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hepatitis C infection

Also see viral hepatitis. Etiology: 1) hepatitis C virus 2) associated disorders a) cryoglobulinemia (types 2 & 3) b) vasculitis, leukocytoclastic vasculitis c) membranoproliferative glomerulonephritis d) porphyria cutanea tarda Epidemiology: 1) worldwide problem 2) 1-2% of Americans; has surpassed HIV1 as a cause of death in the USA [38] - 1 in 20 baby boomers has HCV & does not know it [41] 3) incidence of new infections appears to be declining 4) rarely spread sexually [47] a) generally in patients with multiple sexual partners b) risk of sexual transmission in < 5% in monogomous relationships c) 10 year risk of transmission during vaginal intercourse with monogomous partner is < 0.1% [19] 5) risk factors: a) injection drug use b) sexual or household contact with HCV carriers c) blood transfusion (especially prior to 1993) d) occupational exposure e) see screening for hepatitis C [99] 6) transfusion associated risk is now 1/10,000 units 7) high prevalence among injection drug users & hemophiliacs (60-90%) 8) HCV may be viable & infective for 9 weeks in a used tuberculin syringe with removable needle; infectivity from insulin syringe with permanently attached needle is 1 day [33] 9) 20% of patients on hemodialysis 10) neonatal transmission < 5%, < 6% [83] 11) 60% of patients infected with hepatitis C virus exhibit chronic infection [48] - black patients more often fall into this group 12) 40% of patients infected with hepatitis C show spontaneous resolution [48] - white & Asian patients more often fall into this group 13) increase in hepatitis C detection in women of child-bearing age 2011-2014 [76], 2006-2014 (2-fold) [83] mainly due to increased in injection drug abuse [83] Pathology: 1) incubation period: 2 weeks to 6 months 2) 44% of patients with symptomatic acute hepatitis C spontaneously clear the virus [14] 3) patients with asymptomatic infection may not clear virus 4) 60-85% of patients who acquire HCV infection remain chronically infected [5] 5) liver biopsy - lymphocytic portal inflammation with nodular lymphoid aggregates - steatosis - fibrosis is variable [5] Genetics: - > 10 genotypes (1,2,3 ...) - alleles on chromosome 19, near the interleukin-28B gene & on chromosome 6, near HLA class II genes contribute to risk of chronic hepatitis C vs spontaneous resolution [48] - 15% of the variation in resolution rates is explained by these alleles [48] - genetic variation in IFNL4 is associated with susceptibility to hepatitis C virus (HCV) infection Clinical manifestations: 1) most patients remain asymptomatic 2) acute hepatitis is uncommon a) progresses to chronic hepatitis (85-100%) b) fulminant hepatitis is rare (< 5%) 3) symptoms generally result from chronic hepatitis 4) fever uncommon 5) nausea/vomiting common 6) immune complex disease common a) cutaneous leukocytoclastic vasculitis b) mixed cryoglobulinemia (types 2 & 3) 7) other skin manifestations: a) lichen planus b) porphyria cutanea tarda c) spider nevi* 8) arthralgias & arthritis 9) lymphocytic sialoadenitis 10) immune thrombocytopenia 11) renal disease a) membranoproliferative glomerulonephritis & mixed cryoglobulinemia (most common) b) mesangioprolifergative glomerulonephritis c) membranous nephropathy & polyarteritis nodosa Laboratory: 1) HCV Ab in serum/plasma/blood a) 2nd generation tests available in 1993 b) insensitive for detection of acute HCV infection c) antibody does not confer immunity d) also see screening for hepatitis C e) no need to repeat HCV Ab in serum if + - HCV RNA to assess whether infection is active or resolved [95] 2) HCV recombinant immunoblot assay (RIBA II) - other hepatitis C virus serology as indicated - hepatitis C virus antigen as indicated 3) RT-PCR for hepatitis C virus RNA a) confirmation if serology for HCV positive [52] b) viral titer does not predict disease severity c) coinfection with HIV causes HCV RNA to rise following initiation of antiviral therapy- significance unknown [24] d) viral clearance predicts lower mortality [45] e) patients with positive serology but negative HCV RNA do not have hepatitis C infection [5] f) presence of specific disorders [5] - non-Hodgkin's lymphoma, membranoproliferative glomerulonephritis, mixed cryoglobulinemia, porphyria cutanea tarda 4) hepatitis C genotyping at the time of diagnosis [5] - guides selection of treatment 5) liver biopsy - only reliable means of predicting disease severity [27] - necessary in a minority of patients [5] 6) complete blood count (CBC) -> thrombocytopenia* 7) liver function tests a) serum alanine transaminase (serum ALT) 1] levels of 400-600 U/L with acute infection 2] mild elevations with chronic infection 3] normal level does not exclude hepatitis C infection [5] b) serum aspartate transaminase (serum AST)* c) serum alkaline phosphatase (serum ALP) d) serum bilirubin e) prothrombin time (PT) 8) iron studies: serum ferritin, serum iron, TIBC 9) serum alpha-fetoprotein not routinely recommended [38] 10) serum complement C4 may be low [5] 11) rheumatoid factor (RF) may be positive (titer < 1:128) 12) serum antinuclear antibody (ANA) may be positive [5] 13) anti-hepatitis A IgG 14) hepatitis B serology* a) core antibody (HBcAb) b) surface antibody (HBsAb) c) surface antigen (HBsAg) 15) HCV is difficult to culture & no good small animal model is available [33] 16) baseline resistance testing - before starting elbasvir/grazoprevir for HCV genotype 1a [92] 17) see ARUP consult [42] * reactivation of hepatitis B can occur during treatment of hepatitis C [5] (see Complications: below) Special laboratory: - if cirrhosis, upper GI endoscopy (all patients)* * see cirrhosis for surveillance upper GI endoscopy * see cirrhosis Diagnostic criteria: for clinical diagnosis of cirrhosis Radiology: - abdominal ultrasound - no prior imaging - patients with cirrhosis should undergo surveillance for hepatocellular carcinoma every 6 months [5] Complications: 1) carrier state - 85% of patients with anti-HCV have circulating levels of virus by RT-PCR 2) chronic hepatitis - 90% of patients with anti-HCV have evidence of chronic hepatitis on liver biopsy 3) 25-30% progress to cirrhosis over a 20-30 year period a) alcohol increases the risk [6,28] b) thrombocytopenia (platelet count < 140,000/mm3), serum AST > 40 IU/L, spider nevi & male sex are the best predictors of cirrhosis [12] 4) hepatocellular carcinoma may develop with chronic hepatitis (1-5%) [28] a) platelet count < 140,000/mm3, serum AST > 75 IU/L, male sex, poor response to treatment or no treatment are independent risk factors [29] b) successful treatment of hepatitis C reduces risk 76% [49] c) successful treatment of hepatitis C does not reduce risk of hepatocellular carcinoma in patients with cirrhosis [54] d) hepatitis C virus rarely causes hepatocellular carcinoma in the absence of cirrhosis e) lipophilic statins (atorvastatin, simvastatin) may reduce (risk 3% vs 8%) [94] 5) mixed cryoglobulinemia resulting in glomerulonephritis [5,53,56] - 10% of symptomatic vaculitis due to cryoglobulinemia with symptom relapses after complete virologic response to therapy [91] 6) treatment with direct-acting antiviral agents including daclatasvir, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, simeprevir, sofosbuvir, ombitasvir/paritaprevir/ritonavir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, can cause reactivation of hepatitis B in patients with current or previous hepatitis B infection - 24% of patients with chronic hepatitis B [89] - 1.4% with resolved hepatitis B infection [89] 7) skin manifestations: - necrolytic acral erythema - also see clinical manifestations 8) despite treatment resulting in hepatitis C cure, mortality remains high - adjusted mortality per 1000 person-years 10-28 for patients without cirrhosis, & 68-118 for patients with end-stage liver disease (ESLD) - increased relative risk: without cirrhosis (RR=3.0-3.8), ESLD: (RR=9-14) - causes of mortality: drug-related (24%), liver failure (18%), liver cancer (16%), other cancers (12%) [103] * see clinical manifestations for renal complications Management: 1) treat comorbidities & reduce risk factors - treatment of porphyria cutanea tarda takes priority over reducing risk factors 2) indications for antiviral therapy a) symptomatic - a period of 3 months of monitoring recommended for patients with acute HCV infection to allow for the 15-40% chance of spontaneous resolution prior to treatment [5] - recommendation not endorsed [101] & not for period of 6 months - patients whose disease does not resolve with 3 months are generally treated (all patients considered for treatment) [5] - antiviral therapy of acute hepatitis C results in sustained clearance of virus in 80-95% of patients [14,59,60] - women more likely than men to sustain clearance of virus b) treatment considered for: - fluctuating or persistently elevated ALT - moderate to severe inflammation & evidence of fibrosis on liver biopsy - all patients should be considered for treatment [5,92] except those with short life expectancy [5] 3) contraindications to antiviral therapy a) active substance abuse (alcohol or drugs) b) severe comorbid condition - uncontrolled psychiatric disorder (especially depression) - renal transplantation - severe autoimmune disorders c) any patient with comorbid condition other than liver disease with prognosis of < 10 years d) older age itself is not a contraindication [29] e) pregnancy f) latent or untreated hepatitis B infection [82] 4) antiviral therapy - daclatasvir (Daklinza) Bristol-Myers Squibb - sofosbuvir/velpatasvir (Epclusa) Gilead Sciences - usually leads to sustained virologic response at 12 weeks in injection drug users [88] - ledipasvir/sofosbuvir (Harvoni) Gilead Sciences - simeprevir (Olysio) Janssen - sofosbuvir (Sovaldi) Gilead Sciences - ombitasvir/paritaprevir/ritonavir (Technivie) Abbvie - dasabuvir/ombitasvir/paritaprevir/ritonavir (Viekira Pak) Abbvie - elbasvir/grazoprevir (Zepatier) Merck Sharp Dohme [79] - sofosbuvir 400 mg plus ledipasvir 90 mg (Harvoni) daily for 12 weeks for HCV type 1 [69] (see [69] for optional regimens) - 95% effective in cirrhosis-free patients - equally effective among previously untreated as well as previously treated patients, many with cirrhosis [60] - 8 weeks of therapy equivalent to 12 weeks [59] - white or black [90] - cost effective for genotype 1 infection - $12,825 more per quality-adjusted life year compared with standard of care [66] - cost-effective for genotype 2 or 3 infection with cirrhosis or previous treatment with interferon [67] - sofosbuvir 400 mg plus weight-based ribavirin (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 12 weeks for HCV type 2 - 24 weeks of therapy (see sofosbivur) [46] - response in genotypes 2,3 more favorable than genotye 1 - with or without peginterferon superior in efficacy & tolerability versus peginterferon plus ribavirin, especially in patients with HCV genotype 1 [51] - sofosbuvir 400 mg plus weight-based ribavirin (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 24 weeks for HCV type 3 - pegylated interferon, ribavirin & sofosbuvir for HCV type 4 - ombitasvir, paritaprevir, & ritonavir PO QD. even in prior non-responders & patients with cirrhosis [72] - sofosbuvir/velpatasvir (Epclusa) in combination with ribavirin FDA-approved for treatment of all 6 genotypes of HCV [75] - sofosbuvir/velpatasvir/voxilaprevir (Vosevi) FDA-approved for treatment of all 6 genotypes of HCV without cirrhosis [85] - glecaprevir/pibrentasvir (Mavyret) - FDA-approved for genotypes 1-6 with 8 weeks of treatment - useful in patients with renal failure - FDA-approved to treat all genotypes of hepatitis C in children - simeprevir recommended for FDA-approval [55] - grazoprevir in combination with elbasvir (Zepatier) once a day for treatment-naive hepatitis C infection genotypes 1,4,6 [68] - interferon-based regimens have fallen out of favor 5) response to therapy a) discontinue treatment of type 1 if HCV RNA levels don't decrease by at least log 2 after 12 weeks of treatment b) types 2 & 3 more responsive to treatment than type 1 [13,21] - 12 weeks of therapy for types 2 or 3 sufficient for patients who test negative for HCV RNA after 4 weeks [22] - 24 weeks of therapy for types 2 & 3 [5] - successful antiviral treatment of HCV diminishes risk of hepatocellular carcinoma in patients with cirrhosis [32] - 10 year survival in patients with sustained virologic response (91%) similar to general population vs 74% for those without sustained response [64] - effectively treated patients can be re-infected [65] - apparently effective resistance to infection does not develop c) for type 1, virologic response rates >95% for 6 regimens [81] d) for type 3 without cirrhosis, sofosbuvir plus velpatasvir or daclatasvir for 12 weeks most effective [81] - for type 3 with cirrhosis, velpatasvir-sofosbuvir with higher response rates [81] - velpatasvir-sofosbuvir also with > 99% response rates for genotypes 2, 4, 5, & 6 e) patients with HIV1, severe kidney disease, or liver transplant with high response rates & limited adverse events [81] f) black & hispanics may be less likely to achieve sustained virologic response compared to whites (adjusted odds ratio 0.76-0.77) [80] g) sofosbuvir, velpatasvir, & voxilaprevir for 12 weeks may be indicated for prior treatment failure [84] - sustained virologic response across HCV genotypes (96-98%) h) direct-acting antiviral treatment is associated with reduced risks for mortality (RR=0.48) & hepatocellular carcinoma (RR=0.66) [93] 6) hepatitis C treatment has significant adverse effects - benefits of treatment should be weighted against risks [5] 7) guidelines for referral to gastroenterology (GI) a) cirrhosis b) ascites (especially with bacterial peritonitis) c) encephalopathy d) esophageal varices e) candidates for transplant evaluation - bilirubin > 3 mg/dL - albumin < 3 g/dL - prothrombin time (PT) > 3 sec (INR > 1.4) - decompensated cirrhosis - ascites, jaundice, hepatocellular carcinoma, hepatorenal syndrome, variceal hemorrhage, spontaneous bacterial peritonitis, hepatic encephalopathy [5] f) antiviral treatment can be provided in primary care [87] - not FDA-approved for patients under 18 years of age - treatment less effective in African Americans NOT explained by differences in genotype (i.e. treatment resistant genotype 1) [20] - see contraindications to antiviral therapy (above) 8) liver transplantation for end-stage cirrhosis - interferon-free, all-oral antiviral regimen post transplantation - generally safe - nearly 100% effective in achieving sustained virologic response in patients with genotype 1 infection [63] 8) preferred treatments [102] - glecaprevir/pibrentasvir (Mavyret) for 8 weeks - sofosbuvir/velpatasvir (Epclusa) for 12 weeks - no pretreatment genotyping or on-treatment lab monitoring or visits necessary - applicable to people living with HIV. - interrupting HCV treatment for up to 7 days does not affect sustained virologic response [102 10) experimental & early therapies a) new compound BMS-790052 (May 2010) holds promise [33] b) oral regimen of protease inhibitor danoprevir, plus nucleoside polymerase inhibitor RG7128 may suppress HCV replication [34] c) daclatasvir 60 mg QD + asunaprevir 600 mg BID in combination with peginterferon & ribavirin for 12-24 weeks may be beneficial in peginterferon/ribavirin unresponsive patients with HCV genotype 1 infection (90% response) [36]; 36% response with daclatasvir + asunaprevir alone d) microRNA-based treatment appears effective, but relapse occurs when treatment is dicontinued [50] e) interferon-free oral treatment (direct-acting antivirals) - daclatasvir (60 mg daily) plus sofosbuvir (400 mg daily) with or without ribavirin for 24 weeks in patients with genotype 1 infection [57] - ABT-450/r (protease inhibitor ABT-450 plus ritonavir 100 mg) in daily doses of 100 mg, 150 mg, or 200 mg with ABT-267 (an NS5A inhibitor; 25 mg daily) or ABT-333 (nonnucleoside polymerase inhibitor; 400 mg twice daily) or both for 8, 12, or 24 weeks [57] - ABT-450 150 mg, ritonavir 100 mg, ombitasvir 25 mg QD, dasabuvir 250 mg BID, & ribavirin adjusted to body weight for 12-24 weeks [60] - simeprevir plus sofosbuvir, with or without ribavirin, for 12 or 24 weeks for HCV genotype 1 in treatment-naive patients or patients that had not responded to peginterferon plus ribavirin [62] - daclatasvir plus asunaprevir for 24 weeks for HCV genotype 1b in treatment-naive patients or patients who have failed peginterferon plus ribavirin [62] - regimens from ACP (MKSAP18) [5] - grazoprevir + elbasvir - paritaprevir + ombitasvir + dasabuvir - daclatasvir + sofosbuvir - ledipasvir + sofosbuvir (Harvoni) - velpatasvir + sofosbuvir (Epclusa) [5] - Technivie (ombitasvir, paritaprevir, ritonavir) & Viekira XR (dasabuvir sodium, ombitasvir, paritaprevir, ritonavir) have been discontinued by AbbVie in 2019 [105] 11) hydroxychloroquine for arthritis/arthralgias 12) vaccinations: - hepatitis A vaccination if anti-hepatitis A IgG negative - Hepatitis B vaccination if hepatitis B exposure negative 13) patient education a) alcohol is associated with more severe disease - patients should abstain from all forms of alcohol b) patients should not donate blood c) patients should not share razors or toothbrushes d) open cuts should be covered e) avoid unprotected sex during menstruation or in the presence of genital sores f) progression of disease is slow - 10 year mortality is unchanged [10] g) decision to treat is not urgent h) safety of breast-feeding is not confirmed - some studies have found HCV in breast milk - no data to confirm that HCV can be transmitted by breast feeding - breast feeding is not associated with increased risk of transmission of hepatitis C from mother to infant [101] - antiviral treatment for hepatitis C is not necessary to proceed with breast feeding [101] - abstain from breast feeding if nippled become cracked or bleeding [101] i) risk of HCV transmission - risk of vertical transmission to fetus is 5% unlessmother is coinfected with HIV (30%) - risk of heterosexual transmission in monogomous relationships is 5% - low risk of transmission among nonsexual household contacts - transmission occurs by parenteral contact with blood or body fluids 14) follow-up yearly a) focused physical examination b) liver function tests [27] 15) prognosis - disease progression over 20 years is low in patients without comorbitities [23,27] - direct-acting activirals associated with improved outcomes, including long-term overall survival [100] * interferon-based regimens have fallen out of favor - combination therapy peginterferon alfa plus ribavirin - peginterferon alfa-2A or peginterferon alfa-2B - prior to therapy - liver biopsy - hepatitis C genotyping - recommended prior to therapy - patients with type 1b have a poor response - lower doses & shorter duration of therapy for types 2 & 3 - interferon alfa (historically, early treatment) - 3 million units SC or IM 3 times/week - prolonged therapy for 12-18 months results in improved sustained responses compared with 6 months of therapy - 30-50% remission; 15-20% have sustained response - peginterferon alfa 2b (Peg-Intron) may be more effective form of interferon-alfa [21] - peginterferon alfa 2a (Pegasys) as effective as peginterferon alfa 2b (Peg-Intron) [11,30] - more effective than Peg-Intron [44] - peginterferon alfa 2a (Pegasys) 180 ug/week + ribavirin (Virazole) 1000-1200 mg QD divided BID - treatment of choice [29,44] - patients with prior treatment failure [18,26] - patients co-infected with HIV [21] - 20-27% of patients may have sustained antiviral response - 48 weeks as effective as 72 weeks for HCV type 1 [25] - 24 weeks of therapy for HCV type 2 & 3 [5] - response associated with disappearance of HCV RNA from serum - serial transaminases - discontinue after 3 months if transaminases do not normalize - response to therapy: - may diminish progression to cirrhosis - may diminish risk of hepatocellular carcinoma - more severe disease more likely to respond [29] - telaprevir (Incivek) in combination with peginterferon & ribavirin may shorten duration of therapy [36] - boceprevir (Victrelis) in combination with peginterferon & ribavirin for treatment of chronic hepatitis C genotype 1 - telaprevir (Incivek) or boceprevir (Victrelis) in combination with peginterferon alfa 2a (Pegasys) & ribavarin for genotype 1 [5, 44] Notes: - see screening for hepatitis C - Project ECHO, a weekly videoconferencing program, enables primary care clinicians to manage hepatitis C virus infection & increases rates of antiviral treatment [61] - Medicaid eligibility for HCV treatment with sofosbuvir often restricted* to stage 3 or 4, & alcohol abstinence for 6 months [70] - current threshold for health care providers allowed to participate in higher-risk healthcare-associated procedures is undetectble for HCV RNA [98] * depends upon state

Interactions

disease interactions

Related

chronic hepatitis hepatitis C virus hepatitis C virus (HCV) serology hepatitis C virus RNA (HCV RNA) screening for hepatitis C

Specific

Chronic Hepatitis C HIV1/hepatitis C-coinfection

General

viral hepatitis

References

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