Hepatitis C Virus PCR Research Articles

Results from a retrospective case finding and re-engagement exercise for people previously diagnosed with hepatitis C virus to increase uptake of directly acting antiviral treatment

BackgroundDirect acting antivirals (DAAs) for the Hepatitis C virus (HCV) have shifted the World Health Organisation global strategic focus to the elimination of HCV by 2030. In England, the UK Health Security Agency (UKHSA) led a national ‘patient re-engagement exercise’, using routine surveillance data, which was delivered through the HCV Operational Delivery Networks (ODNs) with support from National Health Service England (NHSE), to help find and support people with a positive HCV PCR test result to access treatment. We report a quantitative evaluation of outcomes of this exercise.MethodsIndividuals with a recorded positive HCV antibody or PCR result between 1996 and 2017 were identified using UKHSA’s records of HCV laboratory diagnosis. Linkage with established health-care datasets helped to enhance patient identification and minimise attempts to contact deceased or previously treated individuals. From September to November 2018 each ODN was provided with a local list of diagnosed individuals. ODNs were asked to perform further data quality checks through local systems and then write to each individual’s GP to inform them that the individual would be contacted by the ODN to offer confirmatory HCV PCR testing, assessment and treatment unless the GP advised otherwise. Outcomes of interest were receipt of treatment, a negative PCR result, and death. Data were collected in 2022.ResultsOf 176,555 individuals with a positive HCV laboratory report, 55,329 individuals were included in the exercise following linkage to healthcare datasets and data reconciliation. Participants in the study had a median age of 51 years (IQR: 43, 59), 36,779 (66.5%) were males, 47,668 (86.2%) were diagnosed before 2016 and 11,148 (20.2%) lived in London. Of the study population, 7,442 (13.4%) had evidence of treatment after the re-engagement exercise commenced, 6,435 (11.6%) were reported as PCR negative (96% had no previous treatment records), 4,195 (7.6%) had prescription data indicating treatment before the exercise commenced or were reported to have been treated previously by their ODN, and 2,990 (5.4%) had died. The status of 32,802 (59.3%) people remains unknown.ConclusionsA substantial number of those included had treatment recorded after the exercise commenced, however, many more remain unengaged. Evaluation of the exercise highlighted areas that could be streamlined to improve future exercises.

A novel multisite model to facilitate hepatitis C virus elimination in people experiencing homelessness

Background/aims: Only a handful of countries are on target to achieve hepatitis C virus (HCV) elimination by 2030. People experiencing homelessness (PEH) remain an important HCV reservoir. The END C study evaluated clinical, patient reported and health economic outcomes of a decentralised integrated model. MethodsThis prospective study assessed a decentralised regional service based at multiple homeless sites in southeast England. Novel linkage-care strategies were utilised. We assessed generic and liver specific health-related quality of life (HRQoL) (SF-12v2; EQ-5D-5L and SFLDQol) pre/post HCV treatment and cost per HCV case detected and cured. Primary outcome was intention-to-treat (ITT) sustained virological response (SVR12). ResultsWe recruited 418 individuals, mean age 44.45 ± 10.6, 78% were male, 74% being currently homeless, current injecting drug use/alcohol use being 25% and 65% respectively. Prevalence of cirrhosis (liver stiffness measurement >12kPa) was 12%. Twenty-eight percent (n=116) were HCV PCR positive, of whom n=105 received direct acting antiviral treatment. ITT SVR12 rates were 81% (95% CI 72%-88%), the only predictor of SVR12 being >80% treatment adherence (OR 20.69, 95% CI 6.227-68.772, p<0.001). HRQoL improved significantly after SVR12: SF-12v2 (General Health, Mental Health, Social Functioning, Mental Health Composite Score p<0.049); SFLDQoL (Symptoms/Effects of Liver Disease, Distress, Loneliness p<0.004) and EQ-5D-5L (Index Score, Visual Analog Scale p<0.001). Costs (British pound 2022) per HCV case detected and per case cured were £359 and £257 respectively. Reinfection rates were 6.82/100 person years. ConclusionThe END C study endorses a multisite decentralised service for PEH enabling excellent linkage to care, high SVR12 rates and significant improvements in generic and liver specific HRQoL, all being achieved at modest costs. Such services are paramount to help achieve HCV elimination. Impact and implicationsIn people experiencing homeless, we found a high prevalence of HCV, alcohol and substance misuse including overdoses and mental health issues. Despite this, an integrated and decentralised service resulted in excellent linkage to care with high SVR12 rates. Even in this complex cohort with multiple comorbidities, SVR12 was associated with significant improvements in both generic and liver specific health-related quality of life. This was all achieved at modest costs in a community setting. Such models of care are feasible, easy to replicate and essential if we are to achieve HCV elimination.

Feasibility and Acceptability of Antenatal Hepatitis C Screening: A Pilot Study.

Hepatitis C virus (HCV) is not currently included in the United Kingdom routine antenatal screening program, but the latest guidelines from the Centers for Disease Control and Prevention, American Association for the Study of Liver Diseases, and Infectious Diseases Society of America recommend HCV screening for all pregnant women during each pregnancy. The aim of this study was to collect qualitative data on the feasibility and acceptability of antenatal HCV screening in pregnant women at the time of routine antenatal screening at 12 weeks, to estimate patient knowledge about HCV and identify the prevalence of HCV infection in antenatal women. This was a pilot study targeting a single hospital-based antenatal clinic in Birmingham, initially conducted for eight weeks with a further extension of the study period to enhance recruitment to meet the feasibility target of 500 patients. Data collected included demographic and epidemiological details. Pregnant women attending the antenatal unit were given information regarding HCV and antenatal screening for HCV prior to their initial antenatal visit. During the antenatal visit, research nurses provided further information about the study and HCV infection. Consent was obtained for taking part in the study and testing for HCV using blood samples taken at the same time as other routine antenatal screening blood tests. All women who agreed to participate in the study were asked to complete an acceptability and knowledge questionnaire. All women had HCV antibody testing as the primary screening assay. The test result was communicated in writing to the women and their general practitioner. Confirmatory positive antibody tests were followed up with quantitative HCV PCR and genotype analysis. The outcomes of testing were no evidence of HCV infection and evidence of past HCV infection or current HCV infection. Five hundred and forty-nine women were approached in the antenatal clinic; 30 women refused consent while 29 women were excluded from the study (blood tests not performed after consenting, age less than 18 years, and consent form lost). Four hundred and ninety women were included in the study. The median age of the study population was 29 years (range, 18-46). Knowledge about blood-borne viruses was limited; 75% of women had some understanding about antenatal hepatitis B (HBV) and human immunodeficiency virus (HIV) testing. Previous awareness about hepatitis C was reported by 55%. Ninety-one percent of women found the information they were given about hepatitis C helpful. Ninety-six percent of the women included in this study found the counselling they received about HCV useful and felt that the delivery of this information was carried out in an acceptable manner. Once given information about HCV, 99% felt that universal screening for HCV should be implemented. HCV antibody was negative in 489 women. One patient with a positive HCV antibody (prevalence: 0.2%) had a negative HCV PCR. Routine antenatal screening for HCV is not currently recommended in the UK. Our study suggests that antenatal HCV screening would be both feasible and acceptable to most pregnant women attending antenatal clinics. Though the awareness of HCV was low, with appropriate counselling and communication, 99% of pregnant women were in favor of antenatal screening for HCV. Antenatal screening would identify HCV-positive mothers and allow follow-up of their infants so that any infected mothers and infants could be offered effective curative therapy and prevent the progression of liver disease. The inclusion of HCV antenatal screening would complete the blood-borne virus profile and enhance the WHO target to eliminate HCV in the UK.

TLR3 Gene Polymorphism in HCV Infection in the Kazakh Population of Western Kazakhstan.

Hepatitis C virus (HCV) infection is a common cause of cirrhosis worldwide, leading to significant economic and social burdens. Approximately 170 million people (3% of the population) are infected with HCV, with the risk of developing complications such as cirrhosis and hepatocellular carcinoma. In the United States, HCV is the main cause of liver cirrhosis, accounting for 26% of cases. Recent studies have shown an increase in the proportion of HCV-related liver cirrhosis. A total of 102 patients with chronic hepatitis C in the reactivation phase from the Atyrau and Aktobe regional hepatology centers, who had not previously received antiviral therapy, were examined. A control group, matched by gender and age, included 127 practically healthy individuals of Kazakh nationality. All patients underwent a comprehensive examination, which included a complete blood count, a biochemical blood analysis and PCR for HCV. Venous blood samples were taken from all subjects for molecular genetic analysis. Genotyping of TLR3 polymorphism (rs5743312, rs5743305, rs3775291, rs5743311, rs1879026) was performed using real-time PCR. Thes study is a case control study. In patients with cirrhosis of the liver resulting from chronic hepatitis C (HCV), the results of biochemical analysis were statistically significantly higher than in patients with HCV without liver cirrhosis: the levels of total bilirubin (p 0.017*), alkaline phosphatase (p 0.022*), and gamma-glutamyl transferase (0.041*) were elevated. The results indicated that the CC genotype of TLR3 rs1879026 was associated with the development and chronicity of HCV infection compared to practically healthy individuals (p=0.001). In the distribution of genotypes and alleles for rs5743312, rs5743305, rs3775291, and rs5743311, no significant differences were found between patients with HCV and the healthy control group. The TLR3 rs1879026 gene polymorphism plays a significant role in the predisposition to HCV infection in the Kazakh population of the Aktobe and Atyrau regions.

Incidence of Reactivation of Hepatitis B in Co-Infected HB V/HCV Patients Treated with Regiments of Sofosbuvir and Daclatasvir with or without Ribavirin

Abstract Background HCV management was dramatically changed by the recent advent of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection, where DAA regimens are associated with a sustained virological response (SVR) rate of &amp;gt; 90–95% and are considered safe; nevertheless, a few complications have been reported including reactivation of hepatitis B virus (HBV). Aim of the Work To evaluate the incidence of re activation of HBV among patients treated by sof/dac with or without RBV Patients and Methods This study was held in out in centers for treatment of HCV in –Ain- Shams University Hospital and Aswan Fever Hospital from May 2019 to October 2020., All patients were subjected to history taking, clinical examination, abdominal ultrasound, laboratory investigations (CBC, liver function, HCV Ab, HBsAg, HBV eAg PCR for HCV RNAand PCR for HBV DNA. All patients were positive for HCVAb, HCV PCR, HBVsAg with HBV DNA less than 2000IU/ML and negative for HBVeAg. This study was conducted on 90 patients who were selected according to National Committee for Control of Viral Hepatitis (NCCVH) protocol were divided according to treatment protocol into two groups. Results In our study, 57% of cases aged &amp;lt; 50 years, 33% aged &amp;gt; 50 years, and 61% were males and 39% were females; In the present study, there were 23 patients were smokers,16 patients were diabetics and 21 patients were hypertensives. All treated patients were negative PCR for HCV RNA at week 12 with 100% (SVR12)response in all treated patients which is still negative till end of treatment and 12 week after end of treatment (SVR 24), AS regard HBV DNA, no statistically significant difference was found at the beginning, at the end of 12 weeks, and at the end of 24 week of treatment by DAAs (p-value &amp;gt; 0.05), except for one patient who was treated with SOF/DAC/RBV. This patient, with compensated cirrhosis at baseline, developed fatigue and anorexia at week 12, with HBV reactivation (HBV DNA levels increased from245 IU/mL at baseline to 532000IU/mL), after which entecavir was added to the SOF/RBV regimen. This patient did not show significant increase in ALT level. Conclusion Our study confirmed the importance of screening for HBV in patients undergoing DAA therapy and importance of follow. For those for positive HBsAg, to avoid HBV reactivation and particularly HBV-related hepatitis. Our study limits the benefit of systematic nucleoside analogue prophylaxis for all HBsAg-positive patients. In our Egyptian cohort, for example, if we had followed the EASL recommendation (ie, starting nucleos(t)ide analogue prophylaxis for all 90 HBsAg-positive patients irrespective of their HBV DNA levels at baseline), this could have prevented 1 case of HBV-related reactivation during the course of DAAs, but resulted in overtreatment in the rest of patients

Management of HCV Positive Patients on Maintenance Dialysis

The prevalence of hepatitis C virus (HCV) is quite high in Pakistan, especially among patients on maintenance hemodialysis (MHD). HCV infection is associated with increased morbidity and mortality among patients on maintenance hemodialysis. The current availability of direct-acting antiviral therapy has changed the picture of HCV prevalence in many countries. Objective: The aim of our study is to assess the prevalence and treatment of HCV infection among patients on maintenance hemodialysis in our setting. Methods: This descriptive cross-sectional study was held in the Medicine department of Mayo Hospital, Lahore for six-months duration from 13th January 2022 to 12th July 2022. The study was conducted on 130 patients to assess HCV seroprevalence among patients on MHD. Data on HCV status, PCR positivity and number of patients receiving active treatment were evaluated. Results: A total of 130 patients on maintenance hemodialysis were included in this study. The incidence of HCV infection was 49 (37.7%). All patients underwent PCR and 32 patients were PCR positive. All except 5 of the 32 PCR positive patients started HCV antiviral treatment. Conclusions: In conclusion, our study helps highlight the high prevalence of HCV among maintenance hemodialysis patients and the need to maintain adequate infection control measures. However, it is encouraging to know that most patients have been treated, and future research will highlight the importance of prompt treatment for MHD patients. It is recommended that all of HCV PCR positive patients were being treated with DAA. Keywords: HCV, Hemodialysis, Antivirals, Seroconversion, Health insurance, Infection.

A CURE FOR RECENTLY ACQUIRED HEPATITIS C

Chronic hepatitis C is a global health threat. Most individuals infected with the hepatitis C virus (HCV) will inevitably progress to chronic infection, leading to cirrhosis and hepatocellular carcinoma. The current use of direct-acting antiviral (DAA) agents has changed the outlook for the treatment resulting in a cure for a short time. Recently acquired hepatitis C, also known as acute hepatitis, should be treated with regimens similar to chronic hepatitis C. We report a case of recently acquired hepatitis C manifested with jaundice, confirmed by a positive HCV RNA result and seroconversion. The patient was referred to a gastroenterologist with his girlfriend with newly diagnosed chronic hepatitis C for further evaluation and treatment. Both underwent DAA treatment with glecaprevir/pibrentasvir for two months. Upon completion of the therapy and 12 weeks later, HCV PCR was undetected in both cases. We treated our patient long before the onset of chronic liver disease and long-term complications. The current case underscores the importance of asking about potential ongoing exposure to an HCV-infected person.

Comparison Of Hepatitis C Antibody Assays And Evaluation Of Agreement Between Hepatitis C Antigen And PCR Results.

Hepatitis C is associated with a wide range of health repercussions. Pakistan is one of the highly prevalent countries of Hepatitis C Virus (HCV) infection. The availability of cost-effective, robust, and reliable screening and diagnostic tests for hepatitis C is important to address the disease burden. Standardization of screening and diagnostic assays in clinical laboratories is crucial for achieving big goals. Objectives of this study are to correlate the results of two different HCV antibody (HCV Ab) assays and to examine the correlation of HCV core antigen (HCV c Ag) results with HCV PCR for HCV infection diagnosis. This descriptive cross-sectional study was carried out from November to December 2020 at Dow University of Health Sciences. Total number of 40 HCV Ab samples were analysed by both chemiluminescence (CMIA) and electrochemiluminescence (ECLIA) immunoassays. Tests for HCV RNA PCR and HCV c Ag were performed on all samples. Results of screening and diagnostic assays were correlated and agreements were examined. Statistical analysis for agreement was carried out by using R software version 3.6.3 through AC1 Gwetz Statistic. The study was approved by the institutional ethical review committee. An agreement of 0.73 and 0.95 was found between two different HCV Ab immunoassays and HCV c Ag and HCV PCR, respectively. We found a good correlation between CMIA and ECLIA for HCV Ab. An excellent correlation was found between HCV c Ag and HCV PCR. Based on our study findings, HCV c Ag is a candidate test for the diagnosis of active HCV infection.

Screening and treatment of hepatitis C virus in prisons: 10 years of experience

Introduction and objective: Two-thirds of patients with hepatitis C virus (HCV) infection are unaware of their infection in the European Union. The WHO aims to reduce the number of new cases of chronic hepatitis by 90% by 2030. The proportion of people infected with HCV in prisons can be up to ten times higher compared to the general population. This article is a summary of the results of the HCV screening carried out in the Hungarian prisons between 2007 and 2017. Method: Screening of anti-HCV antibodies has been performed on a voluntary basis followed by HCV PCR and genotyping in positive cases. After obtaining written informed consent from the patients, treatment was started. Treatments were performed under the guidance of hepatologists in collaboration with prison medical staff. Results: HCV screening programs and treatments are in place in 84% of Hungarian prisons. A total of 25 384 patients underwent anti-HCV screening. Anti-HCV positive result was detected in 6.6% and HCV PCR positivity was confirmed in 3.8% of the screened inmates. 55.2% patients from the HCV PCR positive population were put on treatment. Only 143 patients received full treatment, while 162 (42.6%) treatments were terminated prematurely, and the duration of treatment was unknown in 75 patients. Based on the results available on the 24th week after the end of treatment, sustained virologic response rate was 88%. Discussion: Education of patients and collaboration between hepatologists and prison medical staff play an important role in the successful result of treatment. Conclusion: Our experience demonstrates that the test and treat principle is feasible and effective at microeliminating HCV in prisons.

Hepatitis C Virus Prevalence, Medical Status Awareness and Treatment Engagement among Homeless People Who use Drugs: Results of a Street Outreach Study.

Background:Hepatitis C virus (HCV) infection is a primary health concern among people who use drugs (PWUDs). Homeless PWUDs that constitute a key population for HCV transmission remain underrepresented in many surveys.Objectives:We performed a proactive street outreach to evaluate HCV infection prevalence among homeless PWUDs in Tel Aviv, identify risk factors associated with HCV infection, awareness of disease status and linkage to care rate.Results:Thirty-eight percent of approached PWUD were willing to participate in the study. Out of 53 subjects who got tested for anti HCV by rapid test, 29 (54.72%) had a positive result, 20 of 29 anti-HCV positive (69%) patients had positive HCV PCR. Risk factors were investigated using structured questionnaires. Heroin use was reported significantly more frequently in the HCV-positive group (P = .05, CI 95%), whereas other established risk factors did not reach significance in our cohort. While 21 of 29 (72%) HCV-positive participants were aware of their condition, only 4 of 21 (19%) received treatment in the past, and 2 of 4 (50%) failed to achieve treatment goals, as assessed by HCV PCR.Conclusions:Our data indicate a high prevalence of HCV infection among homeless PWUDs. Importantly, despite relatively high awareness of HCV status in this population, we found strikingly low access to care. These findings motivate novel interventional approaches targeted at improving patient access, and compliance among homeless PWUDs, in an effort to reduce HCV transmission.

Effect of Eradication Helicobacter Pylori on Platelet Counts in Hepatitis C Infected Patients

Abstract Background Hepatitis C virus and H.pylori are the world's leading etiologies of bacterial and viral human diseases. Egypt has the world's largest prevalence of HCV, which was estimated to be 14.7 percent nationally. Objective To detect the effect of H. pylori eradication on the platelet counts in hepatitis C virus (HCV)-related CLD patients. Patients and Methods This prospective study was conducted at the Gastroenterology clinic, Internal Medicine department at Ain shams university and El-menofya hospital during the period of September 2017 to June 2018. 30 subjects were included in the study. All of them were chronic HCV infected patients (confirmed by HCV Ab and PCR for HCV) associated with thrombocytopenia (less than 100,000/μ) and were found to be H. pylori-positive (Confirmed active H.pylori infection by positive stool antigen test). Results Our results showed that there was highly statistically significant difference in platelets count with a pre-treatment range of 48-98 with mean±SD 82.40±14.16 and a post-treatment range of 50-123 with mean±SD 96.17±19.27 (10^3/cmm) Conclusion Eradication of Helicobacter Pylori leads to significant improvement of platelet counts in hepatitis C infected patients with thrombocytopenia.

Outcome of Direct Acting Antiviral Drugs (DAADs) for Hepatitis C Virus (HCV) in the Setting of Chronic Kidney Disease (CKD) in Upper Egypt

Abstract Background The frequency of hepatitis C virus (HCV) infection remains high in patients with chronic kidney disease (CKD) and plays a detrimental role in mortality in this population, Patients on maintenance dialysis remain at risk of acquiring hepatitis C virus (HCV) infection and the prevalence of anti-HCV seropositive patients undergoing long-term hemodialysis is significantly greater than in those with normal kidney function. Aim and objectives the aim of the study was to assess outcomes (efficacy, side effects, and possible complications) of DAADs for HCV in presence of CKD, Subjects and methods this was retrospective cohort study that was conducted at Aswan Fever Hospital and Luxor fever hospital for anti HCV therapy between Jan 2018 and July 2018 including 60 patients with all stages of CKD whom receiving DAADs were be recruited from both Aswan fever hospital and Luxor fever hospital, Results the results revealed that Patient’s PC (%) in patients from Aswan was ranged between 61-100 with mean±S.D. 83.09±9.258 while in patients from Luxor was ranged between 66-100 with mean±S.D. 84.95±6.764. There was no statistically significant difference between groups where P = 0.458, Patient’s HCV PCR in patients from Aswan at baseline show that all patients were positive while after 3 months 27(90%) were negative and 3(10%) were positive and after 6months all patients were negative while in patients from Luxor all patients were positive while after 3 months 28(93.3%) were negative and 2(6.7%) were positive and after 6 months all patients were negative. There was no statistically significant difference between groups Conclusion Treatment with newer DAAs is effective and safe for the treatment of HCV-infected chronic kidney disease patients,

Cascade of care during the first 36 months of the treatment as prevention for hepatitis C (TraP HepC) programme in Iceland: a population-based study

WHO has set targets to eliminate hepatitis C virus (HCV) infection as a global health threat by 2030 through a 65% reduction in HCV-related deaths and 80% reduction in HCV incidence. To achieve these goals, WHO set service coverage targets of 90% of the infected population being diagnosed and 80% of eligible patients being treated. In February, 2016, Iceland initiated a nationwide HCV elimination programme known as treatment as prevention for hepatitis C (TraP HepC), which aimed to maximise diagnosis and treatment access. This analysis reports on the HCV cascade of care in the first 3 years of the programme. This population-based study was done between Feb 10, 2016, and Feb 10, 2019. Participants aged 18 years or older with permanent residence in Iceland and PCR-confirmed HCV were offered direct-acting antiviral (DAA) therapy. The programme used a multidisciplinary team approach in which people who inject drugs were prioritised. Nationwide awareness campaigns, improved access to testing, and harm reduction services were scaled up simultaneously. The number of infected people in the national HCV registry was used in combination with multiple other data sources, including screening of low-risk groups and high-risk groups, to estimate the total number of HCV infections. The number of people diagnosed, linked to care, initiated on treatment, and cured were recorded during the study. This study is registered with ClinicalTrials.gov, NCT02647879. In February, 2016, at the onset of the programme, 760 (95% CI 690-851) individuals were estimated to have HCV infection, with 75 (95% CI 6-166) individuals undiagnosed. 682 individuals were confirmed to be HCV PCR positive. Over the next 3 years, 183 new infections (including 42 reinfections) were diagnosed, for a total of 865 infections in 823 individuals. It was estimated that more than 90% of all domestic HCV infections had been diagnosed as early as January, 2017. During the 3 years, 824 (95·3%) of diagnosed infections were linked to care, and treatment was initiated for 795 (96·5%) of infections linked to care. Cure was achieved for 717 (90·2%) of 795 infections. By using a multidisciplinary public health approach, involving tight integration with addiction treatment services, the core service coverage targets for 2030 set by WHO have been reached. These achievements position Iceland to be among the first nations to subsequently achieve the WHO goal of eliminating HCV as a public health threat. The Icelandic Government and Gilead Sciences.

Lactobacillus acidophilus and bifidobacterium bifidum reduce chronic HCV progression: Thesis Abstract

Thesis Abstract Background: Hepatitis C virus (HCV) is a major leading cause of pathogenesis of liver disease which was treated with IFN-based therapy and recently with Sovaldi®. There is a challenge to explore new drugs. Probiotics are the most common natural therapeutic that can ameliorate liver dysfunction. Aim: study the antiviral and antibacterial responses of the probiotics in patients with chronic (HCV). Materials and Methods: patients were treated with IFN/ribavirin, or both IFN and probiotics capsule that was containing L. acidophilus and Bifidobacterium spp. and administered as one capsule per day for a month. Blood and urine samples were collected before and after treatment strategies and were processed for quantitative determination of HCV PCR assay, identification of bacteria by VITEK2 system and 16S r RNA gene sequencing, estimation of probiotics antibacterial activity, as well as counts of leukocytes and CD3+ T cells and CD56+ natural killer cells. Results: Treatment of patients with L. acidophilus and Bifidobacteria spp. enhanced the responses of the patients to IFN-α and ribavirin treatment, as shown by the viral titter of HCV PCR assay that clarified the antiviral activity and also the antibacterial activity against the most common bacterial infections in patients with chronic HCV. Additionally, it increased the numbers of CD3+ and CD56+, Conclusions: Treatment with probiotics before IFN-α and ribavirin therapy can act as a supportive supplement with antiviral, positive immune response and antibacterial activities

Viral hepatitis B and C in HIV-exposed South African infants

BackgroundWhilst much attention is given to eliminating HIV mother-to-child transmission (MTCT), little has been done to ensure the same for hepatitis B virus (HBV) transmission. The introduction of HBV immunization at six weeks of age has reduced HBV horizontal transmission in South Africa. However, in order to eliminate HBV MTCT, further interventions are needed. The risk of hepatitis C virus (HCV) MTCT in HIV-infected (HIV+) African women is not yet well described. This study aimed to determine the rate of HBV and HCV vertical transmission in HIV-exposed infants in South Africa.MethodsSerum samples from infants enrolled in an isoniazid prevention study (P1041) were screened for HBV and HCV serology markers; screening was performed on samples collected at approximately 60 weeks of age of the infants. HBV DNA was quantified in HBsAg positive samples and HBV strains characterized through gene sequencing. All HCV antibody samples with inconclusive results underwent molecular testing.ResultsThree of 821 infants were positive for both HBsAg and HBV DNA. All HBV strains belonged to HBV sub-genotype A1. The rtM204I mutation associated with lamivudine resistance was identified in one infant, a second infant harboured the double A1762T/G1764A BCP mutation. Phylogenetic analysis showed clustering between mother and infant viral genomic sequences. Twenty-one of 821 HIV-exposed infants tested had inconclusive HCV antibody results, none were HCV PCR positive.ConclusionsThis study suggests that HBV vertical transmission is likely to be occurring in HIV-exposed infants in South Africa.. A more robust strategy of HBV prevention, including birth dose vaccination, is required to eradicate HBV MTCT. HCV infection was not detected.

A platform in the use of medicines to treat chronic hepatitis C (PLATINUM C): protocol for a prospective treatment registry of real-world outcomes for hepatitis C

BackgroundSafe, highly curative, short course, direct acting antiviral (DAA) therapies are now available to treat chronic hepatitis C. DAA therapy is freely available to all adults chronically infected with the hepatitis C virus (HCV) in Australia. If left untreated, hepatitis C may lead to progressive hepatic fibrosis, cirrhosis and hepatocellular carcinoma. Australia is committed to eliminating hepatitis as a public health threat by 2030 set by the World Health Organization. However, since the introduction of funded DAA treatment, uptake has been suboptimal. Australia needs improved strategies for testing, treatment uptake and treatment completion to address the persisting hepatitis C public health problem. PLATINUM C is a HCV treatment registry and research platform for assessing the comparative effectiveness of alternative interventions for achieving virological cure.MethodsPLATINUM C will prospectively enrol people with active HCV infection confirmed by recent detection of HCV ribonucleic acid (RNA) in blood. Those enrolled will agree to allow standardised collection of demographic, lifestyle, treatment, virological outcome and other relevant clinical data to better inform the future management of HCV infection. The primary outcome is virological cure evidenced by sustained virological response (SVR), which is defined as a negative HCV PCR result 6 to 18 months after initial prescription of DAA therapy and no less than 12 weeks after the completion of treatment. Study participants will be invited to opt-in to medication adherence monitoring and quality of life assessments using validated self-reported instruments (EQ-5D-5L).DiscussionPLATINUM C is a treatment registry and platform for nesting pragmatic trials. Data collected will inform the design, development and implementation of pragmatic trials. The digital infrastructure, study procedures and governing systems established by the registry will allow PLATINUM C to support a wider research platform in the management of hepatitis C in primary care.Trial registrationThe trial is registered with the Australia and New Zealand Clinical Trials Register (ACTRN12619000023156). Date of registration: 10/01/2019.

Outcome of Direct Acting Antiviral Drugs (DAADs) for Hepatitis C Virus (HCV) in the Setting of Chronic Kidney Disease (CKD) in Upper Egypt

Background: The frequency of hepatitis C virus (HCV) infection remains high in patients with CKD and plays a detrimental role in mortality in this population, and patients undergoing maintenance dialysis are still at risk of developing HCV infection and HCV disease prevalence of anti-hepatitis C virus (HCV) patients who undergo longterm dialysis are significantly greater than those with normal kidney function. Objectives: The aim of the study was to assess outcomes (efficacy, side effects, and possible complications) of DAADs for HCV in presence of CKD. Subjects and methods: this was retrospective cohort study that was conducted at Aswan Fever Hospital and Luxor Fever Hospital for anti HCV therapy between Jan 2018 and July 2018 including 60 patients recruited from both hospitals with all stages of CKD and were receiving DAADs. Results: the results revealed that PC (%) in patients from Aswan ranged between 61-100 with mean ±S.D. 83.09±9.258 while in patients from Luxor it ranged between 66-100 with mean ±S.D. 84.95±6.764. There was no statistically significant difference between groups (P=0.458). HCV PCR in all patients from Aswan at baseline were positive while after 3 months 27 (90%) were negative and 3 (10%) were positive and after 6 months all patients were negative while in patients from Luxor they all were positive while after 3 months 28 (93.3%) were negative and 2 (6.7%) were positive and after 6 months all patients were negative. There was no statistically significant difference between groups. Conclusion: Treatment with newer DAAs is effective and safe for the treatment of HCV-infected chronic kidney disease patients.

Evaluation of Liver Fibrosis by FibroScan in β-Thalassemia Children Infected with Hepatitis C Virus Before and After Ledipasvir/Sofosbuvir Therapy

Background: Thalassemic children develop liver fibrosis because of liver iron overload and hepatitis C virus (HCV) infection. Transient elastography (FibroScan) can be a reliable non-invasive method for evaluating liver fibrosis in thalassemic patients. Treatment with ledipasvir/sofosbuvir (LED/SOF) direct acting antiviral agents can significantly affect liver stiffness measurement (LSM) by FibroScan.&#x0D; Aims: To assess liver fibrosis by non-invasive FibroScan through LSM before and after generic LED/SOF therapy in multi-transfused β-thalassemic children infected with HCV.&#x0D; Place and Duration of Study: Pediatric Hematology Unit, Tanta University Hospital, from November 2017 to May 2019.&#x0D; Methodology: Fifty multi-transfused β-thalassemic treatment-naϊve children (aged 12-18 years and weighing ≥35kg) with chronic HCV infection were subjected to clinical evaluation, quantitative HCV PCR assay, FibroScan examination, and calculation of APRI, FIB4 index and AST/ ALT ratio. In addition to standard therapy, generic LED/SOF (90/400 mg) treatment was given for 12 weeks’ duration with follow up for further 12 weeks after end of treatment.&#x0D; Results: A positive HCV PCR was changed into negative for all studied patients starting from week 4 after treatment. There was highly significant reduction in the LSM values by FibroScan in the studied patients after therapy (p-value &lt;0.001) with median reduction of 19.4 %. The significant reduction in LSM values was particularly prominent in patients with significant (F2) and advanced (F3) liver fibrosis stages as well as cirrhotic patients (F4). There was significant reduction in the values of other non-invasive liver fibrosis markers FIB-4 index, APRI score and AST/ ALT ratio (p-value &lt;0.001, &lt;0.001 and 0.020 respectively) after therapy.&#x0D; Conclusion: Generic LED/SOF therapy for 12 weeks’ duration resulted in eradication of HCV infection that was associated with significant decrease in LSM by FibroScan particularly those with higher baseline liver fibrosis stages.

Quadruple Therapy Offers High SVR Rates in Patients with HCV Genotype 4 with Previous Treatment Failure.

Background and Aims Direct-acting antivirals (DAAs) have made a revolution in hepatitis C virus (HCV) treatment with promising reduction of HCV infection and disease morbidities. However, unfortunately, treatment failure still occurs in about 5–15% of patients treated with DAA‐based combination regimens. The primary aim of the study was to assess the efficacy and safety of a quadruple regimen of (sofosbuvir, daclatasvir, and simeprevir with a weight-based ribavirin) in chronic HCV DAAs-experienced patients. Methods This observational, open-label prospective study was carried out on 103 genotype 4 hepatitis C virus-infected patients who failed to achieve SVR12 after sofosbuvir-daclatasvir with or without ribavirin. Patients were treated for three months with sofosbuvir (400 mg), daclatasvir (60 mg), and simeprevir (150 mg) with a weight-based ribavirin dosage (1000–1200 mg/d). Response to treatment was determined by quantitative PCR for HCV at 3 months after the end of treatment (SVR12), and adverse events during the treatment were recorded. Results SVR was achieved in 100 patients (97.1%) at week 12 after treatment. No dangerous or life-threatening adverse events were recorded. Conclusions Retreatment of HCV genotype 4 patients with quadruple therapy is a good therapeutic option and achieves high response rates with minimal side effects.

Real-world utility of HCV core antigen as an alternative to HCV RNA testing: Implications for viral load and genotype.

Following positive serology, the gold standard confirmatory test of hepatitis C virus (HCV) infection is detection of HCV RNA by PCR. We assessed the utility of HCV core antigen testing to identify active infection among those positive for anti-HCV antibodies, when introduced to routine testing. We identified serum samples that were tested at a single laboratory in Scotland from June 2011to December 2017. Serum samples testing positive for HCV antibodies (HCV Ab positive) followed by reflex HCV core antigen (Ag) testing during the study period were identified. Those patients for whom a PCR test was requested on the baseline sample were also identified. For this group, the sensitivity and specificity of HCV Ag as a diagnostic tool were assessed using HCV PCR as gold standard. In our cohort of 744 patients, we demonstrated a sensitivity of 82.1% (95% CI 77.1%-86.2%) and a specificity of 99.8% (95% CI 98.6%-100%). Genotype 3 was associated with increased odds of a false-negative result (OR=3.59, 95% CI: 1.32-9.71), and reduced odds of a false negative were associated with older age (odds ratio (OR)=0.92, 95% CI: 0.88-0.97 per year) and viral load (OR=0.10, 95% CI: 0.05-0.21 per log10 IU/ml). While the implementation of HCV core antigen testing for diagnosis could lead to significant cost savings in national screening programmes, our data suggest that a significant proportion of HCV-infected individuals may be missed. These findings have implications for HCV diagnosis and determination of viral clearance after treatment, particularly in low- and middle-income regions, where genotype 3 is prevalent.