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길리어드, '렘데시비르' 중증 코로나19 "치사율 38%↓" - 바이오스펙테이터

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길리어드, '렘데시비르' 중증 코로나19 "치사율 38%↓"

입력 2020-07-13 15:04 수정 2020-07-13 15:04

바이오스펙테이터 서윤석 기자

중증 코로나19 환자서 리얼월드데이터와 비교분석..렘데시비르 투여군서 치사율 7.6%, 대조군 12.5%..오는 8월 흡입제형 렘데시비르 임상 시작예정

길리어드가 코로나19 치료제 '렘데시비르'가 중증 환자의 치사율을 38% 감소시킬 수 있다는 결과를 공개했다.

길리어드는 10일(현지시간) 중증 코로나19환자를 대상으로 ‘렘데시비르(remdesivir)’의 임상 3상(SIMPLE-Severe)연구와 리얼월드 후향적 코호트(real-world retrospective cohort)의 비교분석 결과를 발표했다. 렘데시비르의 임상 3상에 참여한 중증 코로나19 환자 312명과 동일기간 동안 표준치료를 받은 특성과 심각도가 유사한 중증 코로나19 환자 818명의 치료효과를 비교한 결과다.

발표에 따르면 길리어드는 렘데시비르로 치료한 중증 코로나19 환자의 치사율이 대조군 대비 38% 감소시킨 결과를 확인했다. 구체적으로 렘데시비르로 치료받은 환자의 치사율은 7.6%로 대조군 12.5%와 비교해 유의미하게 개선됐다(95% CI: 0.22~0.68, p=0.001). 또, 치료 14일차에 렘데시비르로 치료받은 환자의 74.4%, 대조군의 59%가 회복돼 렘데시비르 투여군에서 회복속도도 빨랐다.

수잔 올랜더(Susan Olender) 컬럼비아대 어빙의료센터 의사는 “이번 분석은 렘데시비르에 대한 유용한 정보를 추가로 제공한다”며 “무작위 대조시험만큼은 아니지만, 실제환경에서 분석한 것으로 임상데이터를 보조함으로써 코로나19에 대한 이해를 높일 수 있다"고 말했다.

추가로 길리어드는 렘데시비르와 히드록시클로로퀸의 병용임상 결과와 소아 및 임산부 코로나19 환자를 대상으로 렘데시비르를 동정적 사용(compassionate use)한 결과를 공개했다. 14일간의 추적관찰 결과, 렘데시비르로 치료받은 환자군와 렘데시비르+히드록시클로로퀸을 병용사용한 환자군은 각각 69%, 57%의 회복률을 보였다(HR 0.61, 95% CI: 0.45~0.83, p=0.002). 렘데시비르 단독투여군에서 회복속도가 더 빠른 결과를 나타낸 것이다. 길리어드는 14일간의 분석에서 히드록시클로로퀸 투여군은 치사율에 영향을 보이진 않았으나 더 높은 비율의 이상반응을 보였다고 밝혔다.

세계보건기구(WHO)는 지난 4일 코로나19 환자를 대상으로 진행하던 클로로퀸과 히드록시클로로퀸의 임상을 중단한다고 밝힌 바 있다.

길리어드는 약물의 동정적 사용 프로그램의 일환으로 렘데시비르로 치료받고 있는 77명의 코로나19 소아환자를 분석한 결과, 28일차에 임상상태가 개선돼 73%가 퇴원했다고 밝혔다. 또, 렘데시비르로 치료받은 86명의 임산부 및 산후여성(postpartum women)은 각각 96%, 89%가 산소보조수치(oxygen supportive level)가 개선됐다. 기준선대비 임산부와 산후여성은 각각 렘데시비르 투여 후 93%, 89%로 비슷한 수준의 회복률(recovery rate)을 보였다. 침습적인 산소치료(invasive oxygen support)를 받지 않은 임산부는 회복하는데 평균 5일이 걸렸으며, 인공호흡기 치료를 받은 임산부와 산후여성은 평균 13일의 회복시간을 가졌다.

한편, 길리어드는 오는 8월 흡입형 렘데시비르에 대한 임상을 시작할 예정으로, 만약 승인된다면 초기 환자의 경우 분무기를 사용해 스스로 약물을 투여할 수 있을 것으로 기대된다.

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