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Download HCV Studies Performed on New DAA Drugs
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HCV Studies Performed on New Iranian DAA Drugs Shahin Merat, M.D. Professor of Medicine Digestive Disease Research Institute Tehran University of Medical Sciences 1 Studies Performed by DDRI • Digestive Disease Research Institute (DDRI) of Tehran University of Medical Sciences (TUMS) • SOF5 • Sofosbuvir, pegylated interferon, ribavirin • 5 patients, easiest to treat • SD6 • Sofosbuvir, daclatasvir (Sovodak) • 6 patients, easiest to treat • SD100 • Sofosbuvir, daclatasvir (Sovodak), ribavirin • 100 patients, most difficult to treat 2 The SOF5 Study • Five easy-to-treat patients • Genotype 1a/1b • Treatment naïve • Non-cirrhotic • Treated for 12 weeks: • Weekly PEG-IFN (pegaferon), 180 micg SQ • Ribavirin (1000mg/d for <75kg, 1200mg/d for>75kg) PO in two divided daily doses • Sofosbuvir 400 mg daily PO 3 SOF5 Study Results • Viral count at week 1 • All non-detectable • Viral count at week 4 • All non-detectable • Viral count at week 12 (end of treatment) • All non-detectable • Viral count at week 24 (SVR) • All non-detectable Response rate: 100% 4 The SD6 Study • Six easy-to-treat patients • Genotype 1a/1b • Treatment naïve • Non-cirrhotic • Treated for 12 weeks: • Sofosbuvir 400 mg/Daclatasvir 60 mg in a single caplet (Sovodak), once daily 5 SD6 Study Results • Viral count at week 1 • All non-detectable • Viral count at week 4 • All non-detectable • Viral count at week 12 (end of treatment) • All non-detectable • Viral count at week 24 (SVR) • One lost to follow-up, other 5 non-detectable Response rate (per-protocol): 100% 6 7 The SD100 Study • 100 difficult-to-treat patients • • • • Cirrhotics, including decompensated and Child’s C All genotypes, including genotype 3 (difficult to treat) Previous treatment failures HIV, post transplant, immune supressors… • Treated for 12 weeks: • Sofosbuvir 400 mg/Daclatasvir 60 mg in a single caplet (Sovodak), once daily • Ribavirin (1000mg/d for <75kg, 1200mg/d for>75kg) in two divided daily doses 8 SD100 Study Subjects • • • • 100 patients included, all cirrhotic Age: mean 54.8 years Male/Female: 66/34 Genotype • • • • • • • • 55 genotype 1 42 genotype 3 1 genotype 4 2 unknown 2 HIV 4 post transplant 6 decompensated cirrhosis 1 AIH 9 Follow-up • One patient developed increased creatinine level following severe diarrhea and gastroenteritis Excluded • Two patients died from unrelated reasons • perforated duodenal ulcer • sepsis following IV drug abuse in an HIV patient • Five patients lost to follow-up • 92 subjects finished the study. 10 Viral Counts During Treatment • Viral count at week 1 available for 94 patients • All non-detectable except for 1 (145 IU/ml) • Viral count at week 4 available for 90 patients • All non-detectable • Viral count at week 12 available for 92 patients • All non-detectable 11 Final Results • Viral count at week 24 (SVR12) available for 92 patients • 90 non-detectable, 2 recurrence • One genotype 1 • One genotype 3 • Response rate: • Per protocol: 97.8% • Intention to treat: 90% Remember these are cirrhotics. The response rate for cirrhotics in the literature is around 80% 12
