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Screening for HIV Infection in Asymptomatic, Nonpregnant Adolescents and Adults: a Systematic Review for the U.S

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Screening for HIV Infection in Asymptomatic, Nonpregnant Adolescents and Adults: a Systematic Review for the U.S Evidence Synthesis Number 176 Screening for HIV Infection in Asymptomatic, Nonpregnant Adolescents and Adults: A Systematic Review for the U.S. Preventive Services Task Force Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. HHSA-290-2015-00009-I, Task Order No. 7 Prepared by: Pacific Northwest Evidence-Based Practice Center Oregon Health & Science University Mail Code: BICC 3181 SW Sam Jackson Park Road Portland, OR 97239 www.ohsu.edu/epc Investigators: Roger Chou, MD Tracy Dana, MLS Sara Grusing, BA Christina Bougatsos, MPH AHRQ Publication No. 18-05246-EF-1 November 2018 This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2015-00009-I, Task Order No. 7). The findings and conclusions in this document are those of the authors, who are responsible for its contents, and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients). The final report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report. Acknowledgments The authors thank the Agency for Healthcare Research and Quality Medical Officer, Howard Tracer, MD, as well as the U.S. Preventive Services Task Force. Screening for HIV in Nonpregnant Adolescents/Adults ii Pacific Northwest EPC Structured Abstract Background: A 2012 systematic review on human immunodeficiency virus (HIV) screening for the U.S. Preventive Services Task Force (USPSTF) found strong evidence that antiretroviral therapy (ART) is associated with improved clinical outcomes in people with CD4+ T helper cell (CD4) counts <500 cells/mm3 and substantially decreases risk of HIV transmission, with certain antiretroviral agents potentially associated with long-term cardiovascular harms. The USPSTF previously found HIV screening tests to be highly accurate. Purpose: To systematically update the 2012 USPSTF review on HIV screening in adolescents and adults, focusing on research gaps identified in the prior review. Data Sources: We searched the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews and MEDLINE (2012 to June 2018), and manually reviewed reference lists. Study Selection: Randomized controlled trials (RCTs) and controlled observational studies on benefits and harms of screening versus no screening and on the yield of screening at different intervals; the effects of earlier versus later initiation of ART; and long-term (≥2 years) harms of ART. Data Extraction: One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Data Synthesis (Results): We did not identify any studies on benefits or harms of HIV screening versus no screening, or on the yield of repeat versus one-time screening or of screening at different intervals. Two new RCTs conducted completely or partially in low-resource settings found initiation of ART in people with CD4 counts >500 cells/mm3 associated with lower risk of composite clinical outcomes (mortality, AIDS-defining events, or serious non-AIDS events) (relative risk [RR] 0.44, 95% confidence interval [CI] 0.31 to 0.63 and RR 0.57, 95% CI 0.35 to 0.95); early ART was not associated with increased risk of cardiovascular events. A large observational study also found initiation of ART in people in high-resource settings with CD4 counts >500 cells/mm3 to be associated with reduced risk of mortality or AIDS events, though the magnitude of effect was smaller. New evidence regarding the association between abacavir use and increased risk of cardiovascular events was inconsistent and certain antiretroviral regimens were associated with increased risk of long-term neuropsychiatric, renal, hepatic, and bone adverse events. Limitations: Only English-language articles were included. Observational studies were included. Studies conducted in resource-poor settings were included, which might limit applicability to general screening in the United States. Conclusions: New evidence extends effectiveness of ART to asymptomatic people with CD4 counts >500 cells/mm3. Certain ART regimens may be associated with long-term cardiovascular, Screening for HIV in Nonpregnant Adolescents/Adults iii Pacific Northwest EPC neuropsychiatric, hepatic, renal, or bone harms, but early ART is not associated with increased risk of cardiovascular events. Research is needed to inform optimal screening intervals. Screening for HIV in Nonpregnant Adolescents/Adults iv Pacific Northwest EPC Table of Contents Chapter 1. Introduction and Background .................................................................... 1 Purpose ...................................................................................................................................... 1 Condition Background .............................................................................................................. 1 Condition Definition ..................................................................................................................2 Prevalence and Burden of Disease/Illness .................................................................................2 Etiology and Natural History .....................................................................................................3 Risk Factors ...............................................................................................................................5 Rationale for Screening/Screening Strategies ............................................................................5 Interventions/Treatment .............................................................................................................6 Current Clinical Practice/Recommendations of Other Groups ..................................................7 Chapter 2. Methods ..................................................................................................................10 Key Questions and Analytic Framework .................................................................................. 6 Search Strategies ....................................................................................................................... 6 Study Selection ......................................................................................................................... 6 Scope of Review ....................................................................................................................... 7 Data Abstraction and Quality Rating ........................................................................................ 7 Data Synthesis ........................................................................................................................... 8 External Review ........................................................................................................................ 8 Chapter 3. Results ........................................................................................................ 14 Key Question 1. What are the benefits of screening for HIV infection in asymptomatic, nonpregnant adolescents and adults on mortality, AIDS and opportunistic infections, quality of life, function, and reduced transmission of HIV and other sexually transmitted infections? ..........................................................................................................................14 Key Question 2. What is the yield (number of new diagnoses per tests performed) of screening for HIV infection at different intervals in asymptomatic, nonpregnant adolescents and adults, and how does the screening yield vary in different risk groups? ...............................................................................................................................14 Key Question 3. What are the harms of screening for HIV infection in asymptomatic, nonpregnant adolescents and adults? .................................................................................14 Key Question 4. What are the effects of initiating antiretroviral therapy in adolescents and adults with chronic HIV infection at a higher versus lower CD4 count on mortality, AIDS and opportunistic infections, quality of life, function,
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