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Main | | | | | | | |
| Brand Name | Viread | | | | | |
| Generic Name | tenofovir | | | | | |
| Indication | HIV, HBV | | | | | |
| | 250,000 US patients who are undiagnosed. | | | | | |
| | 1.0m-1.2m patients with HIV in the US. 750k-900k are diagnosed. 500k are on ARV. 310k are on tenofovir. | | | | | |
| Price | 7% increase as of 4/1/06. $482/mo - Q2 2007 | | | | | |
| IP | 5922695 - Issued 6/13/99, Filed 6/25/97. | | | | | |
| Clinical Trials | | | | | | |
| | Study 934 - HIV - 3-year data coming up at IAS | | | | | |
| | 96-week data comparing Viread/Emtriva/Sustiva to Combivir/Sustiva | | | | | |
| | 75% vs 62% efficacy superiority (p=0.004) | | | | | |
| | 7% is due to AE withdrawal and >4% is due to virologic rebound | | | | | |
| | SS increase in limb fat in Viread and a SS decrease in Combivir. This demonstrates less lipodystrophy than Combivir. | | | | | |
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| | Study 903 - 5-year data at IAS | | | | | |
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| | Phase III HBV n=375 - Study 102 | | | | | |
| | Met primary endpoint of non-inferiority to Hepsera in HBV-e-antigen-negative patients. | | | | | |
| | 70.8% complete response for Viread vs 48.8% for Hepsera (nodal score and viral load reduction). | | | | | |
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| | Phase III HBV - Study 103 | | | | | |
| | e-antigen-positive patients, which are harder. | | | | | |
| | Same endpoint - 66.5% vs 12.2% response rate. | | | | | |
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| | | NDC | | | Combivir | Epivir |
| | | TRx | TRx % | | TRx % | TRx |
| | 1/12/2007 | 9707 | 0.121 | | 0.138 | 0.08 |
| | 1/5/2007 | 9456 | 0.125 | | 0.14 | 0.083 |
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| | Phase III CAPRISA 004 | | | | | |
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| | Phase III iPrEx | | | | | |