`US 8,889,159 B2
`(10) Patent No.:
`(12)
`Clearyet al.
`(45) Date of Patent:
`*Nov.18, 2014
`
`
`US008889159B2
`
`(54) COMPOSITIONS AND METHODS FOR
`TREATING HEPATITIS C VIRUS
`.
`(71) Applicant: Gilead Pharmasset LLC,Foster City,
`CA (US)
`
`(56}
`
`(72)
`
`Inventors: Darryl G. Cleary, Chapel Hill, NC
`(US); Charles J. Reynolds, Greenville,
`NC (US): Miriam Michelle Berrey,
`Durham, NC(US): Robert G. Hindes,
`Skillman, NJ (US), William T.
`.
`rN
`S53
`cr
`isc.
`Symonds, San Francisco, CA (US);
`Adrian S. Ray, Redwood City, CA
`(US); Hongmei Mo, Palo Alto, CA (US);
`Christy M. Hebner, Belmont, CA (US);
`.
`ic
`;
`Reza Oliyai, Burlingame, CA (US):
`Vahid Zia, San Carlos, CA (US);
`Dimitrios Stefanidis, Mountain View,
`CA (US); Rowchanak Pakdaman, San
`Carlos, CA (US): Melissa Jean Casteel,
`Burlingame, CA (US)
`
`.
`
`References Cited
`5
`erean
`ees
`.
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`Continued)
`FOREIGN PATENT DOCUMENTS
`
`
`
`(73) Assignee: Gilead Pharmasset LLC, Foster City,
`CA(US)
`M4
`S
`
`,
`CA
`CN
`
`2682230 Al
`10L108870 A
`
`10/2008
`1/2008
`
`(*) Notice:
`
`Subject to any disclaimer, the termofthis
`parent satand ees under 35
`S.C,
`ays.
`‘This patent is subject to a terminal dis-
`claimer
`‘
`(21) Appl. No.: 13/686,664
`nt.
`New
`Filed:
`Nov. 27, 2012
`yo Dehieet
`Prior Publication Data
`.
`US 2013/0136776 Al
`May 30, 2013
`
`(22)
`(65)
`
`(Continued)
`OTHER PUBLICATIONS
`GS-7977 structure provided by Chembest Research Laboratories
`Led.
`(biochembest.com/product, detail.asp?m2&id=1 178
`&classid! =65&nclassid=195). (last visit for this website was made
`on Jun. 27,2013)"
`World Health Organization (hereinafter ‘WHO’), “Pharmaceutical
`excipients-~an overviewincluding considerations for paediatric dos-
`ing.” (Jun. 2010).*
`Gane, E., “Future Hepatitis C Virus Treatment: Interferon-Sparing
`Combinations,” Liver International (2011) 3 (SL): 62-67.
`Gane, E., “Future Treatment
`for Chronic Hepatitis C:
`IPN or
`Ribavirin-Free Regimens,” Hepatol. Int (2012) 6:16-17 (Abstract
`#TCS 10-03).
`
`(Continued)
`
`(60)
`
`Related U.S. Application Data
`d
`Pri
`Examiner —Ernst V
`.
`Lo,
`.
`oer
`No. ay rani von o xron ;
`application
`of
`(63) Continuation-in-part
`PC'1/US2012/055621, filed on Sep. 14, 2012, anda
`458/8/4Rt Sxaininer — Kyung
`SOOK CRANE
`continuation-in-part of application No. 13/661,509, (74) Attorney, Agent, or Firm—Sheppard Mullin Richter &
`
`filed on Oct. 26, 2012.
`Hampton LLP
`ABSTRACT
`Provisional application No. 61/564,500, filed on Nov.
`(57)
`29, 2011. provisional application No. 61/707,459,
`Disclosed herein are a composition and unit dosage form for
`filed on Sep. 28, 2012.
`the treatment ofhepatitis C virus (HC‘V) infection comprising
`GS-7977 and at least one pharmaceutically acceptable excipi-
`ent, as well as methods for making said composition and unit
`dosage form. Also disclosed herein isa 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 ofGS-7977 and an effective
`amount of ribavirin.
`In one aspect,
`the method comprises
`administering to the subject an interferon-free treatment regi-
`men 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
`HCVRNAin the subject forat least 12 weeksafter the end of
`the time period,
`Gilead 2004
`37 Claims, 3 Drawing Sheets
`I-MAKv. Gilead
`IPR2018-00126
`
`(51)
`
`Int. Ch
`(2006.01)
`A6LK 47/10
`(2006.01)
`COTH 19/04
`(2006.01)
`AGIK 31/813
`(2006.01)
`AGIK 31/675
`(2006 01)
`AGIK 31/4196
`—_—
`(52) U S Cl
`<
`.
`a
`CPO eosernsseen AOTK 31/675 (2013.01); AGEK 31/513
`.
`(2013.01): AGIK 31/4196 (2013.01)
`USPC eeeecsesetessenees 424/400, 514/86; 536/26.8
`reid of Classification Search
`one
`See applicationfile for complete search history.
`
`(58)
`
`
`
`US 8,889,159 B2
` Page 2
`
`(56)
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