Dr Paul Thulavath – Mercy 2016 EASL update
1. Hepatitis C update Dr. Paul Thulava
i. ASTRAL phase 3 program sofosbuvir + velpatasvir (400 and 100 mg) – Pangenotypic RAV (resistance associated Virus) , AE similar to placebo
ii. Hardest to treat is genotype 3
iii. ? early response = better cure rate.. NOT TRUE. So not needed to check PCR. This is for the Gilead drug Sof plus Vel
iv. ABT – 493 -+ ABT – 530 From Abbvie. Pangenotypic. This is second or third generation drug for pangenotypic. Can be used with renal failure. SURVEYOR –II study. Abstract showed cure rate 100 for type 3. No AE different than placebo (headache, fatigue insomnia)
v. Rx for genotype 3 plus cirrhosis – 60% of people in India have it. Sof plus Dac plus Rib for 24 weeks gives 85% cure rate. Sof plus peg plus ribavirin has 88% cure rate. But surveyer 2 study showed 100% cure rate !! in 3 months. (ABT 493 plus ABT 530) combination
vi. Drugs on NS5B are sofosbuvir and Dasabuvir. NS5A Dac
viii. NS5A RAV – 0.3 to 2.8 % in GT 1. Y93H and L31M subtype of NS5A has a high RAV. Similar there are subtypes of NS5B has some subtypes with high RAV
ix. NS5A and NS5B post treatment have high post treatment residual RAV. Not true for NS3. Which only has 9% residual RAV compared to more than 75% for NS5A or NS5B (this is mostly present in GT 1b.
x. RAV for NS3 subtype Q80 –
xi. Viekera pack type 1b if NS5 RAV response rate is 87% and not 92%
xii. ASTRAL study – RAV has no impact but RAV in GT 3 has 87% response instead of 87%
xiii. MAGELLAN – I study from Abbvie. They studied patients who had failed harvoni etc the newest treatment. More than 80% RAV in this population. SVT was 91 and 86% success rate !!! The 2 failure rate had crohns and rapid transit.
xiv. DAA – direct acting antiviral acronym for those who fail viekera, harvoni etc.
xv. SWIFT elbasvir, grazoprevir plus sofosbuvir plus ribavarin – 100% in DAA failed cased.
xvi. LBO3 – at EASL got standing ovation. They used drugs made in India. The drug was identical to those made in USA. Same cure rate for generic and brand name !
1. Grazoprevir plus Elbasvir : effective in coinfection, renal failure, cirrhosis type A and B and type 1, 4 and 6
2. Side effects are headache, fatigue and nausea
3. Ribavarin use in addition improves rate in HIV by 5 %