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Background and Aim: The NIACE score provides prognostic values for hepatocellular carcinoma (HCC) in European studies. We aim to evaluate the prognostic value of the NIACE score in Asian patients. Methods: Patients with HCC were retrospectively enrolled from a tertiary medical center in Taiwan during 2009–2014, and their clinical information were collected. The NIACE score was calculated according to the Nodular numbers, tumor Infiltration, Alpha‐fetoprotein level, Child–Pugh score, and Eastern Cooperative Oncology Group score. The prognostic values of NIACE score for overall survival according to individual treatment and the Barcelona clinic liver cancer (BCLC) staging were analyzed. Results: A total of 468 patients were included with a median follow‐up of 30 months. A greater NIACE score correlated with lower median survival and higher BCLC staging. Regardless of treatment modalities, NIACE scores (0, 1–1.5, 2.5–3, and 4–7) significantly predicted survival between groups (log–rank P < 0.001). Specifically, NIACE score (0, 1–1.5, 2.5–3, and 4–7) significantly predicted survival in patients receiving transarterial chemoembolization (log–rank P < 0.001). NIACE score 1, 2.5, and 4 further distinguished overall survival in BCLC A, B, and C patients, respectively (all log–rank P < 0.01). After adjustment of the confounders and the BCLC staging, NIACE score of 2.5–3 and 4–7 (vs 0) had a significantly increased risk of mortality with a hazard ratio of 4.04 (95% confidence interval: 2.14–7.64, P < 0.001) and 7.45 (95% confidence interval: 3.22–17.23, P < 0.001), respectively. Conclusions: The NIACE score helps refine differential prognosis among BCLC A, B, and C subgroups of Asian patients with HCC, especially in those receiving transarterial chemoembolization. [ABSTRACT FROM AUTHOR]

Background and Aim: Data regarding the efficacy and safety of paritaprevir/ritonavir, ombitasvir plus dasabuvir (PrOD) for East Asian non‐cirrhotic hepatitis C virus genotype 1b (HCV GT1b) patients receiving hemodialysis were limited. Methods: Forty‐six HCV GT1b non‐cirrhotic patients receiving hemodialysis who received PrOD for 12 weeks were prospectively enrolled in seven academic centers in Taiwan. The primary efficacy endpoint was sustained virologic response 12 weeks off‐therapy (SVR12). Patients' baseline characteristics, early virokinetics, and HCV resistance‐associated substitutions (RASs) potentially related to SVR12 were analyzed. The safety profiles were also assessed. Results: The SVR12 rate was 100% (46 of 46 patients). Patients' baseline characteristics, on‐treatment viral decline, and baseline HCV resistance‐associated substitutions did not affect SVR12. All patients tolerated treatment well. One patient with folliculitis temporarily discontinued treatment, and another two patients had serious adverse events (SAEs), which were considered not related to PrOD treatment. The common adverse events were pruritus (19.6%), fatigue (15.2%), and upper respiratory tract infection (6.5%). Twelve (19.6%) and one (2.2%) patients had hemoglobin levels < 10 and 8.5 g/dL, respectively, which were related to renal impairment. Five (10.9%) patients had on‐treatment total bilirubin level of 1.5–3.0 mg/dL, but none developed hepatic decompensation. The bilirubin levels peaked at week 1 of treatment and then declined with continuous treatment. Conclusion: Treatment with PrOD for 12 weeks is efficacious and well‐tolerated for East Asian non‐cirrhotic HCV GT1b patients receiving hemodialysis. [ABSTRACT FROM AUTHOR]

Background and Aim: Data regarding the comparative effectiveness and safety of sofosbuvir (SOF) in combination with ribavirin (RBV), daclatasvir (DCV), or ledipasvir (LDV) for hepatitis C virus genotype 2 (HCV‐2) patients were limited. We aimed to evaluate the performance of these regimens in Taiwan. Methods: One hundred eighty‐seven HCV‐2 patients with compensated liver diseases receiving SOF in combination with RBV (n = 82), DCV (n = 66), or LDV (n = 39) for 12 weeks were retrospectively enrolled. The effectiveness was determined by sustained virologic response 12 weeks off therapy (SVR12). The patient characteristics potentially related to SVR12 were compared. The safety profiles and laboratory abnormalities were assessed. Results: The SVR12 rates were 93.9% (95% confidence interval [CI]: 86.5–97.4%), 98.5% (95% CI: 91.9–99.7%), and 100% (95% CI: 91.0–100%) in patients receiving SOF combined with RBV, DCV, and LDV, respectively. All patients tolerated treatment well. The stratified SVR12 rates were comparable regardless of baseline characteristics or week 4 viral decline among these regimens. Six (3.2%) patients had serious adverse events which were not related to treatment. The rates of fatigue, pruritus, and anemia tended to be higher in patients receiving RBV (22.0%, 19.5%, and 8.5%) combination than those receiving DCV (10.6%, 6.1%, and 1.5%) or LDV (10.3%, 5.1%, and 0%) combination. Conclusions: Sofosbuvir in combination with RBV, DCV, or LDV for 12 weeks is effective and well‐tolerated for HCV‐2 patients. Compared with DCV or LDV combination, the risks of fatigue, pruritus, and anemia are higher in patients receiving RBV combination. [ABSTRACT FROM AUTHOR]

Background and Aims: Patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are at risk of developing adverse outcomes. Coinfection with both viruses may further increase the risk. Currently, little is known about the role of fibrosis‐4 (FIB‐4) index, a simple liver fibrosis stage biomarker, in predicting the clinical outcomes. Methods: We retrospectively enrolled 152 non‐cirrhotic patients with dual chronic HCV and HBV infection: 56 patients received pegylated interferon/ribavirin therapy, while 96 patients remained untreated. The association between the FIB‐4 index and the incidence of liver cirrhosis and hepatocellular carcinoma (HCC) was explored. Results: After a 9.88‐year follow‐up, the incidence of hepatitis B surface antigen seroclearance was 4.97 (95% confidence interval: 3.13–7.89) per 100 person‐years in the treated group and was 1.77 (1.10–2.85) in the untreated group. Of the treated group, only three and six patients developed HCC and liver cirrhosis, respectively, while 17 and 23 patients developed HCC and liver cirrhosis, respectively, in untreated group. Baseline FIB‐4 index correlated with the development of liver cirrhosis in multivariable analysis of all subjects. High baseline FIB‐4 index (per 1 point increase) in the treated groups was associated with a higher risk of developing liver cirrhosis (P = 0.001) and HCC (P = 0.038) in univariable analysis. FIB‐4 index decreased only in the treated group who achieved sustained virological response (n = 34, FIB‐4 index decreasing from 1.84 to 1.55). Conclusions: In Taiwanese patients coinfected with HCV and HBV, FIB‐4 index helps identify patients at risk of developing adverse events, even in patients receiving pegylated interferon/ribavirin therapy. [ABSTRACT FROM AUTHOR]

Abstract: Background and Aim: The real‐world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) remain limited for East Asian hepatitis C virus genotype 1b (HCV‐1b) patients. The study aimed to evaluate the antiviral responses of PrOD‐based regimens for HCV‐1b patients in Taiwan. Methods: The study performed a retrospective analysis of 103 HCV‐1b patients receiving PrOD with or without ribavirin (RBV) for 12 weeks. Data were analyzed to assess the on‐treatment and off‐therapy HCV viral load and on‐treatment adverse events. The pre‐specified characteristics related to sustained virologic response 12 weeks off therapy (SVR12) were compared. Results: At treatment week 4, 100 of 102 patients (98.0%) had serum HCV RNA level < 25 IU/mL. The SVR12 was achieved in 101 of 103 patients (98.1%, [95% confidence interval: 93.2–99.5%]). All except one (99.0%) patients tolerated treatment well without treatment interruption. One cirrhotic patient discontinued treatment at week 1 due to hepatic decompensation. Twenty‐four patients (23.3%) had ≥ grade 2 elevation in total bilirubin levels, and 21 of them (87.5%) had indirect type hyperbilirubinemia. The stratified SVR12 rates were comparable in terms of sex, age, body mass index, prior treatment experience, hepatitis B virus surface antigen status, RBV usage, baseline and week 2 viral load, renal function, and hepatic fibrosis stage. Conclusions: Paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without RBV are efficacious and generally well tolerated for treatment of HCV‐1b patients in Taiwan. [ABSTRACT FROM AUTHOR]

Background and Aims The diagnostic accuracy of a novel serological panel (BioFibroScore®) to predict hepatic fibrosis in patients with chronic hepatitis C virus (HCV) infection is unknown. Methods Three markers of BioFibroScore, including urokinase plasminogen activator, matrix metalloproteinase-9, and beta-2 microglobulin, were retrospectively evaluated in 635 HCV-infected patients who received percutaneous liver biopsy and FibroScan®. The formula of BioFibroScore to predict the severity of hepatic fibrosis was developed by adaptive boosting algorithm. The diagnostic accuracy of hepatic fibrosis was assessed both for BioFibroScore and FibroScan, taking METAVIR fibrosis score as the reference standard. Results Urokinase plasminogen activator and beta-2 microglobulin were positively and matrix metalloproteinase-9 was negatively associated with the severity of hepatic fibrosis. Thirty-five (5.5%) patients had failed FibroScan assessment. By adaptive boosting model for BioFibroScore and the established reference ranges for FibroScan, 85.7% and 89.0% of the patients had an identical result for F0-1, F2, F3, and F4, as compared with liver biopsy. The concordance rate between BioFibroScore and FibroScan was 80.7%. BioFibroScore overestimated and underestimated the stage of hepatic fibrosis in 8.3% and 6.0% patients, and most patients had one stage error. Among patients with failed FibroScan assessment, 82.9% of them were correctly diagnosed by BioFibroScore. Bootstrap analysis for BioFibroScore showed the diagnostic accuracy was 80.9-88.4%. Conclusions BioFibroScore is accurate to assess the stage of hepatic fibrosis in HCV-infected patients. Applying this noninvasive test can substantially reduce the need for invasive liver biopsy and can play a role for fibrosis evaluation when FibroScan assessment was unavailable or unreliable. [ABSTRACT FROM AUTHOR]

Background and Aim Patients with hepatitis B virus ( HBV) genotype B infection experience hepatitis B e-antigen ( HBeAg) seroconversion at an earlier stage than do patients with genotype C infection. Therefore, this study investigated whether the differential phenotypes are related to HBV genomic evolution. Methods Thirty-three HBeAg-positive patients with a mean follow-up of 3.1 years were enrolled: 16 at the immune tolerance stage (group I) and 17 at the immune clearance stage (group II). The evolution rates of paired viral genomes at enrollment and at the final follow-up in the full-length genome (μf), nonoverlapping regions (synonymous [μs] and nonsynonymous [μa]), and overlapping regions (μ) were calculated. The evolution rates were then compared according to serum alanine aminotransferase ( ALT) levels and HBV genotype. Results The overall μf evolution rate was lower in group I than in group II (1.4 × 10−5 ± 3.3 × 10−5 vs 1.2 × 10−3 ± 1.2 × 10−3 nucleotide substitution/site/year, P < 0.001). We observed similar results for the μs, μa, and μ evolution rates. All evolution parameters were comparable between genotypes B and C. We determined a positive correlation between μa/y and the area under the average ALT time curve in genotype B (R2 = 0.6935, P < 0.0001), but not in genotype C (R2 = 0.1606, P = 0.124). Conclusion The evolution rate of the HBV genome is higher at the immune clearance stage than at the immune tolerance stage. Host immune selection might play a role in triggering evolution of genotype B. [ABSTRACT FROM AUTHOR]

Background and Aims Acute exacerbation ( AE) of chronic hepatitis B virus ( HBV) infection is common and negatively impacts the clinical outcome. Although upsurge of viral load always precedes or coincides with AE, the underlying immunological mechanisms remain unclear and were investigated. Methods We prospectively followed the serum cytokine/chemokine profiles, viral load, and alanine aminotransferase ( ALT) levels in 250 patients and identified 44 consecutive patients (male: 72.7%; age: 40.4 ± 9.7 years; hepatitis B e antigen [ HBeAg] positivity: 63.6%; genotype B/ C: 75%/25%) who developed AE during the follow-up in a medical center. The impact of clinical characteristics (age, gender, HBeAg, ALT, HBV genotype), cytokines (tumor necrosis factor-alpha, interferon gamma, interleukin [ IL]-2, IL-4, IL-6, and IL-10), and chemokines ( CXCL10/interferon gamma-induced protein [ IP]-10, CCL2/ MCP-1, CXCL9/ MIG, CCL5/ RANTES, and CXCL8/ IL-8) on the serum HBV DNA dynamics at different time points (baseline, peak of serum HBV DNA level, peak of serum ALT level, and after AE) were analyzed. Results Of 44 patients, serum HBV DNA level surged before the peak of serum ALT level in 23 (52.3%), and coincided with the peak of ALT in 21 (47.7%). The upsurge of serum viral load significantly correlated with the increase of IL-10 ( P = 0.0037) and CXCL10/ IP-10 ( P = 0.0044). Upsurge of serum viral load was preceded by an increase in serum IL-4 ( P < 0.05), IL-6 ( P < 0.05), and IL-10 ( P < 0.05). Combination of HBV genotype, IL-6 level at baseline, and ALT level at the peak of serum HBV DNA reliably predicted subsequent AE pattern ( P = 0.0116). Conclusions Enhanced Th2 activity is likely involved in the surge of HBV DNA level before hepatitis exacerbation. [ABSTRACT FROM AUTHOR]

Background and Aims The level of hepatitis B surface antigen ( HBsAg) has been shown to complement hepatitis B virus ( HBV)- DNA level in predicting disease progression in hepatitis B e antigen ( HBeAg)-negative patients, especially those with low viral loads. Whether this finding could be seen in spontaneous HBeAg seroconverters remains unclear. Methods A retrospective cohort of 390 Taiwanese spontaneous HBeAg seroconverters with a mean follow-up period of 7.4 years was enrolled. The relationships between HBV- DNA/ HBsAg levels and HBeAg-negative hepatitis/active viral replication ( HBV- DNA level ≥ 2000 IU/mL) were investigated. Results In the overall cohort, serum HBV- DNA level served as a better predictor for HBeAg-negative hepatitis compared with HBsAg level. However, in those with HBV- DNA level < 2000 IU/mL, a higher HBsAg level was associated with a higher risk of HBeAg-negative hepatitis ( P = 0.015). Multivariate analysis showed the hazard ratio of HBsAg level ≥ 1000 IU/mL versus < 1000 IU/mL was 4.1 (95% confidence interval: 1.3-13.6). When using the end-point of active viral replication, HBsAg ≥ 1000 IU/mL remained as an independent risk factor, with a hazard ratio of 2.5 (95% confidence interval: 1.1-5.9). Conclusions In spontaneous HBeAg seroconverters with HBV- DNA level < 2000 IU/mL, HBsAg level ≥ 1000 IU/mL is associated with increased risks of HBeAg-negative hepatitis and active viral replication. Combining HBV- DNA < 2000 IU/mL and HBsAg level < 1000 IU/mL may be used to define minimal viral activity. [ABSTRACT FROM AUTHOR]

Background and Aim Chronic hepatitis C ( CHC) infection is a leading cause of cirrhosis and hepatocellular carcinoma worldwide. Pegylated interferon ( PEG-IFN) plus ribavirin ( RBV) combination therapy remains the standard of care for CHC genotype 1 in many Asian countries, and single nucleotide polymorphism or genotype of the interleukin- 28B ( IL28B) gene is associated with the development of sustained virologic response ( SVR). The predictive value of IL28B genotype for retreatment outcomes of patients with CHC was only partly clarified and deserves further investigation. Methods A total of 75 CHC genotype 1 Taiwanese patients who relapsed after 24-week PEG-IFN/ RBV combination therapy and received retreatment with a 48-week PEG-IFN/ RBV therapy were consecutively enrolled since November 2009. The associations among IL28B rs8099917 genotype, virologic kinetics, and treatment outcomes were evaluated. Results Rapid virologic response ( RVR) at week 4, end-of-treatment virologic response ( EOT-VR) and SVR was 37%, 73%, and 52%, respectively. Relapse rate was 29%. None of patients had rs8099917 GG genotype. Patients with TT genotype ( n = 54, 72%) had higher rates of RVR (50% vs 5%, P = 0.0002), end-of-treatment virologic response (85% vs 43%, P = 0.0001), and SVR (67% vs 14%, P = 0.0001) than those with GT genotype ( n = 21, 28%). Combination of IL28B TT genotype and achieving RVR had 85% positive and 90% negative predictive values of SVR. Conclusions About half of the Taiwanese CHC relapsers to a previous 24-week combination therapy achieve SVR after retreatment for 48 weeks. IL28B genotype influences on-treatment viral kinetics and SVR rate in these retreated patients. Baseline IL28B genotype and RVR can serve as early predictors for treatment success. [ABSTRACT FROM AUTHOR]

Determines the characteristic features of hepatocellular carcinoma (HCC) from different countries. Establishment of standard criteria that can be used worldwide to estimate disease progression; Stratification of patients from each country according to the index by the Cancer of the Liver Italian Program (CLIP); Evaluation of HCC patients admitted and treated in Tokyo University in Japan.

AbstractBackground: Reactivation of hepatitis B after organ transplantation in hepatitis B surface antigen (HBsAg) carriers may be fatal. In this study, we reported our experience of lamivudine treatment in HBsAg carriers who had post-transplant reactivation of hepatitis B. Methods: The patients were 15 men and one woman. Nine received kidney transplants, six received heart transplants, and one received a lung transplant. They developed a reactivation of hepatitis B 1–101 months (median, 14 months) after transplantation. They received lamivudine 100 mg daily on a compassionate-use basis, and had regular follow ups. The median pretreatment total serum bilirubin level was 3.0 mg/dL, and the alanine aminotransferase level was 357 U/L. Four of the 16 patients were positive for HBeAg. The serum hepatitis B virus (HBV) DNA levels were > 3000 pg/mL in 13 (81%) patients. Three were coinfected with hepatitis C virus. Results: The overall survival rate was 75%. All four fatal cases had a pretreatment total serum bilirubin level of ≥ 3 mg/dL. Serum HBV-DNA soon became undetectable in 12 survivors. Of the 12 survivors, after a median treatment period of 101 weeks, a lamivudine-resistant strain with variation in the YMDD motif of the HBV polymerase gene developed in three (25%). None had significant adverse reactions to lamivudine treatment. Conclusions: These results indicated that lamivudine is effective in the treatment of post-transplant hepatitis B reactivation, including patients with dual chronic hepatitis B and C. Early recognition of HBV reactivation and prompt lamivudine treatment are important to prevent mortality. [ABSTRACT FROM AUTHOR]

Abstract Hepatitis C virus infection is a global health problem; however, the interaction between pregnancy and chronic hepatitis C remains controversial. A Taiwanese woman with chronic hepatitis C had an uncomplicated pregnancy and gave birth to a female baby through spontaneous vaginal delivery. The serum levels of alanine aminotransferase and hepatitis C virus (HCV) RNA were measured before pregnancy, in the first and third trimesters, 1 and 3 months after delivery, respectively. During her pregnancy, the serum aminotransferase levels became normalized, while the serum HCV-RNA levels declined significantly and consecutively with the lowest viral load in the third trimester. One month after delivery, she had an abrupt elevation of serum HCV-RNA level, paralleling a hepatitis flare with serum aminotransferase level more than 20-fold the upper normal limit. The serum HCV-RNA levels declined thereafter, and serum aminotransferase levels became normalized 3 months postdelivery. She was infected with HCV genotype 1a throughout the entire follow-up period, and other causes of hepatitis flare were excluded. In conclusion, post-partum acute exacerbation of chronic hepatitis may occur in HCV-carrier mothers, and an abrupt elevation of serum HCV-RNA level may be associated with the acute exacerbation. [ABSTRACT FROM AUTHOR]

Abstract Background and Aims Consensus interferon (CIFN) is a newly developed type I interferon. The aim of this study was to investigate the safety and efficacy of CIFN in the treatment of patients with chronic hepatitis C and to determine the predictors for sustained response. Methods Patients were randomized to receive 3 μg or 9 μg CIFN three times a week for 24 weeks, followed by 24 weeks of observation. Efficacy was assessed by normalization of serum transaminase levels and disappearance of serum hepatitis C virus (HCV)-RNA at the end of treatment and at 24 weeks after stopping treatment. Histologic response was defined as a decrease of at least two points in the Knodell necroinflammatory score at week 48 and was compared with baseline. Results There were no serious adverse effects related to CIFN therapy. Overall, 44% of patients receiving 3 μg and 48% of patients receiving 9 μg had normalization of serum transaminase levels and disappearance of HCV viremia at the end of treatment. At 24 weeks after stopping treatment, 16% of patients in receiving 9 μg and 12% of patients receiving 3 μg had sustained responses. The histologic responses in patients receiving 9 μg and those receiving 3 μg were 60% and 36%, respectively. The necroinflammatory score was significantly reduced from baseline to week 48 in both groups. In addition, bodyweight < 60 kg and pretreatment serum HCV-RNA level < 0.5 MEq/mL can serve as predictors for sustained response to CIFN treatment. Conclusions These findings suggest that 9 μg CIFN is safe and effective in the treatment of patients with chronic hepatitis C. [ABSTRACT FROM AUTHOR]

Abstract Background: The TT virus (TTV) is a newly identified human DNA virus and little is known about its non-parenteral transmission. The aim of the present study was to explore the prevalence of TTV infection in spouses of index cases and the related risk factors. Methods: Serum TTV-DNA was studied in spouses of 41 subjects with TT viremia. For couples in which both husband and wife had TT viremia, nucleotide sequences of the open reading frame-1 region were analyzed by phylogenetic tree constructions. Results: Three (7%) of 41 spouses were positive for TTV-DNA. No differences were noted between index patients with seropositive spouses and those without seropositive spouses with regard to clinical characteristics, including parenteral risk factors and exposure duration. Nucleotide sequence comparison and phylogenetic tree analysis of the viral genome in three TTV-infected couples revealed the isolates to be closely related in two, with a homology of 97 and 98%, respectively. Conclusions: These results suggest that interspousal transmission of TTV does occur; however, the efficiency of transmission is low compared with hepatitis C virus and GB virus-C. There are no apparent risk factors for transmission between spouses and further studies are needed to clarify other modes of non-parenteral transmission. [ABSTRACT FROM AUTHOR]

Abstract Hepatitis B virus (HBV) infection is prevalent in the Asia–Pacific region and the disease burden caused by chronic HBV infection has been enormous. Although vaccination programmes have been implemented in the past decade, and there are extremely successful countries in the region, many countries still cannot afford a control program. These countries are often populous and highly endemic for HBV infection. To overcome this, aid from developed countries or private foundations should be actively sought. In the developing countries of this region, HBV infection in early childhood is the main cause of chronic HBV status, and thus universal vaccination of all infants is the best way to control HBV infection. Because of the expense and extra costs of screening pregnant women, the use of hepatitis B immune globulin may not be essential. To achieve the goal of universal infant vaccination, public education should be done in parallel with education of health professionals and control measures. The Asia–Pacific region has more people with chronic hepatitis B than any other part of the world, and control of HBV infection in this region will no doubt be the most important and challenging task to be taken in the beginning of the new millennium. [ABSTRACT FROM AUTHOR]

Abstract Hepatitis C virus (HCV) infection is a major public health problem. The epidemiology of HCV infection in different parts of Asia is similar, with an average seroprevalence of hepatitis C antibody (anti-HCV) less than 2.5% in healthy adults. The infection is rarely seen in children. The major routes of HCV transmission in Asia during the past few decades have been through administration of therapeutic blood products and injecting drug use, similar to the pattern observed in other parts of the world. However, obvious parenteral routes of transmission only account for 30–60% of anti-HCV-positive cases, depending on the geographic area. Other inapparent parenteral or per-mucosal exposures, including medical intervention, tattooing, acupuncture, vertical and sexual transmission, accidental needlestick and household contact, are also possible routes of HCV transmission. Although screening of blood donors for anti-HCV and improvements in infection control have significantly decreased the exposure to HCV, it is believed that HCV is still spreading in some areas of Asia because of the lack of routine screening of donated blood, injecting drug usage, traditional medicine practices or medical treatment under suboptimal hygienic conditions that involve blood contamination, and tattooing. Accordingly, until effective and safe immunoprophylaxis is available, interruption of transmission routes, such as implementation of blood donor screening for anti-HCV, adequate sterilization of surgical instruments or the use of disposable medical instruments, especially needles and syringes, and avoidance of sharing personal grooming aids remains the mainstay to prevent HCV infection in Asia today. [ABSTRACT FROM AUTHOR]

AbstractBackground: Interspousal transmission of hepatitis C virus (HCV) has been documented; however, the annual risk of interspousal transmission remains unclear. Methods: A long-term prospective study to define the risk of interspousal transmission of HCV was conducted. One hundred and twelve index patients with chronic hepatitis C and their anti-HCV seronegative spouses were enrolled. Results: The mean follow-up period was 45.9 months. Antibodies to HCV (anti-HCV) and HCV-RNA were tested for in each seronegative spouse every year. Seroconversion of anti-HCV occurred in only one spouse, 2 years after enrolment, with a concomitant acute hepatitis. This subject and his spouse were infected with HCV genotype 1b. Nucleotide sequence comparison of the hypervariable region of their HCV genomes showed a homology of 98%. Further phylogenetic analysis suggested that they had virtually the same isolate. Accordingly, the annual risk of interspousal transmission of HCV infection was 0.23% per year. Conclusions: These findings suggest a low incidence of interspousal transmission of HCV; however, the risk may be cumulative and such couples should be educated to avoid HCV infection from their spouses. [ABSTRACT FROM AUTHOR]