scholarly journals The Alaska Native/American Indian experience of hepatitis C treatment with sofosbuvir-based direct-acting antivirals

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0260970
Author(s):  
Lisa Townshend-Bulson ◽  
Elena Roik ◽  
Youssef Barbour ◽  
Dana J. T. Bruden ◽  
Chriss E. Homan ◽  
...  
Keyword(s):  
Native American ◽  
Hepatitis C ◽  
American Indian ◽  
Alaska Native ◽  
Sustained Virologic Response ◽  
Real Life ◽  
Virologic Response ◽  
Native People ◽  
Common Symptom ◽  
Direct Acting

Background Direct-acting antiviral (DAA) drugs have been effective in the treatment of chronic hepatitis C virus (HCV) infection. Limited data are available on safety, tolerability, and efficacy in American Indian or Alaska Native people. We aim to evaluate the treatment outcomes of sofosbuvir- based regimens for treatment of HCV in a real life setting in Alaska Native/American Indian (AN/AI) people. Methods AN/AI patients within the Alaska Tribal Health System with confirmed positive anti-HCV and HCV RNA, who were 18 years of age and older were included in the study. Pretreatment baseline patient characteristics, treatment efficacy based on sustained virologic response (SVR) 12 weeks after treatment completion, and adverse effects were assessed. The following treatments were given according to the American Association for the Study of Liver Diseases/Infectious Disease Society of America (AASLD/IDSA) HCV Guidance: ledipasvir/sofosbuvir, sofosbuvir plus weight-based ribavirin, and sofosbuvir/velpatasvir. Results We included 501 patients with a mean age of 54.3 (range 21.3–78.3) in the study. Overall SVR was achieved in 95.2% of patients who received one of the three DAA regimens. For those with cirrhosis, overall SVR was 92.8% and for those with genotype 3 91.1% achieved SVR. The most common symptom experienced during treatment was headache. Joint pain was found to decrease during treatment. One person discontinued sofosbuvir plus ribavirin due to myocardial infarction and one discontinued sofosbuvir/velpatasvir due to urticaria. Conclusions In the real-world setting, sofosbuvir-based treatment is safe, effective, and well tolerated in AN/AI patients. Sustained virologic response was high regardless of HCV genotype or cirrhosis status.

scholarly journals The Alaska Native/American Indian experience of hepatitis C treatment with sofosbuvir-based direct-acting antivirals

2021 ◽  
Author(s):  
Lisa Townshend-Bulson ◽  
Elena Roik ◽  
Youssef Barbour ◽  
Dana Bruden ◽  
Chriss Homan ◽  
...  
Keyword(s):  
Native American ◽  
Hepatitis C ◽  
American Indian ◽  
Alaska Native ◽  
Sustained Virologic Response ◽  
Real Life ◽  
Virologic Response ◽  
Native People ◽  
Common Symptom ◽  
Direct Acting

AbstractBackgroundDirect-acting antiviral (DAA) drugs have been effective in the treatment of chronic hepatitis C virus (HCV) infection. Limited data are available on safety, tolerability, and efficacy in American Indian or Alaska Native people. We aim to evaluate the treatment outcomes of sofosbuvir-based regimens for treatment of HCV in a real life setting in Alaska Native/American Indian (AN/AI) people.MethodsAN/AI patients within the Alaska Tribal Health System with confirmed positive anti-HCV and HCV RNA, who were 18 years of age and older were included in the study. Pretreatment baseline patient characteristics, treatment efficacy based on sustained virologic response (SVR) 12 weeks after treatment completion, and adverse effects were assessed. The following treatments were given according to the American Association for the Study of Liver Diseases/Infectious Disease Society of America (AASLD/IDSA) HCV Guidance: ledipasvir/sofosbuvir, sofosbuvir plus weight-based ribavirin, and sofosbuvir/velpatasvir.ResultsWe included 501 patients with a mean age of 54.3 (range 21.3 -78.3) in the study. Overall SVR was achieved in 95.2% of patients who received one of the three DAA regimens. For those with cirrhosis, overall SVR was 92.8% and for those with genotype 3 91.1% achieved SVR. The most common symptom experienced during treatment was headache. Joint pain was found to decrease during treatment. One person discontinued sofosbuvir plus ribavirin due to myocardial infarction and one discontinued sofosbuvir/velpatasvir due to urticaria.ConclusionsIn the real-world setting, sofosbuvir-based treatment is safe, effective, and well tolerated in AN/AI patients. Sustained virologic response was high regardless of HCV genotype or cirrhosis status.

scholarly journals Original Versus Generic Direct Acting Antivirals in Treatment of Chronic Hepatitis C Patients: Real Life Data From Latvia

2018 ◽  
Vol 10 (1) ◽  
pp. 63-70
Author(s):  
Ieva Tolmane ◽  
Baiba Rozentale ◽  
Seda Arutjunana ◽  
Agita Jeruma ◽  
Velga Kuse ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Sustained Virologic Response ◽  
Generic Drugs ◽  
Real Life ◽  
Undetectable Viral Load ◽  
Virologic Response ◽  
Direct Acting Antivirals ◽  
Generic Medicines ◽  
Study Results ◽  
Direct Acting

Background: Despite effective treatment available from 2016 in Latvia, there are restrictions - only patients with fibrosis (F, Metavir) stage 3 to 4 have access to reimbursed medicines. Some patients obtain generic drugs from India. Objective: The aim of this study was to evaluate the efficacy of original and generic direct acting antiviral medications in Latvian patients. Materials and Methods: This is a retrospective study of 179 chronic virologic hepatitis C patients. Data were obtained from patients’ medical records. Mean age 49.2 years (SD 10.2, range 24-71), 88 female patients (49%), 91 male patients (51%). Genotype 1b was detected in 157 patients (87.7%). Patients were divided into two groups - patients who received original direct acting antivirals ombitasvir, paritaprevir, ritonavir, dasabuvir + ribavirin (n=144, F3-4, Child-Pugh A) and those who received generic medicines from India (n=35, F0-2) sofosbuvir, ledipasvir (n=7) or sofosbuvir, daclatasvir + ribavirin (n=28). Undetectable viral load 12 weeks after cessation of therapy (sustained virologic response 12 or SVR12) was measured in all patients. Therapy course completed 142 patients from original medicines group and all patients from generics group. Results: In the original medicines group - sustained viralogic response was achieved in 142 patients who completed treatment course (100%), while in generic medicines group in 32 patients (91.4%). Conclusion: Study results show high efficacy of both regimens using original and generic medicines - sustained virologic response was achieved in more than 90% of patients, with slight superiority in original medicines group.

Position Paper on Treatment of Hepatitis C in Romania 2017. Part Two

2017 ◽  
Vol 26 (3) ◽  
pp. 309-317 ◽  
Author(s):  
Liana Gheorghe ◽  
Ioan Sporea ◽  
Speranța Iacob ◽  
Roxana Șirli ◽  
Anca Trifan ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Liver Disease ◽  
Hepatitis C ◽  
Sustained Virologic Response ◽  
Real Life ◽  
Virologic Response ◽  
Position Paper ◽  
Hcv Infection ◽  
End Stage Liver Disease ◽  
End Stage

Background & Aims: Hepatitis C virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments have become available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country.Methodology: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention was created and these were discussed and rated. Decisions were taken by consensus.Recommendations: We present here the second part of the Society’s recommendations for chronic HCV infection treatment. An agreement between experts was reached regarding the therapy of the special categories of patients infected with HCV, complications and monitoring of the therapy, follow-up of the patients who reached sustained virologic response and re-treatment of the patients with therapy failure.Conclusions: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to real-life conditions in Romania. Abbreviations: CKD: Chronic kidney disease; DAAs: Direct-acting antivirals; DDIs: Drug-drug interactions; ESDL: End-stage liver disease; FCH: Fibrosing cholestatic hepatitis; GT: Genotype; HCV: Hepatitis C virus; HCC: Hepatocellular carcinoma; LT: Liver transplantation; MELD score: Mayo-Clinic End-Stage Liver Disease score; PDC: Premature discontinuation; PWID: Persons who inject drugs; RASs: Resistance associated substitutions; RBV: Ribavirin; RCT: Randomized controlled trial; SAE: Serious adverse events; SRGH: Romanian Society of Gastroenterology and Hepatology; SVR: Sustained virologic response.

Hepatitis C “true” late relapse beyond 48 weeks of sustained virologic response after direct acting antiviral therapy

2017 ◽  
Vol 66 (4) ◽  
pp. 862-863 ◽  
Author(s):  
Thomas Klag ◽  
Julia Dietz ◽  
Christoph R. Werner ◽  
Julia M. Schwarz ◽  
Ulrich M. Lauer ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Antiviral Therapy ◽  
Sustained Virologic Response ◽  
Virologic Response ◽  
Late Relapse ◽  
Direct Acting Antiviral ◽  
Direct Acting

scholarly journals Short‐term histological evaluations after achieving a sustained virologic response to direct‐acting antiviral treatment for chronic hepatitis C

2018 ◽  
Vol 6 (9) ◽  
pp. 1391-1400 ◽  
Author(s):  
Masaru Enomoto ◽  
Yoshihiro Ikura ◽  
Akihiro Tamori ◽  
Ritsuzo Kozuka ◽  
Hiroyuki Motoyama ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Sustained Virologic Response ◽  
Antiviral Treatment ◽  
Virologic Response ◽  
Short Term ◽  
Direct Acting Antiviral ◽  
Direct Acting

scholarly journals Sustained Virologic Response Rates of Direct Acting Antivirals in HIV Coinfected Hepatitis C Patients and Its Effect on Liver Fibrosis

2020 ◽  
Vol 3 (2) ◽  
pp. 01-07
Author(s):  
Dora Lebron
Keyword(s):  
Hepatitis C ◽  
Real World ◽  
Sustained Virologic Response ◽  
Virologic Response ◽  
Hiv Care ◽  
Secondary Outcome ◽  
Direct Acting Antivirals ◽  
Fibrosis Regression ◽  
Direct Acting ◽  
End Stage

Background: Hepatitis C virus (HCV) is an important cause of chronic hepatitis with necroinflammation and fibrosis resulting in end stage liver disease and hepatocellular carcinoma. Direct acting antivirals (DAAs) are newer agents that directly interfere with the HCV lifecycle and result in high rates of sustained virologic response (SVR). We evaluated if treatment with DAAs in a real-world setting is as successful in HCV/HIV coinfected patients as it is in HCV monoinfected patients, and if some degree of fibrosis regression can be observed after completion of therapy in both groups. Methods: We retrospectively reviewed data from HCV monoinfected and HCV/HIV coinfected patients who received treatment from 2014-2016 at the East Carolina University Infectious Diseases clinic. The primary outcome was to compare completion and sustained virologic response (SVR) rate at either 12 or 24 weeks between HCV monoinfected patients and HCV/HIV coinfected patients. The secondary outcome was to assess regression of fibrosis at either 12 or 24 weeks after completion of therapy, defined as one METAVIR stage improvement in their FibroSure™, a noninvasive biochemical test to estimate the stage of fibrosis. Results: There were 41 patients in each group. Compared to the coinfected group, patient no show rate was higher in the monoinfected group (p=0.0346). In the HCV monoinfected group, 25 (93%) achieved either SVR 12 or 24. Two patients were non-compliant and had detectable viral load on evaluation at week 12. In the HCV/HIV coinfected group, 37 patients achieved SVR (p=0.0039). One patient in the coinfected group did not complete therapy but achieved SVR. In terms of fibrosis, 12/18 (67%) in the monoinfected group demonstrated improvement in at least 1 Metavir stage and 6/18 (33%) had no change. In the coinfected group, 8/16 (50%) patients demonstrated an improvement in FibroSure™ stage, 5/16 (31%) had no change, and 3/16 (19%) had worsening fibrosis according to FibroSure™ stage, (p=0.4867). Conclusions: In this small, real-world cohort, HCV/HIV coinfected patients treated with DAAs had higher completion and SVR rates than HCV monoinfected patients. Treatment failures in the monoinfected group were all linked to non-adherence, whereas, more coinfected patients achieved SVR, likely related to the fact that they were regularly engaged in routine HIV care. Fibrosis regression based on FibroSure™ was observed more in monoinfected patients than those with coinfection. Although not statistically significant, at least 50% of the patients in each group had regression of fibrosis.

scholarly journals Hepatitis C Virus Infection and Renal Disorders

2019 ◽  
Vol 3 (1) ◽  
pp. 1-14
Author(s):  
Maurizio Salvadori ◽  
Aris Tsalouchos
Keyword(s):  
Hepatitis C Virus ◽  
Renal Transplantation ◽  
Hepatitis C ◽  
Sustained Virologic Response ◽  
Virologic Response ◽  
Antiviral Drugs ◽  
Renal Diseases ◽  
Renal Disorders ◽  
Direct Acting Antiviral ◽  
Direct Acting

Hepatitis C virus (HCV) infection is frequently associated with extrahepatic disorders, among which renal diseases are frequent. This article highlights the most frequent HCV-associated renal disorders, the impact of HCV infection on chronic renal disease and renal transplantation, and the role of current direct-acting antiviral therapies. HCV is associated with membranoproliferative glomerulonephritis, acceleration of end-stage renal diseases in patients with glomerulopathies, and a higher risk of death in patients affected by chronic kidney disease. Before the introduction of direct-acting antiviral drugs as treatment modality, renal transplantation was a challenging clinical problem because the drugs available until 2011 obtained a poor sustained virologic response, had several side effects, and caused acute rejection when used after transplantation. The knowledge of the viral structure and its replication allowed the discovery of new classes of direct-acting antiviral drugs that revolutionized this scenario. These new drugs are comparatively more effective and safer. Accumulating evidence suggests that it is possible to cure HCV-related glomerulonephritis, and obtain a sustained virologic response in patients with renal failure, or on dialysis, before commencing transplantation. Finally, it became possible to transplant HCV-positive kidneys into HCV-positive or HCV-negative recipients.

scholarly journals Sustained Virologic Response of Patients Hospitalized Compared With Those Not Hospitalized During Treatment for Hepatitis C Virus With Direct-Acting Antivirals

2020 ◽  
pp. 106002802096411
Author(s):  
Anthony J. Gentene ◽  
Allison M. Bell ◽  
Alicia Pence ◽  
Kelly Thomas ◽  
Collin Jakubecz ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Liver Disease ◽  
Hepatitis C ◽  
Sustained Virologic Response ◽  
Disease Patient ◽  
Virologic Response ◽  
Great Success ◽  
Direct Acting Antivirals ◽  
Inpatient Mortality ◽  
Direct Acting

Background: Direct-acting antivirals (DAAs) for treatment of hepatitis C virus (HCV) have resulted in great success through high attainment of sustained virologic response (SVR). Risk factors for DAA treatment failure are important to identify because of worsened outcomes with failure and high treatment cost. Objective: We sought to identify whether hospitalization during treatment affects SVR. The primary outcome was the difference in SVR at 12 weeks after treatment Methods: This multicenter, single health system retrospective cohort review compared achievement of SVR between patients hospitalized during DAA treatment for HCV with those not hospitalized during treatment. Results: Patients in the hospitalized cohort (n = 94) had more severe disease at baseline than nonhospitalized patients (n = 167) as indicated through higher Model for End-Stage Liver Disease (MELD) scores, Fibrosis-4 scores, and imaging-suggested or biopsy-confirmed cirrhosis. Patients hospitalized during treatment had lower SVR rates compared with those not hospitalized (87.2% vs 95.2%; P = 0.043) but failed to reach significance when inpatient mortality was excluded on secondary analysis (91.1% vs 95.2%; P = 0.195). Patients who were hospitalized and did not achieve SVR had higher MELD scores, were more likely to have intensive care unit stay, and had longer hospital stay compared with those who achieved SVR. Of 94 patients, 93 provided home supply of DAAs during hospitalization. Conclusion and Relevance: Patients hospitalized during DAA treatment for HCV had reduced rates of SVR. This reduced SVR rate may be driven by inpatient mortality and severity of liver disease. Patient education to bring home supply of medication for use during admission is an effective intervention.

scholarly journals Metabolic Changes in Chronic Hepatitis C Patients Who Carry IFNL4-ΔG and Achieve Sustained Virologic Response With Direct-Acting Antiviral Therapy

2019 ◽  
Vol 221 (1) ◽  
pp. 102-109 ◽  
Author(s):  
Benjamin Emmanuel ◽  
Samer S El-Kamary ◽  
Laurence S Magder ◽  
Kristen A Stafford ◽  
Man E Charurat ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Sustained Virologic Response ◽  
Density Lipoprotein ◽  
Virologic Response ◽  
Direct Acting Antiviral ◽  
Hiv Coinfection ◽  
The Mean ◽  
Direct Acting

Abstract Background Clearance of hepatitis C virus (HCV) results in rapid changes in metabolic parameters early in direct-acting antiviral (DAA) therapy. Long-term changes after sustained virologic response (SVR) remain unknown. Methods We investigated longitudinal changes in metabolic and inflammatory outcomes in chronic hepatitis C (CHC) patients: low-density lipoprotein (LDL), high-density lipoprotein, triglycerides, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) using a general linear model for repeated measurements at 5 clinical time points and by human immunodeficiency virus (HIV) coinfection and IFNL4 genotype. Results The mean LDL increased markedly during DAA therapy (pre-DAA, 86.6 to DAA, 107.4 mg/dL; P < .0001), but then it decreased to 97.7 mg/dL by post-SVR year 1 (P < .001 compared with DAA; P = .0013 compared with SVR). In patients who carry the IFNL4-ΔG allele, mean LDL increased during treatment, then decreased at post-SVR year 1; however, in patients with TT/TT, genotype did not change during and after DAA treatment. The mean ALT and AST normalized rapidly between pre-DAA and DAA, whereas only mean ALT continued to decrease until post-SVR. Metabolic and inflammatory outcomes were similar by HIV-coinfection status. Conclusions Changes in LDL among CHC patients who achieved SVR differed by IFNL4 genotype, which implicates the interferon-λ4 protein in metabolic changes observed in HCV-infected patients.

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