Gilead Sciences hepatitis C (HCV) drug sofosbuvir with ribavarin is currently under review with the FDA for stage 2 and 3 genotype infection. Also under consideration, is sofosbuvir in combination with ribavarin and peglated interferon for the treatment of chronic hepatitis C in treatment naive adult patients with genotype 1 and 4 infection. Approximately 75% of patients with HCV fall into the genotype 1 catagory.
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GILD is currently conducting a phase 3 trial called ION-3 for treatment naive genotype 1 infected patients. This phase 3 study was initiated from the positive results of the phase 2 study called LONESTAR.
LONESTAR Phase 2 Results
Treatment Duration Population Results
Sofosbuvir + ledipasvir 12 weeks GT-1 treatment exp. 95% (18/19) SVR 4
Sofosbuvir + ledipasvir 12 weeks GT-1 treatment exp. 95% (21/21) SVR 4
+ RBV
The phase 2 Lonestar trial results above suggest that a once daily all oral therapy of sofosbuvir + ledipasvir may have the potential to cure most genotype 1 HCV infected patients 100% at 12 weeks naive.
ION-3 Phase 3 Current Study Design
Sofosbuvir + ledipasvir 8 weeks GT-1 treatment naive
Achieved 95% from LONESTAR.
Sofosbuvir + ledipasvir + RBV 8 weeks GT-1 treatment naive
Achieved 100% from LONESTAR.
Sofosbuvir + ledipasvir 12 weeks GT-1 treatment naive
Achieved 100% from LONESTAR.
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GILD has just posted results of their PHOTON-1 phase 3 trial for patients with HCV and HIV.
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GILD is currently conducting a phase 3 trial called ION-3 for treatment naive genotype 1 infected patients. This phase 3 study was initiated from the positive results of the phase 2 study called LONESTAR.
LONESTAR Phase 2 Results
Treatment Duration Population Results
Sofosbuvir + ledipasvir 8 weeks GT-1 treatment naive 95% (19/20) SVR 8
Sofosbuvir + ledipasvir 8 weeks GT-1 treatment naive 100% (21/21) SVR 8
+ RBV
Sofosbuvir + ledipasvir 12 weeks GT-1 treatment naive 100% (19/19) SVR 4Sofosbuvir + ledipasvir 12 weeks GT-1 treatment exp. 95% (18/19) SVR 4
Sofosbuvir + ledipasvir 12 weeks GT-1 treatment exp. 95% (21/21) SVR 4
+ RBV
The phase 2 Lonestar trial results above suggest that a once daily all oral therapy of sofosbuvir + ledipasvir may have the potential to cure most genotype 1 HCV infected patients 100% at 12 weeks naive.
ION-3 Phase 3 Current Study Design
Sofosbuvir + ledipasvir 8 weeks GT-1 treatment naive
Achieved 95% from LONESTAR.
Sofosbuvir + ledipasvir + RBV 8 weeks GT-1 treatment naive
Achieved 100% from LONESTAR.
Sofosbuvir + ledipasvir 12 weeks GT-1 treatment naive
Achieved 100% from LONESTAR.
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GILD has just posted results of their PHOTON-1 phase 3 trial for patients with HCV and HIV.
76% SVR 12 for genotype 1 Hpc/HIV patients after 24 wks of sofosbuvil + ribavirin (no interferon)
88% SVR 12 for genotype 2 Hpc/HIV patients after 12 wks of sofosbuvil + ribavirin
67% SVR 12 for genotype 3 Hpc/HIV patients after 12 wks of sofosbuvil + ribavirin
The phase 3 PHOTON-1 trial results above are impressive given the fact that patient cohorts (Hep C + HIV) were the most refractory among drug therapy, most of them have failed prior treatment.
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Bottom Line: The $20 billion hepatitis C market has grabbed the attention of several companies attempting to enter with new and improved products. From data researched, I believe GILD has the best product and safety profile coming to the market and the best pipeline for HCV. Thank you for reading.
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