Abstract

Since 2008, Dihydroartemisinin-Piperaquine (DHP) has been used as the first-line drug for treatment of falciparum malaria in Papua, which gradually will also be used in other endemic areas. The objective of the study was  to determine the safety and efficacy of DHP. Patients with uncomplicated malaria due to Plasmodium falciparum were enrolled and treated with supervised DHP (arterakin ®, no. batch 010 909) daily dose for three days. Patients were followed for 42 days. Patients during follow up did physical examination and checked for microscopic parasites, measurement of hemoglobin levels (day 0, 14, 28 and 42), making the blood spot PCR (day 0 and day relapse), pregnancy test for women of childbearing age (Day 0 and 28). 119 patients were enrolled in the study. Therapeutic efficacy of DHP by day 42 in ITT and PP population were 98.3% (95% CI: 94.1-99.5%) and 100% (95% CI: 96.9-100%). The means of parasite clearance and fever clearance were 1.0 day and 1.6 days, and clinical symptoms was reduced by over 50% by day-7 follow up. All patients with gametocytes on day 0, generally were cleared on day 28 . There were an increasing number of patients with recovery hemoglobin at day 14, 28 and 42: 61%, 78% and 84%. Adverse events were mild, ie cough (31%) and abdominal pain (10%). Dihydroartemisinin-piperaquine was safe and effective for the treatment of uncomplicated P. falciparum malaria. AbstrakSejak 2008, program telah menggunakan dihidroartemisinin-piperakuin (DHP) sebagai pilihan pertama pengobatan malaria falsiparum di Papua, yang secara bertahap juga akan digunakan di wilayah endemis lainnya. Tujuan penelitian ini adalah untuk menilai keamanan  dan efikasi obat DHP. Pasien malaria falsiparum tanpa komplikasi diikutkan dalam studi dan diobati DHP (arterakin ®, no. batch 010 909) dengan pengawasan minum obat dosis satu kali sehari selama tiga hari. Selanjutnya pasien dipantau selama 42 hari. Pasien selama kunjungan ulang dilakukan pemeriksaan fisik dan cek parasit mikroskopis, diukur kadar hemoglobin (hari 0, 14, 28 dan 42), dibuat spot darah PCR (hari 0 dan hari kambuh), tes kehamilan pada wanita usia subur. Sebanyak 119 pasien direkruit pada penelitian ini. Efikasi terapeutik obat DHP pada hari ke 42 per populasi ITT dan PP adalah 98.3% (95% CI: 94.1-99.5%) dan 100% (95% CI: 96.8-100%). Rerata bebas parasit dan bebas demam adalah 1.0 hari dan 1.6 hari, dan gejala klinis berkurang hingga di atas 50% pada hari ke-7 kunjungan ulang. Pasien dengan karier gametosit pada saat rekruitmen, umumnya pada hari ke-28 sudah bebas gametosit. Terdapat peningkatan jumlah pasien dengan perbaikan hemoglobin pada hari ke 14, 28 dan 42: 61%, 78% dan  84%.  Kejadian sampingan adalah ringan, yaitu batuk (31%) dan sakit perut (10%).Dihidroartemisinin-piperakuin adalah aman dan efektif pada pengobatan malaria falsiparum tanpa komplikasi.