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1 evir, sofosbuvir-daclatasvir, and sofosbuvir-ledipasvir.
2 rring resistance to NS5A inhibitors, such as ledipasvir.
3 sofosbuvir combined with the NS5A inhibitor ledipasvir.
4 S-9451) and after 12 weeks with sofosbuvir + ledipasvir.
5 and gt4r, which respond poorly to sofosbuvir/ledipasvir.
6 2 subtypes, gt1l and gt4r, using sofosbuvir/ledipasvir.
7 : sofosbuvir/velpatasvir (27.3%), sofosbuvir/ledipasvir (26.5%), grazoprevir/elbasvir (12.5%), other
8 treatment groups: 12 weeks of sofosbuvir and ledipasvir; 6 weeks of sofosbuvir, ledipasvir, and GS-96
9 b infection who received the combination of ledipasvir (90 mg) and sofosbuvir (400 mg) (ledipasvir/s
11 reater were randomly assigned 1:1 to receive ledipasvir (90 mg) and sofosbuvir (400 mg) for 12 or 24
12 reater were randomly assigned 1:1 to receive ledipasvir (90 mg) and sofosbuvir (400 mg) for 12 or 24
14 sation sequence to receive 12 or 24 weeks of ledipasvir (90 mg) and sofosbuvir (400 mg) once daily (c
15 were prescribed a fixed-dose combination of ledipasvir (90 mg) and sofosbuvir (400 mg) once daily fo
16 re randomly assigned (1:1) to receive either ledipasvir (90 mg) and sofosbuvir (400 mg) or ledipasvir
17 fosbuvir (400 mg) and the HCV NS5A inhibitor ledipasvir (90 mg), with and without ribavirin--in patie
18 hat the fixed-dose combination of sofosbuvir-ledipasvir alone or with ribavirin has the potential to
20 a fixed-dose combination tablet of 90 mg of ledipasvir and 400 mg of sofosbuvir orally once-daily fo
21 years received a combination tablet of 90 mg ledipasvir and 400 mg sofosbuvir once daily for 12 weeks
22 ven a fixed-dose combination tablet of 90 mg ledipasvir and 400 mg sofosbuvir orally once per day for
23 aily combination fixed-dose tablets of 90 mg ledipasvir and 400 mg sofosbuvir plus weight-based ribav
24 eeks of anti-HCV treatment using sofosbuvir, ledipasvir and a non-nucleoside polymerase-inhibitor (GS
25 went antiviral therapy (AVT) with sofosbuvir/ledipasvir and chemotherapy (14 rituximab plus cyclophos
27 stances where accurate genotyping is absent, ledipasvir and its generic compounds should not be consi
28 single-tablet regimen of the NS5A inhibitor ledipasvir and NS5B nucleotide polymerase inhibitor sofo
30 asvir for 8 weeks (group 1), sofosbuvir plus ledipasvir and ribavirin for 8 weeks (group 2), or sofos
31 usly demonstrated that adding a third DAA to ledipasvir and sofosbuvir (LDV/SOF) can result in high S
32 We assessed PROs in patients treated with ledipasvir and sofosbuvir (LDV/SOF) with and without RBV
33 ype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir-sofosbuvir) for 8
34 roups given fixed-dose combination tablet of ledipasvir and sofosbuvir (n = 25) or ledipasvir and sof
35 enotype 3 patients, 16 of 25 (64%) receiving ledipasvir and sofosbuvir alone achieved SVR12 compared
36 let of ledipasvir and sofosbuvir (n = 25) or ledipasvir and sofosbuvir along with ribavirin (n = 26).
37 r treatment (SVR12) with regimens containing ledipasvir and sofosbuvir and identify factors associate
41 One patient with HCV genotype 3 discontinued ledipasvir and sofosbuvir because of an adverse event (d
43 afety and efficacy of fixed-dose combination ledipasvir and sofosbuvir for 12 weeks in this populatio
45 IV, administration of an oral combination of ledipasvir and sofosbuvir for 12 weeks was associated wi
46 lity of 12 weeks of combination therapy with ledipasvir and sofosbuvir for patients with chronic HCV
48 ents with HCV genotype 1, the combination of ledipasvir and sofosbuvir has been shown to cure high pr
49 domly assigned in a 1:1:1:1 ratio to receive ledipasvir and sofosbuvir in a fixed-dose combination ta
51 ants received a 3-drug regimen consisting of ledipasvir and sofosbuvir plus GS-9451 for 4 weeks, and
52 te the safety, tolerability, and efficacy of ledipasvir and sofosbuvir plus ribavirin in patients wit
53 enotype 3 infection who received 12 weeks of ledipasvir and sofosbuvir plus ribavirin, and by patient
54 with a once-daily, single-tablet regimen of ledipasvir and sofosbuvir resulted in high rates of sust
55 ir fixed-dose combination tablets [Epclusa], ledipasvir and sofosbuvir tablets [Harvoni], insulin lis
58 f a fixed-dose combination tablet containing ledipasvir and sofosbuvir, once daily, plus ribavirin.
59 trial to evaluate the efficacy and safety of ledipasvir and sofosbuvir, with or without ribavirin, in
60 rrent guidelines do not recommend the use of ledipasvir and sofosbuvir, with or without ribavirin, in
61 ons (RASs) on response to the combination of ledipasvir and sofosbuvir, with or without ribavirin, in
64 tion of the hepatitis C virus NS5A inhibitor ledipasvir and the NS5B nucleotide polymerase inhibitor
65 combination therapy with the NS5A inhibitor ledipasvir and the NS5B polymerase inhibitor sofosbuvir
66 he efficacy and safety of the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofos
67 domly assigned to receive the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofos
68 [17%] of six patients receiving sofosbuvir, ledipasvir, and asunaprevir; one [17%] of six patients r
69 12 patients were assigned to sofosbuvir, ledipasvir, and asunaprevir; six to sofosbuvir, daclatas
70 o one of three treatment groups (sofosbuvir, ledipasvir, and asunaprevir; sofosbuvir, daclatasvir, an
71 notype 3a was less sensitive to daclatasvir, ledipasvir, and elbasvir, but equally sensitive to ombit
72 maximum concentration values for sofosbuvir, ledipasvir, and GS-331007 were within the predefined pha
74 of the 20 patients allocated to sofosbuvir, ledipasvir, and GS-9451 for 6 weeks (one patient was los
76 edipasvir for 12 weeks (n = 20), sofosbuvir, ledipasvir, and GS-9669 for 6 weeks (n = 20), or sofosbu
77 of the 20 patients allocated to sofosbuvir, ledipasvir, and GS-9669 for 6 weeks (one patient relapse
78 buvir and ledipasvir; 6 weeks of sofosbuvir, ledipasvir, and GS-9669; or 6 weeks of sofosbuvir, ledip
79 luation of the concentrations of sofosbuvir, ledipasvir, and the sofosbuvir metabolite GS-331007.
80 ovir alafenamide, emtricitabine, sofosbuvir, ledipasvir, and velpatasvir were inactive at concentrati
81 paritaprevir/ritonavir/dasabuvir; sofosbuvir/ledipasvir; and daclatasvir/sofosbuvir, respectively, to
85 the half-maximal effective concentration to ledipasvir by more than 100-fold reduced the rate of SVR
87 py with the nonstructural (NS) 5A inhibitor, ledipasvir, combined with the NS5B polymerase inhibitor,
89 ing sofosbuvir, simeprevir, daclatasvir, and ledipasvir cost $7000, $5500, $5500, and $875 per week,
91 aclatasvir, but no RASs were associated with ledipasvir failure, pointing to a limited efficacy of le
93 inhibitor regimen to receive sofosbuvir plus ledipasvir for 12 weeks (group 4) or sofosbuvir plus led
94 avirin for 24 weeks (n = 55), sofosbuvir and ledipasvir for 12 weeks (n = 20), sofosbuvir, ledipasvir
95 All 14 patients treated with sofosbuvir plus ledipasvir for 12 weeks achieved a sustained virologic r
96 atients who achieved SVR with Sofosbuvir and Ledipasvir for 12 weeks and compared with 15 healthy con
98 , 95% CI 83-100) allocated to sofosbuvir and ledipasvir for 12 weeks; in 19 (95%, 75-100) of the 20 p
99 nt-naive patients to receive sofosbuvir plus ledipasvir for 8 weeks (group 1), sofosbuvir plus ledipa
101 + ribavirin (HCV genotype 2) or sofosbuvir + ledipasvir (genotype 1 or 4) and retreatment with sofosb
103 ed SVR rates it was necessary to assume that ledipasvir, GS-9669 and GS-9451 rapidly reduce virus inf
108 ed the efficacy and safety of sofosbuvir and ledipasvir in renal transplant patients with chronic HCV
109 valuated the effectiveness of sofosbuvir and ledipasvir in treatment-naive and treatment-experienced
110 and P7977-2025) and 5 studies of combination ledipasvir (LDV) and SOF (LDV/SOF; LONESTAR, ELECTRON [L
111 ve was to identify drug interactions between ledipasvir (LDV) and sofosbuvir (SOF) against a genotype
112 tudy, we assessed the efficacy and safety of ledipasvir (LDV) and sofosbuvir (SOF) for 12 weeks in HC
113 tor sofosbuvir (SOF) with the NS5A inhibitor ledipasvir (LDV) or the NS5B non-nucleoside inhibitor GS
114 nt, particularly the use of sofosbuvir (SOF)/ledipasvir (LDV) without RBV in this patient population.
115 f the nonstructural protein (NS)5A inhibitor ledipasvir (LDV), NS3 protease inhibitor vedroprevir (VD
116 l trial to assess the efficacy and safety of ledipasvir (LDV)-SOF plus RBV in patients with genotype
117 We evaluated the safety and efficacy of ledipasvir (LDV)-sofosbuvir (SOF) in treating HCV genoty
120 + RBV, n = 25; SOF + RBV, n = 36; and SOF + ledipasvir, n = 6) between January and November 2014.
121 of different concentrations of daclatasvir, ledipasvir, ombitasvir, elbasvir, ruzasvir, velpatasvir,
122 dy, direct-acting antiviral therapy with SOF/ledipasvir, ombitasvir/paritaprevir/ritonavir + dasabuvi
124 dasabuvir, or combinations of sofosbuvir and ledipasvir or sofosbuvir and velpatasvir had decreased e
125 ntly associated with failure of daclatasvir, ledipasvir, or ombitasvir in patients with genotype 1b i
126 ed interferon and ribavirin, sofosbuvir plus ledipasvir, or sofosbuvir plus ribavirin for 12 weeks ar
127 fosbuvir and an NS5A inhibitor (daclatasvir, ledipasvir, or velpatasvir), 5 (38.5%) also harbored NS5
128 inhibitor sofosbuvir and the NS5A inhibitor ledipasvir resulted in high rates of sustained virologic
129 type) and were treated with sofosbuvir (SOF)/ledipasvir +/- ribavirin (85%) followed by SOF + daclata
133 tasvir (sovodak) plus ivermectin, sofosbuvir/ledipasvir (SOF/LED) plus hydroxychloroquine, and SOF/LE
134 , for genotype 1 infections, sofosbuvir plus ledipasvir, sofosbuvir plus daclatasvir, or ombitasvir,
135 edipasvir (90 mg) and sofosbuvir (400 mg) or ledipasvir, sofosbuvir, and ribavirin (dosed according t
138 d 25 received a 4-drug regimen consisting of ledipasvir, sofosbuvir, GS-9451, and GS-9669 for 4 weeks
139 e analyzed data from 1788 patients receiving ledipasvir-sofosbuvir (282 for 8 weeks, 910 for 12 weeks
141 received a fixed-dose combination tablet of ledipasvir-sofosbuvir (90/400 mg) once daily for 12 week
142 nd 88 of 88 treatment experienced) receiving ledipasvir-sofosbuvir (95% CI 98-100) and 167 (98%) of 1
144 5%] of 170), and headache in those receiving ledipasvir-sofosbuvir and ribavirin (15 [8.8%] of 170).
147 o 99) in the group that received 12 weeks of ledipasvir-sofosbuvir and ribavirin; 99% (95% CI, 95 to
148 = 1) received weight-based doses of combined ledipasvir-sofosbuvir as granules (33.75 mg/150 mg for w
150 hronic HCV genotype 1 infection; the dose of ledipasvir-sofosbuvir currently used in adults was well
151 No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to ad
154 r treatment-naive and -experienced patients, ledipasvir-sofosbuvir for 12 weeks is highly effective f
156 r-sofosbuvir plus ribavirin for 12 weeks and ledipasvir-sofosbuvir for 24 weeks provided similarly hi
157 svir-sofosbuvir plus ribavirin for 12 weeks, ledipasvir-sofosbuvir for 24 weeks, or ledipasvir-sofosb
158 svir-sofosbuvir plus ribavirin for 12 weeks, ledipasvir-sofosbuvir for 24 weeks, or ledipasvir-sofosb
159 s were achieved by 96% of patients receiving ledipasvir-sofosbuvir for 8 weeks (95% CI, 93%-98%), 97%
161 sessed the efficacy and safety of 6 weeks of ledipasvir-sofosbuvir for acute genotype 1 or 4 HCV in H
162 was to establish the safety and efficacy of ledipasvir-sofosbuvir for chronic HCV genotype 1 or 4 in
163 ate of cure with a fixed-dose combination of ledipasvir-sofosbuvir for patients with acute genotype 1
165 study to evaluate the efficacy and safety of ledipasvir-sofosbuvir in adolescents with chronic HCV ge
166 erefore evaluated the safety and efficacy of ledipasvir-sofosbuvir in HCV-infected children aged 3 to
167 f the interferon- and ribavirin-free regimen ledipasvir-sofosbuvir in kidney transplant recipients wi
168 f the interferon- and ribavirin-free regimen ledipasvir-sofosbuvir in kidney transplant recipients wi
169 trial to evaluate the safety and efficacy of ledipasvir-sofosbuvir in Rwandan adults with chronic HCV
173 quentially assigned to either treatment with ledipasvir-sofosbuvir or ledipasvir-sofosbuvir plus riba
175 plus weight-based ribavirin for 12 weeks, or ledipasvir-sofosbuvir plus placebo once daily for 24 wee
176 for a different duration) and 311 receiving ledipasvir-sofosbuvir plus ribavirin (212 for 12 weeks a
177 nd 87 of 87 treatment experienced) receiving ledipasvir-sofosbuvir plus ribavirin (95% CI 95-100).
178 d randomisation, 77 were assigned to receive ledipasvir-sofosbuvir plus ribavirin and 78 ledipasvir-s
180 combination tablet once daily for 12 weeks, ledipasvir-sofosbuvir plus ribavirin for 12 weeks, ledip
181 fixed-dose combination tablet for 12 weeks, ledipasvir-sofosbuvir plus ribavirin for 12 weeks, ledip
184 osbuvir (ledipasvir-sofosbuvir) for 8 weeks, ledipasvir-sofosbuvir plus ribavirin for 8 weeks, or led
185 were 96% (95% CI 89-99) for patients in the ledipasvir-sofosbuvir plus ribavirin group and 97% (91-1
187 ther treatment with ledipasvir-sofosbuvir or ledipasvir-sofosbuvir plus ribavirin in a 1:1 ratio with
188 uvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin, and 95% (95% CI, 9
190 o 99) in the group that received 12 weeks of ledipasvir-sofosbuvir plus ribavirin; 98% (95% CI, 95 to
192 ve patients with genotype 3 HCV, 12 weeks of ledipasvir-sofosbuvir provided a high level of SVR in th
193 sults indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen, on the basis of a noninfe
194 ty, and absence of drug-drug interactions of ledipasvir-sofosbuvir suggest that it could be an import
195 dosing required adjustment during and after ledipasvir-sofosbuvir therapy but antiretroviral regimen
200 The single patient receiving 12 weeks of ledipasvir-sofosbuvir who did not reach SVR12 did not co
202 e rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage po
203 rhosis to receive ledipasvir and sofosbuvir (ledipasvir-sofosbuvir) for 8 weeks, ledipasvir-sofosbuvi
204 nce interval [CI], 90 to 97) with 8 weeks of ledipasvir-sofosbuvir, 93% (95% CI, 89 to 96) with 8 wee
205 sponse in the group that received 8 weeks of ledipasvir-sofosbuvir, the rate in the 12-week group was
212 o 97) in the group that received 12 weeks of ledipasvir-sofosbuvir; 96% (95% CI, 91 to 99) in the gro
213 100) in the group that received 12 weeks of ledipasvir-sofosbuvir; 97% (95% CI, 94 to 99) in the gro
214 100) in the group that received 24 weeks of ledipasvir-sofosbuvir; and 99% (95% CI, 95 to 100) in th
215 o 99) in the group that received 24 weeks of ledipasvir-sofosbuvir; and 99% (95% CI, 97 to 100) in th
216 e (nine [5.3%] of 171) in patients receiving ledipasvir-sofosbuvir; and nasopharyngitis (40 [23.5%] o
220 /ritonavir, ombitasvir, dasabuvir (PrOD) and ledipasvir/sofosbuvir (LDV/SOF) regimens upon mortality.
221 g, and with health insurance likely to cover ledipasvir/sofosbuvir (LDV/SOF) were recruited from 34 U
222 the ION-4 study, black patients treated with ledipasvir/sofosbuvir (LDV/SOF) were significantly less
223 once-daily fixed-dose combination tablet of ledipasvir/sofosbuvir (LDV/SOF) with and without ribavir
226 began treatment with sofosbuvir (n = 2986), ledipasvir/sofosbuvir (n = 11,327), or PrOD (n = 3174),
227 ks of daclatasvir plus sofosbuvir (n = 767), ledipasvir/sofosbuvir (n = 197), or sofosbuvir/velpatasv
229 tudies evaluated a fixed-dose combination of ledipasvir/sofosbuvir +/- ribavirin administered for 8,
231 eeks after the end of treatment (SVR12) with ledipasvir/sofosbuvir and only a small effect in patient
232 infection (no significant difference between ledipasvir/sofosbuvir and PrOD regimens), 86.2% (95% CI,
233 e of SVR12 in treatment-naive patients given ledipasvir/sofosbuvir for 8 weeks (P = .011), but not fo
234 ter clinical trial, investigating 8 weeks of ledipasvir/sofosbuvir for acute HCV infections in men wi
235 sessed the safety and efficacy of 8 weeks of ledipasvir/sofosbuvir for the treatment of acute HCV inf
237 y was to evaluate the safety and efficacy of ledipasvir/sofosbuvir in black patients using data from
238 se RASs had a small effect in patients given ledipasvir/sofosbuvir in combination with ribavirin for
241 ng genotype 1-infected patients treated with ledipasvir/sofosbuvir monotherapy, black patients had si
243 enotype 3 infection (77.9% in patients given ledipasvir/sofosbuvir plus ribavirin, 87.0% in patients
249 afety and efficacy of 8, 12, and 24 weeks of ledipasvir/sofosbuvir with or without ribavirin for the
250 ledipasvir (90 mg) and sofosbuvir (400 mg) (ledipasvir/sofosbuvir) once daily, with or without ribav
251 is study was to model the impact of LDV/SOF (ledipasvir/sofosbuvir), the first Peg-IFN- and RBV-free
252 sofosbuvir, 97.9% (95% CI, 94.8-99.2%) with ledipasvir/sofosbuvir, and 96.5% (95% CI, 88.1-99.0%) wi
253 the real-world effectiveness of sofosbuvir, ledipasvir/sofosbuvir, and paritaprevir/ritonavir/ombita
254 actice setting, daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, and sofosbuvir/velpatasvir achiev
255 l patients received genotype-guided DAAs: 17 ledipasvir/sofosbuvir, eight sofosbuvir plus ribavirin,
256 taining sofosbuvir, simeprevir + sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ombitasvir/ritona
260 e assessed treatment with the NS5A inhibitor ledipasvir, the nucleotide polymerase inhibitor sofosbuv
261 and $875 per week, respectively, sofosbuvir-ledipasvir was cost-effective for genotype 1 and cost $1
262 he fixed-dose combination of sofosbuvir plus ledipasvir was efficacious in a small cohort of patients
266 Among patients treated with sofosbuvir and ledipasvir with or without GS-9669 or GS-9451, 100% (59/
271 rect-acting antiviral drug to sofosbuvir and ledipasvir would allow a shorter treatment duration.