ライフサイエンスコーパス: sofosbuvir

1 from phase 2 and 3 studies of ledipasvir and sofosbuvir.

2 eiving 12 weeks of treatment with ledipasvir/sofosbuvir.

3 genetically stable in cell cultures without sofosbuvir.

4 who received at least one dose of ledipasvir-sofosbuvir.

5 e at 12 weeks after completion of ledipasvir-sofosbuvir.

6 atasvir, beclabuvir, dasabuvir, MK-3682, and sofosbuvir.

7 data from 1788 patients receiving ledipasvir-sofosbuvir (282 for 8 weeks, 910 for 12 weeks, 510 for 2

8 (duration of infection <12 months) received sofosbuvir 400 mg daily and weight-based ribavirin (<75

9 Fifty-two patients received sofosbuvir 400 mg once daily and weight-based ribavirin

10 CC, non-CC]) to simeprevir 150 mg once daily+sofosbuvir 400 mg once daily for 12 or 8 weeks.

11 received oral simeprevir 150 mg once daily + sofosbuvir 400 mg once daily for 12 weeks.

12 ed the combination of ledipasvir (90 mg) and sofosbuvir (400 mg) (ledipasvir/sofosbuvir) once daily,

13 llular carcinoma, received up to 48 weeks of sofosbuvir (400 mg) and ribavirin before liver transplan

14 ned to an all-oral fixed-dose combination of sofosbuvir (400 mg) and velpatasvir (100 mg) once daily

15 All patients received sofosbuvir (400 mg) and velpatasvir (100 mg) plus GS-985

16 signed 1:1 to receive ledipasvir (90 mg) and sofosbuvir (400 mg) for 12 or 24 weeks.

17 signed 1:1 to receive ledipasvir (90 mg) and sofosbuvir (400 mg) for 12 or 24 weeks.

18 ive 12 or 24 weeks of ledipasvir (90 mg) and sofosbuvir (400 mg) once daily (combination tablet), plu

19 :1) to receive either ledipasvir (90 mg) and sofosbuvir (400 mg) or ledipasvir, sofosbuvir, and ribav

20 cg/kg/wk), ribavirin (1000-1200 mg/day), and sofosbuvir (400 mg/day) (n = 24 in the final analysis).

21 to groups given simeprevir (150 mg/day) and sofosbuvir (400 mg/day) (n = 58 in the final analysis) o

22 They received sofosbuvir (400 mg/day) plus daclatasvir (60 mg/day) for

23 or 2 HCV infection were randomly assigned to sofosbuvir, 400 mg, and velpatasvir, 25 or 100 mg, with

24 V genotypes 1 to 6 were randomly assigned to sofosbuvir, 400 mg, with velpatasvir, 25 or 100 mg, for

25 SVR12 with simeprevir + sofosbuvir (83%, 95% confidence interval 76%-91%) met th

26 All patients were treated with ledipasvir-sofosbuvir (90 mg and 400 mg) plus weight-based ribaviri

27 fixed-dose combination tablet of ledipasvir-sofosbuvir (90/400 mg) once daily for 12 weeks.

28 The approval of sofosbuvir, a nucleoside monophosphate prodrug, highligh

29 nts, 16 of 25 (64%) receiving ledipasvir and sofosbuvir alone achieved SVR12 compared with all 26 pat

30 tion should be treated with a combination of sofosbuvir and an NS5A inhibitor for 8 weeks.

31 nder the curve and maximum concentration for sofosbuvir and GS-331007 in adolescents were within pred

32 R12) with regimens containing ledipasvir and sofosbuvir and identify factors associated with treatmen

33 The pharmacokinetics of sofosbuvir and its metabolite GS-331007 were evaluated b

34 The most commonly used regimen was sofosbuvir and ledipasvir (n = 21).

35 According to the label, sofosbuvir and ledipasvir can be prescribed for 8 weeks

36 ieve an ultrarapid response were switched to sofosbuvir and ledipasvir for either 8 weeks or 12 weeks

37 fore, we assessed the efficacy and safety of sofosbuvir and ledipasvir in renal transplant patients w

38 We evaluated the effectiveness of sofosbuvir and ledipasvir in treatment-naive and treatme

39 uvir, MK-3682, dasabuvir, or combinations of sofosbuvir and ledipasvir or sofosbuvir and velpatasvir

40 b, or 4 were treated with the combination of sofosbuvir and ledipasvir without ribavirin for 8 or 12

41 the end of treatment (SVR12) with ledipasvir/sofosbuvir and only a small effect in patients with HCV

42 uvir plus ribavirin, 87.0% in patients given sofosbuvir and pegylated-interferon plus ribavirin, and

43 no significant difference between ledipasvir/sofosbuvir and PrOD regimens), 86.2% (95% CI, 84.6%-87.7

44 Nineteen participants commenced sofosbuvir and ribavirin (89% male, 74% with human immun

45 The patients were treated for 24 weeks with sofosbuvir and ribavirin and underwent sampling longitud

46 Sofosbuvir and ribavirin combination therapy for 24 week

47 Sofosbuvir and ribavirin for 12-24 weeks is safe and wel

48 of this study was to assess the efficacy of sofosbuvir and ribavirin for 6 weeks in individuals with

49 We evaluated the all-oral combination of sofosbuvir and ribavirin in adolescents aged 12-17 with

50 Ledipasvir-sofosbuvir and ribavirin provided high rates of SVR12 fo

51 Moreover, the combination of sofosbuvir and ribavirin results in an additive antivira

52 Sofosbuvir and ribavirin was safe and highly effective i

53 Six weeks of sofosbuvir and ribavirin was safe and well tolerated, bu

54 hose with genotype 2 infection (treated with sofosbuvir and ribavirin), 74.8% (95% CI, 72.2%-77.3%) o

55 26 patients (100%) receiving ledipasvir and sofosbuvir and ribavirin.

56 ave high rates of response to treatment with sofosbuvir and ribavirin.

57 and safety of the NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir for HCV in

58 In patients given sofosbuvir and velpatasvir for 12 weeks (n=90), clinical

59 17.0 points) were observed in patients given sofosbuvir and velpatasvir for 24 weeks (n=90).

60 t-based 1000 mg or 1200 mg) for 12 weeks, or sofosbuvir and velpatasvir for 24 weeks.

61 combinations of sofosbuvir and ledipasvir or sofosbuvir and velpatasvir had decreased efficacy agains

62 elpatasvir (100 mg) once daily for 12 weeks, sofosbuvir and velpatasvir plus oral ribavirin (weight-b

63 In patients given sofosbuvir and velpatasvir plus ribavirin (n=87), PRO sc

64 ed the efficacy of 8 weeks of treatment with sofosbuvir and velpatasvir plus the pangenotypic NS3/4A

65 cirrhosis given a fixed-dose combination of sofosbuvir and velpatasvir with and without ribavirin.

66 lated decompensated cirrhosis who were given sofosbuvir and velpatasvir without ribavirin.

67 re, during, and after antiviral therapy with sofosbuvir and velpatasvir, we found that intrahepatic M

68 ic response after 12 weeks of treatment with sofosbuvir and velpatasvir.

69 orld effectiveness of sofosbuvir, ledipasvir/sofosbuvir, and paritaprevir/ritonavir/ombitasvir and da

70 0 mg) and sofosbuvir (400 mg) or ledipasvir, sofosbuvir, and ribavirin (dosed according to the Japane

71 essed the safety and efficacy of ledipasvir, sofosbuvir, and ribavirin in patients with HCV genotype

72 he pan-genotypic combination of daclatasvir, sofosbuvir, and ribavirin was safe and well tolerated.

73 Regimens containing ledipasvir and sofosbuvir are highly effective for a broad spectrum of

74 riority in SVR12 was assessed for simeprevir+sofosbuvir at 12 and 8 weeks versus a composite historic

75 enotypic NS5A inhibitor) in combination with sofosbuvir at 400 mg once daily (NS5B inhibitor) and rib

76 kidney transplant recipients with ledipasvir-sofosbuvir at our 2 centers.

77 Sofosbuvir-based antiviral therapy for HCV recurrence af

78 SVR12 rates for sofosbuvir-based DAA regimens in HCV-MCS were 83%, signi

79 ctively evaluated the efficacy and safety of sofosbuvir-based direct-acting antiviral therapy, indivi

80 Thirty-nine patients received a sofosbuvir-based regimen and 7 patients received other D

81 patients with HCV-MCS who were treated with sofosbuvir-based regimens and historical controls treate

82 Sofosbuvir-based therapies added 0.56 QALY relative to t

83 The ICER of sofosbuvir-based treatment was less than $100,000 per QA

84 h HCV genotype 3 discontinued ledipasvir and sofosbuvir because of an adverse event (diverticular per

85 ent with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir.

86 The sofosbuvir-containing regimens without interferon for tr

87 Among patients failed by sofosbuvir-containing regimens, L159F was enriched in pa

88 genotype 1 infection; the dose of ledipasvir-sofosbuvir currently used in adults was well tolerated i

89 ived interferon-free regimens, most commonly sofosbuvir + daclatasvir (8/12), for a total of 24 weeks

90 vir; and two [33%] of six patients receiving sofosbuvir, daclatasvir, and asunaprevir) and headache (

91 sofosbuvir, daclatasvir, and simeprevir; or sofosbuvir, daclatasvir, and asunaprevir) until six pati

92 r, daclatasvir, and simeprevir; and eight to sofosbuvir, daclatasvir, and asunaprevir.

93 sofosbuvir plus daclatasvir for 24 weeks or sofosbuvir, daclatasvir, and ribavirin for 12 weeks are

94 osbuvir, ledipasvir, and asunaprevir; six to sofosbuvir, daclatasvir, and simeprevir; and eight to so

95 aprevir; one [17%] of six patients receiving sofosbuvir, daclatasvir, and simeprevir; and two [33%] o

96 ps (sofosbuvir, ledipasvir, and asunaprevir; sofosbuvir, daclatasvir, and simeprevir; or sofosbuvir,

97 d the broadly used, off-label combination of sofosbuvir, daclatasvir, simeprevir, and ribavirin in di

98 For genotype 2, sofosbuvir-ribavirin and sofosbuvir-daclatasvir cost $110 000 and $691 000 per QA

99 r/simeprevir would be expected in 31.4%, for sofosbuvir/daclatasvir in 36.8%, and for sofosbuvir/ledi

100 sofosbuvir/ribavirin, ledipasvir/sofosbuvir, sofosbuvir/daclatasvir, sofosbuvir/simeprevir, ombitasvi

101 ted the efficacy and safety of daclatasvir + sofosbuvir (DCV + SOF) for 12 weeks by antiretroviral (A

102 ed efficacy against infection with the DBN3a sofosbuvir escape variant.

103 These findings indicate that sofosbuvir escape variants could compromise the effectiv

104 Conclusion: Treatment with ledipasvir-sofosbuvir for 12 or 24 weeks was well-tolerated and see

105 Treatment with ledipasvir-sofosbuvir for 12 or 24 weeks was well-tolerated and see

106 SVR12 with simeprevir+sofosbuvir for 12 weeks (97% [150/155; 95% confidence in

107 Simeprevir + sofosbuvir for 12 weeks achieved superiority in SVR12 ra

108 acy of fixed-dose combination ledipasvir and sofosbuvir for 12 weeks in this population.

109 -naive and -experienced patients, ledipasvir-sofosbuvir for 12 weeks is highly effective for the trea

110 Simeprevir+sofosbuvir for 12 weeks is highly effective in the treat

111 SVR12 with simeprevir+sofosbuvir for 8 weeks (83% [128/155; 95% confidence int

112 eved by 96% of patients receiving ledipasvir-sofosbuvir for 8 weeks (95% CI, 93%-98%), 97% receiving

113 in treatment-naive patients given ledipasvir/sofosbuvir for 8 weeks (P = .011), but not for 12 weeks.

114 efficacy and safety of 6 weeks of ledipasvir-sofosbuvir for acute genotype 1 or 4 HCV in HIV-1-coinfe

115 with a fixed-dose combination of ledipasvir-sofosbuvir for patients with acute genotype 1 or 4 HCV i

116 Approval of Ledipasvir/Sofosbuvir for the treatment of chronic hepatitis C (HCV

117 efficacy and safety of 4, 6, and 8 weeks of sofosbuvir, given in combination with the NS5A inhibitor

118 d a 4-drug regimen consisting of ledipasvir, sofosbuvir, GS-9451, and GS-9669 for 4 weeks.

119 The combination of ledipasvir and sofosbuvir has been approved for treatment of genotype 1

120 simeprevir (HCV NS3/4A protease inhibitor) + sofosbuvir (HCV nucleotide analogue NS5B polymerase inhi

121 aluate the efficacy and safety of ledipasvir-sofosbuvir in adolescents with chronic HCV genotype 1 in

122 aluate the safety and efficacy of ledipasvir/sofosbuvir in black patients using data from the three o

123 a small effect in patients given ledipasvir/sofosbuvir in combination with ribavirin for 12 weeks.

124 y and safety of 12 and 8 weeks of simeprevir+sofosbuvir in HCV GT1-infected treatment-naive and treat

125 icacy and safety of 12 weeks of simeprevir + sofosbuvir in HCV GT1-infected treatment-naive or treatm

126 feron- and ribavirin-free regimen ledipasvir-sofosbuvir in kidney transplant recipients with chronic

127 feron- and ribavirin-free regimen ledipasvir-sofosbuvir in kidney transplant recipients with chronic

128 ledipasvir and the NS5B polymerase inhibitor sofosbuvir in patients with HCV genotype 5.

129 ted three DAAs (simeprevir, daclatasvir, and sofosbuvir) in combination with anti-miR-122 treatment a

130 combined with the NS5B polymerase inhibitor, sofosbuvir, in patients with HCV genotype 4.

131 Here, we show that sofosbuvir inhibits the replication of hepatitis E virus

132 The all-oral regimen of ledipasvir and sofosbuvir is an effective and safe treatment for a wide

133 The oral regimen of ledipasvir-sofosbuvir is an effective and well-tolerated treatment

134 Ledipasvir-sofosbuvir is effective at eradicating hepatitis C virus

135 An 8-week regimen of ledipasvir/sofosbuvir is effective for eligible patients with HCV g

136 Eight weeks duration of ledipasvir/sofosbuvir (LDV/SOF) can be considered in genotype 1 hep

137 ed that adding a third DAA to ledipasvir and sofosbuvir (LDV/SOF) can result in high SVR rates in pat

138 The uptake of ledipasvir/sofosbuvir (LDV/SOF) regimens across health care setting

139 ombitasvir, dasabuvir (PrOD) and ledipasvir/sofosbuvir (LDV/SOF) regimens upon mortality.

140 tudy, black patients treated with ledipasvir/sofosbuvir (LDV/SOF) were significantly less likely to a

141 tients taking concomitant PPI and ledipasvir/sofosbuvir (LDV/SOF).

142 osure of Huh7.5 cells infected with DBN3a to sofosbuvir led to identification of an escape variant wi

143 -inhibitor (GS-9451) and after 12 weeks with sofosbuvir + ledipasvir.

144 ed after 6 weeks of anti-HCV treatment using sofosbuvir, ledipasvir and a non-nucleoside polymerase-i

145 fatigue (one [17%] of six patients receiving sofosbuvir, ledipasvir, and asunaprevir; one [17%] of si

146 12 patients were assigned to sofosbuvir, ledipasvir, and asunaprevir; six to sofosbuv

147 er program to one of three treatment groups (sofosbuvir, ledipasvir, and asunaprevir; sofosbuvir, dac

148 e (tau) and maximum concentration values for sofosbuvir, ledipasvir, and GS-331007 were within the pr

149 okinetic evaluation of the concentrations of sofosbuvir, ledipasvir, and the sofosbuvir metabolite GS

150 investigated the real-world effectiveness of sofosbuvir, ledipasvir/sofosbuvir, and paritaprevir/rito

151 regimens containing sofosbuvir, simeprevir + sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ombit

152 ients underwent antiviral therapy (AVT) with sofosbuvir/ledipasvir and chemotherapy (14 rituximab plu

153 for sofosbuvir/daclatasvir in 36.8%, and for sofosbuvir/ledipasvir in 40.2%.

154 We compared using sofosbuvir/ledipasvir or ombitasvir/ritonavir/paritaprev

155 mbitasvir, paritaprevir/ritonavir/dasabuvir; sofosbuvir/ledipasvir; and daclatasvir/sofosbuvir, respe

156 Sofosbuvir may be considered as an add-on therapy to rib

157 ntrations of sofosbuvir, ledipasvir, and the sofosbuvir metabolite GS-331007.

158 Sofosbuvir, MK-3682, dasabuvir, or combinations of sofos

159 Short 8-week ledipasvir/sofosbuvir monotherapy regimens should perhaps be avoide

160 1-infected patients treated with ledipasvir/sofosbuvir monotherapy, black patients had significantly

161 tment with sofosbuvir (n = 2986), ledipasvir/sofosbuvir (n = 11,327), or PrOD (n = 3174), with or wit

162 35 with genotype 4) who began treatment with sofosbuvir (n = 2986), ledipasvir/sofosbuvir (n = 11,327

163 ION-4, and ALLY-2 that evaluated simeprevir; sofosbuvir; ombitasvir, paritaprevir/ritonavir/dasabuvir

164 nation tablet of 90 mg ledipasvir and 400 mg sofosbuvir once daily for 12 weeks.

165 All patients received ledipasvir-sofosbuvir once daily for 6 weeks.

166 (90 mg) and sofosbuvir (400 mg) (ledipasvir/sofosbuvir) once daily, with or without ribavirin twice

167 combination tablet containing ledipasvir and sofosbuvir, once daily, plus ribavirin.

168 terferon or pegylated interferon, ribavirin, sofosbuvir, or a combination of these medications.

169 osbuvir, simeprevir + sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ombitasvir/ritonavir/dasabuv

170 nation tablet of 90 mg ledipasvir and 400 mg sofosbuvir orally once per day for 12 weeks.

171 tablet of 90 mg of ledipasvir and 400 mg of sofosbuvir orally once-daily for 12 weeks.

172 12 to 12 weeks (but not 24 weeks) ledipasvir/sofosbuvir (P < .001).

173 those who are treatment experienced, whereas sofosbuvir, pegylated interferon, and ribavirin for 12 w

174 s standard of care, sofosbuvir/simeprevir or sofosbuvir/pegylated interferon/ribavirin, was included

175 ribavirin for 24 weeks, 4 patients received sofosbuvir plus daclatasvir for 12 weeks, and 2 patients

176 For genotype 3 infections, sofosbuvir plus daclatasvir for 24 weeks or sofosbuvir,

177 l, interferon- and ribavirin-free regimen of sofosbuvir plus daclatasvir in patients with HCV-associa

178 pe 1 infections, sofosbuvir plus ledipasvir, sofosbuvir plus daclatasvir, or ombitasvir, paritaprevir

179 3-drug regimen consisting of ledipasvir and sofosbuvir plus GS-9451 for 4 weeks, and 25 received a 4

180 vir plus pegylated interferon and ribavirin, sofosbuvir plus ledipasvir, or sofosbuvir plus ribavirin

181 Ideally, for genotype 1 infections, sofosbuvir plus ledipasvir, sofosbuvir plus daclatasvir,

182 terferon plus ribavirin has been replaced by sofosbuvir plus pegylated interferon and ribavirin, and

183 For genotype 6, sofosbuvir plus pegylated interferon and ribavirin, sofo

184 erent duration) and 311 receiving ledipasvir-sofosbuvir plus ribavirin (212 for 12 weeks and 81 for 2

185 ron or pegylated interferon +/- ribavirin or sofosbuvir plus ribavirin +/- pegylated interferon thera

186 nd ribavirin, sofosbuvir plus ledipasvir, or sofosbuvir plus ribavirin for 12 weeks are all suitable.

187 sessed the efficacy and safety of ledipasvir/sofosbuvir plus ribavirin for 24 weeks in 9 human immuno

188 eated with DAA therapy (21 patients received sofosbuvir plus ribavirin for 24 weeks, 4 patients recei

189 d for the safety and efficacy of 12 weeks of sofosbuvir plus ribavirin for the treatment of acute HCV

190 tolerability, and efficacy of ledipasvir and sofosbuvir plus ribavirin in patients with genotype 3 HC

191 ted interferon with or without ribavirin, or sofosbuvir plus ribavirin with or without pegylated inte

192 plus ribavirin, and 70.6% of patients given sofosbuvir plus ribavirin), and 89.6% (95% CI 82.8%-93.9

193 nfection (77.9% in patients given ledipasvir/sofosbuvir plus ribavirin, 87.0% in patients given sofos

194 tasvir for 12 weeks, and 2 patients received sofosbuvir plus simeprevir for 12 weeks) in Paris, Franc

195 analogue nonstructural protein 5B inhibitor sofosbuvir plus the nonstructural protein 5A inhibitor v

196 Seven patients (2%) discontinued ledipasvir-sofosbuvir prematurely due to adverse events.

197 Eight-week regimens of ledipasvir/sofosbuvir produced an SVR12 in 94.3% of eligible patien

198 with genotype 3 HCV, 12 weeks of ledipasvir-sofosbuvir provided a high level of SVR in those without

199 uvir; sofosbuvir/ledipasvir; and daclatasvir/sofosbuvir, respectively, to the Canadian Coinfection Co

200 with genotype 2/3, follow-up treatment with sofosbuvir + ribavirin for 12/16 weeks are performed on

201 , 24 weeks for treatment-naive patients; (2) sofosbuvir + ribavirin, 12 weeks for patients with genot

202 uated a fixed-dose combination of ledipasvir/sofosbuvir +/- ribavirin administered for 8, 12, or 24 w

203 c response (SVR12), and safety of ledipasvir/sofosbuvir +/- ribavirin.

204 GT) 1-infected patients receiving simeprevir+sofosbuvir+/-ribavirin for 12 or 24 weeks.

205 For genotype 2, sofosbuvir-ribavirin and sofosbuvir-daclatasvir cost $11

206 Sofosbuvir-ribavirin for 12 weeks for the treatment of a

207 to the rate of 94% (95% CI, 88 to 97) in the sofosbuvir-ribavirin group (P=0.02).

208 perior to those with standard treatment with sofosbuvir-ribavirin.

209 Sofosbuvir/ribavirin had the lowest risk to cause a pote

210 tential for DDIs between all these drugs and sofosbuvir/ribavirin, ledipasvir/sofosbuvir, sofosbuvir/

211 antiviral treatment with regimens containing sofosbuvir, simeprevir + sofosbuvir, ledipasvir/sofosbuv

212 The previous standard of care, sofosbuvir/simeprevir or sofosbuvir/pegylated interferon

213 Significant DDIs for sofosbuvir/simeprevir would be expected in 31.4%, for so

214 dipasvir/sofosbuvir, sofosbuvir/daclatasvir, sofosbuvir/simeprevir, ombitasvir/paritaprevir/ritonavir

215 Sofosbuvir (SOF) + daclatasvir +/- ribavirin (RBV) was u

216 ir (EBR) 50 mg/grazoprevir (GZR) 100 mg with sofosbuvir (SOF) 400 mg for 4-12 weeks.

217 ug interactions between ledipasvir (LDV) and sofosbuvir (SOF) against a genotype 1b replicon to deter

218 virus (HCV) genotypes (GTs) 2 and 3 contain sofosbuvir (SOF) and ribavirin (RBV) for 12 or 24 weeks.

219 oss 11 phase 3 clinical trials of ledipasvir-sofosbuvir (SOF) and SOF, only 12 of 3004 patients had d

220 Sofosbuvir (SOF) exhibits a high barrier to resistance,

221 efficacy and safety of ledipasvir (LDV) and sofosbuvir (SOF) for 12 weeks in HCV genotype-1 (GT-1) p

222 Ledipasvir (LDV)/sofosbuvir (SOF) has demonstrated high efficacy, safety,

223 C virus (HCV)-infected patients treated with sofosbuvir (SOF) in combination with other direct acting

224 ety, and tolerability of regimens containing sofosbuvir (SOF) in the treatment of hepatitis C virus (

225 the safety and efficacy of ledipasvir (LDV)-sofosbuvir (SOF) in treating HCV genotype-4 infected pat

226 Sofosbuvir (SOF) is active against all hepatitis C virus

227 (BOC) or telaprevir (TEL) for 48 weeks, and sofosbuvir (SOF) plus daclastavir (DCV) or simeprevir (S

228 ustained virological response (SVR) rates on sofosbuvir (SOF)-containing regimens in clinical trials.

229 mens posttransplant, particularly the use of sofosbuvir (SOF)/ledipasvir (LDV) without RBV in this pa

230 and 8% GT1 no subtype) and were treated with sofosbuvir (SOF)/ledipasvir +/- ribavirin (85%) followed

231 A (NS5A) inhibitors should be retreated with sofosbuvir (SOF; NS5B inhibitor) combined with simeprevi

232 ypic nonstructural protein 5A inhibitor) and sofosbuvir (SOF; nucleotide nonstructural protein 5B inh

233 e drugs and sofosbuvir/ribavirin, ledipasvir/sofosbuvir, sofosbuvir/daclatasvir, sofosbuvir/simeprevi

234 Sofosbuvir (Sovaldi, SOF) is a nucleotide analog prodrug

235 exposure in adults treated in phase 2 and 3 sofosbuvir studies, the area under the curve and maximum

236 ation of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/

237 ation of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/

238 e either the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the prot

239 nhibitors of NS5A and NS5B and resistance to sofosbuvir-the only nucleotide analog approved for treat

240 uired adjustment during and after ledipasvir-sofosbuvir therapy but antiretroviral regimens did not.

241 l effects on patient responses to ledipasvir/sofosbuvir therapy.

242 n 12 weeks of treatment with simeprevir plus sofosbuvir (treatment duration of up to 16 weeks); 169 o

243 Four weeks of sofosbuvir, velpatasvir, and GS-9857 produced an SVR12 i

244 t weeks of treatment with the combination of sofosbuvir, velpatasvir, and GS-9857 produced an SVR12 i

245 r-velpatasvir-voxilaprevir (163 patients) or sofosbuvir-velpatasvir (151 patients) for 12 weeks.

246 All patients received sofosbuvir-velpatasvir (400 mg/100 mg fixed-dose combina

247 15, and September 1, 2015, patients received sofosbuvir-velpatasvir (400 mg/100 mg in a fixed-dose co

248 cy and safety of a fixed-dose combination of sofosbuvir-velpatasvir (400 mg/100 mg) plus weight-adjus

249 phase 3 study evaluating the combination of sofosbuvir-velpatasvir for 12 weeks in patients with gen

250 Sofosbuvir-velpatasvir for 12 weeks was safe and provide

251 -voxilaprevir for 8 weeks was noninferior to sofosbuvir-velpatasvir for 12 weeks, but the 2 regimens

252 uvir-velpatasvir-voxilaprevir for 8 weeks or sofosbuvir-velpatasvir for 12 weeks.

253 nts were reported in 15 patients (2%) in the sofosbuvir-velpatasvir group and none in the placebo gro

254 rate of sustained virologic response in the sofosbuvir-velpatasvir group was 99% (95% confidence int

255 All patients received sofosbuvir-velpatasvir once daily for 12 weeks.

256 In a phase 2 open-label trial, we found sofosbuvir-velpatasvir plus GS-9857 (8 weeks in treatmen

257 el trial, we found 8 weeks of treatment with sofosbuvir-velpatasvir plus GS-9857 to be safe and effec

258 direct-acting antiviral-based therapies with sofosbuvir-velpatasvir plus ribavirin for 24 weeks was w

259 nsated cirrhosis, 12 weeks of treatment with sofosbuvir-velpatasvir resulted in rates of sustained vi

260 uvir-velpatasvir-voxilaprevir to 12 weeks of sofosbuvir-velpatasvir using a noninferiority margin of

261 n to establish noninferiority to 12 weeks of sofosbuvir-velpatasvir, which produced an SVR in 98% of

262 randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir-voxilaprevir (163 patients) or so

263 confidence interval [CI], 86-100) receiving sofosbuvir-velpatasvir-voxilaprevir alone and 24 of 25 (

264 The most commonly reported AEs with sofosbuvir-velpatasvir-voxilaprevir alone were diarrhea

265 POLARIS-4, the rate of response was 98% with sofosbuvir-velpatasvir-voxilaprevir and 90% with sofosbu

266 agent were assigned randomly to groups given sofosbuvir-velpatasvir-voxilaprevir for 8 weeks or sofos

267 ith HCV infection, we did not establish that sofosbuvir-velpatasvir-voxilaprevir for 8 weeks was noni

268 enotypes (114 patients) were enrolled in the sofosbuvir-velpatasvir-voxilaprevir group.

269 CV genotype 4 infection were enrolled in the sofosbuvir-velpatasvir-voxilaprevir group.

270 alone were diarrhea and bronchitis; and with sofosbuvir-velpatasvir-voxilaprevir plus RBV were fatigu

271 Sofosbuvir-velpatasvir-voxilaprevir taken for 12 weeks p

272 None of the patients discontinued sofosbuvir-velpatasvir-voxilaprevir therapy because of a

273 ned to test the noninferiority of 8 weeks of sofosbuvir-velpatasvir-voxilaprevir to 12 weeks of sofos

274 A fixed-dose combination of sofosbuvir-velpatasvir-voxilaprevir was well tolerated a

275 ment with a fixed-dose combination tablet of sofosbuvir-velpatasvir-voxilaprevir with or without riba

276 ypic NS3/4A protease inhibitor voxilaprevir (sofosbuvir-velpatasvir-voxilaprevir).

277 of sustained virologic response was 96% with sofosbuvir-velpatasvir-voxilaprevir, as compared with 0%

278 V genotype 1a infection receiving 8 weeks of sofosbuvir-velpatasvir-voxilaprevir.

279 3%-97%) of patients had an SVR to 8 weeks of sofosbuvir-velpatasvir-voxilaprevir; this did not meet t

280 sbuvir-velpatasvir-voxilaprevir and 90% with sofosbuvir-velpatasvir.

281 ing the once-daily, pan-genotypic regimen of sofosbuvir/velpatasvir for hepatitis C virus infection,

282 Food and Drug Administration (FDA) approved sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (Vosev

283 study, a 12-week regimen of simeprevir plus sofosbuvir was associated with high rates of SVR and inf

284 Ledipasvir-sofosbuvir was highly effective at treating adolescents

285 e interferon-free regimen of simeprevir plus sofosbuvir was recommended by professional guidelines fo

286 vir and NS5B nucleotide polymerase inhibitor sofosbuvir was shown to be safe and highly effective in

287 A once-daily dosage of ledipasvir/sofosbuvir was similarly effective in black and non-blac

288 econd cohort receiving 8 weeks of ledipasvir-sofosbuvir was to be enrolled.

289 h7.5 cells with increasing concentrations of sofosbuvir was used to promote selection of HCV-resistan

290 Ledipasvir-sofosbuvir was well tolerated.

291 has a high genetic barrier to resistance for sofosbuvir, whereas resistance to this DAA can be induce

292 Patients received treatment with ledipasvir-sofosbuvir, which was provided on site, according to U.S

293 gle patient receiving 12 weeks of ledipasvir-sofosbuvir who did not reach SVR12 did not complete trea

294 ing coadministration of the HCV-NS5B prodrug sofosbuvir with amiodarone was recently reported.

295 We examined the effectiveness of ledipasvir/sofosbuvir with or without ribavirin (LDV/SOF +/- RBV) a

296 fficacy of 8, 12, and 24 weeks of ledipasvir/sofosbuvir with or without ribavirin for the treatment o

297 type 3a variants with reduced sensitivity to sofosbuvir, with increased fitness and with cross-resist

298 esponse to the combination of ledipasvir and sofosbuvir, with or without ribavirin, in patients with

299 reated with a chronic HCV regimen containing sofosbuvir without an NS5A inhibitor.

300 been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.