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New Guidelines, Strategies, and Drugs for Initiation of Antiretroviral Therapy 2013

New Guidelines, Strategies, and Drugs for Initiation of Antiretroviral Therapy 2013. Charles B. Hicks, MD Professor of Medicine Duke University Medical Center Durham, North Carolina. From CB Hicks, MD, at Chicago, IL: May 20, 2013, IAS-USA. Goals of Antiretroviral Therapy.

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New Guidelines, Strategies, and Drugs for Initiation of Antiretroviral Therapy 2013

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  1. New Guidelines, Strategies, and Drugs for Initiation of Antiretroviral Therapy 2013 Charles B. Hicks, MDProfessor of MedicineDuke University Medical CenterDurham, North Carolina From CB Hicks, MD, at Chicago, IL: May 20, 2013, IAS-USA.

  2. Goals of Antiretroviral Therapy • Reduce HIV-associated morbidity and prolong duration and quality of survival • Restore and preserve immunologic function • Maximally and durably suppress HIV-1 RNA • Persistently below level of detection (< 20-75 copies/mL, depending on the assay used) • Isolated “blips” not uncommon in successfully treated patients and not thought to predict virologic failure • Prevent HIV transmission DHHS Guidelines for Antiretroviral Therapy in Adults and Adolescents. March 2012.

  3. Changing Criteria for Antiretroviral Therapy Initiation in DHHS Guidelines *Pregnant women, patients with HIV-associated nephropathy, and patients with HBV that requires treatment. †50% of panel members recommended starting antiretroviral therapy; 50% of members viewed treatment as optional. Wilkin T, et al. Available at: http://inpractice.com.

  4. When to Start: 2013 DHHS Guidelines Changes reflect increasing evidence of the harmful impact of ongoing HIV replication on AIDS and non-AIDS disease progression and the benefit of effective ART in preventing secondary transmission of HIV. ART is recommended for all HIV-infected individuals; strength of recommendation varies according to CD4 cell count. • CD4 cell count <110 cells/mm3 (AI) • CD4 cell count 110-500 cells/mm3 (AII) • CD4 cell count >500 cells/mm3 (BIII) ART is strongly recommended for individuals with the following conditions regardless of CD4 cell count. • Pregnancy (AI) • History of an AIDS-defining illness (AI) • HIV-associated nephropathy (AII) • HIV/HBV coinfection (AII) HBV = hepatitis B virus. DHHS guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. February 12, 2013. Available at: http://aidsinfo.nih.gov. Accessed February 21, 2013.

  5. When to Start: IAS-USA 2012 Guidelines All adults with HIV infection should be offered ART regardless of CD4 cell count. • “When HIV is allowed to replicate uninhibited by ART, resultant immune activation and inflammation are associated not only with immune destruction and opportunistic infections but also increased rates of cardiovascular, renal, hepatic, and neurologic diseases; malignancies; and other serious non-AIDS diseases” • “Evidence from clinical trials, observational cohorts, and pathogenesis studies all point toward the health benefits of earlier ART” IAS-USA = International Antiviral Society-USA. Thompson MA et al. JAMA. 2012;308:387-402. From CB Hicks, MD, at Chicago, IL: May 20, 2013, IAS-USA.

  6. NA-ACCORD Deferred ART was associated with a 69% increase in risk of death versus early initiation in patients with CD4 111-500; 94% increase in risk of death for patients with CD4 >500 Risk of death associated with deferral of ART, according to CD4+ count at baseline, adjusted for HIV RNA level, age, and sex* Kitahata MM, Gange SJ, Abraham AG, et al. N Engl J Med. 2009;360(18):1815-1826.

  7. CNICS: Viremia Copy-Years Predicts Mortality “Viremia copy-years, a measure of cumulative plasma HIV RNA exposure and de novo viral replication, demonstrated a strong association with all-cause mortality in a large sample of HIV-infected patients who started ART.” Mugavero MJ, Napravnik S, Cole SR, et al. CID. 2011;53:927-911.

  8. HPTN 052: 96% Reduction in HIV Transmission Kaplan–Meier estimate for the cumulative probabilities of linked HIV-1 transmission between partners among participants in the early-therapy and delayed-therapy groups Cohen, MS et al. N Engl J Med. 2011;365:493-505.

  9. When to Start Therapy: Balance Now Favors Earlier Antiretroviral Therapy • ↑ potency, durability, simplicity, safety of current regimens • ↓ emergence of resistance • ↓ toxicity with earlier therapy • ↑ subsequent treatment options • Risk of uncontrolled viremia • Near normal survival if CD4+ > 500 • ↓ transmission • Drug toxicity • Preservation of limited Rx options • Risk of resistance (and transmission of resistant virus) Delayed Antiretroviral Therapy Early Antiretroviral Therapy Slide from Joel E. Gallant, MD, MPH.

  10. Change from STR to Multi-tablet Regimen (MTR) After Virologic Suppression 509 patients on STR (TDF/FTC/EFV); 478 (94%) switched to TDF + 3TC + EFV (MTR) Eligibility • STR - first cART regimen in 215 (42%) • On TDF/FTC/EFV ≥ 1 year prior to the change to MTR • No known compliance problems P=ns for change in %VF from wk 0-48 Switched from STR to MTR • Conclusion: • In a well-organized health care setting(free access to ART), switch from TDF/FTC/EFV to a MTR did not change virologic response • Caveats: Generalizability may be limited by single population, observation time Engsig F,et al. 20th CROI; Atlanta, GA; March3-6, 2013. Abst. 579.

  11. Early ART in Patients With Acute OIs Reduces Risk of AIDS Progression or Death • Randomized strategy trial of early vs deferred ART in patients with acute OIs • Results: • 282 enrolled, median CD4 29; OIs: PCP 63%, bacterial infection 12% • Early ART associated with reduced risk of new AIDS complications or death • Supports starting ART within 14 days of OI diagnosis 1.0 0.9 0.8 0.7 0.6 Probability of Surviving WithoutDeath/New AIDS-Defining Event 0.5 Early 0.4 Deferred 0.3 0.2 0.1 0 4 8 12 16 20 24 28 32 36 40 44 48 Time to Death/New AIDS-Defining Event (weeks) No. at Risk 124 119 116 141 129 Early 141 117 108 98 94 Deferred OI = opportunistic infection; PCP = Pneumocystis jiroveci pneumonia. Zolopa A et al. PLoS ONE. 2009;4:e5575. From CB Hicks, MD, at Chicago, IL: May 20, 2013, IAS-USA.

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