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"ABSTRAKLatar Belakang: Penyakit hepatitis C kronik merupakan masalah kesehatan global yang dapat menyebabkan morbiditas serta mortalitas yang tinggi pada kondisi sirosis dan karsinoma hepatoseluler. Adanya terapi sofosbuvir-daclatasvir yang bersifat pangenotipik diharapkan dapat mengatasi penyakit ini. Namun, didapatkan hasil pencapaian SVR 12 yang bervariasi dan lebih rendah pada genotipe 3 dibandingkan genotipe 1. Di Indonesia sendiri belum ada data mengenai pencapaian SVR 12 pada kedua genotipe ini yang menggunakan terapi sofosbuvir-daclatasvir. Tujuan: Mengetahui pencapaian SVR 12 pasien hepatitis C Kronik genotipe 3 dibandingkan genotipe 1 yang mendapatkan terapi sofosbuvir-daclatasvir.Metode: Penelitian ini merupakan studi kohort retrospektif dengan menggunakan data sekunder yang melibatkan 209 pasien hepatitis C kronik genotipe 3 dan 1. Dilakukan analisis dengan membagi pasien menjadi dua kelompok yaitu genotipe 3 dan 1 serta dibandingkan dengan pencapaian keberhasilan SVR 12 menggunakan uji chi-square. Faktor sirosis hepatis dan usia yang dianggap dapat memengaruhi keberhasilan SVR 12 dianalisis dengan menggunakan uji chi-square kemudian dilanjutkan dengan analisis regresi logistik.Hasil: Sampel berjumlah 209 pasien yang terdiri dari 45 pasien genotipe 3 dan 164 pasien genotipe 1. Pencapaian keberhasilan SVR 12 pada genotipe 3 dan 1 yaitu 84,4% dan 98,8%. Kelompok pasien genotipe 3 memiliki keberhasilan SVR 12 lebih rendah dibandingkan kelompok pasien genotipe 1 dengan adjusted OR=0,065 (IK95% 0,013-0,330) dan ARR 14,4%. Sirosis hepatis dan usia tidak memengaruhi keberhasilan SVR 12 (p=1,00 dan p=0,72). Sejumlah 5 dari 9 pasien yang mengalami kegagalan memiki koinfeksi dengan HIV. Simpulan: Pasien hepatitis C kronik genotipe 3 yang menggunakan terapi sofosbuvir-daclatasvir memiliki keberhasilan SVR 12 lebih rendah dibandingkan genotipe 1.

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ABSTRACTBackground. Chronic hepatitis C is a global health problem with high morbidity and mortality in the condition of cirrhosis and hepatocellular carcinoma. sofosbuvir-daclatasvir is pangenotypic therapy that expected to overcome this disease. However, the achievement of SVR 12 was varied and lower in genotype 3 compared to genotype 1. In Indonesia, there is no data about achievement SVR 12 in both genotypes using sofosbuvir-daclatasvir.Objectives. To know SVR 12 achievement between genotype 3 and 1 chronic hepatitis C patients that using sofosbuvir-daclatasvir therapy.Methods. This study is a retrospective cohort using secondary data of 209 hepatitis C chronic genotype 3 and 1. Samples were divided into two groups according to its genotype and compared with achievement of SVR 12 then analyzed using chi-square test. Hepatic cirrhosis and age factors that are considered to affect the achievement SVR 12 were analyzed using chi-square test and logistic regression test.Results. 209 patients participated in this study consisting of 45 genotype 3 and 164 genotype 1. Achievement of SVR 12 succeed in genotypes 3 and 1 were 84,4% and 98,8%. Genotype 3 patients had lower SVR 12 achievement compared to genotype 1 patients with adjusted OR=0,065 (95% CI 0,013-0,330) and ARR 14,4. Hepatic cirrhosis and ages did not affect SVR 12 (p= 1.00 and 0,72, respectively). Five from nine patients who failed have co-infection with HIV.Conclusions. Chronic hepatitis C patients using sofosbuvir-daclatasvir theraphy had lower SVR 12 achievement in genotype 3 than genotype 1."

"Latar Belakang: Saat ini hubungan antara kejadian SVR12 pasien hepatitis C, profil lipid, dan steatosis hati masih belum jelas. Hasil publikasi yang ada saat ini masih tidak konsisten mengenai perubahan nilai parameter tersebut pasca SVR12. Di Indonesia sendiri, belum ada penelitian yang mengevaluasi kejadian steatosis hati pasca SVR12, padahal karakteristik populasi di Indonesia berbeda dengan populasi negara lain. Penelitian ini bertujuan untuk meneliti perubahan derajat steatosis hati dan profil lipid pada pasien hepatitis C saat SVR12 dan mencari hubungannya.Metode: Penelitian dengan desain longitudinal, before and after study yang dilakukan di Rumah Sakit Cipto Mangunkusumo (RSCM). Penelitian dilakukan selama 1 tahun di Poliklinik Hepatobilier, Ruang Prosedur Terpadu (RPT) Divisi Hepatobilier. Pasien yang memenuhi kriteria inklusi akan diikutsertakan dan diperiksa profil lipid dan nilai controlled attenuated parameter sebelum dan sesudah terapi.Hasil: Rerata SD sampel penelitian adalah 45±8.78 tahun. Subjek sebagian besar (62%) berjenis kelamin laki-laki. Nilai rerata SD CAP meningkat, sebelum terapi 196±49.36 dB/m dan setelah terapi 227±47.11 dB/m. Nilai rerata SD kolesterol total meningkat, sebelum terapi 166±40.30 mg/dL dan setelah terapi 190±42.58 mg/dL. Nilai rerata SD trigliserida, sebelum terapi 94±45.39 mg/dL dan setelah terapi 109±49.83 mg/dL. Nilai rerata SD HDL meningkat, sebelum terapi 44.4±15.02 mg/dL dan setelah terapi 47.0±17.20 mg/dL. Nilai rerata SD LDL meningkat, sebelum terapi 109.48±39.57 mg/dL dan setelah terapi 130.88±34.32 mg/dL. Tidak ditemukan korelasi korelasi delta berbagai jenis kolesterol dengan delta CAP. Ditemukan adanya korelasi negatif antara nilai CAP pada pasien hepatitis C sebelum terapi dan perubahan nilai CAP sesudah terapi DAA. Terdapat penurunan nilai rerata SD kekakuan hati, sebelum terapi 6.90±2.34 kPa dan setelah terapi 5.35±1.79 kPa. Terdapat penurunan nilai median APRI, sebelum terapi 0.50 (0.3 – 0.7) dan setelah terapi 0.20 (0.20 – 0.30).Simpulan: 1) Terdapat perbedaan derajat steatosis hati sebelum terapi dan saat SVR12 pada pasien hepatitis C yang mendapat terapi DAA. 2) Terdapat perbedaan kadar kolesterol total, kolesterol HDL, kolesterol LDL, dan trigliserida sebelum terapi dan saat SVR12 pada pasien hepatitis C yang mendapat terapi DAA. 3) Tidak terdapat korelasi perubahan kadar kolesterol total, kolesterol HDL, kolesterol LDL, dan trigliserida terhadap derajat steatosis hati saat SVR12.

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Background: Currently, the relationship between hepatitis C patients' SVR12 events, lipid profiles and liver steatosis remains unclear. Current publications are inconsistent regarding the changes in these parameters after SVR12. In Indonesia alone, there are no studies evaluating the incidence of liver steatosis after SVR12, even though the characteristics of the population in Indonesia are different from those in other countries. This study aims to examine changes in the degree of hepatic steatosis and lipid profile in hepatitis C patients during SVR12 and find out the relationship.

Method: Longitudinal design, before and after study conducted at Cipto Mangunkusumo Hospital (RSCM). The study was conducted for 1 year at the Hepatobiliary Polyclinic, Integrated Procedure Room of the Hepatobiliary Division. Patients who met the inclusion criteria were included and examined for lipid profile and controlled attenuated parameter values before and after therapy.

Results: The mean age SD is 45±8.78 years. Subjects were mostly (62%) male. The mean SD value of CAP increased, before therapy 196±49.36 dB/m and after therapy 227±47.11 dB/m. The mean SD value of total cholesterol increased, before therapy 166±40.30 mg/dL and after therapy 190±42.58 mg/dL. The SD mean value of triglycerides, before therapy 94±45.39 mg/dL and after therapy 109±49.83 mg/dL. The mean SD value of HDL increased, before therapy 44.4±15.02 mg/dL and after therapy 47.0±17.20 mg/dL. The mean SD value of LDL increased, before therapy 109.48±39.57 mg/dL and after therapy 130.88±34.32 mg/dL. There was no correlation between the delta of various types of cholesterol and the delta of CAP. There was a negative correlation between CAP values in hepatitis C patients before therapy and changes in CAP values after DAA therapy. There was a decrease in the mean SD value of liver stiffness, before therapy 6.90±2.34 kPa and after therapy 5.35±1.79 kPa. There was a decrease in the median APRI value, before therapy 0.50 (0.3 - 0.7) and after therapy 0.20 (0.20 - 0.30).

Conclusion: 1) There is a difference in the degree of liver steatosis before therapy and after SVR12 in hepatitis C patients who received DAA therapy. 2) There are differences in total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride levels before therapy and after SVR12 in hepatitis C patients who received DAA therapy. 3) There is no effect of changes in total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides before therapy and after SVR12 on the degree of liver steatosis after SVR12."

"[Association between SNP IL-28B and Sustained Virological Response and Its Relation with Expression of Interferon Lambda-3 and Interferon Lambda-3 Receptor in Liver Tissues of Chronic Hepatitis C Patients Treated with Pegylated Interferon α2 and Ribavirin;Association between SNP IL-28B and Sustained Virological Response and Its Relation with Expression of Interferon Lambda-3 and Interferon Lambda-3 Receptor in Liver Tissues of Chronic Hepatitis C Patients Treated with Pegylated Interferon α2 and Ribavirin, Association between SNP IL-28B and Sustained Virological Response and Its Relation with Expression of Interferon Lambda-3 and Interferon Lambda-3 Receptor in Liver Tissues of Chronic Hepatitis C Patients Treated with Pegylated Interferon α2 and Ribavirin]"

"[ABSTRAKLatar Belakang. SNP IL-28B mempunyai peran penting dalam pencapaian SVR pada pengobatan Hepatitis C kronik antarras manusia dan berpotensi untuk memprediksi keberhasilan terapi Peg-IFN/RBV maupun penyembuhan spontan Hepatitis C akut. Hingga saat ini, mekanisme molekular yang mendasari kaitan SNP IL-28B dengan respons terapi masih belum jelas meskipun diperkirakan terkait dengan ekspresi IFN-l3 dan reseptor IFN-l3 di jaringan hati.Tujuan. Mengetahui hubungan SNP IL-28B dan SVR serta ekspresi IFN-l3 dan reseptor IFN-l3 di jaringan hati serta mendapatkan kemaknaan klinis SNP IL-28B dan kovariat SVR dalam memprediksi respons terapi Peg-IFN/RBV.Metode. Penelitian ini terbagi menjadi dua bagian. Pertama, penelitian potong lintang pada pasien Hepatitis C kronik yang telah selesai menjalani terapi Peg-IFN/RBV dengan melakukan pengambilan data dasar dan sampel darah. Kedua, penelitian kasus kontrol pasien yang menjalani biopsi hati dan pewarnaan imunohistokimia.Hasil. Pencapaian SVR yang lebih tinggi ditemukan pada pasien dengan alel CC SNP IL28B (p=0,014). Alel CC SNP IL28B mempunyai ekspresi IFN-l3 lebih tinggi dibandingkan dengan alel non-CC (p = 0,018). Meskipun demikian, tidak ditemukan adanya perbedaan bermakna antara ekspresi IFN-l3 (p = 0,237) maupun reseptor IFN-l3 dengan SVR (p = 0,237). Pada penelitian ini, diformulasikan persamaan faktor risiko pencapaian SVR sebagai p = 1 / (1 + e-y); e = 2,7, y = -2,498 + 2,652 (SNP IL-28B) + 2,029 (trombosit) untuk praterapi dan sedangkan untuk masa terapi y = -0,223 + 2,621 (RVR).Simpulan. SNP IL-28B merupakan faktor risiko praterapi yang penting dalam pengobatan hep C kronik G1 menggunakan terapi dua kombinasi. Alel mayor IL28B mengekspresikan IFN-l3 dan reseptornya lebih banyak sebagai respons adanya VHC, namun tidak ditemukan adanya hubungan hal tersebut dengan pencapaian SVR. RVR merupakan faktor masa terapi terbaik untuk memprediksi SVR. Penelitian lanjutan diperlukan untuk membuktikan adanya faktor lain yang berperan dalam pencapaian SVR.;

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ABSTRACTBackground: SNP IL-28B played an important role in achieving sustained virological response (SVR) among different ethnics in chronic Hepatitis C patients and is considered potential in predicting treatment response of Pegylated interferon/ribavirin (Peg-IFN/RBV) combination and spontaneous clearance in acute hepatitis. Up to date, molecular mechanism underlying correlation between SNP IL28B and SVR has not been fully understood yet although it is predicted to be related to IFN-λ3 and IFN-λ3 receptor in liver tissues.Aim: Understanding the association between SNP IL-28B and SVR in chronic Hepatitis C treatment and expression of IFN-l3 and IFN-l3 receptor in liver tissues to evaluate clinical importance of SNP IL-28B examination in Hepatitis C treatment of Peg-IFN/RBV through SVR prediction model.Methods: This study consisted of two parts. First, a cross-sectional study on chronic Hepatitis C patients who completed Peg-IFN/RBV therapy. The second part was case control study on patients underwent liver biopsy and immunohistochemical staining.Results: Sustained virological response was significantly higher in CC allele of SNP IL-28B compared to non CC allele (p = 0.015). Higher expression of IFN-l3 was found in CC allele compared to non CC allele (p = 0.018). On the other hand, there is no significant difference between SVR and expression of IFN-l3 (p = 0.237) and IFN-l3 receptor (p = 0.237). Risk factor for SVR probability were formulated into p = 1 / (1 + e-y); e = 2.7, y = -2.498 + 2.652 (SNP IL-28B) + 2.029 (thrombocytes) for pretreatment while for on treatment risk factor y = -0.223 + 2.621 (RVR)Conclusion: SNP IL-28B was important pretreatment risk factor in genotype 1 chronic Hepatitis C treated with dual therapy. Major allele of IL-28B expressed more IFN-l3 and its receptor in response to HCV although no association between both factors was found. RVR was the best on treatment factor for SVR. Further evaluation study was required to find other possible factors affecting SVR achievement, Background: SNP IL-28B played an important role in achieving sustained virological response (SVR) among different ethnics in chronic Hepatitis C patients and is considered potential in predicting treatment response of Pegylated interferon/ribavirin (Peg-IFN/RBV) combination and spontaneous clearance in acute hepatitis. Up to date, molecular mechanism underlying correlation between SNP IL28B and SVR has not been fully understood yet although it is predicted to be related to IFN-λ3 and IFN-λ3 receptor in liver tissues.Aim: Understanding the association between SNP IL-28B and SVR in chronic Hepatitis C treatment and expression of IFN-l3 and IFN-l3 receptor in liver tissues to evaluate clinical importance of SNP IL-28B examination in Hepatitis C treatment of Peg-IFN/RBV through SVR prediction model.Methods: This study consisted of two parts. First, a cross-sectional study on chronic Hepatitis C patients who completed Peg-IFN/RBV therapy. The second part was case control study on patients underwent liver biopsy and immunohistochemical staining.Results: Sustained virological response was significantly higher in CC allele of SNP IL-28B compared to non CC allele (p = 0.015). Higher expression of IFN-l3 was found in CC allele compared to non CC allele (p = 0.018). On the other hand, there is no significant difference between SVR and expression of IFN-l3 (p = 0.237) and IFN-l3 receptor (p = 0.237). Risk factor for SVR probability were formulated into p = 1 / (1 + e-y); e = 2.7, y = -2.498 + 2.652 (SNP IL-28B) + 2.029 (thrombocytes) for pretreatment while for on treatment risk factor y = -0.223 + 2.621 (RVR)Conclusion: SNP IL-28B was important pretreatment risk factor in genotype 1 chronic Hepatitis C treated with dual therapy. Major allele of IL-28B expressed more IFN-l3 and its receptor in response to HCV although no association between both factors was found. RVR was the best on treatment factor for SVR. Further evaluation study was required to find other possible factors affecting SVR achievement]"

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Latar Belakang: Pasien yang menjalani hemodialisis berisiko terinfeksi virus hepatitis C (VHC). Infeksi VHC kronis meningkatkan mortalitas terkait penyakit hati dan kardiovaskular. Direct Acting Anti-viral(DAA) adalah pilihan terapi untuk infeksi VHC pada pasien dengan Penyakit Ginjal Kronis (PGK) termasuk pasien hemodialisis. Namun sampai sekarang pengobatan infeksi VHC pada pasien hemodialisis masih belum optimal karena sebagian besar metabolit DAA diekskesikan melalui ginjal. Grazoprevir dan elbasvir adalah obat pilihan untuk infeksi VHC kronis pada pasien hemodialisis serta memiliki efek anti-virus yang kuat dan efek samping yang minimal. Namun, respons terapeutik dari grazoprevir dan elbasvir pada pasien hemodialisis rutin di Indonesia dan faktor-faktor yang berhubungan masih belum diketahui.

Tujuan:Menilai respon terapeutik grazoprevir dan elbasvir untuk infeksi VHC kronis pada pasien hemodialisis rutin dan faktor-faktor yang berhubungan dengan sustained virological responsepada 12 minggu setelah akhir pengobatan (SVR12).

Metode:Studi kohort prospektif observasional pada semua pasien hemodialisis rutin dengan infeksi VHC kronis yang mendapatkan terapi grazoprevir dan elbasvir selama 12 minggu. Data klinis dan laboratorium, termasuk usia, jenis kelamin, baselineRNA VHC, derajat fibrosis hati, lamanya menjalani Hemodialisis dan pencapaian rapid virological response(RVR) dianalisis menggunakan metode analisis statistik bivariat untuk menentukan faktor yang terkait dengan SVR12.

Hasil:Tujuh puluh lima subyek memenuhi kriteria inklusi. Rata-rata usia adalah 50,2 ± 13,2 tahun, subjek dengan prevalensi perempuan lebih dari laki-laki. Durasi rata-rata hemodialisis adalah 6,9 ± 4,7 tahun. Keberhasilan SVR12 adalah 97,2%. Risiko relatif SVR12 berdasarkan muatan virus <800.000 versus ≥800.000 adalah 1,01 (95% CI 0,93-1,10, p = 1,00), skor Metavir F4 dibandingkan dengan F0-F3 adalah 0,95 (95% CI 0,81-1,10 p = 0,35 ), pencapaian SVR12 pada lama hemodialisis <3 tahun versus ≥3 tahun adalah 1,04 (95% CI 0,99-1,09 p = 1,00). Dengan efek samping dari obat minimal. 

Kesimpulan:Terapi Grazoprevir dan elbasvir didapatkan efektif pada pasien hemodialisis dengan infeksi VHC kronis dengan efek samping yang minimal. SVR12 tidak dipengaruhi oleh muatan virus, derajat fibrosis atau lama hemodialisis

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Background:Patients on hemodialysis are at risk of hepatitis C virus (HCV) infection. Chronic HCV infection increases mortality related to chronic liver and cardiovascular disease. Direct Acting Anti-viral (DAA) is a therapeutic choice for HCV infection in patients with Chronic Kidney Disease (CKD) including patients who are hemodialysis-dependent. But until now the treatment of HCV infections in hemodialysis patients are suboptimum because most of the DAA metabolite eliminated by the kidney. Grazoprevir plus elbasvir is the drug of choice for chronic HCV infection in hemodialysis patients which has strong anti-viral effects and minimal adverse events. However, the therapeutic response of grazoprevir plus elbasvir in routine hemodialysis patients in Indonesia and the factors associated still unknown

Objective: Assessing therapeutic response of grazoprevir plus elbasvir for chronic HCV infection in routine hemodialysis patients and factors associated with sustained virological response at 12 weeks after the end of treatment (SVR12). 

Methods: Observational prospective cohort study on all routine hemodialysis patients with chronic HCV infection that received grazoprevir plus elbasvir for 12 weeks. Clinical and laboratory data, including age, gender, baseline HCV RNA, degree of liver fibrosis, duration of hemodialysis treatment and achievement of rapid virological response (RVR) were analyzed using bivariate method of statistical analysis for determining factors related to SVR12. 

Results: Seventy-five subjects met inclusion criteria. The average age is 50.2±13.2 years, subjects with female were more than male. The average duration of hemodialysis is 6.9±4.7 years. SVR12 achievement is 97,2%. Relative risk of SVR12 based on viral load <800,000 versus ≥  800,000 were 1.01 (95%CI 0.93-1.10, p=1.00), score Metavir F4 versus to F0-F3 were 0,95 (95%CI 0.81-1.10 p=0.35), achieved RVR duration of hemodialysis <3 years versus ≥3 years were 1,04 (95%CI 0.99-1.09 p=1.00). The adverse effect of this drug is minimal. 

 

Conclusions: Grazoprevir plus elbasvir therapy in hemodialysis patients with chronic HCV is an effective, and minimal adverse event. SVR12 is not influenced by either viral load, degree of fibrosis or duration of hemodialysis.

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"Latar Belakang: Pasien yang menjalani hemodialisis (HD) rutin berisiko terinfeksi virus hepatitis C (VHC). Infeksi VHC kronik meningkatkan mortalitas terkait penyakit hati kronik dan kardiovaskuler.Direct Acting Anti-viral(DAA) merupakan pilihan terapi infeksi VHC pada pasien Penyakit Ginjal Kronik, tetapi sebagian besar DAA mengandung metabolit yang diekskresi melalui ginjal. Grazoprevir-elbasvir (GZR-EBV) adalah pilihan utama DAA untuk terapi infeksi VHC pada pasien HD rutin dengan keberhasilanSustained Virological Response(SVR)>90% dan adverse eventyang minimal. Namun masih belum diketahui keberhasilan terapi GZR-EBV dan faktor-faktor yang mempengaruhinya pada pasien HD rutin di Indonesia yang memiliki perbedaan genotip VHC dan genotip pasien HD. Tujuan: Menilai keberhasilan terapi GZR-EBV dan faktor-faktor yang berhubungan dengan keberhasilan terapi pada pasien HD dengan Hepatitis C kronik dan mengetahui gambaran adverse event. Metode: Penelitian ini merupakan studi kohort prospektif observasional pada pasien HD dengan Hepatitis C kronik. Data klinis dan pemeriksaan penunjang dikumpulkan dan dianalisis untuk mengetahui respon terapi, dan untuk mengetahui asosisasi antara faktor muatan virus RNA VHC, derajat fibrosis dan lama HD dengan SVR12. Hasil: Didapatkan 75 subyek yang memenuhi kriteria inklusi. Rerata usia 50,2±13,2 tahun, jenis kelamin perempuan lebih banyak ditemukan. Lama HD 6,9±4,7tahun. Keberhasilan SVR12 mencapai 97,2%. Risiko relatif keberhasilan SVR12 berdasarkan muatan virus <800.000 IU/mL dibandingkan³800.000 IU/mL adalah 1,01 (IK 95% 0,93-1,10; p=1,00), derajat fibrosis hati skor Metavir F4 dibandingkan F0-F3 adalah 0,95 (IK 95% 0,81-1,10; p=0,35) dan lama HD <3 tahun dibandingkan ≥3 tahun adalah 1,04 (IK 95% 0,99-1,09; p=1,00). Adverse eventobat minimal. Simpulan: Terapi GZR-EBV pada pasien hepatitis C kronik yang menjalani HD rutin menunjukkan efektifitas yang baik, dengan adverse eventminimal. Keberhasilan terapi tidak dipengaruhi oleh jumlah muatan virus, derajat fibrosis dan lama HD.

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Background: Patients on hemodialysis are at risk of hepatitis C virus (HCV) infection. Chronic hepatitis C virus infection increases mortality related to chronic liver and cardiovascular disease. Direct Acting Anti-viral (DAA) is a therapeutic choice for HCV infection in patients with Chronic Kidney Disease, but most of the DAA metabolite eliminated by the kidney. Grazoprevir-elbasvir is the drug of choice for chronic HCV infection in hemodialysis patients, and have Sustained Virological Response (SVR) >90% and less adverse event. However, therapeutic response and the factors that influence this drug in routine HD patients in Indonesia is still unknown. Objective: Assessing therapeutic response and side effects of grazoprevir-elbasvir for Hepatitis C Virus in routine hemodialysis patient. Methods: Observational cohort prospective study on all patients with Chronic HCV infection with routine HD. Clinical and laboratory data were analyzed for therapeutic response and determined the factors that related to therapeutic response. Viral load, degree of liver fibrosis, and duration of HD treatment and relation with response SVR12 as analyzed using bivariate method of statistical analysis. Results: Seventy-five subjects met inclusion criteria. The average age is 50.2±13.2 years, subjects with female were more than male. The average duration of HD is 6.9±4.7 years. SVR12 achievement is 97.2%. Relative risk of SVR12 based on viral load <800,000 versus ³800,000 were 1.01 (95%CI 0.93-1.10 p=1.00), Score Metavir F4 versus to F0-F3 were 0.95 (95%CI 0.81-1.10 p=0.35), duration of HD <3 years versus ≥3 years were 1.04 (95%CI 0.99-1.09 p=1.00). The adverse event of this drug is minimal. Conclusions: Grazoprevir-elbasvir therapy in HD patient with chronic HCV is effective, and minimal adverse event. SVR12 is not influenced by either viral load, degree of fibrosis or duration of HD."

"Latar Belakang. Salah satu terapi standar hepatitis C kronik adalah terapi kombinasi interferon alfa (IFN) dan ribavirin (RIB). Namun terapi kombinasi tersebut dapat menimbulkan efek samping anemia. Anemia menyebabkan dosis ribavirin harus diturunkan atau dihentikan sementara yang mengakibatkan penurunan keberhasilan terapi hepatitis C kronik. Oleh karena itu perlu diketahui prevalensi dan faktor risiko anemia pada pasien yang menjalani terapi kombinasi agar anemia dapat diantipasi dan diawasi lebih cermat pada pasien dengan faktor risiko tersebut. Penelitian semacam ini belum pernah dipublikasi di Indonesia.Tujuan. Mengetahui prevalensi dan faktor risiko terjadinya anemia pada pasien hepatitis C kronik yang menjalani terapi interferon alfa dan ribavirin serta mengetahui frekuensi pasien anemia yang mengalami penurunan dan penghentian ribavirin.Metodologi. Pasien hepatitis C kronik yang mendapat pengobatan berupa terapi kombinasi interferon alfa-ribavirin oleh staf divisi Hepatologi FKUIIRSCM diikutsertakan dalam penelitian. Data yang dikumpulkan meliputi anamnesis, pemeriksaan fisik dan pemeriksaan darah tepi pada minggu ke 8 terapi kombinasi. Penelitian menggunakan desain cross sectional dengan variabel yang diteliti adalah umur, jenis kelamin, genotip, dosis ribavirin dan, kadar hemoglobin awal terapi.Hasil. Enam puluh satu subyek penelitian terdiri dari pria 47 (77%), wanita 14 (23%) dan usia rerata 38,9 tahun, 23 (71,9 %) subyek mempunyai genotip 1 dan 4, dan 44 (72,1 %) subyek mendapat dosis ribavirin 1000 mg. Prevalensi anemia sebesar 52,5 % (32 subyek). Dari analisis multivariat hanya kadar hemoglobin awal terapi yang rendah yang berhubungan bermakna dengan anemia.. Jumlah pasien anemia yang mengalami penurunan dosis ribavirin adalah 8 dari 32 pasien anemia.Kesimpulan. Prevalensi anemia pada terapi kombinasi 52,5 %. Kadar hemoglobin awal terapi < 14 gldl merupakan faktor risiko terjadinya anemia sehingga pengawasan lebih ketat dan intervensi terhadap anemia dapat dilakukan pada pasien dengan faktor risiko tersebut. Meskipun umur ? 50 tahun, dan wanita belum terbukti sebagai faktor risiko anemia namun harus tetap menjadi perhatian. Delapan subyek (25 %) Ban 32 pasien anemia memerlukan penurunan dosis ribavirin dan tidak ada yang mengalami penghentian ribavirin.

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Background. Interferon alfa and ribavirin combination therapy is one of effective standard therapy for chronic hepatitis C. However, anemia is a common side effect of this therapy. Therefore, patients have to reduce or discontinue ribavirin therapy and this can reduce the effectivity of the therapy. Hence, it is important to know the prevalence of anemia and to determine the factors associated with anemia.

Objective. To determine the prevalence of anemia and some risk factors associated with anemia caused by combination therapy in chronic hepatitis C, also to know frequencies of anemia patients who received dose reduction or discontinuation ribavirin therapy.

Method. Sixty one patient of chronic hepatitis C received combination therapy from staff of Hepatology Division FKUIfRSCM were included in the study. Data were obtained by anamnesis, physical examination, and measured complete blood count on 8`h week of therapy. This study was conducted by using cross sectional design.

Result. Subjects were 47 males (77%), females 14 (23%) with mean age 38.9 years. Twenty three subjects had genotype 1 and 4 (71.9%) and 44 subject (72.1) received 1000 mg ribavirin. Prevalence of anemia was found to be 52.5 % (32 subjects). It was concluded that risk factors of anemia are: age > 50 years, females, low pretreatment hemoglobin concentration (<14 gldl) were risk factors of anemia. On multivariate analysis only pretreatment hemoglobin concentration < 14 g/dl was determined to be the risk factor of anemia There were 8 subjects from 32 anemia patients had ribavirin reduction, and no patient had discontinuation treatment on Bch week of therapy.

Conclusion. Prevalence anemia was 52,5 % and pretreatment hemoglobin concentration <14 gldl were found to be the risk factors of anemia. Although age > 50 years and female were not yet found to be risk factors of anemia, we should be careful of these risk factors. Therefore patient with these risk factors should be carefully monitored and intervention to prevent anemia should be considered. Eight subjects from 32 anemia patients had ribavirin reduction, and no patient had discontinuation treatment on 8`h week of therapy."

"Karsinoma hepatoseluler (KHS) adalah salah satu kanker dengan laju mortalitas tertinggi di dunia. Kadar serum alfa-fetoprotein (AFP) dapat digunakan sebagai biomarker untuk menegakkan diagnosis dini. Tetapi, perbandingan antara kadar serum AFP dan KHS dengan etiologi infeksi virus dan etiologi non infeksi virus belum diketahui. Mengetahui perbandingan antara kadar serum AFP dan KHS dengan etiologi infeksi virus dan etiologi non infeksi virus. Penelitian potong lintang dilakukan di RSUPN Cipto Mangunkusumo, Jakarta pada Januari-Oktober 2018 dengan melihat data rekam medis dari 287 pasien yang terdiagnosis KHS dalam periode 2013-2017. Nilai median (minimum-maksimum) dari kadar AFP pada pasien KHS dengan etiologi infeksi VHB atau VHC adalah 419 (0.8-400.000). Nilai median (minimum-maksimum) kadar AFP pada pasien KHS dengan etiologi non infeksi VHB-VHC adalah 7.18 (0.6-90.944). Terdapat perbedaan bermakna antara kadar AFP dengan KHS dengan etiologi infeksi VHB atau VHC dan etiologi non infeksi VHB-VHC.

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Hepatocellular carcinoma (HCC) is one of the highest rates of mortality in the world. Serum alpha-fetoprotein (AFP) levels can be used as a biomarker for early diagnosis. However, the comparison between serum AFP and HCC with viral infections etiology and non-viral etiology is unknown. This research aims to determine the comparison between serum AFP and HCC with viral infections etiology and non-viral aetiology. A cross-sectional study conducted in Cipto Mangunkusumo Hospital, Jakarta in January to October 2018 by reviewing 287 medical records of patients diagnosed with HCC from 2013-2017 period of time. The median (minimum-maximum) value of AFP levels in HCC patients with the etiology of HBV or HCV infection is 419 (0.8-400,000). The median value (minimum-maximum) of AFP levels in HCC patients with the etiology of non HBV-HCV infection was 7.18 (0.6-90,944). There were significant differences between AFP levels and KHS with the etiology of HBV or HCV infections and the etiology of non HBV-HCV infections."

"Pendahuluan: Imatinib mesilat (IM) merupakan tirosin kinase inhibitor pertama yang disetujui untuk terapi LGK. Imatinib cukup efektif, tapi diperkirakan sekitar 20-30% pasien mengalami resistensi terhadap imatinib. Kurang lebih 40% resistensi terhadap imatinib berhubungan dengan mutasi pada domain kinase BCR-ABL. Mutasi yang paling umum terjadi dan paling berbahaya adalah mutasi T315I. Penelitian ini bertujuan untuk menilai hubungan antara mutasi T315I dan pencapaian major molecular response (MMR) pada pasien LGK. Penelitian ini juga memeriksa adanya mutasi lain yang letaknya berdekatan dengan mutasi T315I yaitu F311I dan F317L.Metode: Penelitian ini merupakan suatu penelitian potong lintang (cross-sectional). Pada penelitian ini, sebesar 120 sampel darah dianalisis dari pasien LGK pada fase kronik yang mendapat imatinib mesilat selama ≥12 bulan. Dilakukan sekuensing dengan metode Sanger untuk mendeteksi adanya mutasi T315I, F311I, dan F317L.Hasil: Tidak terdapat mutasi T315I, F311I, dan F317L yang ditemukan pada penelitian ini. Akan tetapi didapat adanya 36 substitusi dari A ke G pada posisi 163816 (posisi intron).Kesimpulan: Tidak terdapat mutasi T315I, F311I, dan F317L yang ditemukan pada penelitian ini. Hal ini mengindikasikan bahwa terdapat faktor lain yang mempengaruhi pencapaian MMR pada penelitian iniKata Kunci: imatinib, BCR-ABL, T315I, F311I, leukemia granuloitik kronik

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Background: Imatinib mesylat (IM) is the first tyrosine kinase inhibitor (TKI) that is approved for CML therapy. Imatinib is effective enough, but it is predicted that 20-30% patients  develop resistance to imatinib. Approximately, 40% of imatinib resistance is associated with BCR-ABL kinase domain mutation. The most common and dangerous mutation is T315I. This study aims to examine the association of  T315I mutation and major molecular response (MMR) achievement in CML patients. This study also examine other mutations adjacent to T315I, i.e F311I and F317L.Methods: This is a cross-sectional study. In this study, we analyze 120 blood samples (whole blood) from CML patients in chronic phase who have received imatinib mesylate (IM) for ≥12 months.Results: There is no T315I, F311I, dan F317L mutation found in this study. However we found   36 substitutions from A to G in position 163.816 (according to NG_012034.1)Conclusions: There is no T315I, F311I, and F317L mutations found in this study. It suggests that there are other factors that influence the MMR achievement in our patients.Keyword: imatinib, BCR-ABL, T315I, F311I, chronic myeloid leukemia"

"ABSTRAKPenyakit Hepatitis C yang disebabkan oleh virus Hepatitis C HCV telah menjadi masalah kesehatan serius di banyak Negara. Beberapa studi menunjukkan bahwa komponen utama reaksi imun protektif terhadap HCV adalah respon yang tinggi dari sel T CD 8 dan CD 4 terhadap bagian target dari HCV yang berikatan dengan MHC kelas I dan II yang dipresentasikan kepada sel T. Untuk reaksi imun protektif dibutuhkan respon sel T yang menghasilkan sitokin yang tepat dan memperbanyak diri dengan baik. Untuk mengatasi problem keberagaman dari HCV, maka dirancanglah konstruk yang relatif conserve. Protein core hingga saat ini merupakan bagian paling conserve dari HCV yang dapat menimbulkan reaksi sel T CD 8 bila dapat berikatan dengan MHC kelas I. Dalam penelitian ini dirancang gen pengkode protein CoreE1E2 menggunakan DNA sintetik untuk dikonstruk sebagai kandidat vaksin DNA menggunakan plasmid ekspresi mamalia pCI. Ekspresi protein tersebut dilakukan pada cell line manusia Hep2. Konstruksi pCI-Core-E1-E2 mampu mengekspresikan protein Core-E1-E2 pada sel Hep2 dengan tingkat ekspresi tertinggi pada 48 jam.

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ABSTRACTHepatitis C is a contagious liver disease that results from infection with hepatitis C virus HCV which now have became serious health problem in many countries. There was evidence that the main component of protective immunity against HCV are the high response from both CD 8 T cells and CD 4 T cells against part HCV target which binds with MHC class I and II that will be presented to T cells. T cells have to face HCV diversity problems, but they also could target the internal part of the virus which relatively more conserve. For a protective immune response, T cell response to produce cytokines and could proliferate was needed. With this reason, a construct was made which has a conserve region of HCV that could trigger CD 8 T cell reaction with DNA Vaccine technique. Until now, Core Protein is the most conserve part from HCV which could trigger the CD 8 T cell reaction when it bound with MHC I. HCV protein CoreE1E2 coding gene was designed in this research using synthetic DNA to be constructed into mammalian expression plasmid pCI as a DNA vaccine candidate. pCI Core E1 E2 construct can express Core E1 E2 protein in Hep2 cell line with the highest expression rate in 48th hour."