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Special Patient Groups
Patients Who Do Not Achieve SVR
Patients that are not cured following treatment are considered nonresponders (those people who have some decrease in viral load, but then the levels rebound to pre-treatment levels) or relapsers (people who have undetectable virus at the end of treatment, but the virus reappears at a later time).
Patients who do not achieve an SVR or relapse following the first round of treatment may still benefit from re-treatment with the same or another therapy. Lifestyle changes, such as avoiding alcohol, quitting smoking, and keeping weight down, can also contribute to the health of the patient’s liver and general health and can even increase their chances or recovery.
The REPEAT study, which investigated the efficacy of PEGASYS® plus COPEGUS for the treatment of prior non-responders to PegIntron plus ribavirin, showed that patients can be successfully retreated with PEGASYS® Results demonstrated that extension of the treatment duration to 72 weeks also improved SVR rates for this patient group (Jensen D, et al. 58th AASLD 2007; Abstract LB4).
Patients Co-infected with HIV
Up to one-third of people with HIV (approximately 10 million worldwide) are also co-infected with HCV.1 This is not surprising, given that both viruses are transmitted through blood. In these patients, liver disease progresses more rapidly to cirrhosis, end-stage liver disease and HCC (liver cancer).
Figure 3-14: HIV-HCV co-infection results in more rapid disease progression to cirrhosis than HCV alone
While improvements in antiviral treatments for HIV have improved survival rates, it is well established that HIV infection hastens the progression of HCV-related (as well as HBV-related) liver damage.2 As a result, liver disease is now the leading cause of death in patients with HIV.3
Risk of Passing on the Virus
It seems as though HIV assists the transmission of hepatitis C, perhaps because people who are co-infected with HIV and HCV tend to have larger amounts of hepatitis C virus in their body (a high viral load).
People who have both HIV and HCV and who take part in unprotected sexual activities may be more likely to transmit the hepatitis C virus to their partner, compared with people who have hepatitis C only.4 Also, the risk of passing the hepatitis C virus from mother to child is greater when the mother also has HIV.4
However, the effects of hepatitis C on the progression of HIV are less certain. Some scientists think that certain hepatitis C genotypes may cause faster progression to AIDS than others, but this is not known for sure.
While treatment strategies for HIV-HCV co-infected patients are evolving, the current consensus, published in January 2006, is to stabilise HIV according to current HIV treatment guidelines. Treatment can then focus on HCV, using the approved therapy of pegylated interferon alfa-2a and ribavirin in combination.5
The probability of SVR is lower in HIV/HCV coinfected patients. Recent data have proven that if on-treatment responses like RVR or cEVR are achieved, the chance of SVR can be similar to that of monoinfected patients.
Patients Co-infected with HBV
HBV is one of the most common infections in the world today, with more than 350 million people affected worldwide.6 Although relatively rare in North America and Western Europe, HBV is endemic in Asia and Africa, parts of Central and Eastern Europe, and in the Middle East and India.
HBV is 100 times more infectious than HIV and is found in body fluids of infected people (eg, blood, sweat, tears, breast milk and semen). The virus is extremely resilient, surviving for up to a week outside the body, and causes acute and chronic hepatitis, which progress to liver disease, liver cancer and death. Over one million people die each year due to HBV, making it the tenth leading cause of death worldwide.2
Approximately 25 per cent of patients with HCV are also infected with HBV.46 Co-infection with evidence of chronic HBV and HCV seems to result in more severe liver disease than either infection alone,7 with an increased risk of liver cancer.8 It is important to note that a vaccination is available for HBV.
While specific treatments are recommended for HBV and HCV monoinfection, there are no guidelines for treating HBV-HCV co-infection.
Patients with End-Stage Renal Disease (ESRD)
When the kidneys permanently fail to work, the patient has ESRD and requires dialysis. This process removes waste substances and fluid from the blood that are normally eliminated by the kidneys.
ESRD patients have been at high risk for HCV infection due to frequent blood product transfusions or transplantation with an HCV-infected kidney. Ten to 20 per cent of dialysis patients have hepatitis C.9,10
Standard treatment for HCV is pegylated interferon and ribavirin. However, there is no recommendation for anti-HCV combination therapy in patients with ESRD. Small studies have shown that patients with ESRD and HCV infection can benefit from monotherapy with peginterferon (Peck-Radosavljevic, et al. 43rd EASL 2008, Abstract # 999).
Patients Who Have Undergone Liver Transplant
As many as 95 per cent of patients who have undergone liver transplantation as a result of HCV infection are at risk of re-infection as early as 4 weeks post-surgery.11 The virus stays in the blood and then attacks the patient’s new liver. Furthermore, viral levels that exceed those prior to surgery are common, probably due to the effects of immunosuppressive drugs needed to stop the body from rejecting the new liver.
Traditionally, patients with recurrent HCV have had little success in preventing or eradicating the virus through treatment. However, a number of recent studies investigating pegylated interferon therapy both before and after liver transplantation have demonstrated improvements in cure rates.12 Furthermore, long-term outcomes for patients who received liver transplants due to HCV infection have been found similar to those of patients who received transplants due to other diseases.13
Injecting Drug Users
Despite the fact that current IDUs make up such a large proportion of HCV patients, there has been limited research in this group. This is in part due to the exclusion of IDUs from HCV treatment because of complications thought to be associated with substance addiction, depression, re-infection and poor adherence to therapy.
However, a recent study of young people (aged between 18 and 35 years) with HCV who were actively injecting drugs has shown low rates of re-infection and treatment completion rates similar to those of non-IDU-HCV patients.13
These findings suggest that antiviral treatment in this group of patients an have important public health implications by lowering the presence of the virus in the IDU population. In addition, the regular visits with a medical professional can help these patients address their drug use.
Children
Information about the merit of treating children with chronic hepatitis C is limited. In the 1980s and 1990s, before routine screening of blood products for HCV, most children were infected through blood transfusion.4 The major cause of new cases today, however, is through perinatal transmission when the mother is HCV-positive.4 The natural history of HCV infection is different in children than in adults: there is less frequent progression to cirrhosis and HCC. Clinical studies show that response rates to interferon combination therapy in children with chronic hepatitis C were similar to those of adult HCV patients.14 Also, children have a similar incidence of adverse events to that seen in adults.14
References:
1. Vallet-Pichard A, Pol S. Natural history and predictors of severity of chronic hepatitis C virus (HCV) and human immunodeficiency virus (HIV) co-infection. J Hepatol 2006;44(1 Suppl):S28-34.
2. Soriano V, Sulkowski M, Bergin C, et al. Care of patients with chronic hepatitis C and HIV co-infection: recommendations from the HIV-HCV International Panel. Aids 2002;16(6):813-28.
3. Bica I, McGovern B, Dhar R, et al. Increasing mortality due to end-stage liver disease in patients with human immunodeficiency virus infection. Clin Infect Dis 2001;32(3):492-7.
4. National Institutes of Health Consensus Development Conference Statement: Management of hepatitis C; June 10-12, 2002. Hepatology 2002;36 (5 Suppl 1):S3-20.
5. Torriani FJ, Rodriguez-Torres M, Rockstroh JK, et al. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 2004;351(5):438-50.
6. Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat
2004;11(2):97-107.
7. Sato S, Fujiyama S, Tanaka M, et al. Coinfection of hepatitis C virus in patients with chronic hepatitis B infection. J Hepatol 1994;21(2):159-66.
8. Zarski JP, Bohn B, Bastie A, et al. Characteristics of patients with dual infection by hepatitis B and C viruses. J Hepatol 1998;28(1):27-33.
9. Vargas V, Comas P, Castells L, et al. Incidence and outcome of hepatitis C virus infection after liver transplantation. Transpl Int 1994;7 Suppl 1:S216-20.
10. Al Alwan AJ, et al. Sustained virological response of 65% in patients treated with combination antiviral therapy for recurrent HCV following liver transplantation. In: 55th AASLD; Boston, MA; 2004.
11. Gane EJ, Portmann BC, Naoumov NV, et al. Long-term outcome of hepatitis C infection after liver transplantation. N Engl J Med 1996;334(13):815-20.
12. Swan T, Raymond D. Hepatitis C virus (HCV) and HIV-HCV co-infection: a critical review of research and treatment. Treatment Action Group 2004.
13. Hagan H, Latka MH, Campbell JV, et al. Eligibility for treatment of hepatitis C virus infection among young injection drug users in 3 US cities. Clin Infect Dis 2006;42(5):669-72.
14. Schwartz K, Mohan P, Narkewicz M, et al. The safety, efficacy, and pharmacokinetics of peginterferon alfa-2a (40 KD) in children with chronic hepatitis C. DDW 2003:18-21.