Evidence map›Paper›PMID 29027387›Full record

ArticleInfection & chemotherapy2017

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 and 6 more

Open access · goldAbstract read
In one paragraph

Article in Infection & chemotherapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Heawon AnnGlaxoSmithKline Korea, Seoul, Korea.ORCID https://orcid.org/0000-0003-3170-0109
Ki Hyon KimGlaxoSmithKline Korea, Seoul, Korea.
Hyun Young ChoiGlaxoSmithKline Korea, Seoul, Korea.
Hyun Ha ChangDepartment of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
Sang Hoon HanDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Kye Hyung KimDepartment of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.
Jin Soo LeeDivision of Infectious Diseases, Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.
Yeon Sook KimDivision of Infectious Diseases, Department of Internal Medicine, Chungnam National University School of Medicine, Daejon, Korea.
Kyung Hwa ParkDepartment of Infectious Disease, Chonnam National University Medical School, Gwangju, Korea.
Young Keun KimDepartment of Internal Medicine, Wonju College of Medicine, Yonsei University, Wonju, Korea.
Jang Wook SohnDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
Na Ra YunDepartment of Internal Medicine, Chosun University School of Medicine, Gwangju, Korea.
Chang Seop LeeDepartment of Internal Medicine and Research Institute of Clinical Medicine, Chonbuk National University Medical School and Hospital, Jeonju, Korea.
Young Wha ChoiDepartment of Infectious Disease, Ajou University School of Medicine, Suwon, Korea.
Yil Seob LeeGlaxoSmithKline Korea, Seoul, Korea.
Shin Woo KimDepartment of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea. ksw2kms@knu.ac.kr.ORCID https://orcid.org/0000-0002-3755-8249
The Genetics Society of Korea · KRYonsei University · KRKyungpook National University · KRAjou University · KRChonnam National University · KRChosun University · KRInha University · KRJeonbuk National University · KRKorea University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAbacavir 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

methodsAn 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.

resultsA 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.

conclusionOur 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.

Indexed as

AbacavirDrug-related side effects and adverse reactionsHuman immunodeficiency virusPharmacoepidemiology

Identifiers

PMID29027387
PMCPMC5620387
OpenAlexW2754643281

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.