Journal List > Korean J Gastroenterol > v.56(1) > 1006740

Moon, Kang, Seo, Jung, Lee, Park, Lee, and Seol: 24 Weeks Treatment with Pegylated Interferon Alfa Plus Ribavirin May Be Possible in Genotype 1 Chronic Hepatitis C Patients with Rapid Virological Response Who Have Low Pretreatment Viremia

Abstract

Background/Aims

The standard treatment for chronic hepatitis C infected with hepatitis C virus (HCV) genotype 1 is a combination of pegylated interferon alfa and ribavirin over a 48 weeks period. It is unclear if 24 weeks treatment is possible for patients showing a rapid virological response (RVR) without compromising the sustained virological response (SVR) in Korea.

Methods

Between June 2005 and September 2008, among patients chroni-cally infected with the HCV genotype 1 who were treated with pegylated interferon alfa subcutaneously once weekly plus ribavirin based on body weight, 55 patients who had low pretreatment viral load (<600,000 IU/mL) and RVR were enrolled. A total of 55 patients were divided into 24 weeks treatment group (n=29) and the standard treatment group (n=26). The HCV RNA was quantitatively assessed before treatment, and after 12 weeks of treatment, and also qualitatively assessed after 4 weeks of treatment, at end of treatment (24 weeks), and 24 weeks after end of treatment. RVR was defined as undetectable HCV RNA at the 4 weeks of treatment.

Results

Among the 55 patients, SVR was achieved in 100% (29/29) of the patients in 24 weeks treatment and 96.2% (25/26) of the patients in the standard treatment (p=0.473).

Conclusions

HCV genotype 1 infected patients with a low baseline HCV RNA concentration who become HCV RNA negative at week 4 may be treated for 24 weeks without compromising sustained virlolgical response. However, an additional trial will be needed to opti-mize the treatment duration.

REFERENCES

1. Global surveillance and control of hepatitis C. Report of a WHO consultation organized in collaboration with the Viral Hepatits Preventiion Board Antwerp, Bilgium. J Viral Hepa. 1999; 6:35–47.
2. Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002; 36(suppl 1):S35–S46.
crossref
3. Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004; 39:1147–1171.
4. EASL international consensus conference on hepatitis C. Paris, 26-28, February 1999, Consensus Statement. European Association for the Study of the Liver. J Hepatol. 1999; 30:956–961.
5. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001; 358:958–965.
crossref
6. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon al-fa-2b plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002; 347:975–982.
7. Hadziyannis SJ, SetteJr H Jr, Morgan TR, et al. Peginterfer-on-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004; 140:346–355.
8. Russo MW, Fried MW. Side effects of therapy for chronic hepatitis C. Gastroenterology. 2003; 124:1711–1719.
crossref
9. Fried MW. Side effects of therapy of hepatitis C and their management. Hepatology. 2002; 36(suppl):S237–S244.
crossref
10. McHutchison JG, Manns M, Patel K, et al. Adherence to combination therapy enhances sustained response in geno-type-1-infected patients with chronic hepatitis C. Gastroenterology. 2002; 123:1061–1069.
crossref
11. Davis GL, Wong JB, McHutchison JG, Manns MP, Harvey J, Albrecht J. Early virologic response to teratment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C. Hepatology. 2003; 38:645–652.
12. Zeuzem S, Buti M, Ferenci P, et al. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. J hepatol. 2006; 44:97–103.
crossref
13. Jensen D, Morgan T, Marcellin P, et al. Rapid virological response at week 4 (RVR) of peginterferon alfa-2a(40KD) (PEGASIS) plus ribavirin(RBV, COPEGUS) treatment predicts sustained virological response(SVR) after 24 weeks in genotype 1 patients. Hepatology. 2005; 42(suppl 1):650A.
14. Ferenci P, Bergholz U, Laferl H, et al. Is shorter treatment with peginterferon alfa-2a(40KD)(PEGASIS) plus ribavirin (COPEGUS) possible in HCV genotype 1'super-responder’? preliminary results of a prospective randomized clinical trial. Hepatology. 2005; 42(suppl 1):218A.
15. Yu ML, Dai CY Huang JF, et al. Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Hepatology. 2008; 47:1884–1893.
crossref
16. Kang MJ, Jung EU, Park SW, et al. Effects of interferon and ribavirin in Korean patients with chronic hepatitis C virus infection. Korean J Hepatol. 2008; 14:318–330.

Table 1.
Baseline Characteristics and Virologic Response of the Enrolled Patients
Standard treatment 24 weeks treatment p-value
Patients (N) 26 29
Age 45.77±10.73 46.24±11.54 0.876
Sex (M/F) 12/14 21/8 0.047
BMI 23.5±2.54 23.8±2.26 0.573
Pretx. HCV RNA (IU/mL) 1.935×105 (1.0×104-5.967×105) 1.31×105 (3.4×103-4.976×105) 0.102§
AST (U/mL) 67.58±35.78 64±46.1 0.748
ALT (U/mL) 103.62±69.55 99.34±132.3 0.88
SVR 25/26 29/29 0.473

BMI, body mass index; HCV RNA, hepatitis C virus RNA; AST, aspartate aminotransferase; ALT, alanine aminotransferase; SVR, sustained virological response.

Median.

Student t-test.

Chi-square test.

§ Mann-Whitney test.

Table 2.
Baseline Characteristics and Virological Response of 24 Weeks Treatment Patients
Sex Age BW (kg) Height (cm) Titer (IU/mL) AST (U/mL) ALT (U/mL) SRVR RVR EVR ETR SVR
pt1 M 60 60 169 80,700 45 36 N-C Y Y Y Y
pt2 F 30 56 160 36,600 23 36 N-C Y Y Y Y
pt3 F 47 65 158 131,000 94 47 Y Y Y Y Y
pt4 M 65 68 170 248,000 81 168 Y Y Y Y Y
pt5 F 48 52 160 4,100 28 5 Y Y Y Y Y
pt6 M 35 70 170 379,300 77 228 N Y Y Y Y
pt7 M 40 72 170 234,500 79 124 Y Y Y Y Y
pt8 M 26 82 178 148,300 180 250 N Y Y Y Y
pt9 M 31 85 172 282,100 63 198 Y Y Y Y Y
pt10 M 36 70 173 134,800 51 77 Y Y Y Y Y
pt11 M 37 70 170 237,200 141 121 Y Y Y Y Y
pt12 M 37 65 176 249,300 36 87 N Y Y Y Y
pt13 M 64 77 174 3,400 44 19 Y Y Y Y Y
pt14 F 62 53 153 20,000 35 54 N-C Y Y Y Y
pt15 M 49 76 178 497,600 68 105 Y Y Y Y Y
pt16 M 50 80 175 54,100 28 29 N-C Y Y Y Y
pt17 F 41 64 158 469,000 21 10 Y Y Y Y Y
pt18 M 39 70 170 3,400 213 701 Y Y Y Y Y
pt19 M 62 66 168 427,600 100 95 N-C Y Y Y Y
pt20 M 51 55 175 8,000 41 39 N-C Y Y Y Y
pt21 M 48 71 169 23,200 76 24 N-C Y Y Y Y
pt22 F 44 64 161 48,600 40 46 N-C Y Y Y Y
pt23 F 57 61 155 3,400 53 38 Y Y Y Y Y
pt24 M 48 59 154 48,300 23 15 Y Y Y Y Y
pt25 M 30 72 172 62,000 40 68 Y Y Y Y Y
pt26 M 37 75 172 179,300 39 67 N Y Y Y Y
pt27 M 47 72 170 379,300 68 97 Y Y Y Y Y
pt28 F 55 55 150 172,100 23 25 Y Y Y Y Y
pt29 M 65 57 171 106,900 46 72 Y Y Y Y Y
Mean± SD   46.2±11.5 67.0±8.9 167.3±8.0 131,000 64.0±46.1 99.3±132.3          
(3400-497600)

SRVR, super-rapid virological response, HCV RNA negative at treatment week 2; RVR, rapid virological response, HCV RNA negative at treatment week 4; EVR, early virological response, HCV RNA negative at treatment week 12; ETR, end of treatment response, HCV RNA negative at the end of treatment; SVR, sustained virological response, HCV RNA negative 24 weeks after the end of treatment; Titer, HCV RNA titer; N-C, not checked; Y, yes; N, no.

Median (range).

TOOLS
Similar articles