment 
  • Consider the overarching principles of providing people-centered care with a focus on the health needs and preferences of patients. People should be supported in making informed decisions regarding when to start treatment

Experts agree that early initiation of ART can provide a multitude of benefits for PLWH.

ART, antiretroviral therapy; CD4, cluster of differentiation 4; DHHS, US Department of Human and Health Services; IAS-USA, International Antiviral Society–USA; RNA, ribonucleic acid; STD, sexually transmitted disease; STI, sexually transmitted infection; WHO, World Health Organization.

References:

  1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Updated May 26, 2023. Accessed July 24, 2023. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/guidelines-adult-adolescent-arv.pdf
  2. 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 US public health setting. J Acquir Immune Defic Syndr. 2017;74(1):44-51.
  3. Rosen S, Maskew M, Fox MP, et al. Initiating antiretroviral therapy for HIV at a patient’s first clinic visit: the RapIT randomized controlled trial. PLoS Med. 2016;13(5):e1002015.
  4. Hoenigl M, Chaillon A, Moore DJ, et al. Rapid HIV viral load suppression in those initiating antiretroviral therapy at first visit after HIV diagnosis. Sci Rep. 2016;6:32947.
  5. Sereti I, Krebs SJ, Phanuphak N, et al. Persistent, albeit reduced, chronic inflammation in persons starting antiretroviral therapy in acute HIV infection. Clin Infect Dis. 2017;64(2):124-131.
  6. Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 recommendations of the International Antiviral Society–USA Panel. JAMA. 2020;320(4):379-396.
  7. Lundgren JD, Babiker AG, et al. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015;373(9):795-807.
  8. Danel C, Moh R, Gabillard D, et al. A trial of early antiretrovirals and isoniazid preventive therapy in Africa. N Engl J Med. 2015;373:808-822.
  9. Heisler S, Cohn J, Lukomski D, Tuinier K. Ending the HIV epidemic: rapid ART start at the Detroit STD Clinic. Oral presentation at: International AIDS Society Conference on HIV Science 2020. July 6 –10, 2020. Oral abstract PEB0341.
  10. Coffey S, Bacchetti P, Sachdev D, et al. RAPID antiretroviral therapy: high virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population. AIDS. 2019;33(5):825-832.
  11. World Health Organization. Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy. Published July 2017. Accessed July 5, 2021. https://www.who.int/publications/i/item/9789241550062