Favipiravir adalah antivirus yang diberikan izin penggunaan darurat untuk mengobati COVID-19 di Indonesia. Bukti efektivitas dan keamanan favipiravir masih terbatas sehingga perlu dilakukan evaluasi. Penelitian kohort retrospektif ini bertujuan untuk mengevaluasi efektivitas favipiravir berdasarkan perbaikan klinis pasien dan keamanan favipiravir berdasarkan reaksi obat yang tidak dikehendaki (ROTD) yang dianalisis menggunakan algoritma Naranjo. Rekam medis pasien dengan derajat keparahan ringan-sedang di RSUD Pasar Minggu Jakarta diambil secara konsekutif, 105 pasien masuk ke dalam kelompok favipiravir, sedangkan 105 pasien masuk ke dalam kelompok oseltamivir. Pasien dikatakan mengalami perbaikan klinis jika pasien tersebut telah memenuhi kriteria isolasi 10 hari ditambah 3 hari tidak mengalami demam dan gangguan pernapasan. Kelompok favipiravir lebih banyak mengalami perbaikan klinis dibandingkan kelompok oseltamivir (60% vs 44,8%; RR = 1,340, 95% Cl = 1,030-1,745; p = 0,038). ROTD favipiravir yang terlapor pada penelitian ini diantaranya adalah mual (8,6%), insomnia (3,8%), hiperurisemia (2,9%), peningkatan enzim transaminase (2,9%), pusing (2,9%), konstipasi (1,9%), muntah (1,9%), nyeri perut (1,9%), penurunan jumlah neutrofil (1,9%), diare (1,0%), dan nyeri lutut (1,0%). Pada penelitian ini, terdapat 6 kasus mungkin, 16 kasus cukup mungkin ROTD, dan tidak ada ROTD serius dari favipiravir. Favipiravir lebih efektif dalam mencapai perbaikan klinis dibandingkan oseltamivir dan memiliki profil keamanan yang baik.

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Favipiravir is an antiviral that has been granted an emergency use authorization for the treatment of COVID-19 in Indonesia. The effectiveness and safety evidence of favipiravir is still limited thus needs to be evaluated. This retrospective cohort study aimed to evaluate the effectiveness by assessing clinical improvement of the patient and safety of favipiravir by adverse drug reaction (ADR) analyzed using the Naranjo algorithm. Medical records of COVID-19 patients with mild-moderate illness at Pasar Minggu Jakarta District Hospital were collected consecutively, a total of 105 patients were included in the favipiravir group, whereas 105 patients were included in the oseltamivir group. Patients were stated as having clinical improvement if the patients had met the isolation criteria for 10 days after symptoms onset, plus at least three additional days without fever and respiratory symptoms. Favipiravir group was found to have better clinical improvement than oseltamivir group (60% vs 44.8%; RR = 1.340, 95% Cl = 1.030-1.745; p = 0.038). ADRs of favipiravir that were observed are nausea (8.6%), insomnia (3.8%), hyperuricemia (2.9%), elevated transaminases (2.9%), dizziness (2.9%), constipation (1.9%), vomiting (1.9%), abdominal pain (1.9%), low neutrophils count (1.9%), diarrhea (1.0%), dan knee pain (1.0%). There are 6 probable, 16 possible and no serious ADR cases of favipiravir. In conclusion, favipiravir is more effective in achieving clinical improvement and has a better safety profile than oseltamivir.