Gilead Sciences, Inc.

Gilead Pharmasset LLC

K.u. Leuven Research & Development

Other

Janssen Sciences Ireland Uc

Gerhard Puerstinger

Puerstinger, Gerhard

Vahid Zia

Reza Oliyai

Dimitrios Stefanidis

Ernest A Carra

Erik Mogalian

Irene Chen

David A Oare

Steven S Bondy

Eric Dowdy

Eric Gorman

Lauren Wiser

Scott E Lazerwith

Katie Ann Keaton

Rowchanak Pakdaman

Melissa Jean Casteel

Choung U Kim

Adrian S Ray

Winston C Tse

Johan Neyts

Kenneth M Kent

Terrence C Dahl

Darryl G Cleary

Hongmei Mo

Gerhard Pürstinger

Charles J Reynolds

Robert G Hindes

Miriam Michelle Berrey

William T Symonds

Christy M Hebner

Norma J Tom

Bing Shi

Fang Wang

Ben Chal

Goedele De Smedt

Regina Driesen

Dominiek Henrist

Greet Kauwenberghs

Sandeep Mathur

Kathleen Dashner

Hyuk-Jun Jung

Scott McCallister

Mun Sik Seo

Roel Mertens

Richard Nettles

Magda Opsomer

William Pyrz

Katia Boven

Eric Davis Dowdy

Disclosed are pharmaceutical compositions comprising Compound I, having the formula: and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.

Combination formulation of two antiviral compounds

The present invention relates to crystalline forms and co-crystals of (2R,5S,13aR)-8-hydroxy-7,9-dioxo-N-(2,4,6-trifluorobenzyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2&#x2032;:4,5]pyrazino[2,1-b][1,3]oxazepine-10-carboxamide, the pharmaceutical formulations, and the therapeutic uses thereof. The present invention also relates to novel crystalline forms of sodium (2R,5S,13aR)-7,9-dioxo-10-(2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1&#x2032;,2&#x2032;:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate Form I.

Crystalline forms of (2R,5S,13aR)-8-hydroxy-7,9-dioxo-N-(2,4,6-trifluorobenzyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2&#x2032;:4,5]pyrazino[2,1-b][1,3]oxazepine-10-carboxamide

The disclosure is directed to methods of treating subjects infected with HIV, once daily, with single unit dosage forms that include darunavir (or a hydrate or solvate thereof), cobicistat, emtricitabine, and a tenofovir prodrug, or salt thereof.

Compositions and methods of treating HIV

The present invention relates to sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2&#x2032;:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate Form I, pharmaceutical formulations, and uses thereof for treating or prophylactically preventing an HIV infection.

Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2&#x2032;:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate

The present invention relates to crystalline forms and co-crystals of (2R,5S,13aR)-8-hydroxy-7,9-dioxo-N-(2,4,6-trifluorobenzyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2&#x2032;:4,5]pyrazino[2,1-b][1,3]oxazepine-10-carboxamide, the pharmaceutical formulations, and the therapeutic uses thereof. The present invention also relates to novel crystalline forms of sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1&#x2032;,2&#x2032;:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate Form I.

Crystalline forms of (2R,5S,13AR)-8-hydroxy-7,9-dioxo-N-(2,4,6-trifluorobenzyl)-2,3,4,5,7,9,13,13A- octahydro-2,5-methanopyrido[1',2&#x2032;:4,5]pyrazino[2,1-B] [1,3] oxazepine-10-carboxamide

Disclosed are pharmaceutical compositions having an effective amount of substantially amorphous ledipasvir and an effective amount of substantially crystalline sofosbuvir.

The present invention relates to sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl) carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2&#x2032;:4,5]pyrazino[2,1-b][1,3] oxazepin-8-olate Form I and the therapeutic uses thereof.

Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2&#x2032;:4,5]pyrazino[2, 1-b][1, 3]oxazepin-8-olate

Crystalline forms of (2R,5S,13AR)-8-hydroxy-7,9,-dioxo-N-(2,4,6-trifluorobenzyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2&#x2032;:4,5]pyrazino[2,1-b][1,3]oxazepine-10-carboxamide

Disclosed herein are a composition and unit dosage form for the treatment of hepatitis C virus (HCV) infection comprising GS-7977 and at least one pharmaceutically acceptable excipient, as well as methods for making said composition and unit dosage form. Also disclosed herein is a method of treating a subject, preferably a human, infected with hepatitis C virus, said method comprising administering to the subject for a time period an effective amount of GS-7977 and an effective amount of ribavirin. In one aspect, the method comprises administering to the subject an interferon-free treatment regimen comprising an effective amount of GS-7977 and an effective amount of ribavirin. In a particular aspect, the method is sufficient to produce an undetectable amount of HCV RNA in the subject for at least 12 weeks after the end of the time period.

Compositions and methods for treating hepatitis C virus

Crystalline solid forms of the anti-HCV compound (S)-isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2- yl)methoxy)(phenoxy)phosphorylamino)propanoate (Compound I) are described Also provided are processes of making and methods of using the crystalline forms.

Solid forms of an antiviral compound

A crystalline compound of formula (1) and its salts and solvates are provided for the treatment or prophylaxis of hepatitis C virus infections Methods of making and formulating crystalline compound (1) are provided.

Crystalline pyridazine compound

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Palo Alto, CA, United States of America

Vahid Zia