Safety and efficacy of Ziagen (abacavir sulfate) in HIV-infected Korean patients

Heawon Ann, Ki Hyon Kim, Hyun Young Choi, Hyun Ha Chang, Sang Hoon Han, Kye Hyung Kim, Jin Soo Lee, Yeon Sook Kim, Kyung Hwa Park, Young Keun Kim, Jang Wook Sohn, Na Ra Yun, Chang Seop Lee, Young Wha Choi, Yil Seob Lee, Shin Woo Kim

Research output: Contribution to journalArticle

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Abstract

Background: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). Materials and Methods: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. Results: A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. Conclusion: Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea.

Original languageEnglish
Pages (from-to)205-212
Number of pages8
JournalInfection and Chemotherapy
Volume49
Issue number3
DOIs
Publication statusPublished - 2017 Jan 1

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HIV
Safety
Korea
Drug-Related Side Effects and Adverse Reactions
abacavir
Hypersensitivity
Observation
Reverse Transcriptase Inhibitors
Dyspepsia
Virus Diseases
Exanthema
Nucleosides
Myocardial Ischemia
HIV-1
Diarrhea
RNA
Delivery of Health Care
Therapeutics

All Science Journal Classification (ASJC) codes

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Ann, H., Kim, K. H., Choi, H. Y., Chang, H. H., Han, S. H., Kim, K. H., ... Kim, S. W. (2017). Safety and efficacy of Ziagen (abacavir sulfate) in HIV-infected Korean patients. Infection and Chemotherapy, 49(3), 205-212. https://doi.org/10.3947/ic.2017.49.3.205
Ann, Heawon ; Kim, Ki Hyon ; Choi, Hyun Young ; Chang, Hyun Ha ; Han, Sang Hoon ; Kim, Kye Hyung ; Lee, Jin Soo ; Kim, Yeon Sook ; Park, Kyung Hwa ; Kim, Young Keun ; Sohn, Jang Wook ; Yun, Na Ra ; Lee, Chang Seop ; Choi, Young Wha ; Lee, Yil Seob ; Kim, Shin Woo. / Safety and efficacy of Ziagen (abacavir sulfate) in HIV-infected Korean patients. In: Infection and Chemotherapy. 2017 ; Vol. 49, No. 3. pp. 205-212.
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abstract = "Background: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen{\circledR} (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). Materials and Methods: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. Results: A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7{\%} of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3{\%}) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91{\%} of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. Conclusion: Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea.",
author = "Heawon Ann and Kim, {Ki Hyon} and Choi, {Hyun Young} and Chang, {Hyun Ha} and Han, {Sang Hoon} and Kim, {Kye Hyung} and Lee, {Jin Soo} and Kim, {Yeon Sook} and Park, {Kyung Hwa} and Kim, {Young Keun} and Sohn, {Jang Wook} and Yun, {Na Ra} and Lee, {Chang Seop} and Choi, {Young Wha} and Lee, {Yil Seob} and Kim, {Shin Woo}",
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Ann, H, Kim, KH, Choi, HY, Chang, HH, Han, SH, Kim, KH, Lee, JS, Kim, YS, Park, KH, Kim, YK, Sohn, JW, Yun, NR, Lee, CS, Choi, YW, Lee, YS & Kim, SW 2017, 'Safety and efficacy of Ziagen (abacavir sulfate) in HIV-infected Korean patients', Infection and Chemotherapy, vol. 49, no. 3, pp. 205-212. https://doi.org/10.3947/ic.2017.49.3.205

Safety and efficacy of Ziagen (abacavir sulfate) in HIV-infected Korean patients. / Ann, Heawon; Kim, Ki Hyon; Choi, Hyun Young; Chang, Hyun Ha; Han, Sang Hoon; Kim, Kye Hyung; Lee, Jin Soo; Kim, Yeon Sook; Park, Kyung Hwa; Kim, Young Keun; Sohn, Jang Wook; Yun, Na Ra; Lee, Chang Seop; Choi, Young Wha; Lee, Yil Seob; Kim, Shin Woo.

In: Infection and Chemotherapy, Vol. 49, No. 3, 01.01.2017, p. 205-212.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and efficacy of Ziagen (abacavir sulfate) in HIV-infected Korean patients

AU - Ann, Heawon

AU - Kim, Ki Hyon

AU - Choi, Hyun Young

AU - Chang, Hyun Ha

AU - Han, Sang Hoon

AU - Kim, Kye Hyung

AU - Lee, Jin Soo

AU - Kim, Yeon Sook

AU - Park, Kyung Hwa

AU - Kim, Young Keun

AU - Sohn, Jang Wook

AU - Yun, Na Ra

AU - Lee, Chang Seop

AU - Choi, Young Wha

AU - Lee, Yil Seob

AU - Kim, Shin Woo

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Background: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). Materials and Methods: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. Results: A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. Conclusion: Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea.

AB - Background: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). Materials and Methods: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. Results: A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. Conclusion: Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea.

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