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1.
Martina Vitrone Roberto Andini Irene Mattucci Ciro Maiello Luigi Atripaldi Emanuele Durante‐Mangoni Rosa Zampino 《Transplant infectious disease》2018,20(1)
Direct‐acting antiviral agents (DAAs) are a safe and effective treatment for chronic hepatitis C (CHC). This may be particularly valuable for patients with severe comorbidities or baseline conditions, including non‐liver solid organ transplant. We report cases of two heart transplant recipients with CHC treated with DAAs (sofosbuvir and daclatasvir) achieving sustained virological response. Treatment was well tolerated and no relevant side effects were observed. The drug‐drug interactions and graft function were carefully monitored. 相似文献
2.
Dual treatment with sofosbuvir plus ribavirin is as effective as triple therapy with pegylated interferon plus sofosbuvir plus ribavirin in predominant genotype 3 patients with chronic hepatitis C 下载免费PDF全文
Sandeep Satsangi Manu Mehta Ajay Duseja Sunil Taneja Radha K Dhiman Yogesh Chawla 《Journal of gastroenterology and hepatology》2017,32(4):859-863
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Safety and efficacy of sofosbuvir and ribavirin for genotype 2 hepatitis C Japanese patients with renal dysfunction 下载免费PDF全文
Atsushi Nagasaka Yoshiya Yamamoto Ken Furuya Kenichi Kumagai Minoru Uebayashi Katsumi Terashita Tomoe Kobayashi Izumi Tsunematsu Manabu Onodera Takashi Meguro Megumi Kimura Jun Ito Machiko Umemura Takaaki Izumi Naoki Kawagishi Masatsugu Ohara Yuji Ono Masato Nakai Mitsuteru Natsuizaka Kenichi Morikawa Koji Ogawa Naoya Sakamoto for the NORTE Study Group 《Hepatology research》2018,48(7):529-538
4.
Intrapatient viral diversity and treatment outcome in patients with genotype 3a hepatitis C virus infection on sofosbuvir‐containing regimens 下载免费PDF全文
N. Bhardwaj M. Ragonnet‐Cronin B. Murrell K. Chodavarapu R. Martin S. Chang M. D. Miller J. J. Feld M. Sulkowski A. Mangia J. O. Wertheim A. Osinusi J. McNally D. Brainard H. Mo E. S. Svarovskaia 《Journal of viral hepatitis》2018,25(4):344-353
Treatment with the direct‐acting antiviral agent (DAA) sofosbuvir (SOF), an NS5B inhibitor, and velpatasvir (VEL), an NS5A inhibitor, demonstrates viral cure rates of ≥95% in hepatitis C virus (HCV) genotypes (GT) 1‐6. Here, we investigated intrapatient HCV diversity in NS5A and NS5B using Shannon entropy to examine the relationship between viral diversity and treatment outcome. At baseline, HCV diversity was lowest in patients infected with HCV GT3 as compared to the other GTs, and viral diversity was greater in NS5A than NS5B (P < .0001). Treatment outcome with SOF/VEL or the comparator regimen of SOF with ribavirin (RBV) was not correlated with baseline diversity. However, among persons treated with SOF/VEL, a decrease in diversity from baseline was observed at relapse in the majority virologic failures, consistent with a viral bottleneck event at relapse. In contrast, an increase in diversity was observed in 27% of SOF+RBV virologic failures. We investigated whether the increase in diversity was due to an increase in the transition rate, one mode of potential RBV‐mediated mutagenesis; however, we found no evidence of this mechanism. Overall, we did not observe that viral diversity at baseline influenced treatment outcome, but the diversity changes observed at relapse can improve our understanding of RBV viral suppression in vivo. 相似文献
5.
Tawhida Y. Abdel Ghaffar Suzan El Naghi Manal Abdel Gawad Sarah Helmy Aisha Abdel Ghaffar Medhat Yousef Mohamad Moafy 《Journal of viral hepatitis》2019,26(2):263-270
Direct‐acting antivirals have become available for treating chronic HCV (hepatitis C virus) infection in adults and, recently, in children at least 12 years old. Our aim was to investigate the safety and efficacy of combined sofosbuvir (SOF)/daclatasvir (DCV) for HCV Genotype 4 in children aged 8 to 18 years or weighing 17 kg or more. A total of 40 chronic HCV‐infected, treatment‐naïve children with well compensated livers were recruited from two sites. Patients received combined therapy of SOF (400 mg/d for patients weighing greater than 45 kg; 200 mg/d for patients weighing 17 to 45 kg) and DCV (60 mg/d for patients weighing greater than 45 kg; 30 mg/d for patients weighing 17 to 45 kg) for 12 weeks. They were followed up regularly by clinical examination and laboratory tests during treatment (weekly in the first month then monthly to the end of treatment), every 3 months for 6 months post‐treatment, and at 48 weeks post‐treatment. In our cohort, which included 45% of children below the age of 12 years (72.5% genotype 4 and 27.5% mixed genotype 4 and 1), end of treatment response (ETR) was 97.5%. Sustained virologic response for weeks 12 and 24 post‐treatment (SVR12 and SVR24) were 97.5% and 95%, respectively, on an intention to treat basis, and 100% and 100% for those who completed the study protocol. Observed side effects were mild and none required drug cessation. Combined SOF/DCV was found to be effective and safe for treating HCV Genotype 4‐infected children, 8 years of age and above. 相似文献
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Prevalence and characteristics of naturally occurring sofosbuvir resistance‐associated variants in patients with hepatitis C virus genotype 1b infection 下载免费PDF全文
Jun Ito Goki Suda Yoshiya Yamamoto Atsushi Nagasaka Ken Furuya Kenichi Kumagai Hideaki Kikuchi Takuto Miyagishima Tomoe Kobayashi Megumi Kimura Kazushi Yamasaki Machiko Umemura Takaaki Izumi Seiji Tsunematsu Fumiyuki Sato Yoko Tsukuda Katsumi Terashita Masato Nakai Takuya Sho Mitsuteru Natsuizaka Kenichi Morikawa Koji Ogawa Naoya Sakamoto for the NORTE Study Group 《Hepatology research》2016,46(13):1294-1303
8.
Dong‐Bo Wu Wei Jiang Yong‐Hong Wang Bin Chen Meng‐Lan Wang Ya‐Chao Tao En‐Qiang Chen Hong Tang 《Journal of viral hepatitis》2019,26(3):316-322
Optional treatments for patients with chronic hepatitis C virus (HCV) genotype (GT) 6 infection have not been extensively studied. This study aimed to evaluate the safety and efficacy of sofosbuvir (SOF)‐based direct‐acting antiviral agents (DAAs) for HCV GT6. We performed a retrospective study at the West China Hospital of Sichuan University in Southwest China from January 2016 to May 2017. Our study screened 130 treatment‐naïve patients with chronic HCV GT6 and without liver cirrhosis. A total of 60 HCV GT6 patients were ultimately enrolled. All patients received SOF‐based DAAs therapy, including SOF 400 mg plus daclatasvir (DCV) 60 mg daily or SOF 400 mg plus velpatasvir (VEL) 100 mg daily for 12 weeks. The sustained virological response 12 weeks after treatment (SVR12) was 100% (60/60) in treatment‐naïve patients with HCV GT6, including 100% (37/37) of patients receiving SOF plus DCV therapy and 100% (23/23) of patients receiving SOF plus VEL therapy. Measurements of liver stiffness were significantly decreased in patients at week 12 (P = 0.014) and week 24 (P < 0.001) of DAAs treatment compared to baseline values. The serum biomarker aspartate aminotransferase‐to‐platelet ratio index (APRI) and fibrosis‐4 score were also significantly reduced at week 12 and week 24 compared to before treatment (both P < 0.001). SOF‐based therapy was well‐tolerated, and no serious adverse events were reported. In conclusion, SOF plus DCV and SOF plus VEL were safe and achieved a high SVR12 rate for treatment‐naïve patients with HCV GT6 without liver cirrhosis. 相似文献
9.
Community‐based real‐world treatment outcomes of sofosbuvir/ledipasvir in Asians with chronic hepatitis C virus genotype 6 in the United States 下载免费PDF全文
R. J. Wong M. T. Nguyen H. N. Trinh A. Huynh M. T. Ly H. A. Nguyen K. K. Nguyen J. Yang R. T. Garcia B. Levitt E. da Silveira R. G. Gish 《Journal of viral hepatitis》2017,24(1):17-21
Sofosbuvir/ledipasvir (SOF/LDV) is the first all‐oral ribavirin‐free treatment approved for chronic hepatitis C virus (HCV) genotype 6, offering a safe and highly efficacious treatment option. Large studies evaluating real‐world outcomes of this regimen are lacking. We aim to evaluate real‐world treatment outcomes for HCV genotype 6. A retrospective cohort study evaluated 65 adults (age ≥18) with chronic HCV genotype 6 treated with SOF/LDV without ribavirin at a community gastroenterology clinic in the United States from November 2014 to May 2016. Rates of undetectable virus at week 4 on treatment, at end of treatment (EOT) and SVR12 were stratified by the presence of cirrhosis and prior treatment (treatment naïve vs treatment experienced). Among 65 patients with chronic HCV genotype 6 treated with SOF/LDV (52.3% male, mean age 66.3 years [SD 9.7], 41.5% cirrhosis and 15.4% treatment experienced), 97.3% had undetectable virus at week 4 on treatment, 96.9% had undetectable virus at EOT and 95.3% achieved SVR12. SVR12 was 100% in females vs 91.2% in males, P=.096, and 92.3% in patients with cirrhosis vs 97.4% in those without cirrhosis, P=.347. Resistance testing of treatment failures was attempted but unsuccessful due to lack of conforming primers to define the possible resistance mutations. Among the largest U.S. community‐based real‐world cohort of Asian chronic HCV genotype 6 patients treated with all‐oral SOF/LDV without ribavirin, SVR12 was similar to SVR12 reported in clinical trials, confirming the safety and effectiveness of this regimen and validating current HCV genotype 6 treatment guideline recommendations. 相似文献
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Naomi Khaing Than Hlaing Gayatri Nangia Kyaw Thet Tun Sithu Lin Moe Zaw Maung Khin Thuzar Myint A. Mi Mi Kyaw Soe Thiha Maung Sithu Sein Win Aung Hlaing Bwa Bao‐Li Loza Khin Maung Win K. Rajender Reddy 《Journal of viral hepatitis》2019,26(10):1186-1199
Exclusive HCV therapy clinical trials with genotype 6 patients in high prevalence areas have been sparse. We analysed the safety and efficacy of two generic, pangenotypic NS5A/NS5B combination oral DAA regimens, primarily in genotypes 3 and 6, in a real‐world setting: (a) daclatasvir/sofosbuvir (DCV/SOF) ± ribavirin (RBV) and (b) Velpatasvir/sofosbuvir (VEL/SOF ± RBV). Between December 2015 and November 2017, data from 522 patients were analysed, 311 of whom were treated with DCV/SOF ± RBV for 12/24 weeks (genotype 3: n = 193, genotype 6: n = 89) and 211 were treated with VEL/SOF ± RBV for 12/24 weeks (genotype 3: n = 83, genotype 6: n = 77). Overall SVR rates were high for both DCV/SOF ± RBV (96.1%, n = 299/311) and VEL/SOF ± RBV (95.3%, n = 201/211), and there was a good adverse event profile. Treatment naïve status and inclusion of RBV (in advanced fibrosis/cirrhosis) were significant independent predictors of achieving SVR12, while type of DAA regimen was not predictive. In this large cohort of genotypes 3 (n = 276) and 6 (n = 166; n = 127 unique subtype of 6c‐l), high SVR rates of 94.9% (n = 262/276) and 95.2% (n = 158/166), respectively, were noted. In conclusion, generic and pangenotypic DCV/SOF and VEL/SOF ± RBV regimens were highly effective and safe, in genotypes 3 and 6 chronic HCV in Myanmar. These efficacious pangenotypic regimens suggest that baseline genotype testing can be eliminated moving forward. While RBV may still be needed for those with advanced fibrosis/cirrhosis, in a global elimination strategy it would not be practical even if it does compromise SVR in a minority with difficult to treat characteristics. 相似文献
12.
Efficacy and safety of ombitasvir/paritaprevir/ritonavir combination therapy for genotype 1b chronic hepatitis C patients complicated with chronic kidney disease 下载免费PDF全文
Taeang Arai Masanori Atsukawa Akihito Tsubota Tadashi Ikegami Noritomo Shimada Keizo Kato Hiroshi Abe Tomomi Okubo Norio Itokawa Chisa Kondo Shigeru Mikami Toru Asano Yoshimichi Chuganji Yasushi Matsuzaki Hidenori Toyoda Takashi Kumada Etsuko Iio Yasuhito Tanaka Katsuhiko Iwakiri 《Hepatology research》2018,48(7):549-555
13.
Arka De Swati Charak Naveen Bhagat Sahaj Rathi Nipun Verma Madhumita Premkumar Sunil Taneja Aman Sharma Kapil Goel Virendra Singh Ajay Duseja 《Journal of viral hepatitis》2023,30(9):740-745
Hepatitis C virus (HCV) infection is more prevalent in people living with HIV-AIDS (PLHA) and portends a poorer prognosis. Pharmacokinetic studies suggest the absence of significant interaction between velpatasvir and dolutegravir which has been recently recommended as part of preferred first-line antiretroviral therapy (ART) regimens by WHO. However, clinical data on the use of velpatasvir-based regimen in PLHA taking dolutegavir is lacking. Hence, we aimed to assess the efficacy and safety of sofosbuvir and velpatasvir (SOF + VEL) in HCV and HIV coinfected patients on dolutegravir-based ART. Forty-five consecutive PLHA with HCV coinfection on dolutegravir-based ART were prospectively enrolled. All patients were treated SOF + VEL for 12 weeks. Complete haemogram, liver and renal function tests were assessed at baseline, 4 weeks and at end of treatment. Sustained virological response (SVR) was assessed at 12 weeks after end of treatment. The majority were males (95.5%) with a mean age of 32.8 ± 12.3 years. Cirrhosis was present in 6 (13.3%) patients. All patients completed 12 weeks of therapy with SOF + VEL, but SVR could not be assessed in two patients. Forty-two (97.7%) of the remaining 43 patients attained SVR-12. SVR-12 rate was 97.7% and 93.3% by per protocol and intention to treat analysis, respectively. No grade III/IV adverse events were reported, and there was no worsening of blood counts, liver or renal function test parameters. The pan-genotypic regimen of SOF + VEL is safe and effective in PLHA with HCV coinfection who are on dolutegravir-based ART. 相似文献
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G. Camus T. Asselah D. Hsieh H. Dvory‐Sobol J. Lu E. Svarovskaia R. Martin B. Parhy M. D. Miller D. M. Brainard K. Kersey A. Abergel H. Mo 《Journal of viral hepatitis》2018,25(2):134-143
HCV genotype 4 (GT4) has often been overlooked in drug development, even though it infects ~20 million people worldwide. Ledipasvir/sofosbuvir and sofosbuvir/velpatasvir were highly efficacious in GT4 HCV‐infected patients from GS‐US‐337‐1119 and GS‐US‐342‐1138. Here, we characterize the resistance profile of ledipasvir (LDV) and velpatasvir (VEL) in patients with GT4 HCV infection. NS5A deep‐sequencing was performed for 454 patients infected with HCV GT4 at baseline, including 44 patients enrolled in GS‐US‐337‐1119 and 116 patients enrolled in GS‐US‐342‐1138, and at relapse for patients with virologic failure. LDV and VEL susceptibilities of 56 patient isolates were determined. In GS‐US‐337‐1119, SVR12 rates were 100% for all subtypes except 4b and 4r. Phenotypic assessment of 56 HCV NS5A patient isolates from various GT4 subtypes indicated that LDV had high potency for the common subtypes 4a/d, and subtypes 4c/f/k/l/m/n/o/p/r/t despite the presence of resistance‐associated substitutions (RASs). For the rare GT4b, LDV median EC50 was higher, but with a broad range of individual values. Importantly, all GT4b isolates tested had 2‐4 NS5A RASs, some including Y93H. Similarly, the 2 GT4r infected patients who had virologic relapse had rare triple RASs. Reversion of these substitutions to the consensus residue significantly increased LDV susceptibility. In GS‐US‐342‐1138, all patients achieved SVR12, regardless of their subtype or presence of RASs. In vitro data confirmed that VEL is potent against all GT4 isolates tested. LDV and VEL are potent antiviral drugs, estimated to be effective against >95% and >99%, respectively, of GT4 HCV isolates. 相似文献
16.
L Tang H Ward S Kattakuzhy E Wilson 《Expert Review of Gastroenterology & Hepatology》2016,10(1):21-36
Sofosbuvir is the first pan-genotypic direct acting antiviral agent to be approved. This article provides an overview of the pharmacology of sofosbuvir and ribavirin and a comprehensive summary of the phase 2 and 3 studies supporting dual sofosbuvir and ribavirin therapy for chronic hepatitis C infection. With the production of generic formulations of sofosbuvir, we anticipate this regimen leading the first wave for widespread, IFN-free treatment and becoming first line for all genotypes (including genotype 1) for much of the world—in particular in developing and middle income countries. We discuss the continued challenges with this regimen including among patients with decompensated liver disease and post-liver transplant, and renal failure. We address concerns of emerging resistance. We also discuss the future prospects including the global uptake of sofosbuvir and ribavirin for the treatment of all genotypes. 相似文献
17.
Until recently, the standard of care for hepatitis C virus genotype 3 infection was response‐guided therapy with pegylated interferon plus ribavirin for 16 to 48 or 72 weeks. The introduction of sofosbuvir plus ribavirin has revolutionized hepatitis C virus therapy. Nowadays, the recommend treatment regimen is a combination of sofosbuvir and a weight‐based ribavirin dose for 24 weeks. For easy to treat patients (e.g. naïve or previously treated patients without cirrhosis), this combination achieves high sustained virologic response rates and is well tolerated. However, in treatment‐experienced patients with cirrhosis, sustained virologic response is lower due to unknown reasons. The combination of two direct‐acting antiviral agents, sofosbuvir and daclatasvir, for 12 weeks is also associated with low sustained virologic response rates in this special population, for whom new drugs and different strategies are now under evaluation. Currently, the high cost of all these drugs limits access to treatment in many countries. 相似文献
18.
Ledipasvir‐sofosbuvir for treating Japanese patients with chronic hepatitis C virus genotype 2 infection 下载免费PDF全文
Yasuhiro Asahina Yoshito Itoh Yoshiyuki Ueno Yasushi Matsuzaki Yasuhiro Takikawa Hiroshi Yatsuhashi Takuya Genda Fusao Ikeda Takuma Matsuda Hadas Dvory‐Sobol Deyuan Jiang Benedetta Massetto Anu O. Osinusi Diana M. Brainard John G. McHutchison Norifumi Kawada Nobuyuki Enomoto 《Liver international》2018,38(9):1552-1561
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Chen‐Hua Liu Sheng‐Shun Yang Cheng‐Yuan Peng Woan‐Tyy Lin Chun‐Jen Liu Tung‐Hung Su Tai‐Chung Tseng Pei‐Jer Chen Ding‐Shinn Chen Jia‐Horng Kao 《Journal of viral hepatitis》2020,27(6):568-575
Data are limited regarding the real‐world effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI). We aimed to evaluate the performance of GLE/PIB in patients with chronic kidney disease (CKD) stage 4 or 5 in Taiwan. 108 chronic HCV patients with CKD stage 4 (n = 32) or 5 (n = 76) receiving GLE/PIB for 8‐12 weeks were retrospectively recruited at 4 academic centres in Taiwan. The effectiveness was determined by sustained virologic response at off‐therapy week 12 (SVR12) for evaluable (EP) and per‐protocol populations (PP). The safety profiles were also assessed. By EP and PP analyses, the SVR12 rate was 99.1% (107 of 108 patients; 95% confidence interval (CI): 94.9%‐99.8%) and 100% (107 of 107 patients; 95% CI: 96.5%‐100%). The SVR12 rates were 100% (95% CI: 89.3%‐100%) and 98.7% (95% CI: 92.9%‐99.8%) in patients with CKD stage 4 and 5, respectively. One patient, who declined off‐therapy follow‐up after permanently discontinuing GLE/PIB at on‐treatment week 9 due to scheduled cardiac surgery, had nonvirologic failure. Sixteen (14.8%) patients had serious adverse events (AEs), which were judged not related to GLE/PIB. The three most common AEs were pruritus (19.4%), fatigue (15.7%) and nausea (13.9%). None had ≥3‐fold upper limit of normal for total bilirubin and alanine aminotransferase levels. None of the 9 patients with hepatitis B virus (HBV) coinfection developed HBV‐associated hepatitis. In conclusion, GLE/PIB for 8‐12 weeks is effective and well‐tolerated in HCV patients with severe RI. 相似文献