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논문 기본 정보

자료유형
학술저널
저자정보
저널정보
대한감염학회 Infection and Chemotherapy Infection and Chemotherapy 제51권 제2호
발행연도
2019.1
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150 - 160 (11page)

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Background Lamivudine and abacavir sulfate are widely used nucleoside/tide reverse transcriptase inhibitors (NRTI) backbone agents, which are recommended in major international treatment guidelines. The fixed-dose combination of lamivudine and abacavir sulfate has been developed to contribute to low pill burden of antiretroviral therapy (ART) regimen and patient adherence. A mandatory post-marketing surveillance was conducted in Korea to monitor the safety of Kivexa (lamivudine 300 mg/abacavir 600 mg). Materials and Methods An open label, multi-center, non-interventional post-marketing surveillance was conducted to monitor the safety of Kivexa from July 2011 to July 2017 in 23 hospitals in Korea. Subjects over 12 years old taking Kivexa per prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events during the study period. Secondary outcomes included the occurrence of adverse drug reaction, the occurrence of serious adverse events and the effectiveness of Kivexa. Results A total of 600 patients from 23 hospitals were enrolled within the 6 years of study. The total observation period was 1,004 person-years. Three hundred and ten patients reported 674 adverse events. The incidence of upper respiratory infection (65 cases, 10.9%) was the highest, followed by diarrhea (20 cases, 3.3%), and nausea (18 cases, 3.0%). 109 subjects reported 71 events of adverse drug reactions, and the most common reaction was nausea in 2.33% of the subjects. Thirty-one subjects reported serious adverse events, none of them were considered drug related. From the total of 600 subjects, excluding 48 subjects who were ‘effectiveness unassessable’ by investigators, 552 patients were eligible for the subjective effectiveness analysis. 459 (83.2%) were evaluated as ‘improved’. Proportion of subjects whose human immunodeficiency virus-RNA is <50 copies/ml was 61.2% (309/505) at the beginning of observation and increased to 91.9% (464/505) at the end of study period. Conclusions The post-marketing surveillance showed the safety of Kivexa in HIV-1 patients in Korea. Ischemic cardiovascular events and hypersensitivity associated with Kivexa were few. There was no significant new safety information. This data may be helpful in implementing Kivexa and lamivudine/abacavir sulfate containing drugs in Korea.

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참고문헌 (23)

참고문헌 신청
Saag MS / 2018 / Antiretroviral drugs for treatment and prevention of HIV infection in adults : 2018 recommendations of the international antiviral society-USA panel / JAMA 320:379~396 google schola AIDS info / Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV google schola 대한에이즈학회 / 2015 / The 2015 Clinical Guidelines for the Diagnosis and Treatment of HIV/AIDS in HIV-Infected Koreans / Infection and Chemotherapy 47(3):205~211 google schola Walmsley SL / 2013 / Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection / N Engl J Med 369:1807~1818 google schola Orrell C / 2017 / Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, openlabel, non-inferiority, phase 3b study / Lancet HIV 4:e536~e546 google schola

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