scholarly journals A Two-Year Outcome Evaluation of Government-Led Initiative to Upscale Hospital-Based Hepatitis C Treatment Using a Standard Two-Drug Regimen in Malaysia

2021 ◽  
Vol 21 (3) ◽  
Author(s):  
Huan-Keat Chan ◽  
Mohamed Azmi Hassali ◽  
Rosaida Md Said ◽  
Haniza Omar ◽  
Noor Aliza Abd Mutalib ◽  
...  

Background: Malaysia has been fully committed to the global endeavor to eliminate hepatitis C virus (HCV) infection by 2030. In early 2018, the Ministry of Health (MOH) embarked on a “one-size-fits-all strategy” by introducing generic versions of sofosbuvir and daclatasvir as the standard treatment for HCV infection in public hospitals nationwide. Objectives: To evaluate the outcomes of such an initiative in multiple aspects, including the number and characteristics of patients treated, the extent of evidence-based drug use, the treatment completion status, individual responses to treatment, common side effects of treatment, and its economic implications. Methods: The findings were generated from the data compiled by the MOH, capturing the information regarding the treatment provided to adult HCV-infected patients in 16 selected hospitals between April 2018 and March 2020, along with the drug costs incurred. Results: A total of 1,797 patients were treated, nearly four times more than the patients receiving interferon-based treatment across the country in the preceding two years. Approximately one-third of them had liver cirrhosis, and the main HCV genotypes were 3 (46.9%) and 1a (20.0%). Dosing, treatment duration and the addition of ribavirin to the treatment generally agreed with the recommendations of the MOH. More than 90% of the patients completed the treatment course, and a sustained virologic response (SVR) rate of 95.4% (95% CI: 94.2, 96.7%) was recorded in those with a known treatment outcome (n = 1,163). The SVR achievement did not vary across HCV genotypes and cirrhosis status, but those ≥ 50 years of age (adjusted OR: 2.13; 95% CI: 1.16, 3.92) were more likely to fail the treatment. Side effects were rare. Anemia and fatigue caused treatment discontinuation in only 0.3% of the patients. The total drug expenditure reached US$678,258.20, and the mean cost of a 12-week treatment course of sofosbuvir and daclatasvir (US$235.16) was lower than the cost expected by the MOH (US$300). Conclusions: The findings demonstrate a high degree of real-world effectiveness, safety, and affordability of the standard treatment, suggesting that such a government-led initiative was reasonable and timely and could be extended to include more public health institutions.

2003 ◽  
Vol 49 (8) ◽  
pp. 503-507 ◽  
Author(s):  
Regina Moreira ◽  
João Renato Rebello Pinho ◽  
Jorge Fares ◽  
Isabel Takano Oba ◽  
Maria Regina Cardoso ◽  
...  

The aims of this study were to (i) evaluate the prevalence and the incidence of hepatitis C virus (HCV) infection in hemodialysis patients in two different centers in São Paulo (Brazil), (ii) determine the time required to detect HCV infection among these patients by serology or PCR, (iii) establish the importance of alanine aminotransferase determination as a marker of HCV infection, and (iv) identify the HCV genotypes in this population. Serum samples were collected monthly for 1 year from 281 patients admitted to hospital for hemodialysis. Out of 281 patients, 41 patients (14.6%) were HCV positive; six patients seroconverted during this study (incidence = 3.1/1000 person-month). In 1.8% (5/281) of cases, RNA was detected before the appearance of antibodies (up to 5 months), and in 1.1% (3/281) of cases, RNA was the unique marker of HCV infection. The genotypes found were 1a, 1b, 3a, and 4a. The presence of genotype 4a is noteworthy, since it is a rare genotype in Brazil. These data pointed out the high prevalence and incidence of HCV infection at hemodialysis centers in Brazil and showed that routine PCR is fundamental for improving the detection of HCV carriers among patients undergoing hemodialysis.Key words: HCV genotypes, hemodialysis, hepatitis C, PCR, prevalence, incidence.


2006 ◽  
Vol 63 (9) ◽  
pp. 819-825
Author(s):  
Dragan Delic ◽  
Zorica Nesic ◽  
Milica Prostran ◽  
Ivan Boricic ◽  
Nada Tomanovic ◽  
...  

Background/aim: The natural history of hepatitis C virus (HCV) infection is variable and the factors determining the course of the illness are unclear. There are geographical variations in the distribution of different HCV genotypes, and some of them are related to the specific infection routes. Regarding our country, the dominant genotype is genotype 1b. It is unclear and still remains a question whether the distinct histopathological manifestations are related to the particular genotypes of HCV. Thus, the aim of this study was to determine whether the distinct histopathological manifestations of HCV infection might be in relation to the individual virus genotype. Methods. In this study we examined 126 patients with chronic HCV infection regarding the histopathological features, demographic data, and virus genotype. The observed groups of patients were predominantly infected with HCV genotypes 1b and 3a. Results. In this study we found that the patients infected with HCV genotype 1b had more frequently moderate or severe necroinflammatory activity of the disease, significantly higher grading score as compared with other genotypes (p < 0.0001). A higher degree of fibrosis was, also, more common in the patients infected with genotype 1b of HCV as compared with other genotypes (p < 0.05). There were no significant correlations between the necroinflammatory activity of the disease and the stage of fibrosis in 1b, 4 and mixed genotypes. Conclusion. The present data support the hypothesis that distinct genotypes of HCV are associated with the particular histopathological manifestation of the disease.


Author(s):  
Pin-Sheng Wu ◽  
Te-Sheng Chang ◽  
Sheng-Nan Lu ◽  
Hsiang-Jou Su ◽  
Shu-Zhi Chang ◽  
...  

Background: Hepatitis C virus (HCV) infection is one of the major causes of liver cirrhosis and hepatocellular carcinoma globally. The advent of direct-acting antivirals (DAAs) with high cure rates provides an opportunity to reduce the rising HCV disease burden. However, few studies have explored the side effects and physiological benefits of DAA therapy in rural areas. The aim of this study was to investigate the subjective reports of discomfort, patient feedback about the course of treatment, and physiological changes after DAA treatment in HCV patients. Methods: A descriptive, prospective, comparative cohort study was conducted from January to August 2019 in western coastal Yunlin County, Taiwan. Data regarding demographic characteristics, subjective discomfort levels, and physiological responses were collected through face to face interviews and from medical records by a cooperating hospital. Results: Six-hundred-and-twenty-three participants with an active HCV infection were identified; 555 (89.1%) had completed treatment, and sustained virologic response was achieved in 99.6% (n = 553). The mean age was 64.9 (standard deviation = 13.1) years, and 35% of patients experienced discomfort during DAA treatment, including fatigue, itching, and dizziness. After three months of treatment, physiological markers, including body weight (p < 0.001), waist circumference (p < 0.05), blood pressure (p < 0.001), alanine aminotransferase (p < 0.001), and aspartate aminotransferase (p < 0.001), had significantly improved. Almost all participants provided positive feedback about the treatment experience and reported manageable side effects. Conclusions: The findings showed that, in an endemic rural area, DAA treatment had a high cure rate and improved physiological markers with few discomforts. These results can be used to reduce the barriers HCV patients face in adopting new medications.


Author(s):  
Rana Moustafa Al Adawi ◽  
Zainab Jassim ◽  
Dina Eltayeb Elgaily ◽  
Rizwan Imanullah ◽  
Mohamed Izham Mohamed Ibrahim

Background: Hepatitis C virus (HCV) infection is associated with significant morbidity and mortality. The effectiveness of sofosbuvir, as a new direct-acting antiviral (DAA) for chronic HCV infection, needs to be assessed and evaluated among patients with or without cirrhosis with all HCV genotypes. Aims: This study was conducted to determine the effectiveness of chronic HCV treatment as part of a combination therapy for all HCV genotypes in patients with or without cirrhosis. Study Design: A retrospective observational study. Methodology: All patients who received sofosbuvir treatment from the Pharmacy Department of Hamad General Hospital during a 12-month period (between 2014 and 2015) were included. Patients were observed up to 12 weeks after treatment course completion. Data were analyzed descriptively and compared using a paired t-test (alpha=0.05). Results: A total of 95 patients received sofosbuvir. All of these patients received sofosbuvir in combination with other antiviral medications. All HCV genotypes were included; 1a and 4 were the most dominant genotypes (37% and 30.5%, respectively). Half of the patients were treatment naïve. All patients achieved undetectable virus ribonucleic acid (RNA) starting from week 4 of the treatment. A sustained virological response at 12 weeks (SVR12) after completion of the treatment period was maintained in 95% of patients. Relapse was mostly observed in patients with genotype 1a (40%); no patients with HCV genotype 3 exhibited relapse. Conclusion: The SVR12 after sofosbuvir treatment was maintained in most patients, regardless of genotype, HCV complications HCV or co-administered drugs.


2006 ◽  
Vol 59 (5-6) ◽  
pp. 230-234 ◽  
Author(s):  
Dragan Delic ◽  
Zorica Nesic ◽  
Jasmina Simonovic ◽  
Neda Svirtlih ◽  
Ljubisa Dokic ◽  
...  

Introduction. Hepatitis C virus (HCV) RNA status and HCV genotypes have become extremely important for exact diagnosis, prognosis, duration of treatment and monitoring of antiviral therapy of chronic HCV infection. Material and methods. For the purpose of precise and objective assessment of virologic analyses, such as the determination of the number of virus copies and virus genotypes, 110 patients with chronic HCV infection were tested. Genotyping of HCV isolates and HCV RNA quantification were performed by using the PCR method. Genotype lb infection was verified in 49.1% of patients, genotype 3a infection was found in 28.2%, genotype 4 in 9.1%, genotype 2 in 4.5%, while mixed genotype infections were diagnosed in 9.1% of cases. Results. Patients infected by genotype lb had significantly higher serum HCV RNA level in relation to patients infected by other genotypes (p<0.05). Over 70% of patients infected by genotype lb had more than 2xl06 virus copies in 1 ml of blood, while in genotypes 2, 3a and 4, the percentage was 40%, 38.5% and 30%, respectively. Male patients had approximately 7.7x10.6 virus copies in 1 ml of blood, which was significantly higher in comparison with female patients (2.3xl06 copies/ml; p<0.05). Conclusion. Our results are in concordance with the results of other authors reporting that genotype lb is predominant in Europe, as well as significantly higher incidence of viremia in patients with genotype lb infection in relation to other HCV genotypes. Based on these results, we can conclude that our patients, most commonly, present with severe clinical course of chronic HCV infection and require longer treatment (48 weeks), which causes economic problems. .


2015 ◽  
Vol 4 (1) ◽  
pp. 32-35
Author(s):  
Dipesh Gurubacharya ◽  
Mohan Khadka ◽  
Khadga B Shreshta ◽  
Prem Khadga ◽  
Sashi Sharma

Introduction: Hepatitis C virus (HCV) infection is a major public health challenge. It is a major cause for cirrhosis and hepatocellular carcinoma worldwide. Both the genotype and viral load of HCV determine the choice of therapy as well as outcome of therapy. The aim of this study was to evaluate clinical, biochemical and virological profile and association of HCV genotypes with viral load and liver biochemical profile.Material and Methods: This was descriptive observational study of chronic HCV infected patients who attended at the outpatient clinic of Department of Gastroenterology of TUTH, IOM from April 2013 to November 2014. During this study period 38 patients with chronic HCV infection were analyzed. Clinical profile, possible risk factors for transmission of HCV infection and liver biochemical profile were recorded. Virological profile included HCV viral load and HCV genotypes.Results: Out of 38 patients 34(89.5%) were male and 4(10.5%) were female. Injection drug use (IDU) was the most common mode for acquisition of HCV infection (55.3%). Genotype 3 was found in 21(55.26%) patients and genotype 1 was found in 17(44.74%) patients. There was no significant association between HCV genotypes and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level. And also there was no significant association between HCV viral load and different HCV genotypes.Conclusions: In our study HCV genotype 3 was the most prevalent genotype in patients with chronic HCV infection. Injection drug use was identified as most common identifiable risk factor for transmission of HCV infection. There was no significant association between different HCV genotypes and serum ALT, AST level and HCV viral load. Journal of Nobel College of Medicine Vol.4(1) 2015: 32-35


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Sherif A Megahed ◽  
Maha A El Touny ◽  
Iman A Ragab ◽  
Ossama A Ahmed ◽  
Shereen A Ibrahim ◽  
...  

Abstract Background and Objectives B-thalassemia major patients are susceptible to Hepatitis C Virus (HCV) infection owing to life-long dependency for blood-transfusion. Moreover, this patient population is at risk of progression of liver fibrosis or development of cirrhosis as a consequence of both iron overload and HCV infection. However, patients with haemoglobinopathies and CHC have been excluded from the major clinical trials that led to the approval of DAAs, Hence, at present, limited experience is available regarding the safety and efficacy of DAAs in this population which is traditionally considered difficult to treat. Hence, this study was carried out to evaluate efficacy and safety of the combination regimen of sofosbuvir and daclatasvir for HCV infection in B-thalassemia major patients. Methods This study was conducted on 200 subjects divided into two groups, first group contains150 HCVThalassemic patients while the second group contains 50 HCV only patients. Each group was classified into easy to treat or difficult to treat and received sofosbuvir 400mg + daclatasvir 60mg once/day for the duration of 12 or 24 weeks according to the NCCVH Hepatitis C treatment protocol 2015. Sustained virological response at post-treatment week-12 (SVR-12) was defined as negative HCV-RNA at week-12 post treatment. Results In group (I), successful SVR was achieved in all patients (100%) in subgroup (Ia) while in subgroup (Ib) 12 patients didn’t achieve SVR (15.38%), 4 patients stopped due to side effects(5.13%) and 62 patient achieved SVR (79.49) with overall successful SVR of 134 out of 150 HCV-Thalassemic patients in group (I) (89.33%). in group (II), 2 patients didn’t achieve SVR (5.71%)and 33 patients achieved SVR (94.29%) in subgroup (IIa) while in subgroup (IIb) 2 patients didn’t achieve SVR (13.33%) and 13 patients achieved SVR (86.67%) with overall successful SVR of 46out of 50 HCV only patients in group (II) (92%). few patients suffered from minor side effects that didn’t require cessation of treatment but 4 patients developed major side effects in group (Ib) that required cessation of treatment. There were marked improvement in liver enzymes, Fib4 score, hemoglobin level and transfusion requirements in HCVThalassemic group after treatment. Conclusion A combination of sofosbuvir and daclatasvir is an efficacious and tolerable treatment regimen with negligible side effects for patients with thalassemia major and HCV infection.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Maria Musso ◽  
Silvia Mosti ◽  
Gina Gualano ◽  
Paola Mencarini ◽  
Rocco Urso ◽  
...  

Abstract Background Multidrug-resistant tuberculosis (MDR-TB) requires lengthy use of second-line drugs, burdened by many side effects. Hepatitis C virus (HCV) chronic infection increases risk of drug-induced liver injury (DILI) in these patients. Data on MDR-TB patients with concurrent HCV chronic infection treated at the same time with second-line antitubercular drugs and new direct-acting antivirals (DAAs) are lacking. We evaluate if treating at the same time HCV infection and pulmonary MDR-TB is feasible and effective. Cases presentation In this study, we described two cases of patients with pulmonary MDR-TB and concurrent HCV chronic infection cured with DAAs at a Tertiary Infectious Diseases Hospital in Italy. During antitubercular treatment, both patients experienced a DILI before treating HCV infection. After DAAs liver enzymes normalized and HCV RNA was undetectable. Then antitubercular regimen was started according to the institutional protocol, drawn up following WHO MDR-TB guidelines. It was completed without further liver side effects and patients were declared cured from both HCV infection and MDR-TB. Conclusions We suggest to consider treatment of chronic hepatitis C with DAAs as a useful intervention for reintroduction of second-line antitubercular agents in those patients who developed DILI, reducing the risk of treatment interruption when re-exposed to these drugs.


2015 ◽  
Vol 22 (11) ◽  
pp. 1390-1396
Author(s):  
Abdul Majeed Akhtar ◽  
Sadia Majeed ◽  
Muhammad Jamil ◽  
Abdul Rehman

Objectives: The aim of the current study was to estimate the seroprevalence andrisk factors investigation associated with hepatitis C virus (HCV) infection in general patientsattending various public and private hospitals of Lahore metropolitan. Study Design: Crosssectional study. Setting: Out Patient Departments (OPDs) of public hospitals, comprising ofMayo Hospital, Sir Ganga Ram Hospital, Services Hospital, Jinnah Hospital and Lahore GeneralHospital of Lahore. Period: 2012. Material and Methods: A total of 904 patients from outpatientdepartments of five public and two private hospitals were enrolled during 2012. Bloodsamples were collected to evaluate their anti-HCV status using 3rd generation ELISA. To findout the risk factors associated with HCV infection, the data was collected on a pretested andvalidated questionnaire. Results: The seroprevalence was estimated to be 14.6%. Mean ageof reactive and non-reactive general patients was significantly associated (P=0.012) with anti-HCV status. Marital status (OR=2.042), socioeconomic status, blood donation (OR=2.15),prescription by doctor or non-doctor (OR=2.664), route of drug administration, relatives havinghepatitis and towel sharing (OR=1.987) were significantly associated (P<0.05) risk factors forHCV infection. Conclusion: The study reveals a higher prevalence of HCV infection in generalpatients of Lahore due to poor socioeconomic status, treatment by quacks, excessive use ofinjectable drugs, house hold contacts with hepatitis patients and lack of awareness about theHCV transmission.


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