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Gilead Sciences Inc said it would allow generic-drug makers to produce a new version of its Sovaldi hepatitis C treatment. The new drug is currently still undergoing clinical trials, but Gilead believes the new version will be more effective at treating the hepatitis C virus, which infects 130 million people worldwide a year.
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El interferón se inyecta bajo la piel, y ribavirin se toma por vía oral. Hoja informativa 680 contiene más información sobre estos medicamentos. Sofosbuvir se puede tomar con o sin comida. Sofosbuvir debe ser almacenado a temperatura ambiente (por debajo de 86°F o 30°C).
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The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
Encouraging Results on Gilead's Sovaldi Zacks Friday, April 11, 2014 Zacks Equity Research
Gilead Sciences, Inc. ( GILD ) announced encouraging results from two phase II studies and a compassionate access study on Sovaldi in patients suffering from chronic hepatitis C virus (:HCV) infection with advanced liver disease.
Hepatitis C currently infects more than 170 million people around the world, leading to significant morbidity and mortality. The current standard of care for HCV infection, including one of the two protease inhibitors, telaprevir or boceprevir, for 12-32 weeks, along with pegylated interferon alfa-2a (PEG-IFN-α) and ribavirin for up to 48 weeks, is unsatisfactory in many cases, either because of lack of efficacy or because of treatment-related adverse effects. There is an urgent need of new drugs with improved efficacy as well as a safety profile. Sofosbuvir, a recently approved nucleotide analog, is a highly potent inhibitor of the NS5B polymerase in the Hepatitis C virus (HCV), and has shown high efficacy in combination with several other drugs, with and without PEG-INF, against HCV. It offers many advantages due to its high potency, low side effects, oral administration, and high barrier to resistance. The efficacy and safety were demonstrated in many large and well-designed phase 2 and phase 3 clinical trials like NEUTRINO, PROTON, ELECTRON, ATOMIC, COSMOS, FUSION, FISSION, NUCLEAR, POSITRON, and the like. It is generally well-tolerated. Adverse events that occurred include: Headache, insomnia, fatigue, nausea, dizziness, pruritis, upper respiratory tract infections, rash, back pain, grade 1 anemia, and grade 4 lymphopenia; however, the exact safety profile can only be judged when this drug is actually used on a large scale.
"En Brasil hicieron un combo, sofosbuvir y daclatasvir, una unión de dos laboratorios", dijo Brahm.
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