Brief Report: Safety and Tolerability of Inguinal Lymph Node Biopsy in Individuals With Acute HIV Infection in Thailand

Michelle Chintanaphol, Carlo Sacdalan, Suthat Chottanapund, Suteeraporn Pinyakorn, Supranee Buranapraditkun, Trevor A Crowell, Eugene Kroon, Sopark Manasnayakorn, Jeffrey G Chipman, Timothy W Schacker, Nelson Michael, Nittaya Phanuphak, Serena S Spudich, Donn J Colby, Jintanat Ananworanich, Michelle Chintanaphol, Carlo Sacdalan, Suthat Chottanapund, Suteeraporn Pinyakorn, Supranee Buranapraditkun, Trevor A Crowell, Eugene Kroon, Sopark Manasnayakorn, Jeffrey G Chipman, Timothy W Schacker, Nelson Michael, Nittaya Phanuphak, Serena S Spudich, Donn J Colby, Jintanat Ananworanich

Abstract

Introduction: Latent HIV reservoirs are rapidly established in lymphoid tissues during acute HIV infection (AHI). Sampling these tissues provides important information about HIV pathogenesis. This period is associated with viral replication and immune activation that may affect procedure-related adverse events (AEs). We examined the safety and tolerability of inguinal lymph node (LN) biopsy in research participants with AHI in Bangkok, Thailand.

Methods: Between 2013 and 2016, 67 AHI participants in the RV254/SEARCH010 study underwent at least one optional inguinal LN biopsy during AHI at the baseline visit and/or after antiretroviral therapy (median 48 weeks after antiretroviral therapy). Biopsy-related AEs were graded according to NIH Division of AIDS guidelines. Poisson regression was used to calculate incidence rate ratios and 95% confidence intervals to evaluate associations of demographic and HIV characteristics, procedure timing, and repetition with AE incidence.

Results: Of the 67 participants, 97% were male with a median age of 26. Among 78 LN biopsies (39 at baseline and 39 at follow-up), 10 (12.8%) AEs were reported: 6 (7.7%) grade 1 and 4 (5.1%) grade 2. The AEs were biopsy-site discomfort (n = 8, 10.2%) and hematoma (n = 2, 2.6%). No factors were significantly associated with AE incidence. All biopsy-related AEs were transient and self-limited.

Conclusions: Inguinal LN biopsies were safe and well tolerated in mostly Thai men with AHI. As LN biopsies become an integral part of HIV research, this study provides information to participants, researchers, and institutional review boards that these samples can be safely obtained.

Trial registration: ClinicalTrials.gov NCT00796146.

Conflict of interest statement

M.C. interned at Royalty Pharma. T.A.C. has received a speaker fee from Gilead Sciences. S.S.S. codirects a clinical research study that receives donated study medications from ViiV Healthcare. J.A. has received honorarium for participating in advisory meetings for ViiV Healthcare, Merck, AbbVie, and Roche. The remaining authors have no conflicts of interest to disclose.

References

    1. Siliciano JD, Siliciano RF. The latent reservoir for HIV-1 in resting CD4+ T cells: a barrier to cure. Curr Opin HIV AIDS. 2006;1:121–128.
    1. Pace MJ, Agosto L, Graf EH, et al. HIV reservoirs and latency models. Virology. 2011;411:344–354.
    1. Churchill MJ, Deeks SG, Margolis DM, et al. HIV reservoirs: what, where and how to target them. Nat Rev Microbiol. 2016;14:55–60.
    1. Pierson T, McArthur J, Siliciano RF. Reservoirs for HIV-1: mechanisms for viral persistence in the presence of antiviral immune responses and antiretroviral therapy. Annu Rev Immunol. 2000;18:665–708.
    1. Skarda DE, Taylor JH, Chipman JG, et al. Inguinal lymph node biopsy in patients infected with the human immunodeficiency virus is safe. Surg Infect. 2007;8:173–177.
    1. Meditz AL, Connick E, McCarter M. Safety of excisional inguinal lymph node biopsies performed for research purposes in HIV-1-infected women and men. Surg Infect. 2014;15:399–403.
    1. Rothenberger MK, Mutuluuza CK, Ssali F, et al. Inguinal lymph node and anorectal mucosal biopsies for human immunodeficiency virus research protocols in an emerging nation: patient outcomes and lessons learned. Surg Infect. 2015;16:68–71.
    1. Robb ML, Eller LA, Kibuuka H, et al. Prospective study of acute HIV-1 infection in Adults in East Africa and Thailand. N Engl J Med. 2016;374:2120–21130.
    1. Crowell TA, Colby DJ, Pinyakorn S, et al. Acute retroviral syndrome is associated with high viral burden, CD4 depletion, and immune activation in systemic and tissue compartments. Clin Infect Dis. 2017;66:1540–1549.
    1. De souza MS, Phanuphak N, Pinyakorn S, et al. Impact of nucleic acid testing relative to antigen/antibody combination immunoassay on the detection of acute HIV infection. AIDS. 2015;29:793–800.
    1. Phanuphak N, Teeratakulpisarn N, van Griensven F, et al. Anogenital HIV RNA in Thai men who have sex with men in Bangkok during acute HIV infection and after randomization to standard vs. intensified antiretroviral regimens. J Int AIDS Soc. 2015;18:19470.
    1. Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS. 2003;17:1871–1879.
    1. Crowell TA, Fletcher JLK, Sereti I, et al. Initiation of antiretroviral therapy before colonic infiltration by HIV reduces viral reservoirs, inflammation and immune activation. J Int AIDS Soc. 2016;19:21163.
    1. Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institute of Health. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. Version 2.0. Bethesda, MD: US Department of Health and Health Services; 2014.
    1. Kroon BK, Lont AP, Valdés Olmos RA, et al. Morbidity of dynamic sentinel node biopsy in penile carcinoma. J Urol. 2005;173:813–815.
    1. Kretschmer L, Thoms KM, Peeters S, et al. Postoperative morbidity of lymph node excision for cutaneous melanoma-sentinel lymphonodectomy versus complete regional lymph node dissection. Melanoma Res. 2008;18:16–21.
    1. Dindo D, Demartines N, Clavien P. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–213.

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