Displaying publications 1 - 20 of 161 in total

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  1. Yasmin AM
    Med J Malaysia, 1997 Jun;52(2):188-92; quiz 193.
    PMID: 10968083
    Matched MeSH terms: Hepatitis C/complications; Hepatitis C/drug therapy
  2. Hamidah A, Yong JF, Zulkifli HI, Jamal R
    Med J Malaysia, 2002 Sep;57(3):353-6.
    PMID: 12440276
    We describe two cases of transfusion dependent thalassaemics with chronic hepatitis C virus infection whom were treated successfully with interferon and ribavirin, following failure of response or relapse after an initial response to interferon monotherapy. They had sustained virological response for more than twelve months after completing therapy. Transfusion requirements were significantly increased during the combination therapy, probably due to ribavirin-induced haemolysis. Serum ferritin level decreased significantly during the treatment. Combination therapy with interferon alfa and ribavirin may be a feasible treatment option for some nonresponders to prior interferon monotherapy.
    Matched MeSH terms: Hepatitis C, Chronic/complications*; Hepatitis C, Chronic/drug therapy*
  3. Gane E
    Med J Malaysia, 2005 Jul;60 Suppl B:72-6.
    PMID: 16108179
    Matched MeSH terms: Hepatitis C, Chronic/drug therapy*; Hepatitis C, Chronic/epidemiology; Hepatitis C, Chronic/physiopathology
  4. Tan SS, Leong CL, Lee CK
    Med J Malaysia, 2015 Oct;70(5):281-7.
    PMID: 26556116
    BACKGROUND: Co-infection by human immunodeficiency and hepatitis C viruses (HIV/HCV) is common and results in significant morbidity and mortality despite effective antiretroviral therapies (ART).
    METHOD: A retrospective and prospective evaluation of the efficacy and safety of pegylated interferon alfa 2a/2b plus ribavirin (PEG-IFN/RBV) in consecutive HIV/HCV co-infected patients treated in real life clinical practice in Malaysia.
    RESULTS: Forty-five HIV/HCV co-infected patients with a median age (interquartile range, IQR) of 41 years (37; 47) were assessed for treatment with PEG-IFN/RBV. All except one are of male gender and the most common risk behaviour was injecting drug use. At baseline 75.5% was on ART and the median (IQR) CD4 count was 492 cells/μl (376; 621). The HCV genotypes (GT) were 73 % GT3 and 27% GT1. Liver biopsies in forty patients showed 10% had liver cirrhosis and another 50% had significant liver fibrosis. The treatment completion rate was 79.5% with 15.9% dropped out of treatment due to adverse effects (AE) or default and 4.6% due to lack of early virological response. The AE causing premature discontinuations were neuropsychiatric and haematological. The overall sustained virological response (SVR) was 63.6% with a trend towards higher SVR in GT3 compared with GT1 (71.9% vs. 41.7%; p=0.064). In patients with bridging fibrosis plus occasional nodules or cirrhosis on liver biopsy, the SVR was significantly lower at 20% (p=0.030) compared to those with milder fibrosis.
    CONCLUSION: HIV/HCV co-infected patients can be successfully and safely treated with PEG-IFN/RBV achieving high rates of SVR except in cirrhotic patients.

    Study site: co-infection clinics at Sungai Buloh Hospita
    Matched MeSH terms: Hepatitis C*
  5. Kanapathipillai R, McManus H, Kamarulzaman A, Lim PL, Templeton DJ, Law M, et al.
    PLoS One, 2014;9(2):e86122.
    PMID: 24516527 DOI: 10.1371/journal.pone.0086122
    INTRODUCTION: Magnitude and frequency of HIV viral load blips in resource-limited settings, has not previously been assessed. This study was undertaken in a cohort from a high income country (Australia) known as AHOD (Australian HIV Observational Database) and another cohort from a mixture of Asian countries of varying national income per capita, TAHOD (TREAT Asia HIV Observational Database).

    METHODS: Blips were defined as detectable VL (≥ 50 copies/mL) preceded and followed by undetectable VL (<50 copies/mL). Virological failure (VF) was defined as two consecutive VL ≥50 copies/ml. Cox proportional hazard models of time to first VF after entry, were developed.

    RESULTS: 5040 patients (AHOD n = 2597 and TAHOD n = 2521) were included; 910 (18%) of patients experienced blips. 744 (21%) and 166 (11%) of high- and middle/low-income participants, respectively, experienced blips ever. 711 (14%) experienced blips prior to virological failure. 559 (16%) and 152 (10%) of high- and middle/low-income participants, respectively, experienced blips prior to virological failure. VL testing occurred at a median frequency of 175 and 91 days in middle/low- and high-income sites, respectively. Longer time to VF occurred in middle/low income sites, compared with high-income sites (adjusted hazards ratio (AHR) 0.41; p<0.001), adjusted for year of first cART, Hepatitis C co-infection, cART regimen, and prior blips. Prior blips were not a significant predictor of VF in univariate analysis (AHR 0.97, p = 0.82). Differing magnitudes of blips were not significant in univariate analyses as predictors of virological failure (p = 0.360 for blip 50-≤1000, p = 0.309 for blip 50-≤400 and p = 0.300 for blip 50-≤200). 209 of 866 (24%) patients were switched to an alternate regimen in the setting of a blip.

    CONCLUSION: Despite a lower proportion of blips occurring in low/middle-income settings, no significant difference was found between settings. Nonetheless, a substantial number of participants were switched to alternative regimens in the setting of blips.

    Matched MeSH terms: Hepatitis C/complications*; Hepatitis C/virology
  6. Al-Kubaisy, Waqar A., Niazi, Amjad D.
    Int J Public Health Res, 2011;1(2):72-78.
    MyJurnal
    Introduction Hepatitis C Virus (HCV) recently was identified as a major cause of post transfusion hepatitis world wide. To evaluate the role of blood transfusion on the prevalence of HCV infection, by testing antibody and RNA as well as the genotypes of HCV .Also to detect if Blood transfusion acts as unconfounding risk factor for HCV infection.
    Methods Sera from 3491 pregnant women were investigated for the presence of HCV antibodies (anti-HCV) by using third generation enzyme immunoassay (EIA-3) as screening test, followed by immunoblot assay (Lia Tek-III). In addition 94 sera of studied women were subjected to molecular analysis (at laboratories of Sorin BioMedica - Italy) for the detection of viral RNA and genotypes of HCV. Using RT-PCR & DNA Enzyme immunoassay (DEIA) method.
    Results Our study revealed, that seroprevalence rate of HCV specific Ab & RNA were significantly higher (16.32 %, 80% respectively) among women with a history of blood transfusion, compared to those (2.53%, 56.5%) with no such history P=0.0001, P=0.01. And there is a significant direct linear correlation between number of blood transfused and the seropositive rate of anti-HCV (r=0.7, p=0.046). Based on multivariate analysis, interestingly, this study confirmed that, blood transfusion significantly acting as unconfounding risk factor for acquiring HCV infection (Adjusted OR=1.938,95% C.I=1.646-2.28). And the risk of exposure is increases with increased number of blood transfused. Although, we found no significant association between, HCV genotypic distribution and history of blood transfusion. However, high proportion of women with a history of blood transfusion were harboring HCV genotype -4 or 1b, 50%,40%, resepctively.
    Conclusions Our study shows, evidence that, blood transfusion acts as unconfounding risk factor for acquiring and in a mode of transmission of HCV infection. Therefore strict screening of blood donor for HCV-Abs and / or RNA is highly recommended.
    Matched MeSH terms: Hepatitis C; Hepatitis C Antibodies
  7. Menon BS, Aiyar S
    Med J Malaysia, 1997 Dec;52(4):331-4.
    PMID: 10968109
    This study examined the prevalence of hepatitis B and C markers in 55 paediatric oncology patients who had completed treatment at the Hospital Universiti Sains Malaysia in Kota Baru. All these children had received blood products and had been treated between 1985-1996. Forty seven per cent of patients were positive for hepatitis B or C. Twenty nine per cent were positive for hepatitis C and twenty two per cent were HBsAg positive. Two children were positive for both and none were HIV positive. Four children had an elevated ALT level and one child had jaundice and hepatomegaly. Some children were marker-positive despite immunization and screening of blood.
    Matched MeSH terms: Hepatitis C Antibodies/blood*
  8. Ng KP, Saw TL, Wong NW, Goh KL, Chuah SY, Nagaratnam M
    Med J Malaysia, 1995 Dec;50(4):302-5.
    PMID: 8668047
    Anti-HCV antibody was detected in 1.9% of the blood donors in University Hospital. Among the risk groups, 33.3% of the patients with post-transfusion hepatitis were tested positive for anti-HCV antibody. The anti-HCV antibody was detected in 30% of the IDU. Haemodialysis patients, patients with acute and chronic hepatitis and patients with liver cirrhosis appeared to have increased risk of Hepatitis C virus infection. The results indicate that the frequency of HCV infection increases with the exposure to blood or blood products.
    Matched MeSH terms: Hepatitis C Antibodies/blood*
  9. Chan HLY, Chen CJ, Omede O, Al Qamish J, Al Naamani K, Bane A, et al.
    J Viral Hepat, 2017 10;24 Suppl 2:25-43.
    PMID: 29105283 DOI: 10.1111/jvh.12760
    Factors influencing the morbidity and mortality associated with viremic hepatitis C virus (HCV) infection change over time and place, making it difficult to compare reported estimates. Models were developed for 17 countries (Bahrain, Bulgaria, Cameroon, Colombia, Croatia, Dominican Republic, Ethiopia, Ghana, Hong Kong, Jordan, Kazakhstan, Malaysia, Morocco, Nigeria, Qatar and Taiwan) to quantify and characterize the viremic population as well as forecast the changes in the infected population and the corresponding disease burden from 2015 to 2030. Model inputs were agreed upon through expert consensus, and a standardized methodology was followed to allow for comparison across countries. The viremic prevalence is expected to remain constant or decline in all but four countries (Ethiopia, Ghana, Jordan and Oman); however, HCV-related morbidity and mortality will increase in all countries except Qatar and Taiwan. In Qatar, the high-treatment rate will contribute to a reduction in total cases and HCV-related morbidity by 2030. In the remaining countries, however, the current treatment paradigm will be insufficient to achieve large reductions in HCV-related morbidity and mortality.
    Matched MeSH terms: Hepatitis C, Chronic/drug therapy; Hepatitis C, Chronic/mortality*; Hepatitis C, Chronic/epidemiology*
  10. Ross IN, Madhavan HN, Tan SH, Abdul Rahim K
    Med J Malaysia, 1985 Dec;40(4):301-6.
    PMID: 3025569
    Serological markers were used to determine the infective agents causing acute viral hepatitis in 246 patients. The frequencies of the five viral infections investigated were: non-A, non-B hepatitis - 99 patients (40.2%); hepatitis A - 98 patients (39.8%); hepatitis B - 43 patients (17.5%); cytomegalovirus - 4 patients (1.6%); and Epstein-Barr virus - 2 patients (0.8%). The log mean ages of presentation for the three predominant infections were: hepatitis A - 18 years; hepatitis B - 25 years; and non-A, non-B hepatitis - 30 years (F = 18.8, p =< 0.001). 52% of all cases were Malays (expected 32. 7%); 32% Chinese (expected 54.6%); and 16% Indians (expected 1l.5%) (X2 = 53, p = < 0.001). Hepatitis A virus infection was more common amongst Malays whilst non-A, non-B hepatitis was more frequent amongst Chinese and Indians. 28% of children <16 years) and 50% of adults had serological markers of previous hepatitis B infection. The variation in frequency for the different forms of hepatitis amongst the three main ethnic groups would suggest that socioeconomic and/or cultural factors are important in the propagation of acute viral hepatitis in Malaysia. HBsAg-negative chronic liver disease in our community may be a product of the high incidence of non-A, non-B hepatitis.
    Matched MeSH terms: Hepatitis C/epidemiology*
  11. Neoh CF, Kong DC
    Expert Rev Pharmacoecon Outcomes Res, 2014 Jun;14(3):319-34.
    PMID: 24708054 DOI: 10.1586/14737167.2014.906306
    Hepatitis C virus (HCV) infection is costly to treat and, has high morbidity and mortality. The addition of new protease inhibitors (i.e., boceprevir, telaprevir), to the standard dual therapy with pegylated interferon-α and ribavirin, for the treatment of HCV infection has demonstrated superior efficacy with shorter treatment duration, but at higher drug acquisition costs and incidence of adverse events. Robust economic data are required to inform healthcare decision for the optimal use of these expensive antiviral agents. Accordingly, this review will explore the clinical and economic aspects of boceprevir-based treatment strategies. Important considerations, challenges and gaps for future pharmacoeconomic research in this setting are highlighted.
    Matched MeSH terms: Hepatitis C/drug therapy*
  12. Tan SS, Adlin Nadia Z
    Med J Malaysia, 2017 06;72(3):165-174.
    PMID: 28733564 MyJurnal
    AIM: To describe the clinical characteristic of hepatitis C (HCV) patients and the results of pegylated interferon and ribavirin (PegIFN/RBV) therapy in a routine clinical practice.

    METHODS: A retrospective review of consecutive HCV patients treated with PegIFN/RBV in 2004 to 2012.

    RESULTS: A total of 273 patients received treatment. The mean age was 44.16 ± 10.5 years and 76% were male. The top 2 self-reported risks were blood or blood product transfusion before 1994 and injection drug use, found in 57.1% of patients. The predominant HCV genotype (GT) was 3 at 60.6%, second was GT1 at 36.1% and other GTs were uncommon at about 1% or less. About half of our patients have high baseline viral load (>800,000 iu/ml), 18.3% had liver cirrhosis and 22.3% had HIV co-infection. Co-morbid illness was found in 42.9%, hypertension and type 2 diabetes were the two most common. The overall sustained virological response (SVR) by intention-to-treat analysis were 54.9% (n=150/273), 41.2% (40/97) for GT1, 100% (5/5) for GT2 and 62% (101/163) for GT3. Subgroup analysis for HCV monoinfected, treatment naïve showed SVR of 49.2% (31/63) for GT1, 100% (5/5) for GT2 and 67% (69/103) for GT3. In HCV mono-infected and treatment experienced (n=29), the SVR was 28.6% (4/14) for GT1, 21.4% (69/103) for GT3. In the HIV/HCV co-infected, treatment naïve (n=56), the SVR was 28.6% (4/14) for GT1 and 64.3% (27/42) for GT3. Treatment naïve GT3 mono-infected patients had a statistically significant higher SVR compared to treatment experienced patients (P=0.001). In GT3 patients who achieved rapid virological response, the SVR was significantly higher at 85.2% (P< 0.001). The SVR for cirrhotics were low especially for GT1 at 21% (4/19) and 31% (4/13) based on all patients and treatment naïve HCV monoinfected respectively. In GT3 cirrhotics the corresponding SVR were 57.1% (16/28) and 60.9% (14/23). Premature discontinuation rate was 21.2% with the majority due to intolerable adverse events at 12.1%.

    CONCLUSIONS: In our routine clinical practice, the HCV patients we treated were young, predominantly of GT3 and many had difficult-to-treat clinical characteristics. The SVR of our patients were below those reported in Asian clinical trials but in keeping with some "real world" data.

    Matched MeSH terms: Hepatitis C, Chronic/drug therapy*; Hepatitis C, Chronic/pathology
  13. Ramli M, Zulkafli Z, Chambers GK, Zilan RSAR, Edinur HA
    Oman Med J, 2020 Nov;35(6):e189.
    PMID: 33110633 DOI: 10.5001/omj.2020.86
    Objectives: Blood bank centers routinely screen for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) to ensure the safety of blood supply and thus prevent the dissemination of these viruses via blood transfusion. We sought to evaluate the detection of transfusion-transmitted infection (TTI) markers using standard serological methods and nucleic acid testing (NAT) among blood donors in Hospital Universiti Sains Malaysia.

    Methods: Donated blood units were assessed for the presence or absence of HBV, HCV, and HIV using two screening method: serology and NAT. Reactive blood samples were then subjected to serological confirmatory and NAT discriminatory assays.

    Results: A total of 9669 donors were recruited from September 2017 to June 2018. Among these, 36 donors were reactive either for HBV, HCV, or HIV by serological testing and eight by NAT screening. However, only 10 (three for HBV and seven for HCV) donors tested positive using serological testing and five (two for HBV and three for HCV) by NAT discriminatory assays. Note that all five NAT positive donors detected in the NAT discriminatory assays were confirmed to be serologically reactive. Therefore, the prevalence of HBV, HCV, and HIV was 0.03%, 0.1%, and 0.0%, respectively, in our donor pool.

    Conclusions: Both serological and NAT screening and confirmatory assays should be used routinely to reduce the risk of infection transmission via the transfusion of blood and blood components.

    Matched MeSH terms: Hepatitis C
  14. Goh KL
    Malays J Med Sci, 2019 Mar;26(2):18-29.
    PMID: 31447605 DOI: 10.21315/mjms2019.26.2.3
    The landscape of liver diseases in Malaysia has changed dramatically since the time of Professor Balasegaram Manickavasagar-an eminent surgeon in the 1960s. The most significant discoveries in hepatology have been that of hepatitis B virus in 1963 and hepatitis C virus in 1989, which have both been shown to be predominantly blood borne diseases. Hepatitis B and C infections result in long term carrier state and a high propensity to develop liver cirrhosis and cancer. Hepatitis B is the most common cause of liver cirrhosis and cancer in Malaysia. Blood bank screening and public health preventive measures have reduced the disease burden significantly and an effective vaccination for hepatitis B is now incorporated in our National Immunisation Programme. Although no vaccine is available for hepatitis C, highly effective eradication therapies were introduced in 2011. These agents will significantly change the disease scenario across the world. A "new" disease was described in 1980, by Ludwig et al.-non-alcoholic fatty liver (NAFLD) disease. With the global epidemic of obesity and diabetes mellitus, NAFLD is set to increase exponentially across the world including in Malaysia. It will be the most important liver disease in the future, replacing hepatitis B and C infections.
    Matched MeSH terms: Hepatitis C
  15. Naing C, Sitt T, Aung AT, Aung K
    Medicine (Baltimore), 2015 Jul;94(30):e1234.
    PMID: 26222859 DOI: 10.1097/MD.0000000000001234
    In Myanmar, hepatitis C virus (HCV) infection prevalence is 2%. A combination therapy of pegylated interferon alfa-2a and ribavirin (PEG-IFNa/RBV) is a standard treatment, but the effect of this antiviral therapy needs evaluation as to determine the efficacy and safety of dual PEG-IFNa/RBV therapy in treating patients infected with HCV in Myanmar.This was a retrospective analysis of data from a single clinic exclusively for gastrointestinal diseases in Yangon, Myanmar. We assessed treatment responses at the defined time points and stratified by genotypes of HCV. We also determined incidences of adverse events (AEs). We investigated independent predictors of sustained virologic response (SVR) in the participants.A total of 362 HCV-infected cases were included in this study. The majority were females (51.7%) with mean age of 47.12 years (±11.6) and noncirrhosis patients (82%). Rapid virologic response (RVR), early virologic response (EVR), end of treatment response (ETR), and SVR 24 weeks after completion of the dual treatment were 50.3% (178/362), 88% (314/357), 80.1% (286/357), and 85.6% (167/195), respectively. The most frequently reported AEs were nausea/anorexia (72.8%) and flu-like symptoms (62.4%). In multivariate analysis, 4 factors were independently associated with SVR; SVR to genotype 3 (odds ratio [OR] 2.4, 95% CI: 1.24-4.62), EVR (OR 0.54, 95% CI: 0.3-0.95), and duration of treatment (OR 1.52, 95% CI: 1.18-1.98). Study limitations were acknowledged.The efficacy and safety of the dual therapy in treating HCV-infected patient in Myanmar was acceptable. We recommend a prospective randomized control trial looking at duration of therapy and rates of achieving SVR, which could significantly impact the care of HCV-infected patients in Myanmar and perhaps other countries as well.
    Matched MeSH terms: Hepatitis C, Chronic/drug therapy*; Hepatitis C, Chronic/virology
  16. Mellor J, Walsh EA, Prescott LE, Jarvis LM, Davidson F, Yap PL, et al.
    J Clin Microbiol, 1996 Feb;34(2):417-23.
    PMID: 8789027
    Previous surveys of the prevalences of genotypes of hepatitis C virus (HCV) in different populations have often used genotyping assays based upon analysis of amplified sequences from the 5' noncoding region (5'NCR), such as restriction fragment length polymorphism (RFLP) or hybridization with type-specific probes (e.g., InnoLipa). Although highly conserved, this region contains several type-specific nucleotide polymorphisms that allow major genotypes 1 to 6 to be reliably identified. Recently, however, novel HCV variants found in Vietnam and Thailand that are distantly related to the type 6a genotype (type 6 group) by phylogenetic analysis of coding regions of the genome often have sequences in the 5'NCR that are similar or identical to those of type 1 and could therefore not be identified by an assay of sequences in this region. We developed a new genotyping assay based upon RFLP of sequences amplified from the more variable core region to investigate their distribution elsewhere in southeast (SE) Asia. Among 108 samples from blood donors in seven areas that were identified as type 1 by RFLP in the 5'NCR, type 6 group variants were found in Thailand (7 from 28 samples originally identified as type 1) and Burma (Myanmar) (1 of 3) but were not found in Hong Kong (n = 43), Macau (n = 8), Taiwan (n = 6), Singapore (n = 2), or Malaysia (n = 18). Although this small survey suggests a relatively limited distribution for type 6 group variants in SE Asia, larger studies will be required to explore their distribution in other geographical regions and the extent to which their presence would limit the practical usefulness of 5'NCR-based genotyping assays for clinical or epidemiological purposes.
    Matched MeSH terms: Hepatitis C/epidemiology; Hepatitis C/virology
  17. AR Siti Nurul Fazlin, H Hairul Aini, HM Hadzri, MM Mohammed Imad
    MyJurnal
    Hepatitis C virus (HCV) genotyping is very important for the clinical management of HCV-infected patients. The aim of this study was to determine the genotypes of HCV-infected patients and to identify their risk factors and comorbidities.
    Matched MeSH terms: Hepatitis C
  18. Chen DS, Hamoudi W, Mustapha B, Layden J, Nersesov A, Reic T, et al.
    J Viral Hepat, 2017 10;24 Suppl 2:44-63.
    PMID: 29105286 DOI: 10.1111/jvh.12759
    The hepatitis C virus (HCV) epidemic was forecasted through 2030 for 17 countries in Africa, Asia, Europe, Latin America and the Middle East, and interventions for achieving the Global Health Sector Strategy on viral hepatitis targets-"WHO Targets" (65% reduction in HCV-related deaths, 90% reduction in new infections and 90% of infections diagnosed by 2030) were considered. Scaling up treatment and diagnosis rates over time would be required to achieve these targets in all but one country, even with the introduction of high SVR therapies. The scenarios developed to achieve the WHO Targets in all countries studied assumed the implementation of national policies to prevent new infections and to diagnose current infections through screening.
    Matched MeSH terms: Hepatitis C, Chronic/diagnosis; Hepatitis C, Chronic/drug therapy; Hepatitis C, Chronic/mortality*; Hepatitis C, Chronic/epidemiology*
  19. Khwairakpam G, Burry J
    Curr Opin HIV AIDS, 2019 01;14(1):1-6.
    PMID: 30480583 DOI: 10.1097/COH.0000000000000514
    PURPOSE OF REVIEW: With increasing availability of generic direct-acting antivirals (DAAs) and associated price reductions, various governments, multilateral institutions, and donors have started providing testing and treatment for hepatitis C virus (HCV) infection. More data on the quality of these generic medicines and on cost-effectiveness of their use are becoming widely available. This review seeks to describe some of the treatment programs for HCV that are evolving in Cambodia, India, Indonesia, Malaysia, Myanmar, and Thailand.

    RECENT FINDINGS: The quality of multiple generic DAAs has been shown to be bioequivalent to innovator formulations, with generic versions achieving high cure rates in real-world settings. Although published materials are limited, there is expanding experience with local pilot and national treatment programs which are largely being funded by national governments and other institutions.

    SUMMARY: Countries and other public health stakeholders are recognizing the need to scale up HCV diagnosis and treatment programs using generic DAAs. However, local pilot or national treatment programs need to be massively expanded to eliminate HCV in high-burden areas.

    Matched MeSH terms: Hepatitis C
  20. Wei L, Lim SG, Xie Q, Văn KN, Piratvisuth T, Huang Y, et al.
    Lancet Gastroenterol Hepatol, 2019 02;4(2):127-134.
    PMID: 30555048 DOI: 10.1016/S2468-1253(18)30343-1
    BACKGROUND: Treatment with combined sofosbuvir and velpatasvir has resulted in high sustained virological response rates in patients chronically infected with hepatitis C virus (HCV) with genotypes 1-6 in clinical trials and real-world settings, but its efficacy and safety has not been assessed in Asia, a region with diverse HCV genotypes.

    METHODS: In this single-arm, open-label, phase 3 trial, we recruited patients from 38 sites across China, Thailand, Vietnam, Singapore, and Malaysia, who were chronically infected with HCV genotypes 1-6, and were HCV treatment-naive or treatment-experienced, either without cirrhosis or with compensated cirrhosis. Patients self-administered a combined sofosbuvir (400 mg) and velpatasvir (100 mg) tablet once daily for 12 weeks. The primary efficacy endpoint was sustained virological response, defined as HCV RNA less than 15 IU/mL at 12 weeks after completion of treatment (SVR12), assessed in all patients who received at least one dose of study drug. The primary safety endpoint was the proportion of adverse events leading to premature discontinuation of study drug. This trial is registered with ClinicalTrials.gov, number NCT02671500, and is completed.

    FINDINGS: Between April 14, 2016, and June 30, 2017, 375 patients were enrolled in the study, of whom 374 completed the full treatment course and one discontinued treatment. Overall, 362 (97% [95% CI 94-98]) of 375 patients achieved SVR12. Among 42 patients with HCV genotype 3b, all of whom had baseline resistance-associated substitutions in NS5A, 25 (89% [95% CI 72-98]) of 28 patients without cirrhosis and seven (50% [23-77]) of 14 patients with cirrhosis achieved SVR12. The most common adverse events were upper respiratory tract infection (36 [10%] patients) and headache (18 [5%] patients). There were no discontinuations due to adverse events. Serious adverse events were reported in three (1%) patients, none of which was judged to be related to sofosbuvir-velpatasvir treatment.

    INTERPRETATION: Consistent with data from other phase 3 studies, single-tablet sofosbuvir-velpatasvir for 12 weeks is an efficacious and safe treatment for Asian patients with chronic HCV infection, but might have lower efficacy in those infected with HCV genotype 3b and with cirrhosis.

    FUNDING: Gilead Sciences.

    Matched MeSH terms: Hepatitis C, Chronic/blood; Hepatitis C, Chronic/complications; Hepatitis C, Chronic/drug therapy*; Hepatitis C, Chronic/virology
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