TREAT ASAP

clock treat as soon as possible

Treat HIV as soon as possible

As new evidence has emerged, guidelines have changed to reflect the benefits of starting treatment as soon as possible. This shift has allowed patients to start treatment at the time of diagnosis, regardless of CD4 count.1

The management of HIV has changed considerably with the advancement of newer, more potent antiretroviral therapy (ART) agents as compared to the first treatments developed in the 1990s.1-3

Early initiation of ART4-7

  • 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 also:

  • Reduce inflammation and immune activation1
  • Restore and preserve normal immune function (immune system damage may occur early)1,8
  • Decrease future risk of AIDS events and non-AIDS health complications1

Treatments best suited for early initiation are those that are not commonly associated with transmitted resistance mutations and hypersensitivity.1 During baseline evaluations, decide how soon you could initiate treatment, determine which HIV regimen to use, and establish long-term treatment goals.1

See how HIV treatments have changed over the past 20 years.
Download the infographic HIV Treatment Then and Now: Strides in HIV Therapy.

globe global guidelines

US and global guidelines recommend starting ART as soon as possible after diagnosis

DHHS1

  • ART should be initiated as soon as possible in all patients living with HIV, regardless of CD4 count
  • In persons 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. Treatment may be deferred on a case-by-case basis, as clinically appropriate.

WHO9

  • Rapid antiretroviral (ARV) therapy initiation, defined as within seven days of diagnosis, should be offered to all patients with HIV*

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.

IAS–USA10

  • ART should be initiated as soon as possible after diagnosis, including immediately after diagnosis, unless patient is not ready to commit to starting therapy
  • Immediate initiation (eg, rapid start), if clinically appropriate, requires improving linkage to care, adequate staffing, specialized services, and careful selection of medical therapy

*Rapid initiation is defined as within seven days from the day of HIV diagnosis; people with advanced HIV disease should be given priority for assessment and initiation.

DHHS, Department of Health and Human Services; IAS–USA, International Antiviral Society–USA; WHO, World Health Organization.

Visit the resource library for access to DHHS, WHO, and IAS–USA guidelines.

medical considerations when initiating treatment

CONSIDERATIONS WHEN INITIATING TREATMENT

Before starting ART, consider a patient's resistance profile, and determine what laboratory tests are needed.1 Additionally, assess potential side effects and possible interactions with concomitant medications. The DHHS Guidelines recommend starting treatment-naive patients on a triple therapy consisting of a dual NRTI in combination with an INSTI.1

chart of validation studies

STUDIES DEMONSTRATING EARLY INITIATION OF ART

START (Strategic Timing of Antiretroviral Therapy) and TEMPRANO were two large randomized controlled trials that1:

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

START1,11

  • A 57% (95% Cl, 0.30 to 0.62) relative reduction was reported for primary endpoint outcomes with the immediate treatment with ART
  • Benefits of immediate ART were evident across all participant subgroups (including men and women, older and younger, high and low plasma HIV-1 RNA levels, residents of high-income and low/middle-income countries)
    • Immediate ART also significantly reduced the relative rate of pooled serious and non‐AIDS‐related events by 39% (relative reduction; 95% Cl, 0.38 to 0.97) and serious AIDS-related events by 72% (relative reduction; 95% Cl, 0.15 to 0.50)

View Study Design

TEMPRANO12

  • 204 primary endpoint events were recorded in 175 patients (3.8 events per 100 person-years; 95% CI, 3.3 to 4.4), including 68 in patients with a baseline CD4 count of at least 500 cells/mm3 (3.2 events per 100 person-years; 95% CI, 2.4 to 4.0)
  • Early ART reduced the risk of death or severe HIV‑related illness (components of composite primary endpoint) as compared to deferred initiation of ART by 44% (hazard ratio, 0.56; 95% CI, 0.41 to 0.76; adjusted hazard ratio among patients with a baseline CD4 count of ≥500 cells/mm3, 0.56; 95% CI, 0.33 to 0.94)

View Study Design

These studies demonstrated that initiating ART as soon as possible is optimal—prompting a change in guidelines to treating HIV as soon as possible after diagnosis, regardless of CD4 cell count.1

Early treatment initiation focuses on shortening the time between diagnosis and treatment. Some studies have shown benefits of starting therapy as early as the same day of diagnosis. Specifically, these studies of varying design and patient populations have1:

  • Concluded that ART initiation on the day of diagnosis can improve/sustain viral suppression4,5
  • Represented a shift in the established treatment paradigm, demonstrating that earlier initiation is not only possible but feasible4,5

RAPID4

Timeframe assessed: as soon as possible and ideally on the day of first referral

  • 94.9% (37 of 39) of patients began ART within 24 hours
  • Improved time to virologic suppression for patients initiated same day (1.8 months to viral load <200 copies/mL vs 4.3 months in standard arm, P=0.0001)
  • Intervention included education, screening, insurance services, and telephone follow-up

View Study Design

RapIT5

Timeframe assessed: within 24 hours of HIV clinic visit

  • Improvements in uptake of ART and viral suppression with single-visit initiation
  • 64% of rapid initiation arm (119/187) were virally suppressed at 10 months compared to 51% (96/190) in standard initiation arm (HR=1.06; 95% CI, 0.61 to 1.84)
  • Post-initiation loss to care was higher in the rapid arm, and pre-initiation loss to care was higher in the standard arm; attrition rates remained similar in both groups

View Study Design

SABES Study6

Timeframe assessed: early initiation in acute recent HIV

  • Demonstrated rapid reduction in plasma and semen viral load
  • Greater declines in plasma cytokines across phases of infection, and faster time to viral load decay for patients in earlier stages of infection
    • The absolute difference in plasma viral load (log viral load change/week) through 24 weeks was 0.07 for the early treatment arm vs 0.02 for the deferred arm (P<0.001)

View Study Design

ART Observational7

Timeframe assessed: within 30 days of diagnosis

  • 26% (22/86) initiated ART at first visit
  • 79% of those who initiated upon clinical intake achieved viral suppression at Week 12 vs 57% of remaining study population (P=0.068)
  • Shorter time to viral suppression with integrase-inhibitor-based vs protease-inhibitor-based regimens (P=0.022)

View Study Design

My main goal is to get started as soon as possible and maintain whatever immune system function we have, maintain that, perhaps build it, and get our viral loads as low as possible—as fast as possible—with the goal to get completely virologically suppressed."

–Cynthia Rivera, MD

Video thumbnail Watch

Learn more about baseline evaluations and watch 3 HIV specialists discuss how they educate and connect with their patients.

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REFERENCES:

  1. US Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. https://aidsinfo.nih.gov/contentfiles/adultandadolescentgl.pdf. Updated May 30, 2018. Accessed June 4, 2018.
  2. Nachega JB, Parienti JJ, Uthman OA, et al. Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: a meta-analysis of randomized controlled trials. Clin Infect Dis. 2014;58(9):1297-1307.
  3. Halkitis PN, Shrem MT, Zade DD, Wilton L. The physical, emotional and interpersonal impact of HAART: exploring the realities of HIV seropositive individuals on combination therapy. J Health Psychol. 2005;10(3):345-358.
  4. 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.
  5. 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. doi:10.1371/journal.pmed.1002015.
  6. Gilada TI, Lama JR, Bender Ignacio RA, et al. Dynamics of viral load and cytokines when ART is initiated soon after HIV acquisition. Poster presented at: International Antiviral Society-USA Conference on Viruses and Opportunistic Infections (CROI); February 13-16, 2017; Seattle, WA.
  7. 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. doi:10.1038/srep32947.
  8. 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.
  9. World Health Organization. Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy. http://apps.who.int/hiv/pub/guidelines/advanced-HIV-disease/en/. Published July 2017. Accessed July 5, 2018.
  10. Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the International Antiviral Society-USA Panel. JAMA. 2018;320(4):379-396.
  11. INSIGHT START Study Group, Lundgren JD, Babiker AG, et al. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015;373(9):795-807.
  12. TEMPRANO ANRS 12136 Study Group, Danel C, Moh R, et al. A trial of early antiretrovirals and isoniazid preventive therapy in Africa. N Engl J Med. 2015;373(9):808-822.