Sofosbuvir based therapy in Hepatitis C patients with and without cirrhosis: Is there difference?

Sarwar, Shahid; Khan, Abdul Wali

doi:10.12669/pjms.331.12163

Cited by 13 publications

(13 citation statements)

References 21 publications

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“…SOF-based dual or triple therapy has so far shown to be very effective in genotype 3 patients, with a SVR24 of 82.2–99.34%. However, the results are suboptimal, especially in patients with a decompensated liver and with or without significant fibrosis [ 69 , 70 , 71 , 72 ]. So far, the largest study with a cohort of 1375 patients from Lahore performed during 2014 to 2016 has also shown a remarkable SVR rate of 97–99% in genotype 3-infected patients after SOF treatment as double or triple therapy regime [ 73 ].…”

Section: Preliminary Data Regarding the Success Rate Of Daas Againmentioning

confidence: 99%

Current Status of Direct Acting Antiviral Agents against Hepatitis C Virus Infection in Pakistan

Khaliq

Raza

2018

Medicina

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In Pakistan, the burden of the hepatitis C virus (HCV) infection is the second highest in the world with the development of chronic hepatitis. Interferon-based combination therapy with ribavirin was the only available treatment until a few years back, with severe side-effects and high failure rates against different genotypes of HCV. Interferon-free all-oral direct-acting antiviral agents (DAAs) approved by the FDA have revolutionized the HCV therapeutic landscape due to their efficiency in targeting different genotypes in different categories of patients, including treatment naïve, treatment failure and relapsing patients, as well as patients with compensated and decompensated cirrhosis. The availability and use of these DAAs is limited in the developing world. Sofosbuvir (SOF), a uridine nucleotide analogue and inhibitor of HCV encoded NS5B polymerase, is now a widely available and in-use DAA in Pakistan; whereas daclatasvir was recently added in the list. According to the documented results, there is hope that this disease can be effectively cured in Pakistan, although a few concerns still remain. The aim of this article is to review the effectiveness of DAAs and the current status of this treatment against HCV genotype 3 infection in Pakistan; various factors associated with SVR; its limitations as an effective treatment regime; and future implications.

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Section: Preliminary Data Regarding the Success Rate Of Daas Againmentioning

confidence: 99%

Current Status of Direct Acting Antiviral Agents against Hepatitis C Virus Infection in Pakistan

Khaliq

Raza

2018

Medicina

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“…This study also showed that there was a statistically significant difference among the SVR achievers and failed patients with respect to baseline serum albumin, presence or absence of cirrhosis and CTP scores. 24 In the study by Reddy et al, the treatment of decompensated HCV patients with different regimens, including SOF and RBV showed that these drugs are safe and efficacious in this group with a SVR of 75% in G2. This study showed that lesser the MELD, higher the response rate.…”

Section: Discussionmentioning

confidence: 97%

Results of Sofosbuvir Plus Ribavirin in Patients With Hepatitis C Related Decompensated Cirrhosis

Tmu

Kumar

Sharma

et al. 2019

Journal of Clinical and Experimental Hepatology

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Background: Sofosbuvir (SOF), a direct acting antiviral, has revolutionized the treatment of chronic Hepatitis C Virus (HCV) infection. However, data is scarce about efficacy of SOF plus Ribavarin (RBV) in Indian patients with decompensated cirrhosis. We evaluated the efficacy of SOF plus RBV in decompensated cirrhosis, and compared the outcome with compensated cirrhosis and non-cirrhotics. Patients and methods: Consecutive decompensated cirrhotic patients of chronic HCV with detectable HCV RNA were treated with 24-week course of SOF (400 mg) plus weight based RBV. Sustained Virological Response (SVR), Child Turcotte Pugh (CTP) and Model for Endstage Liver Disease (MELD) scores were assessed at 36 weeks (i.e. 12 weeks after completion of therapy). Non-cirrhotic chronic hepatitis C patients and patients with compensated cirrhosis treated with SOF plus RBV during the same period were used as controls. During the period of this study ledipasvir and daclatasvir were not available in India. Results: A total of 47 patients [median age 50 (29-82) years, 64% males] with decompensated cirrhosis were included as 'cases' in the study; while, 27 patients with compensated cirrhosis and 29 patients with chronic hepatitis were included as 'controls'. Age, gender, HCV RNA levels, and genotype distribution were similar in cases and controls. The median CTP and MELD scores of cases were 8 (7-12) and 13 (6-25), respectively. Among cases 39 (83%) could complete the therapy, while 1 (2%) was intolerant and 7 (15%) died before completion of therapy. End of Treatment Response (ETR) was achieved in 37/39 (95%) cases. Of these, another 3 died before SVR, and 7 failed to achieve SVR, thus 27/34 (79%) could achieve SVR. Thus according to intention-to-treat analysis, only 27/47 (57%) cases could achieve SVR. In comparison, 24/28 (86%) compensated cirrhotics and 27/28 (96%) of chronic hepatitis achieved SVR. There was a significant improvement in mean CTP score in cases who achieved SVR (P < 0.01) compared to those who did not achieve SVR/ETR. On multivariate analysis the only independent factor influencing successful outcome patients was a serum albumin >3.5 g/dL. Conclusions: A 24-week course of SOF plus ribavirin in decompensated HCV cirrhosis could lead to SVR in only 57% of patients. The failure of therapy in 43% patients was either due to non-response, intolerance, or death. A serum albumin of more than 3.5 is associated with success of antiviral therapy. Thus an early initiation of antiviral therapy is recommended before decompensation sets in as it precludes successful outcome.

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“… 26 Sarwar et al in his observational study has also found 83.1% achieving SVR of which 89.2% achieving with triple therapy and 82.2% achieving with sofosbuvir/ribavirin therapy. 27 The PROTON randomized double blind trial has also demonstrated sofosbuvir to be highly efficacious especially in genotypes 1-3 with achievement of SVR in greater than 90%.…”

Section: Discussionmentioning

confidence: 99%

Rapid and Early Virological Response of Patients Treated With Sofosbuvir in Chronic Hepatitis C.

Siddique¹,

Shoaib²,

Saad³

et al. 2017

Pak J Med Sci

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Objective:To determineRapid & End treatment response of patients treated with Sofosbuvir in Chronic Hepatitis C at tertiary care hospital.Methods:It was an observational study conducted at Memon Medical Institute from January 2016 to July 2017. The inclusion criteria for patients was 18 years of age or older, having chronic infection with HCV. Total=201 received sofosbuvir with or without interferon in our OPDs. Patients were categorized into Treatment naïve, treatment experienced and decompensated chronic liver disease. Pregnant patients and those not willing to participate were excluded. Initially genotyping and Quantitative HCV RNA test was done.Results:A total of 201 subjects were included in the study with mean age of the patients was 46.22± 14.41 years. Of 201 patients, n= 131 (65.2%) chronic hepatitis C, compensated cirrhosis n= 47(23.4%), and with decompensated cirrhosis n=23(11.4%). Most commonly genotype 3 n= 180 (89.6%) was present followed by genotype 1 n=9(4.5%), genotype 2 n=1(0.5%), genotype 4 n=1(0.5%). Of patients with genotype 3, 123 received dual therapy and 57 were given triple therapy. After one month of therapy HCV RNA by PCR, 200(99.5%) achieved RVR, 199(99%) achieved ETR and SVR achieved in 178(88.5%) while remaining 1 patient did not achieved RVR, 2 ETR and 12 patients did not achieved SVR and remaining 11 SVR lost follow up.Conclusion:Sofosbuvir has shown to be very effective andsuccessfulwith achievement of virological response with little or no resistance in all genotypes mainly genotype 3 treated in our study population. The promising results of our study will aid in better outcomes and therefore help in eradication of the virus.

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Sofosbuvir based therapy in Hepatitis C patients with and without cirrhosis: Is there difference?

Cited by 13 publications

References 21 publications

Current Status of Direct Acting Antiviral Agents against Hepatitis C Virus Infection in Pakistan

Current Status of Direct Acting Antiviral Agents against Hepatitis C Virus Infection in Pakistan

Results of Sofosbuvir Plus Ribavirin in Patients With Hepatitis C Related Decompensated Cirrhosis

Rapid and Early Virological Response of Patients Treated With Sofosbuvir in Chronic Hepatitis C.

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