Indian J Gastroenterol (July–August 2014) 33(4):343–349 DOI 10.1007/s12664-014-0451-5
ORIGINAL ARTICLE
Treatment of chronic hepatitis C with pegylated interferon plus ribavirin in treatment-naïve ‘real-life’ patients in India Ajit Sood & Vandana Midha & Omesh Goyal & Syed Hissar & Suresh Kumar Sharma & Pankaj Khanna
Received: 1 October 2013 / Accepted: 13 February 2014 / Published online: 12 March 2014 # Indian Society of Gastroenterology 2014
Abstract Purpose/Aim Results of treatment of chronic hepatitis C (CHC) with pegylated interferon plus ribavirin (PEG-RBV) are mainly available from well-designed clinical trials, and only few ‘real-life’ studies which give a true picture of success of therapy are available. Such data in Indian patients is scarce. This prospective study aimed to evaluate the efficacy, safety, and factors associated with sustained virological response (SVR) in Indian CHC patients treated with PEG-RBV in ‘real-life’ setting. Material and Methods All treatment-naïve patients with CHC/compensated cirrhosis treated with PEG-RBV between January 2004 and December 2010 were included. Results Of 592 patients started on treatment, 524 (88.5 %) completed therapy (mean±SD age—42.0±12.1 years; 74.3 % males). Genotype 3 (73.6 %) was the commonest, followed by genotype 1 (19.3 %). In intention to treat analysis, SVR rates for ‘all’ patients, genotype 1 and genotype 3 patients were 72.3 % (428/592), 57 % (65/114), and 78.2 % (341/436), respectively (in per-protocol analysis—81.7 %, 69.1 %, and 85.3 %, respectively). Noncirrhotics had better SVR rates compared to cirrhotics treated for the same duration. About A. Sood (*) : O. Goyal : P. Khanna Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana 141 001, India e-mail:
[email protected] V. Midha Department of Medicine, Dayanand Medical College and Hospital, Ludhiana 141 001, India S. Hissar G B Pant Hospital, Jawaharlal Nehru Marg, New Delhi 110 002, India S. K. Sharma College of Nursing, Dayanand Medical College and Hospital, Ludhiana 141 001, India
20 % patients had both low viral load and achieved rapid virological response (RVR). Factors significantly associated with SVR were age 40 IU/L). HCV viral load >400,000 IU/mL was present in 44.6 % (n=264). Comorbidities were present in 15.5 % (n=92) [diabetes mellitus 8.4 % (n=50), cardiovascular disease 2.4 % (n=14), respiratory diseases 2.2 % (n=13), neurological diseases 2 % (n=11), renal disorders 0.3 % (n=2), and others 0.3 % (n=2)]. Cirrhosis was present in 21.6 % (n=128) patients. Baseline characteristics of the patients are shown in Table 1.
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Majority of the patients had genotype 3 (73.6 %; 436/592), and genotype 1 (19.3 %; 114/592) was the second most common genotype (Table 2). In the intention to treat analysis, the overall SVR rate was 72.3 % (428/592). The SVR rate in genotype 1 patients was 57 % (65/114), while in genotype 3 patients was 78.2 % (341/436) (p=0.0001; Table 2). In the per-protocol analysis, the SVR rates among all patients who completed treatment was 81.7 % (428/524), in genotype 1 patients was 69.1 % (65/94) and in genotype 3 patients was 85.3 % (341/400). Patients with HCV genotype 3 and no evidence of cirrhosis (77.1 %; 336/436) were treated for 24 weeks. Among the genotype 3 patients with cirrhosis (22.9 %; 100/436), 35 % (35/100) agreed for extended treatment of 48 weeks, while the rest 65 % (65/100) took treatment for 24 weeks only (Table 3). The SVR rate in noncirrhotic genotype 3 patients (treated for 24 weeks) was significantly higher than the SVR rate of cirrhotic patients treated for 24 weeks [83.9 % (282/336) and 49.2 % (32/65) respectively; p=0.0001). Genotype 3 cirrhotics treated for 48 weeks achieved a SVR rate similar to that of noncirrhotics treated for 24 weeks [77.1 % (27/35) and 83.9 % respectively; p=0.339], and which was significantly higher than that of cirrhotics treated for 24 weeks (77.1 % and 49.2 % respectively; p=0.01; Table 3). Of the total 114 patients with genotype 1, 75.4 % (86/114) had no evidence of cirrhosis while 24.6 % (28/114) had compensated cirrhosis. All patients were treated for 48 weeks. The noncirrhotic genotype 1 patients had a significantly higher SVR rate than the genotype 1 patients with cirrhosis [66.3 % (57/86) vs. 28.6 % (8/28) respectively, p=0.0008; Table 3). The SVR rate among genotype 1 cirrhotics (treated for 48 weeks) was significantly lower as compared to genotype 3 cirrhotics treated for 48 weeks (28.6 % and 77.1 %, respectively; p=0.0001). A sub-group analysis was performed for patients (n=308) in whom the complete RVR and SVR data were available, to see the impact of RVR on SVR. Of the total 308 patients, 77.6 % (n=239) achieved RVR, while 22.4 % (n=69) did not achieve RVR. The SVR rate in RVR achievers was significantly higher than that in RVR non-achievers [90.4 % (216/ 239) vs. 43.5 % (27/69); p=0.0001]. On analyzing genotypes 1 and 3 patients separately, a similar significant difference in the SVR rate was noted among the RVR achievers and RVR non-achievers (Fig. 1). Overall, out of the patients who achieved RVR, 48.9 % (n=117) had no cirrhosis and had low viral load (40 years Males (%) Weight (kg)
42.0±12.1 45.4 (269) 74.3 (440) 69.8±12.0
BMI BMI >25 AST (IU/L) ALT (IU/L) ALT >40 IU/L HCV RNA >4,00,000 IU/mL Presence of cirrhosis Presence of any comorbid condition Presence of diabetes mellitus Past history of alcohol use
24.2±3.6 37.8 (224) 83.1±69.2 106.2±73.3 86.9 (515) 44.6 (264) 21.6 (128) 15.5 (92) 8.4 (50) 11.1 (66)
Data shown is either mean±SD or percentage (number) ALT alanine transaminase, AST aspartate transaminase, BMI body mass index, HCV RNA hepatitis C virus ribonucleic acid
Factors associated with SVR The baseline patient-related factors that were evaluated for their potential association with SVR were: sex, age, BMI, ALT, HCV genotype, HCV viral load, cirrhosis, past alcohol use, comorbidities, and diabetes mellitus. On univariate analysis, factors significantly associated with SVR were age
