BACKGROUND Direct-acting antiviral(DAA)therapy regimens are highly effective at eliminating hepatitis C virus(HCV)infection but rates of sustained virologic response(SVR)are lower in patients with decompensated cirrho...BACKGROUND Direct-acting antiviral(DAA)therapy regimens are highly effective at eliminating hepatitis C virus(HCV)infection but rates of sustained virologic response(SVR)are lower in patients with decompensated cirrhosis or hepatocellular carcinoma.Since many of these patients will be referred for liver transplant,they will require retreatment after transplantation.Sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX)is recommended by guidelines as the preferred regimen to treat HCV in DAA-experienced patients following liver transplant however there is limited data.CASE SUMMARY We present the cases of six liver transplant recipients who had previous treatment failure with sofosbuvir-based DAA therapy prior to transplantation and who then received SOF/VEL/VOX after transplant.CONCLUSION This case series demonstrate the real-world efficacy and safety of SOF/VEL/VOX in the post liver transplant setting.Treatment was successful with all patients achieving SVR,it was well tolerated,and there were minimal drug-drug interactions with their immunosuppressants.展开更多
BACKGROUND Hepatitis C virus(HCV)is a leading cause of liver cirrhosis and hepatocellular carcinoma globally.Sofosbuvir/velpatasvir(SOF/VEL)is an effective pangenotypic direct-acting antiviral combination for treatmen...BACKGROUND Hepatitis C virus(HCV)is a leading cause of liver cirrhosis and hepatocellular carcinoma globally.Sofosbuvir/velpatasvir(SOF/VEL)is an effective pangenotypic direct-acting antiviral combination for treatment of chronic HCV infection.While the addition of ribavirin(RBV)to SOF/VEL improved sustained virological response(SVR12)in genotype 3(GT3)decompensated cirrhosis patients,the benefits of RBV in GT3 compensated cirrhosis patients receiving SOF/VEL remains unclear.AIM To evaluate the efficacy and safety of SOF/VEL,with or without RBV in GT3 compensated cirrhosis patients.METHODS We searched four electronic databases(PubMed/Medline,Embase,Cochrane Library and Web of Science)from inception up to June 2021 using both free text and MeSH terms.There was no restriction on language,geography,publication dates and publication status(full text or abstracts).All GT3 compensated cirrhosis patients treated with 12 wk of SOF/VEL,with or without RBV,were included,regardless of age,gender or prior treatment experience.The primary outcome was sustained virological response 12-wk posttreatment(SVR12).The secondary outcome was treatment-related adverse events,as defined by symptomatic anemia requiring transfusion or a drop in hemoglobin beyond 2 g/dL.The pooled relative risk(RR),95%CI and heterogeneity(I^(2))were estimated using Review Manager version 5.3.RESULTS From 1752 citations,a total of seven studies(2 randomized controlled trials,5 cohort studies)with 1088 subjects were identified.The SVR12 was similar in GT3 compensated cirrhosis patients,regardless of the use of RBV,for both the intention-to-treat RR 1.03,95%CI:0.99-1.07;I^(2)=0%)and the per-protocol analysis(RR:1.03,95%CI:0.99-1.07;I^(2)=48%).The overall pooled rate of treatment-related adverse events was 7.2%.Addition of RBV increased the pooled risk of treatment-related adverse events in GT3 compensated cirrhosis patients receiving SOF/VEL(RR:4.20,95%CI:1.29-13.68;I^(2)=0%).Subgroup analysis showed that RBV was associated with a higher SVR12 in GT3 compensated cirrhosis patients with baseline resistance-associated substitutions.However,addition of RBV did not significantly increase the SVR12 among treatment-experienced GT3 compensated cirrhosis patients.CONCLUSION Ribavirin was not associated with higher SVR12 in GT3 compensated cirrhosis patients receiving SOF/VEL.Our findings suggest a limited role for RBV as routine add-on therapy to SOF/VEL in GT3 compensated cirrhosis patients.展开更多
The direct acting antivirals(DAAs)are now the standard of care for hepatitis C virus(HCV)treatment with high and effective sustained virologic responserate(SVR)and great safety profile,including solid organ transplant...The direct acting antivirals(DAAs)are now the standard of care for hepatitis C virus(HCV)treatment with high and effective sustained virologic responserate(SVR)and great safety profile,including solid organ transplant patients.There are increasing reports showing DAAs are effective with high SVR rates and safety profile in kidney transplant recipients.There are reports on drug-drug interaction(DDI)between tacrolimus with DAAs.However,data remain lacking on potential DDIs between tacrolimus and DAA regimens and the management process.This case series reports three kidney transplant patients on tacrolimus who were successfully treated for HCV with multidisciplinary approach,although there was DDI between tacrolimus with sofosbuvir/velpatasvir and glecaprevir/pibrentasvir,which required tacrolimus dose adjustment to maintain therapeutic level during and after DAA treatment.Such DDIs should be aware of and closely monitored by pharmacist and physicians with tacrolimus dose adjustment as needed during and right after DAA treatment in post-kidney transplant patients.展开更多
Hepatitis C virus(HCV) affects 3% of the world population. It represents the main cause of chronic liver disease and is responsible for extra-hepatic complications, such as type 2 diabetes and cardiovascular diseases....Hepatitis C virus(HCV) affects 3% of the world population. It represents the main cause of chronic liver disease and is responsible for extra-hepatic complications, such as type 2 diabetes and cardiovascular diseases. HCV includes 7 genotypes differing in the nucleotide sequence variability, the geographic distribution, the rates of viral clearance, the risk of progression to liver fibrosis and to hepatocellular carcinoma, and the response to therapy. Last years have seen remarkable advances in the field of HCV infection with the approval of direct antiviral agents(DAAs) targeting key viral proteins involved in the HCV replication. Several oral regimens combining DAAs from different families have been developed and these regimens showed increased and sustained virological response rates to above 90% reducing the treatment duration to 12 wk or less. In particular, sofosbuvir, a nucleotide analogue nonstructural(NS)5B polymerase inhibitor, and velpatasvir, a NS5 A inhibitor, have been tested in two phase 3 trials, the ASTRAL-2(against HCV genotype 2) and the ASTRAL-3(against HCV genotype 3), demonstrating to be effective, safe, and well tolerated in patients who were 18 years of age or older and had at least a 6-mo history of HCV infection with a compensated liver disease.展开更多
Introduction: The treatment of viral hepatitis C (HCV), a major public health problem, has evolved considerably since the introduction of direct-acting anti-virals (DAAs). The aim of this study was to evaluate the str...Introduction: The treatment of viral hepatitis C (HCV), a major public health problem, has evolved considerably since the introduction of direct-acting anti-virals (DAAs). The aim of this study was to evaluate the strategy for initiating treatment with Sofosbuvir/Daclatasvir, and also to assess its efficacy. Patients and Methods: Included were patients aged at least 15 years, with detectable hepatitis C viremia and treated with a pan-genotypic Sofosbuvir/Daclatasvir regimen at the Centre “Hospitalier Universitaire la Référence Nationale de N’Djamena” between October 2019 and October 2023. The APRI score was used to assess fibrosis. Cure was defined by an undetectable viral load 12 weeks after the end of treatment. Results: A total of 835 patients were included (sex ratio 1.55, mean age 50.5 ± 13.73, extremes 20 and 84 years). The 60 - 69 age group was the most represented. The mean APRI score was 0.42 ± 0.29, with extremes of 0.019 and 1.84. The mean viral load was 2,316,193.086 IU/mL. All subjects had good renal function. Cytolysis was absent in 70% of cases. Without genotyping, a pan-genotypic regimen was used in all patients: Sofosbuvir (400 mg)/Daclatasvir (60 mg). The cure rate was 99.4%, with good tolerability. However, four cases of failure were recorded out of the 668 patients who underwent follow-up HCV-PCR testing after 12 weeks of treatment. Conclusion: The Sofosbuvir/Daclatasvir regimen is highly effective, with an excellent safety profile. However, the still high cost of these molecules limits their accessibility to a large proportion of patients.展开更多
Glecaprevir/pibrentasvir in combination with sofosbuvir may serve as a safe and effective option for treatment of recurrent hepatitis C virus post-liver transplant in patients who previously failed direct-acting antiv...Glecaprevir/pibrentasvir in combination with sofosbuvir may serve as a safe and effective option for treatment of recurrent hepatitis C virus post-liver transplant in patients who previously failed direct-acting antivirals.展开更多
Combination therapy with peginterferon (pegIFN)-α and ribavirin (RBV) has been the standard of care (SOC) for chronic hepatitis C. Unfortunately, not all patients can achieve a sustained virologic response (SVR) with...Combination therapy with peginterferon (pegIFN)-α and ribavirin (RBV) has been the standard of care (SOC) for chronic hepatitis C. Unfortunately, not all patients can achieve a sustained virologic response (SVR) with this regimen. SVR rates are approximately 80% in patients with hepatitis C virus (HCV) genotype 2, 3, 5 and 6 and 40%-50% in patients with genotype 1 and 4. Therefore, strategies to improve SVR rates have been an important issue for clinical physicians. Several direct acting antiviral agents (DAAs) have significantly higher SVR rates when combined with pegIFN-α and RBV than pegIFN-α and RBV alone. Treatments containing DAAs have several advantages over the previous SOC, including higher specificity and efficacy, shorter treatment durations, fewer side effects, and oral administration. Based on these advantages, treatment with pegIFN-α and RBV plus telaprevir or boceprevir has become the current SOC for patients with genotype 1 HCV infection. However, many patients are either not eligible for therapy or decline treatment due to coexisting relative or absolute contraindications as well as an inability to tolerate the hematological side effects and adverse events caused by the new SOC. These factors have contributed to the advent of pegIFN-α-free regimens. The newest therapeutic regimens containing sofosbuvir and ABT-450 have shown promising results. In this review, we summarize the development of anti-HCV agents and the clinical efficacy of sofosbuvir and ABT-450-based therapies as well as the potential for future HCV studies.展开更多
Hepatitis C virus(HCV) infection is a serious problem worldwide.The use of interferon-based therapy has made HCV eradication challenging.The recent appearance of direct-acting antiviral agents(DAAs) has changed HCV th...Hepatitis C virus(HCV) infection is a serious problem worldwide.The use of interferon-based therapy has made HCV eradication challenging.The recent appearance of direct-acting antiviral agents(DAAs) has changed HCV therapy.Combining the use of DAAs with peginterferon and ribavirin has improved treatment efficacy.Furthermore,the combination of different orally administered DAAs has enabled interferon-free therapy with much higher efficacy and safety.In particular,sofosbuvir,a nucleotide-based NS5 B inhibitor,prevents HCV RNA synthesis by acting as a "chain terminator".Treatment with sofosbuvir has attained an extremely high rate of sustained virologic response.The current review summarizes the efficacy and safety of sofosbuvir therapy.展开更多
AIM To prospectively evaluate the efficacy of sofobuvir(SOF) in hepatitis C patients infected with hepatitis C virus(HCV) genotype 3 in Pakistan.METHODS The present study was performed with the coordination of gastroe...AIM To prospectively evaluate the efficacy of sofobuvir(SOF) in hepatitis C patients infected with hepatitis C virus(HCV) genotype 3 in Pakistan.METHODS The present study was performed with the coordination of gastroenterology and pathology departments of Shalamar Hospital Lahore from August 2014 to May 2016. The total number of patients included in this study was 1375 and all of them were infected with HCV genotype 3. On the basis of drug combinations, all the patients were separated into two groups. The first group of patients was treated for 24 wk with SOF(Sovaldi? by Gilead Sciences) plus ribavirin(RBV) [Ribazol? by Getz Pharma Pakistan(PVT) Ltd], while the patients of the second group were treated with SOF + RBV + pegylatedinterferon(peg IFN) alfa-2 a(Ropegra by Roach) for 12 wk. HCV genotyping and viral load measurement were performed on fully automated Abbott Real-Time PCR system(Abbott m24 sp automated nucleic acid extraction system and Abbott m2000 rt amplification system; abbott Molecular, Des Plaines, IL, United States). For the assessment of sustained virological response(SVR), all HCV RNA negative patients were followed for 12weeks after the treatment completion. Any patient with less than 12 IU/m L viral load after 12 wk of treatment completion was considered as a sustained virological responder(SVR-12).RESULTS A total of 1375 patients chronically infected with HCV genotype 3 were treated with two drug combinations SOF + RBV and SOF + RBV + peg IFN alfa-2 a. On the basis of these drug combinations, patients were divided into two groups(first and second). Overall SVR-12 was excellent in both groups(99.17% and 97.91%). Older patients(> 40 years) of second group showed lower SVR-12(93.46%) compared to first group older patients(98.79%), while in the younger patients of both groups, the SVR-12 rate was almost the same(99.54% in first group and 99.05% in second group). No such difference regarding SVR-12 rate was seen in males and females of first group patients(99.68% and 98.88%, respectively), while in second group the males were found to be better responders compared to females(98.96% and 95%). The SVR-12 rate in previously treated patients of first group was better(99.34%) than second group(93.70%), while na?ve patients of second group were marginally better responders(99.25%) than first group(97.80%). Rapid viral response at week-4 was found to be a very effective predictor for assessing the SVR rate at this stage of therapy in both groups. Headache, anemia and fatigue were common side effects in both groups either treated with SOF + RBV or SOF + RBV + peg IFN alfa-2 a, while the overall percentage of the side effects was higher in second group.CONCLUSION The remarkable SVR response rate of HCV genotype 3 infected patients to SOF provided a new way to look forward to eliminate hepatitis C from our region.展开更多
AIM To assess the efficacy and safety of sofosbuvir and daclatasvir regimens for kidney transplantation(KT) patients with hepatitis C virus(HCV) infection.METHODS This study enrolled a prospective cohort of consecutiv...AIM To assess the efficacy and safety of sofosbuvir and daclatasvir regimens for kidney transplantation(KT) patients with hepatitis C virus(HCV) infection.METHODS This study enrolled a prospective cohort of consecutive Chinese KT patients with HCV infection. They were given sofosbuvir combined with daclatasvir, with or without ribavirin. They were monitored regularly during and after the treatment. RESULTS Six patients were recruited in our prospective study cohort. All patients were male and naive to directacting antiviral treatment. The treatment duration was 12 wk. Most patients(4/6) were infected with HCV genotype 1b. HCV RNA was undetectable at week 4 after treatment and at the end of treatment in all patients. Sustained virological response rate at 12 wk was 100%(6/6). Two patients had to accept a half dose of sofosbuvir due to serum creatinine elevation during treatment. Kidney function in the remaining patients was stable. No serious adverse events(AEs) were observed. No patient discontinued antiviral therapy due to side effects. CONCLUSION Sofosbuvir and daclatasvir for treatment of KT recipients with HCV infection are highly efficient and safe. Patients tolerated the medications well, and no serious AEs were observed. Larger prospective cohort studies are needed to validate these results.展开更多
文摘BACKGROUND Direct-acting antiviral(DAA)therapy regimens are highly effective at eliminating hepatitis C virus(HCV)infection but rates of sustained virologic response(SVR)are lower in patients with decompensated cirrhosis or hepatocellular carcinoma.Since many of these patients will be referred for liver transplant,they will require retreatment after transplantation.Sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX)is recommended by guidelines as the preferred regimen to treat HCV in DAA-experienced patients following liver transplant however there is limited data.CASE SUMMARY We present the cases of six liver transplant recipients who had previous treatment failure with sofosbuvir-based DAA therapy prior to transplantation and who then received SOF/VEL/VOX after transplant.CONCLUSION This case series demonstrate the real-world efficacy and safety of SOF/VEL/VOX in the post liver transplant setting.Treatment was successful with all patients achieving SVR,it was well tolerated,and there were minimal drug-drug interactions with their immunosuppressants.
基金Supported by the Nurturing Clinician Scientist Scheme(NCCS)award by SingHealth Duke-NUS Academic Medical Centre and National Medical Research Council Singapore.
文摘BACKGROUND Hepatitis C virus(HCV)is a leading cause of liver cirrhosis and hepatocellular carcinoma globally.Sofosbuvir/velpatasvir(SOF/VEL)is an effective pangenotypic direct-acting antiviral combination for treatment of chronic HCV infection.While the addition of ribavirin(RBV)to SOF/VEL improved sustained virological response(SVR12)in genotype 3(GT3)decompensated cirrhosis patients,the benefits of RBV in GT3 compensated cirrhosis patients receiving SOF/VEL remains unclear.AIM To evaluate the efficacy and safety of SOF/VEL,with or without RBV in GT3 compensated cirrhosis patients.METHODS We searched four electronic databases(PubMed/Medline,Embase,Cochrane Library and Web of Science)from inception up to June 2021 using both free text and MeSH terms.There was no restriction on language,geography,publication dates and publication status(full text or abstracts).All GT3 compensated cirrhosis patients treated with 12 wk of SOF/VEL,with or without RBV,were included,regardless of age,gender or prior treatment experience.The primary outcome was sustained virological response 12-wk posttreatment(SVR12).The secondary outcome was treatment-related adverse events,as defined by symptomatic anemia requiring transfusion or a drop in hemoglobin beyond 2 g/dL.The pooled relative risk(RR),95%CI and heterogeneity(I^(2))were estimated using Review Manager version 5.3.RESULTS From 1752 citations,a total of seven studies(2 randomized controlled trials,5 cohort studies)with 1088 subjects were identified.The SVR12 was similar in GT3 compensated cirrhosis patients,regardless of the use of RBV,for both the intention-to-treat RR 1.03,95%CI:0.99-1.07;I^(2)=0%)and the per-protocol analysis(RR:1.03,95%CI:0.99-1.07;I^(2)=48%).The overall pooled rate of treatment-related adverse events was 7.2%.Addition of RBV increased the pooled risk of treatment-related adverse events in GT3 compensated cirrhosis patients receiving SOF/VEL(RR:4.20,95%CI:1.29-13.68;I^(2)=0%).Subgroup analysis showed that RBV was associated with a higher SVR12 in GT3 compensated cirrhosis patients with baseline resistance-associated substitutions.However,addition of RBV did not significantly increase the SVR12 among treatment-experienced GT3 compensated cirrhosis patients.CONCLUSION Ribavirin was not associated with higher SVR12 in GT3 compensated cirrhosis patients receiving SOF/VEL.Our findings suggest a limited role for RBV as routine add-on therapy to SOF/VEL in GT3 compensated cirrhosis patients.
文摘The direct acting antivirals(DAAs)are now the standard of care for hepatitis C virus(HCV)treatment with high and effective sustained virologic responserate(SVR)and great safety profile,including solid organ transplant patients.There are increasing reports showing DAAs are effective with high SVR rates and safety profile in kidney transplant recipients.There are reports on drug-drug interaction(DDI)between tacrolimus with DAAs.However,data remain lacking on potential DDIs between tacrolimus and DAA regimens and the management process.This case series reports three kidney transplant patients on tacrolimus who were successfully treated for HCV with multidisciplinary approach,although there was DDI between tacrolimus with sofosbuvir/velpatasvir and glecaprevir/pibrentasvir,which required tacrolimus dose adjustment to maintain therapeutic level during and after DAA treatment.Such DDIs should be aware of and closely monitored by pharmacist and physicians with tacrolimus dose adjustment as needed during and right after DAA treatment in post-kidney transplant patients.
文摘Hepatitis C virus(HCV) affects 3% of the world population. It represents the main cause of chronic liver disease and is responsible for extra-hepatic complications, such as type 2 diabetes and cardiovascular diseases. HCV includes 7 genotypes differing in the nucleotide sequence variability, the geographic distribution, the rates of viral clearance, the risk of progression to liver fibrosis and to hepatocellular carcinoma, and the response to therapy. Last years have seen remarkable advances in the field of HCV infection with the approval of direct antiviral agents(DAAs) targeting key viral proteins involved in the HCV replication. Several oral regimens combining DAAs from different families have been developed and these regimens showed increased and sustained virological response rates to above 90% reducing the treatment duration to 12 wk or less. In particular, sofosbuvir, a nucleotide analogue nonstructural(NS)5B polymerase inhibitor, and velpatasvir, a NS5 A inhibitor, have been tested in two phase 3 trials, the ASTRAL-2(against HCV genotype 2) and the ASTRAL-3(against HCV genotype 3), demonstrating to be effective, safe, and well tolerated in patients who were 18 years of age or older and had at least a 6-mo history of HCV infection with a compensated liver disease.
文摘Introduction: The treatment of viral hepatitis C (HCV), a major public health problem, has evolved considerably since the introduction of direct-acting anti-virals (DAAs). The aim of this study was to evaluate the strategy for initiating treatment with Sofosbuvir/Daclatasvir, and also to assess its efficacy. Patients and Methods: Included were patients aged at least 15 years, with detectable hepatitis C viremia and treated with a pan-genotypic Sofosbuvir/Daclatasvir regimen at the Centre “Hospitalier Universitaire la Référence Nationale de N’Djamena” between October 2019 and October 2023. The APRI score was used to assess fibrosis. Cure was defined by an undetectable viral load 12 weeks after the end of treatment. Results: A total of 835 patients were included (sex ratio 1.55, mean age 50.5 ± 13.73, extremes 20 and 84 years). The 60 - 69 age group was the most represented. The mean APRI score was 0.42 ± 0.29, with extremes of 0.019 and 1.84. The mean viral load was 2,316,193.086 IU/mL. All subjects had good renal function. Cytolysis was absent in 70% of cases. Without genotyping, a pan-genotypic regimen was used in all patients: Sofosbuvir (400 mg)/Daclatasvir (60 mg). The cure rate was 99.4%, with good tolerability. However, four cases of failure were recorded out of the 668 patients who underwent follow-up HCV-PCR testing after 12 weeks of treatment. Conclusion: The Sofosbuvir/Daclatasvir regimen is highly effective, with an excellent safety profile. However, the still high cost of these molecules limits their accessibility to a large proportion of patients.
文摘Glecaprevir/pibrentasvir in combination with sofosbuvir may serve as a safe and effective option for treatment of recurrent hepatitis C virus post-liver transplant in patients who previously failed direct-acting antivirals.
基金Supported by Grants from the National Key Basic Research Program of China, No. 2009CB522507, No. 2012CB519005Beijing Nova Program of China, No. Z12110702512071
文摘Combination therapy with peginterferon (pegIFN)-α and ribavirin (RBV) has been the standard of care (SOC) for chronic hepatitis C. Unfortunately, not all patients can achieve a sustained virologic response (SVR) with this regimen. SVR rates are approximately 80% in patients with hepatitis C virus (HCV) genotype 2, 3, 5 and 6 and 40%-50% in patients with genotype 1 and 4. Therefore, strategies to improve SVR rates have been an important issue for clinical physicians. Several direct acting antiviral agents (DAAs) have significantly higher SVR rates when combined with pegIFN-α and RBV than pegIFN-α and RBV alone. Treatments containing DAAs have several advantages over the previous SOC, including higher specificity and efficacy, shorter treatment durations, fewer side effects, and oral administration. Based on these advantages, treatment with pegIFN-α and RBV plus telaprevir or boceprevir has become the current SOC for patients with genotype 1 HCV infection. However, many patients are either not eligible for therapy or decline treatment due to coexisting relative or absolute contraindications as well as an inability to tolerate the hematological side effects and adverse events caused by the new SOC. These factors have contributed to the advent of pegIFN-α-free regimens. The newest therapeutic regimens containing sofosbuvir and ABT-450 have shown promising results. In this review, we summarize the development of anti-HCV agents and the clinical efficacy of sofosbuvir and ABT-450-based therapies as well as the potential for future HCV studies.
文摘Hepatitis C virus(HCV) infection is a serious problem worldwide.The use of interferon-based therapy has made HCV eradication challenging.The recent appearance of direct-acting antiviral agents(DAAs) has changed HCV therapy.Combining the use of DAAs with peginterferon and ribavirin has improved treatment efficacy.Furthermore,the combination of different orally administered DAAs has enabled interferon-free therapy with much higher efficacy and safety.In particular,sofosbuvir,a nucleotide-based NS5 B inhibitor,prevents HCV RNA synthesis by acting as a "chain terminator".Treatment with sofosbuvir has attained an extremely high rate of sustained virologic response.The current review summarizes the efficacy and safety of sofosbuvir therapy.
文摘AIM To prospectively evaluate the efficacy of sofobuvir(SOF) in hepatitis C patients infected with hepatitis C virus(HCV) genotype 3 in Pakistan.METHODS The present study was performed with the coordination of gastroenterology and pathology departments of Shalamar Hospital Lahore from August 2014 to May 2016. The total number of patients included in this study was 1375 and all of them were infected with HCV genotype 3. On the basis of drug combinations, all the patients were separated into two groups. The first group of patients was treated for 24 wk with SOF(Sovaldi? by Gilead Sciences) plus ribavirin(RBV) [Ribazol? by Getz Pharma Pakistan(PVT) Ltd], while the patients of the second group were treated with SOF + RBV + pegylatedinterferon(peg IFN) alfa-2 a(Ropegra by Roach) for 12 wk. HCV genotyping and viral load measurement were performed on fully automated Abbott Real-Time PCR system(Abbott m24 sp automated nucleic acid extraction system and Abbott m2000 rt amplification system; abbott Molecular, Des Plaines, IL, United States). For the assessment of sustained virological response(SVR), all HCV RNA negative patients were followed for 12weeks after the treatment completion. Any patient with less than 12 IU/m L viral load after 12 wk of treatment completion was considered as a sustained virological responder(SVR-12).RESULTS A total of 1375 patients chronically infected with HCV genotype 3 were treated with two drug combinations SOF + RBV and SOF + RBV + peg IFN alfa-2 a. On the basis of these drug combinations, patients were divided into two groups(first and second). Overall SVR-12 was excellent in both groups(99.17% and 97.91%). Older patients(> 40 years) of second group showed lower SVR-12(93.46%) compared to first group older patients(98.79%), while in the younger patients of both groups, the SVR-12 rate was almost the same(99.54% in first group and 99.05% in second group). No such difference regarding SVR-12 rate was seen in males and females of first group patients(99.68% and 98.88%, respectively), while in second group the males were found to be better responders compared to females(98.96% and 95%). The SVR-12 rate in previously treated patients of first group was better(99.34%) than second group(93.70%), while na?ve patients of second group were marginally better responders(99.25%) than first group(97.80%). Rapid viral response at week-4 was found to be a very effective predictor for assessing the SVR rate at this stage of therapy in both groups. Headache, anemia and fatigue were common side effects in both groups either treated with SOF + RBV or SOF + RBV + peg IFN alfa-2 a, while the overall percentage of the side effects was higher in second group.CONCLUSION The remarkable SVR response rate of HCV genotype 3 infected patients to SOF provided a new way to look forward to eliminate hepatitis C from our region.
基金Supported by the Project of Science and Technology Development Plan of Jinan City,No.201506004Youth Fund of the Second Hospital of Shandong University,No.Y2014010014
文摘AIM To assess the efficacy and safety of sofosbuvir and daclatasvir regimens for kidney transplantation(KT) patients with hepatitis C virus(HCV) infection.METHODS This study enrolled a prospective cohort of consecutive Chinese KT patients with HCV infection. They were given sofosbuvir combined with daclatasvir, with or without ribavirin. They were monitored regularly during and after the treatment. RESULTS Six patients were recruited in our prospective study cohort. All patients were male and naive to directacting antiviral treatment. The treatment duration was 12 wk. Most patients(4/6) were infected with HCV genotype 1b. HCV RNA was undetectable at week 4 after treatment and at the end of treatment in all patients. Sustained virological response rate at 12 wk was 100%(6/6). Two patients had to accept a half dose of sofosbuvir due to serum creatinine elevation during treatment. Kidney function in the remaining patients was stable. No serious adverse events(AEs) were observed. No patient discontinued antiviral therapy due to side effects. CONCLUSION Sofosbuvir and daclatasvir for treatment of KT recipients with HCV infection are highly efficient and safe. Patients tolerated the medications well, and no serious AEs were observed. Larger prospective cohort studies are needed to validate these results.
