FDA Menyetujui Penggunaan Krintafel (tafenoquine) untuk Pengobatan Kekambuhan Malaria Akibat Plasmodium vivax

FARMASI-ID.COM > BLOG | FARMASI-ID.COM > FDA Menyetujui Penggunaan Krintafel (tafenoquine) untuk Pengobatan Kekambuhan Malaria Akibat Plasmodium vivax

FDA menyetujui penggunaan Krintafel (tafenoquine) sebagai obat dosis tunggal untuk mencegah kekambuhan malaria yang disebabkan oleh parasit Plasmodium vivax pada pasien berusia lebih dari 16 tahun yang menerima terapi antimalaria. Persetujuan ini menjadikan Krintafel (tafenoquine) sebagai obat pertama yang disetujui untuk infeksi parasit Plasmodium vivax dalam lebih dari 60 tahun terakhir.

“Persetujuan Krintafel (tafenoquine) untuk digunakan sebagai perawatan baru untuk infeksi Plasmodium vivax selama lebih dari 60 tahun merupakan suatu kemajuan bagi orang-orang yang menderita kekambuhan malaria.” kata hal Baron, MD, selaku chief scientific officer sekaligus presiden R&D dari GlaxoSmithKline (GSK). “Bersama dengan partner kami Medicine of Malaria Venture (MMV), kami percaya Krintafel (tafenoquine) akan menjadi obat yang penting bagi pasien malaria dan akan berkontribusi dalam usaha untuk mengeradikasi penyakit ini”, tambahnya.

Tafenoquine adalah turunan 8-aminoquinoline dengan aktivitas melawan semua tahap dari siklus hidup Plasmodium vivax, termasuk hypnozoite. Ia pertama kali disintesa oleh imuwan di Walter Reed Army Institute of Research pada 1978 dan pada 2008, GSK masuk untuk bekerjasama dengan MMV untuk mengembangkan tafenoquine sebagai obat anti kekambuhan malaria.

Setelah nyamuk menggigit, parasit Plasmodium vivax menginfeksi darah dan menyebabkan episode malaria akut serta juga dapat masuk dan menetap (tidak aktif) di hati (dalam bentuk yang dikenal sebagai hypnozoite) dari tempat itu secara periodik aktif kembali sehingga menyebabkan kekambuhan yang dapat terjadi berminggu-minggu, berbulan-bulan, atau bahkan bertahun-tahun setelah terjadinya infeksi awal dan itu tidak dengan mudah dapat diobati oleh terapi antimalaria kebanyakan. Primaquine, suatu 8-aminoquinolone, merupakan satu-satunya obat yang disetujui oleh FDA untuk menargetkan tahap tidak aktifnya parasit itu di dalam hati untuk mencegah kekambuhan. Namun efektivitasnya baru terjadi setelah 14 hari perawatan dengan tingkat kepatuhan pasien yang rendah.

“Persetujuan FDA Amerika Serikat pada Krintafel (tafenoquine) merupakan suatu langkah besar dan signifikan pada usaha global untuk mengeradikasi malaria. Dunia menunggu selama puluhan tahun untuk obat baru yang dapat melawan kekambuhan malaria akibat Plasmodium vivax. Hari ini kami dapat mengatakan penantian itu sudah berakhir. Selain itu, sebagai dosis tunggal pertama untuk indikasi ini, Krintafel (tafenoquine) akan membantu meningkatkan kepatuhan pasien.”, ucap David Reddy, PhD, CEO MMV.

Persetujuan Krintafel (tafenoquine) diberikan berdasarkan data efikasi dan keamanan yang dikumpulkan dari program pengembangan klinis global yang komprehensif untuk pencegahan kekambuhan Plasmodium vivax yang dirancang oleh GSK dan MMV dalam persetujuan dengan FDA. Program ini terdiri dari 13 studi yang menilai keamanan 300 mg dosis tunggal Krintafel (tafenoquine), termasuk 3 studi double-blind yang disebut sebagai DETECTIVE Bagian 1 dan 2 dan GATHER.

Diberikannya persetujuan penggunaan Krintafel (tafenoquine), membuat GSK mendapat penghargaan dari FDA. Saat ini GSK masih menunggu persetujuan Australian Therapeutics Good Administration sebagai pihak yang berwenang mengeluarkan izin terhadap obat-obatan agar Krintafel (tafenoquine) dapat digunakan di Australia.

Plasmodium vivax diketahui menyebabkan 8,5 juta orang di seluruh dunia mengalami infeksi klinikal setiap tahunnya, khususnya di Asia Selatan, Asia Tenggara, Amerika Latin, Somalia, Djibouti, dan Eritrea. Gejala yang ditimbulkan seperti demam, menggigil, muntah, malaise, sakit kepala dan nyeri otot, dan dapat menyebabkan kematian pada kasus yang parah.

Krintafel (tafenoquine) tidak boleh diberikan kepada: pasien yang memiliki kekurangan glukosa-6-fosfat dehidrogenase (G6PD) atau belum diuji untuk defisiensi G6PD, pasien yang menyusui anak yang diketahui memiliki kekurangan G6PD atau yang belum diuji untuk defisiensi G6PD , atau pasien yang alergi terhadap tafenoquine atau salah satu bahan dalam tafenoquine atau yang memiliki reaksi alergi terhadap obat-obatan serupa yang mengandung 8-aminoquinolines.


Daftar pustaka:

  • US FDA approves Krintafel (tafenoquine) for the radical cure of P. vivax malaria. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-krintafel-tafenoquine-for-the-radical-cure-of-p-vivax-malaria/. Diakses 24 Juli 2018.
  • GSK gets priority review for Krintafel to prevent malaria relapse. https://www.pharmaceutical-technology.com/news/gsk-priority-review-krintafel-prevent-malaria-relapse/. Diakses 24 Juli 2018.
  • Is GSK headed for a breakup? As rumors circulate, drug giant wins approval for malaria drug. https://www.wraltechwire.com/2018/07/23/is-gsk-headed-for-a-breakup-as-rumors-circulate-drug-giant-wins-approval-for-malaria-drug/. Diakses 24 Juli 2018.
  • Plasmodium vivax treatment, Krintafel, receives FDA nod. http://outbreaknewstoday.com/plasmodium-vivax-treatment-krintafel-receives-fda-nod-73558/. Diakses 24 Juli 2018.
  • FDA Approves Drug to Stop Some Malaria Relapses. https://www.voanews.com/a/fda-approves-drug-to-stop-some-malaria-relapse/4492286.html. Diakses 24 Juli 2018.

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