Sorry, you need to enable JavaScript to visit this website.
This promotional website is developed and funded by Gilead Sciences Ltd and intended for healthcare professionals in Great Britain.
This promotional website is developed and funded by Gilead Sciences Ltd and intended for healthcare professionals in the UK and Ireland.
Report adverse events
International guidelines recommend starting treatment in all people living with HIV, regardless of the CD4+ cell count, to reduce the risk of disease progression and to prevent transmission.1-4
These recommendations are based on findings from two large, randomised controlled trials that determined the efficacy of immediate treatment initiation: START5 and TEMPRANO6,7.

 

 

The START trial

START was a multicontinental randomised trial designed and conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), designed to assess the risks and benefits of immediate or deferred initiation of antiretroviral therapy (ART).5

Asymptomatic people living with HIV (N=4685) with CD4+ counts >500 cells/mm3 were randomised 1:1 to immediate ART or deferred therapy (when CD4+ count dropped to <350 cells/mm3 or until development of AIDS-related symptoms).5

A 56% reduction in the risk of any serious event (primary composite endpoint; AIDS- related, non-AIDS-related, or death) was reported in participants who began ART immediately compared to deferred therapy (hazard ratio [HR]: 0.43; 95% confidence interval [CI]: 0.30-0.62; p<0.001).5

 

The TEMPRANO trial

TEMPRANO was an unblinded multicentre, randomised controlled trial of more than 2000 participants that assessed the effects of early ART, 6 months of concomitant isoniazid prophylaxis (IPT), or both. People living with HIV with CD4+ counts of <800 cells/mm3 were randomised to four treatment arms of either immediate or deferred ART, both with and without IPT.6

Early ART significantly reduced the risk of death, AIDS-defining disease, non–AIDS-defining cancer, or non–AIDS-defining invasive bacterial disease by 44% (primary end point; HR: 0.56; 95% CI: 0.41–0.76; p=0.0002) compared with deferred ART.6 Data from the post-trial phase also suggested a 26% reduction in risk of death post 30 months of early ART compared with deferred ART (HR: 0.74; 95% CI: 0.48,1.13; p=0.17).7

 

 

Evidence for rapid initiation

There is growing evidence that rapid initiation of ART – starting within 7 days of HIV diagnosis – can provide sustained viral suppression and reduce HIV transmission:

 

RAPID programme

People living with acute or recent HIV infection (<6 months), or CD4 <200 cells/mm3, were managed according to a RAPID protocol (n=39), with a same-day appointment and first ART dose and were shown to achieve a shorter time to virologic suppression (<200 copies/mL) compared with participants treated with a standard protocol (n=47) (median: 1.8 vs. 4.3 months, respectively; p=0001).8 A retrospective analysis of the RAPID protocol confirmed these results in a vulnerable urban population with 95.8% achieving viral suppression (CD4+ count <200 cells/μL) at least once.9

 

RapIT trial

When people living with HIV received their first supply of ART on the day of their first HIV-related clinic visit (n=187), medication uptake and viral suppression were higher compared to those who were followed a standard initiation (n=190) with a relative risk of 1.36 (95% CI: 1.24-1.49) and 1.26 (95%CI: 1.05-1.50), respectively.10

 

Sabes study

At Week 48 of this longitudinal study, the proportion of participants who received immediate ART following diagnosis achieved greater viral suppression compared to those who received deferred treatment (24 weeks following diagnosis) (78.1 vs 63.1%, p=0.016), though there was no significant difference at week 24 (64.8 vs 63.1%). The CD4+ cell count, was significantly higher for those who received immediate ART compared to those who received deferred ART at week 12, but this difference narrowed over time. At baseline, all participants had low CD4/CD8 ratios; however, at week 24, CD4/CD8 ratios in participants who received immediate ART had normalised but the CD4/CD8 ratios for those who received deferred treatment remained low (median ratio: 1.07 vs 0.71; p=0.0001).

Adverse events were the lowest in participants with the most prompt initiation of ART: 85 in participants starting within 30 days (n=38) vs 163 in participants starting between 31-90 days (n =76) vs 125 in participants starting after 90 days (n=97) (p=0.03).11

 

 

Once started on ART, it is important to consider long-term factors that might impact life-long health in people living with HIV, including the adoption of appropriate adherence strategies while also considering comorbidities and potential for drug-drug interactions.

You might also like

Patient couple holding hands

Comorbidities and HIV

Discover the importance of considering comorbidities in the management of HIV

Read now
Calendar visual

Importance of adherence strategies

Discover the challenges and strategies to improve treatment adherence in people living with HIV

Read now
HCP with a patient

Treatment goals

Understand the goals of antiretroviral therapy for people living with HIV

Read now

References:

  1. European AIDS Clinical Society. EACS Guidelines v10.1. 2020. Available at:https://eacs.sanfordguide.com/. Accessed October 2023.
  2. World Health Organization. Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy. Available at:https://www.who.int/publications/i/item/9789241550062. Accessed October 2023.
  3. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. 2021. Available at: https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines Accessed October 2023.
  4. 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 Jul 24;320(4):379-396.
  5. INSIGHT START Study Group. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807.
  6. TEMPRANO ANRS 12136 Study Group. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22.
  7. Badje A, Moh R, Gabillard D et al. Effect of isoniazid preventive therapy on risk of death in west African, HIV-infected adults with high CD4 cell counts: long-term follow-up of the Temprano ANRS 12136 trial. Lancet Glob Health. 2017 Nov;5(11):e1080-e1089.
  8. 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 Jan 1;74(1):44-51.
  9. Coffey S, Bacchetti P, Sachdev D. RAPID antiretroviral therapy: high virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population. AIDS. 2019 Apr 1;33(5):825-832.
  10. 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 May 10;13(5):e1002015.
  11. Lama JR, Ignacio RAB, Alfaro R et al. Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study. Clin Infect Dis. 2021 Mar 15;72(6):1042-1050.

UK-BVY-0705 Date of preparation October 2023