1395. The Safety of Substitution of Antiretroviral Regimen in Non-Clinical Trial Settings in Asian Countries
Session: Poster Abstract Session: HIV: Antiretroviral Therapy
Friday, October 6, 2017
Room: Poster Hall CD

Although substitutions of antiretroviral regimen are generally safe, most data on substitutions are based on results from clinical trials. The objective of this study was to evaluate the safety of substituting antiretroviral regimen in virologically suppressed HIV-infected patients in non-clinical trial settings in Asian countries.


HIV-infected patients enrolled in the TREAT Asia HIV Observational Database (TAHOD) were included in this analysis if they started combination antiretroviral therapy (cART) after 2002, were being treated at a centre that documented a median rate of viral load (VL) monitoring ≥ 1 tests/patient/year, and experienced a minor or major treatment substitution while on virally suppressive cART (VL < 200 copies/ml). Minor regimen substitutions were defined as within-class changes and major regimen substitutions were defined as changes to a drug class. Virologic failure was defined as having had two viral load measurements > 400 copies/ml. The patterns of substitutions and rate of virologic failure after substitutions were analysed.


Of 3,994 adults who started ART after 2002, 3,119 (78.1%) had at least one period of virological suppression. Among these, 1,170 (37.5%) underwent a minor regimen substitution, and 296 (9.5%) underwent a major regimen substitution during suppression. The rates of virological failure were 1.48/100person years (95%CI 1.14-1.91) in the minor substitution group and 2.85/100person years (95%CI 1.88-4.33) in the major substitution group, and 2.53/100person years (95%CI 2.20-2.92) among patients that did not undergo a treatment substitution.


The rate of virological failure was relatively low in both major and minor substitution groups, showing that regimen substitution is generally safe in non-clinical trial settings in Asian countries.

In Young Jung, MD1, David Boettiger, PhD2, Wingwai Wong, MD3, Man Po Lee, MD4, Sasisopin Kiertiburanakul, MD, MHS5, Romanee Chaiwarith, MD6, Anchalee Avihingsanon, MD, PhD7, Junko Tanuma, MD8, N. Kumarasamy, M.B.B.S., PhD9, Adeeba Kamarulzaman, MD10, Fujie Zhang, MD11, Pacharee Kantipong, MD12, Oon Tek Ng, MBBS(Singapore), MRCP(UK), FAMS, MPH13, Benedict Lh Sim, MD14, Matthew Law, MD15, Jeremy Ross, MD16 and Jun Yong Choi, MD, PhD1, (1)Division of Infectious Disease, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of (South), (2)The Kirby Institute, UNSW Australia, Sydney, Australia, (3)Taipei Veterans General Hospital, Taipei, Taiwan, (4)Queen Elizabeth Hospital, Hong Kong, China, (5)Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, (6)Internal Medicine, Faculty of Medicine Chiang Mai University, Muang, Thailand, (7)HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok, Thailand, (8)National Center for Global Health and Medicine, Tokyo, Japan, Tokyo, Japan, (9)YRG Center for AIDS Research and Education, Chennai, India, (10)University Malaya Medical Centre, Kuala Lumpur, Malaysia, Kuala Lumpur, Malaysia, (11)Beijing Ditan Hospital, Capital Medical University, Beijing, China, (12)Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand, Chiang Rai, Thailand, (13)Tan Tock Seng Hospital, Singapore, Singapore, (14)Hospital Sungai Buloh, Sungai Buloh, Malaysia, (15)The Kirby Institute, UNSW Sydney, Sydney, Australia, Sydney, Australia, (16)TREAT Asia, amfAR - The Foundation for AIDS Research, Bangkok, Thailand


I. Y. Jung, None

D. Boettiger, None

W. Wong, None

M. P. Lee, None

S. Kiertiburanakul, None

R. Chaiwarith, None

A. Avihingsanon, None

J. Tanuma, None

N. Kumarasamy, None

A. Kamarulzaman, None

F. Zhang, None

P. Kantipong, None

O. T. Ng, None

B. L. Sim, None

M. Law, None

J. Ross, None

J. Y. Choi, None

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