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4 New HCV Drugs: 1st SVR Results from NS5A BMS790052; 2 nucleotides in combination PSI938 + PSI7977; cyclophillin inhibitor Debo25;
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Reported by Jules Levin
There were 4 important presentations on studies with new HCV drugs presented today, 4 potent drugs at various stages of development. All these study results are highly impressive. BMS reported the first SVR data on their potent NS5A inhibitor, the first in class NS5A inhibitor, plus peg/rbv & they reported week 12 SVR. 48 treatment-naive genotype 1 patients were randomized to 3 different doses of once-daily BMS-790052 (3, 10 or 60 mg) plus peg/rbv for 48 weeks of triple therapy or standard of care of peg/rbv. SVR 12 is 12 weeks after the end of therapy: "BMS-790052 3 mg, 10 mg, and 60 mg SVR12 rates were 42% (5/12 subjects),92% (11/12), and 83% (10/12), respectively, versus 25% (3/12) for placebo. Early HCV RNA response (RVR and eRVR) correlates well with Week 12 SVR for subjects treated with BMS-790052 plus pegIFNα-2a/RBV. Virologic breakthrough and relapse were uncommon in the 10 mg and 60 mg dose groups. In an exploratory analysis evaluating the IL28B RS12979860 SNP, 10 mg and 60 mg BMS-790052 plus pegIFNα-2a/RBV resulted in high rates of SVR at Week 12 regardless of the host genotype (CC, CT, or TT; Figure 4)."
Pharmasset reported 2 separate studies: in one study genotype 1 treatment-naive patients received only 2 nucleotides (PSI-938 and PSI-7977) without peg/ribv, so only oral HCV drugs, and after 14 days of therapy 94% had undetectable viral load, "No viral breakthrough was observed during therapy...No significant PK interaction between PSI-738 & PSI-7977 was observed....PSI-938 and PSI-7977 as monotherapy and in combination were generally safe and well tolerated over 7-14 days".
Novartis reported results from a phase 2b study of Debo25, a cyclophilin inhibitor (host-targeting antiviral, chemically modified from cyclosporin A) plus peg/rbv in genotype 1 treatment-naive patients who were randomized to 3 different Debo25 arms or peg/rbv only for 48 or 24 weeks. In the 48 week group 76% achieved SVR, in the 24-week response guided therapy group 69% achieved SVR: "Superior SVR versus PegIFN/RBV alone (76 vs 55%)....6.8% in the 48-week group experienced hyperbilirubinemia, Hyperbilirubinaemia was transient and reversible, and not associated with hepatotoxicity or cholestasis". Novartis recently announced phase studies are starting.
I will report in this and following emails the precise data reported in all the posters & slides: the Deb25 study was presented in an oral session this afternoon, the others were Late breaker posters this morning. This afternoon's late session from 5-8 included oral presentations on IL28b in telaprevir and boceprevir and lead-in results from studies.
Tomorrow Friday and saturday will be more studies presented on new HCV drugs. This is a landmark meeting because of all the exciting new study results that take us to new highs in therapy including the results reported above but also results reported in the remainder of the meeting, stay tuned for more.
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