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Background It is estimated that approximately 10 million individuals in Pakistan are infected with hepatitis C virus (HCV). Historically, it was very difficult not just to cure but even treat HCV as available options did not have desirable outcomes. However, the approval of directly acting antiviral (DAA) drugs has revolutionized treatment and management. These are specific proteases and polymerase inhibitors with profound capability for accomplishing elimination and overtime eradication of the virus. Objective The aim of this study was to evaluate the efficacy and safety of sofosbuvir (SOF) in combination with ribavirin (RIB) for the treatment of chronic hepatitis C virus with genotype 3. Materials and methods This prospective observational study was conducted at the gastroenterology section of Medical Unit IV, Jinnah Post-graduate Medical Center, Karachi and Medical Unit II, Dow University of Health Sciences, Ojha Campus, Karachi from January 2016 to December 2016. Patients aged 18 years or older of either gender having chronic active HCV infection as demonstrated by a positive Anti-HCV (ELISA) test and a qualitative polymerase chain reaction (PCR) analysis along with genotype analysis showing only type 3 were inducted into the study. Treatment was initiated with either 12-week or 24-week regimen of SOF 400 mg once daily along with weight-adjusted RIB orally. Successful treatment was indicated by the elimination of the virus, i.e., undetectable viral load/levels by PCR qualitative analysis. Rapid virological response (RVR), end of treatment response (ETR), and sustained virological response (SVR) were defined as the undetectable viral load at four, 12, and 24 weeks, respectively. Results A total of 300 patients were inducted into the study, predominantly female (57%). The mean age of presentation was 41.14 ± 11.48, and most (70.33%) were treatment naïve. The mean alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) levels at presentation were 41.89 ± 46.23 IU/l, 68.57 ± 83.62 IU/l, and 54.52 ± 77.57 IU/l, respectively. ALT, AST, and GGT levels at 24 weeks were 33.84 ± 13.60 IU/l, 32.44 ± 16.16 IU/l, and 37.59 ± 22.41 IU/l, respectively, showing significant improvement. ETR was achieved in 99.1% (209) treatment-naïve patients and 98.9% (88) treatment-experienced patients. SVR rates were almost similar with 98% (208) achieving it in the treatment-naïve group and 96.6% (86) achieving it in the treatment-experienced group. Conclusion SOF in combination with RIB is safe and remarkably efficacious in the treatment of chronic HCV, genotype 3. Not only is this regimen associated with the elimination of viral replication but it also improved transaminase levels. Outcomes are rarely, if ever, affected by previous use of antiviral medications.
RESUMO
Introduction Hepatitis C virus (HCV) is the leading cause of cirrhosis. The advent of Directly Acting Antivirals (DAAs) like Sofosbuvir (SOF) has dramatized the treatment and is the cornerstone for the treatment of HCV. Most trials have been conducted in HCV genotype 1 (GT-1) and data for Interferon-free regimen in genotype 3 (GT-3) is limited especially in cirrhotic patients. Aim To evaluate the safety and efficacy of SOF plus Ribavirin® (RIB) in patients with compensated and decompensated cirrhosis. Methods This was a quasi-experimental study in HCV patients with compensated and decompensated cirrhosis. Each group (compensated and decompensated) was further subdivided into the treatment-naïve and treatment-experienced groups. Efficacy was assessed by end treatment response (ETR) and sustained viral response (SVR) in the treatment-naïve and experienced groups. Adverse events were recorded on designed proforma on serial follow-up visits. Results The study consisted of 110 consecutive patients. Among 110 patients, 51 had compensated cirrhosis and 59 had decompensated cirrhosis. The mean age was 53.8 ± 11 years. Males were n=56 (50.9%) and females were n=54 (49.1%). All the patients in Child-Turcotte-Pugh class A were in the compensated group. CTP B class was found to be 10.5% and 89.5% in the compensated and decompensated groups, respectively, whereas all the patients in CTP class C were in the decompensated group. In the compensated cirrhosis group, ETR was achieved in 36 (87.8%) treatment-naïve and 8 (88.9%) experienced patients. In decompensated cirrhosis, treatment-naïve and experienced patients achieved ETR in 28 (82.4%) and 18 (85.7%) patients, respectively. Whereas in compensated cirrhosis treatment-naïve and experienced patients, SVR was achieved in 25 (83.3%) and five (71.4%), respectively. In decompensated cirrhosis, 21 (77.8%) treatment-naïve and 12 (75%) experienced patients achieved SVR. The most common adverse events experienced by the patients were fatigue followed by myalgia, nausea, and diarrhea. The new onset of complications found due to cirrhosis were ascites, followed by hepatoma, upper gastrointestinal bleed, portosystemic encephalopathy, acute on chronic liver failure, and death. Conclusion Sofosbuvir in combination with Ribavirin® is safe but suboptimal in treatment outcomes, particularly in treatment-experienced patients with decompensated cirrhosis than in treatment-naive patients with compensated cirrhosis due to HCV GT-3.
RESUMO
Background Hepatitis B virus (HBV) infection is a serious health problem in Pakistan. In view of the serious socioeconomic consequences, identifying patient characteristics and the current treatment for the disease will enhance HBV regulation and its medical management. Aims To describe the epidemiology, clinical characteristics, and current management status of patients infected by HBV. Methods We undertook an observational, cross-sectional, and epidemiological study at the Jinnah Postgraduate Medical Centre, Karachi, during the period from January 2014 to November 2017. Male and female patients of any age and with documentation for an HBV infection were eligible for inclusion in the study. An HBV infection was defined as a positive hepatitis B surface antigen test. Results A total of 500 patients were analyzed. The mean age at presentation was 29.86±13.68 years. The majority of the patients (25.6%) were ethnically Sindhi followed by Pathan (24.4%), indicating a high prevalence among the rural-based population of Pakistan. The mean duration of the disease was 3.51±4.46 years. The most common cause for the spread was positive family history (40.4%) followed by roadside barbers (30.0%). Most patients were Child-Pugh (CP) class A (84.6%) and the median Modified End-Stage Liver Disease (MELD) score was 7. Upper gastrointestinal bleeding was the most frequent hepatic complication (6.2%). Antiviral medications had been received by 18.6% of patients previously. Peg-interferon (6.0%) was the major antiviral medication prescribed to treatment-experienced patients. Conclusions This observational, real-life study has identified some gaps between clinical practice and guideline recommendations in Pakistan. To achieve better health outcomes, several improvements, such as disease monitoring and optimizing antiviral regimens, should be made to improve disease management.
