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Hepatitis C: An Overview

Prevalence | Incidence | Demographics | Natural History | Transmission
Prevention | HCV Testing | Treatment | What You Need To Know

Treatment

Who should be treated?

  • NIH Consensus Statement
    • Treatment is recommended for patients with increased risk of developing cirrhosis.
      • Detectable HCV RNA
      • A liver biopsy with portal or bridging fibrosis
      • At least moderate inflammation and necrosis
      • (Majority also have persistently elevated ALTs.)
    • In some patient populations, the risks and benefits of treatment are less clear and should be determined on an individual basis.
  • AASLD Practice Guidelines
    • Provides guidance under the following three categories:
      • Characteristics of Persons for Whom Therapy is Widely Accepted
      • Characteristics of Persons for Whom Therapy Should be Individualized
      • Characteristics of Person for Whom Therapy is Currently Contraindicated
  • Psychiatric Illness
    • Individuals with major, uncontrolled depressive illness
      • AASDL: Listed as a characteristic of persons for whom therapy is currently contraindicated.
    • History of depression but condition is well controlled.
      • AASDL: Listed as a characteristic of persons for whom treatment is widely accepted.
  • Active Substance Abuse
    • AASDL: Listed as characteristic of persons for whom therapy should be individualized
      • Current users of illicit drugs or alcohol but willing to participate in substance abuse program or alcohol support group
    • 2002 NIH:
      • Treatment of active injection drug users should be considered on a case-by-case basis.
      • Continued alcohol use during therapy adversely affects treatment response, and abstinence is strongly recommended before and during HCV treatment.
  • Treatment Goal
    • To prevent complications of infection; principally achieved by eradication of the virus.
    • HCV is considered to be eradicated when there is a Sustained Viral Response (SVR).
    • An SRV is defined as the absence of detectable HCV RNA (virus) six months after treatment ends.
    • A qualitative viral detection test is used for this purpose.
  • Standard of Care
    • Treatment with Peginterferon and Ribavirin
    • Peginterferon is administered once a week by subcutaneous injection.
    • Ribavirin is administered orally twice a day.
  • Genotype 1
    • 48-week course of treatment
    • Higher rates of SVR achievement are seen with longer therapy.
    • Test for HCV RNA level at initiation or shortly before starting treatment
    • Start therapy with peginterferon and ribavirin
    • At 12 weeks retest for HCV RNA level.
    • If HCV RNA is negative or there has been greater than a two log drop, it is considered an Early Viral Response (EVR)
    • EVR is highly predictive of achievement of SVR.
    • IF EVR is achieved, continue treatment for 48 weeks.
    • Throughout treatment, monitor symptoms, blood counts, and ALT.
    • Test for HCV RNA at end of treatment.
    • An End-of-Treatment Response (ETR) is defined as a lack of detectable HCV RNA at the end of treatment.
    • If test at end of treatment is negative, test for HCV RNA 24 weeks after completion of therapy.
    • Sustained Viral Response (SVR) is a lack of detectable virus 6 months post treatment.
  • Genotype 2 and 3
    • Start 24-week therapy with pegintron and ribavirin
    • Throughout treatment, monitor symptoms, blood counts, and ALT.
    • Test for HCV RNA at end of treatment to determine if ETR was achieved.
    • IF ETR is achieved test for HCV RNA at 24 weeks to determine if SVR was achieved.
  • Rates of Viral Clearance
    • Genotype 1
      • SVR – 40 to 45 percent
    • Genotype 2/3
      • SVR – 70 to 80 percent
  • Note:
    • Key studies were done in naive patients.
    • Key studies excluded those with co-morbid conditions and decompensated cirrhosis.
  • Strongest Predictor of Response
    • Genotype
  • Other Predictors of Response
    • Higher SVR rates seen in patients:
      • With lower pre-treatment viral loads
      • Of younger ages
      • With lower body weights
      • With minimal liver damage
      • Who are women
    • Lower SVR rates seen in African Americans with genotype 1
  • Other Treatment Terminology
    • Non-Responder – HCV RNA levels remain stable during treatment.
    • Partial Responder – HCV RNA levels decline but never become undetectable.
    • Relapser – HCV RNA levels undetectable during treatment but detected again after treatment ends.
  • Common Side Effects of Peginterferon
    • Occurring in more than 10 percent of patients
      • Fatigue
      • Muscle aches
      • Headaches
      • Nausea and vomiting
      • Skin irritation on injection site
      • Low-grade fever
      • Weight loss
      • Depression
      • Mild bone marrow suppression
      • Hair loss
  • Common Side Effects of Ribavirin
    • Occurring in more than 20 percent of patients
      • Anemia
      • Fatigue and irritability
      • Itching
      • Rash
      • Nasal stuffiness, sinusitis, and cough
      • Ribiviran can cause birth defects
      • Must use strict contraceptive methods during treatment and for six months after. (AASDL)
  • Uncommon Side Effects of Treatment
    • Less than 2 percent of patients
      • Autoimmune disease (especially thyroid disease)
      • Severe bacterial infections
      • Marked thrombocytopenia (decreased platelets)
      • Marked neutropenia (decreased white blood cells)
      • Seizures
      • Depression and suicidal idea or attempts
      • Retinopathy (microhemorrhages)
      • Hearing loss and tinnitus
  • Rare Side Effects
    • Acute congestive heart failure
    • Renal failure
    • Vision loss
    • Pulmonary fibrosis
    • Sepsis
  • Careful monitoring of all patients is needed for early identification and management of side effects.
  • In some cases, treatment may need to be discontinued.
  • General Management Issues (AASLD)
    • Advise HCV infected people of measures that might reduce or prevent further fibrosis
      • Alcohol use
      • Obesity
      • Hepatitis A vaccination
      • Hepatitis B vaccination
  • HIV/HCV Co-Infection
    • 25 percent with HIV have HCV
    • 10 percent with HCV may have HIV
  • Testing (AASDL)
    • All HIV infected person should be tested for HCV
    • All HCV infected person with HIV risk factors should be tested for HIV
  • Treatment
    • Urgency of treatment may be greater.
    • Likelihood of achieving SRV is lower.
    • There are no FDA approved drugs for the treatment of co-infection. (2004)
    • Most existing studies have treated co-infected people for 48 weeks regardless of genotype.
    • There may be additional safety concerns due to side effects and medication interactions.

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