1. HCV Studies Performed on New Iranian DAA Drugs
Shahin Merat, M.D.
Professor of Medicine
Digestive Disease Research Institute
Tehran University of Medical Sciences

2. 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

3. The SOF5 Study Five easy-to-treat patients Treated for 12 weeks:
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

4. SOF5 Study Results Viral count at week 1 Viral count at week 4
All non-detectable
Viral count at week 4
Viral count at week 12 (end of treatment)
Viral count at week 24 (SVR)
 Response rate: 100%

5. The SD6 Study Six easy-to-treat patients Treated for 12 weeks:
Genotype 1a/1b
Treatment naïve
Non-cirrhotic
Treated for 12 weeks:
Sofosbuvir 400 mg/Daclatasvir 60 mg in a single caplet (Sovodak), once daily

6. SD6 Study Results Viral count at week 1 Viral count at week 4
All non-detectable
Viral count at week 4
Viral count at week 12 (end of treatment)
Viral count at week 24 (SVR)
One lost to follow-up, other 5 non-detectable
 Response rate (per-protocol): 100%

8. The SD100 Study 100 difficult-to-treat patients Treated for 12 weeks:
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

9. 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

10. 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.

11. 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

12. Final Results Response rate: Per protocol: 97.8%
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%