Journal
CLINICAL INFECTIOUS DISEASES
Volume 73, Issue 7, Pages E1408-E1414Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciaa1037
Keywords
integrase strand transfer inhibitors; treatment-naive adults with HIV; trial emulation; efavirenz; antiretroviral therapy
Categories
Funding
- National Institutes of Health [U01AI069918, F31AI124794, F31DA037788, G12MD007583, K01AI093197, K01AI131895, K23EY013707, K24AI065298, K24AI118591, K24DA000432, KL2TR000421, N01CP01004, N02CP055504, N02CP91027, P30AI027757, P30AI027763, UL1TR000083, U01AI068634, U24AA020794, U01AI038855, U01AI038858]
- Agency for Healthcare Research and Quality [CDC-200-2006-18797, CDC-200-2015-63931]
- Health Resources and Services Administration [90047713]
- Canadian Institutes of Health Research [90051652, CBR-86906, CBR-94036, HCP-97105, TGF-96118]
- Centers for Disease Control and Prevention [CDC-200-2006-18797, CDC-200-2015-63931]
- Ontario Ministry of Health and Long Term Care
- Government of Alberta, Canada
- National Institute of Allergy and Infectious Diseases
- National Cancer Institute
- National Heart, Lung, and Blood Institute
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- National Human Genome Research Institute
- National Institute for Mental Health
- National Institute on Drug Abuse
- National Institute on Aging
- National Institute of Dental and Craniofacial Research
- National Institute of Neurological Disorders and Stroke
- National Institute of Nursing Research
- National Institute on Alcohol Abuse and Alcoholism
- National Institute on Deafness and Other Communication Disorders
- National Institute of Diabetes and Digestive and Kidney Diseases
- ViiV Healthcare
- Emory University Center for AIDS Research [AI050409]
- The National Institutes of Health [U01DA036935, U10EY008057, U10EY008052, U10EY008067, U01HL146192, U01HL146193, U01HL146194, U01HL146201, U01HL146202, U01HL146203, U01HL146204, U01HL146205, U01HL146208, U01HL146240, U01HL146241, U01HL146242, U01HL146245, U01HL146333, UL1RR024131, UL1TR000004, U01AA020790]
- A National Institutes of Health [U01AA013566, P30AI027767, P30AI036219, P30AI050409, P30AI050410, P30AI094189, P30AI110527, P30MH62246, R01AA016893, R01AI157758, U01AI068636, U01AI069432, U01AI069434, U01DA03629, R01DA011602, R01DA012568, R01 AG053100, R24AI067039, Z01CP010214, K01AI125087, U54MD007587]
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The study found that InSTI-based and EFV-based initial ART regimens had similar 6-year composite clinical outcomes, highlighting the substantial risk of adverse clinical outcomes even when initiating modern ART.
Background. Integrase strand transfer inhibitor (InSTI)-based regimens are now recommended as first-line antiretroviral therapy (ART) for adults with human immunodeficiency virus, but evidence on long-term clinical effectiveness of InSTI-based regimens remains limited. We examined whether InSTI-based regimens improved longer-term clinical outcomes. Methods. We included participants from clinical cohorts in the North American AIDS Cohort Collaboration on Research and Design who initiated their first ART regimen, containing either InSTI (ie, raltegravir, dolutegravir, and elvitegravir-cobicistat) or efavirenz (EFV) as an active comparator, between 2009 and 2016. We estimated observational analogs of 6-year intention-to-treat and per-protocol risks, risk differences (RDs), and hazard ratios (HRs) for the composite outcome of AIDS, acute myocardial infarction, stroke, end-stage renal disease, end-stage liver disease, or death. Results. Of 15 993 participants, 5824 (36%) initiated an InSTI-based and 10 169 (64%) initiated an EFV-based regimen. During the 6-year follow-up, 440 in the InSTI group and 1097 in the EFV group incurred the composite outcome. The estimated 6-year intention-to-treat risks were 14.6% and 14.3% for the InSTI and EFV groups, respectively, corresponding to a RD of 0.3% (95% confidence interval, -2.7% to 3.3%) and a HR of 1.08 (.97-1.19); the estimated 6-year per-protocol risks were 12.2% for the InSTI group and 11.9% for the EFV group, corresponding to a RD of 0.3% (-3.0% to 3.7%) and a HR of 1.09 (.96-1.25). Conclusions. InSTI- and EFV-based initial ART regimens had similar 6-year composite clinical outcomes. The risk of adverse clinical outcomes remains substantial even when initiating modern ART.
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