llllllllllllllllllllllllllllllllllllllllllllllllIllllllllllllllllllll
`
`U3008889159B2
`
`(121 United States Patent
`(10) Patent N0.:
`US 8,889,159 B2
`
`Cleary et a1.
`(45) Date of Patent:
`*Nov. 18, 2014
`
`(54) COMPOSITIONS AND M'lC'l'lil(')l)S FOR
`TRE \TING HEPATITIS C VIRUS
`f
`
`(56)
`
`References Cited
`.
`.
`,.
`-
`.
`U.S. l’ATle DOCUMENTS
`
`(71) Applicant; (iilead Pharmasset LLC. Foster City.
`CA (US)
`
`3.798.209 A
`3.852.267 A
`RE29,835 E
`
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`
`.
`
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`2 33? 8:33:32“: 11
`(ii/992 llettel
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`[(3% 33% gm“ 01M],
`1
`r
`.
`8.16110 Z 0121 .
`3/ 993 Hostetleretal,
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`419995 Schinazi etal.
`5” 995 “05‘0“” 6‘ 31'
`COlmHWd)
`FOREIGN RATENT DOCUMENTS
`
`(72)
`
`Inventors: Darryl G. Cleary. Chapel Hill. NC
`(US); Charles J. Reynolds, Greenville,
`NC (US): lVliriam Michelle Berrey,
`Durham, NC (US); Robert G. Hindes,
`Skillman, NJ (US); William T.
`.
`1
`‘_
`T.‘
`'
`~
`S-‘mf’nds’ Simmmswi C‘VA‘ (US),
`Adrian S. Ray. Redwood City, CA
`(US); Hongmci Mo. Palo Alto, CA (US);
`Christy M Hebner Belmont CA (US)
`.
`.
`.
`’
`’
`‘
`.
`’
`Reza Oliyar. Burlingame, CA (US);
`Vahid Lia. San Carlos, CA (US);
`Dimitrios Stefanidis, Mountain View.
`CA (US); Rowchanak Pakdaman, San
`Carlos, CA (US); Melissa Jean Casteel,
`Burlingame. CA (US)
`
`4314677 A
`2339;? j:
`5118:1320 A
`5.149.794 A
`3133,2221; It
`I
`4-”
`I‘
`5.194.654 A
`5,210,015 A
`5.223.263 A
`5,256,641 A
`5,256,798 A
`5,372,808 A
`5.376.380 A
`51405.?98 A
`5‘4 1 [J47 A
`
`
`
`(73) Assignee: Gilead Pharmasset LLC. Foster City.
`_
`("\ (Ug)
`
`‘
`(TN
`CA
`
`101108870 A
`2682230 A1
`
`1/2008
`10/2008
`
`( * ) Notice:
`
`Subject to any disclaimer. the term ot‘this
`{fascist 11853:)??ng :ryadiusted under 35
`.t .
`a ‘s.
`This patent is subject to a terminal dis-
`claimer
`
`'
`
`(21) Appi. No.2 13/686,664
`..
`.2
`,
`‘
`,
`Filed.
`Nov. 27, 2012
`.
`,
`)
`,
`3‘
`I “0“ I uhlication Data
`
`(22)
`
`(65)
`
`‘
`US 2013/0136776 Al
`
`May 30‘ 2013
`
`Related U.S. Application Data
`..
`.
`..
`,
`No.
`(63) Continuat10n~m~part
`oi
`application
`PC'lYUSQOlZ/‘055621. filed on Sep. 14. 2012, and a
`continuation-in-part of application No.
`lit/661.509.
`filed on Oct. 26. 2012.
`Provisional application No. 6l/564.500. filed on Nov.
`29, 2011. provisional application No. 61/707,459.
`filed on Sep. 28, 2012.
`
`(60)
`
`(51)
`
`( 52)
`
`(58)
`
`Int, Cl,
`(2006.01)
`A61K 47/10
`(2006.01)
`C0711 19/04
`(2006.01)
`A61K 31/513
`(2006.01)
`A6IK {1/6 75
`(7006 01)
`A61K‘11/4196
`..
`'
`.U s (:1
`_
`.
`" ' "
`CFC """"""" A61K31/67j5(2()]3‘01)’A61K31/313
`‘
`(2013.01).A61K.?1/4l96(2()13.()1)
`USPC -------------------------- 424/4003 514/867- 336/268
`Field ofClassification Search
`Nonc
`See application file for complete search histoiy.
`
`(CUUUHUW)
`011va PURHCA’l‘lONS
`(rs-7977 stmciure provided by Chembest Research Laboratories
`Ltd.
`(biochembest.com/product "detail.asp?m“'"2&id=-“l 178
`&classidl~‘=65&.nclzissid:195). (last visit for this website was made
`
`,
`_
`_
`on 199273013)?“ _
`World Health Organization (hereinafier ‘WHO‘). “Pharmaceutical
`excipientsw-an overview including considerations forpaediatric dos-
`mg,” (hm. 2010)}.
`Gone. EL, “Future Hepatitis C Virus Treatment: lnterferon—Spm’ing
`Combinations.” Liver international (201 1) 31(81): 62—67.
`Gone. 13., “Future Treatment
`for Chronic Hepatitis C:
`lFN or
`Ribavirin-l"1‘ee Regimens,” llepatol. Int (2012) 6:16—17 (Abstract
`#TCS [003).
`
`(Continued)
`
`"
`1'
`'4m1“V.
`d
`:fl‘lil‘mfl‘v [£111,117ch
`tight U :11):le ’
`_
`.
`* “PM“ “WWW “ Y1111,: ”‘i We
`(74) Attorney,Agen/, orlizrm Sheppard MullinRichter&
`”ammo“ LLP
`ABS TRACI
`K57)
`Disclosed herein are a composition and unit dosage form for
`the treatment ofhcpatitis Cvirus (l'lCV) infection comprising
`68—7977 and at least one pharmaceutically acceptable excipi—
`cut, as well as methods for making said composition and unit
`dosage form. Also disclosed herein is a method or: treating a
`subject, preferably a human, intected w1th 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
`administeringto the subject an interteron-freetreatment regi-
`men comprising an cl‘l'ective amount of 68-7977 and an
`olToctivo amount of ribziivirin.
`lit a particular aspect,
`the.
`method is sufficient to produce an undetectable amount of
`HCV RNA in the subject l'orat least 12 weeks alter the end of
`[he time period_
`Gilead 2004
`
`37 Claims, 3 Drawing Sheets
`
`l—MAK v. Gilead
`
`lPR2018—00126
`
`

`

`US 8,889,159 B2
` Page2
`
`(56)
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`

`

`US 8,889,159 B2
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