CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS JOHN I. MCNEIL, - - PowerPoint PPT Presentation
CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS JOHN I. MCNEIL, MD, FACP MAXIMED ASSOCIATES MARYLAND APRIL 26, 2018 CME Disclosures: Planning Committee And Speaker Speaker: The following speaker has nothing to disclose in relation to
JOHN I. MCNEIL, MD, FACP MAXIMED ASSOCIATES MARYLAND APRIL 26, 2018
CME Disclosures: Planning Committee And Speaker
Speaker: The following speaker has nothing to disclose in relation to this activity: John I. McNeil, MD
Sponsor Accreditation: Howard University College
for Continuing Medical Education to provide continuing medical education for physicians. Credits for Physicians: Howard University College
designates this live activity for a maximum of 1.0 AMA PRA Category I Credit(s)TM . Physicians should claim
participation in the activity. Goulda A. Downer, PHD, RD, LN, CNS – Principal Investigator/Project Director
CME Disclosures: Planning Committee And Speaker
AETC-Capitol Region Telehealth Project Planning Committee: The following committee members have nothing to disclose in relation to this activity:
Goulda A. Downer, PhD, RD, LN, CNS John I. McNeil, MD John Richards, MA-AITP Denise Bailey, MED
Speaker: The following speaker has nothing to disclose in relation to this activity: John I. McNeil, MD
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Ø Five major types, maybe six minor types Ø Estimated 3.5 million people in the US have chronic HCV Ø Yearly, 17,000 get infected Ø Long-term incubation can eventually result in liver failure, liver cancer Ø Every year approximately 12, 000 die from HCV related liver disease
ØIt is typically spread when blood from a person infected with the hepatitis
ØYes, and sex ØTransfusions (before 1982)
http://www.healthline.com/health/hepatitis-c/facts-statistics-infographic
Ø Silent for years Ø Signs of eventual liver damage
ØCompared to HCV monoinfection
www.hcvonline.org
http://hivinsite.ucsf.edu/InSite?page=kb-05-03-05#S1X
Kim and Chung Gastroenterology 2009
ØCD4 count less than 200 cells/mm3 ØAlcohol consumption ØOlder age at time of HCV acquisition
Di Martino et al Hepatology 2001
¡ Diabetes/ insulin resistance ¡ Coinfection with HBV ¡ Marijuana
AASLD-IDSA
Highly effective, simple, well-tolerated
Cure Rates
Sustained HCV Virologic Response (%)
IFN 6 Mos PegIFN/RBV 12 Mos IFN 12 Mos IFN/RBV 12 Mos PegIFN 12 Mos
2001 1998 2011 Standard Interferon (IFN) Ribavirin (RBV) Peginterferon (pegIFN) 1991
PegIFN/ RBV + DAA IFN/RBV 6 Mos
6 16 34 42 39 55 70+ 20 40 60 80 100
DAA + RBV PegIFN
90+ 2013
All–Oral DAA RBV
Current 95+ All-Oral Therapy Direct-Acting Antivirals (DAAs) Box T, Clinical Care Options. 2017
ØCure rates are much higher today, in some populations close to 100% ØThere is far less medication toxicity ØLength of treatment is shorter ØTreatment is much more expensive ØTreatments are now more complex and depend on genotype, degree of
Ø “All persons with current active HCV infection should be linked to a practitioner who
is prepared to provide comprehensive management.”3
Ø New potent and well-tolerated hepatitis C treatments present an opportunity
to expand the number of advanced practice practitioners and primary care physicians trained in the management and treatment of HCV infection.
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ØSchedule patient intakes ØSubmit and track prior authorizations ØResolve pharmacy and medication delivery issues ØMake reminder calls for patient visits and labs ØField patient questions
ØReview who and when to treat ØGoal should be to treat whenever possible to reduce HCV transmission
ØTreatment may not be of sufficient benefit to justify the cost if life
Ø Approval for treatment varies by insurer. Factors may include: ¡ Fibrosis stage ¡ Sobriety requirements ¡ Prescriber type: Hepatology, ID, primary care Ø Some states provide and require a certification process to prescribe HCV
medications
¡ HCV treatment usually not urgent ¡ Avoids confounding comorbid symptoms with treatment side effects
¡ HCV medications are expensive – use resources wisely by working aggressively to
resolve barriers to success before treating
ØEvaluate symptoms and medical comorbidities ØAsk about alcohol and drug use that may impact treatment ØElicit information about housing or food insecurity that may impact
ØReconcile medication list ØLook for stigmata of liver disease
ØFibrosis staging:
¡ AASLD-IDSA recommends combining a serum biomarker assay (such as
FibroSURE, FIBROSpect II) and elastography (vibration-controlled transient liver elastography, MR elastography, acoustic radiation force impulse)
¡ Liver biopsy is reserved for situations in which discordance between serum and
elastography tests will impact clinical decisions
¡ Individuals with clinically evident cirrhosis do not require additional staging (biopsy
ØLiver ultrasound
Ø Any time prior to treatment:
¡ HCV genotype and
VL (but insurers often require a VL within 6 months of treatment)
Ø Labs <12 weeks prior to treatment:
¡ HIV – 4th-generation test preferred (if not already known to be HIV infected) ¡ HAV Ab and HBV cAb, sAb, sAg (vaccinate if not immune) ¡ LFTs, INR – needed to calculate Child-Turcotte-Pugh score ¡ CBC (for platelets) and BMP creatinine/eGFR ¡ TSH if IFN to be used
ØPrior treatment history, whether with IFN or DAAs ØHCV genotype ØPresence or absence of cirrhosis ØIf cirrhotic: compensated vs. decompensated ØRenal impairment ØOther comorbid conditions and medication interactions
ØNo DAAs are approved for use during pregnancy ØRibavirin is highly teratogenic
¡ Women of childbearing age need dependable contraception when taking ribavirin
and for 6 months thereafter
¡ Men taking ribavirin should avoid close contact with pregnant women during
treatment and for 6 months thereafter
ØSee Guidelines for full review of HCV management in pregnant women ØBottom line: do not treat HCV during pregnancy
ØProtease inhibitors: “previr”
¡ e.g., simeprevir, paritaprevir
ØNS5A inhibitors: “asvir”
¡ e.g., elbasvir, ombitasvir
ØNS5B nucleotide polymerase inhibitors: “buvir”
¡ e.g., sofosbuvir, dasabuvir
ØRibavirin
ØThere is no cross-resistance between classes ØRecommendations include discussion of how to screen for resistance if
Ø 4-week HCV VL, eGFR, LFTs for all regimens
¡ Plus other labs for some specific regimens – see guidelines ¡ HCV
VL check is recommended by AASLD-IDSA and required by some insurers, but treatment should not be stopped if the HCV VL is not done
¡ Consult guidelines for stopping treatment based on side effects or lab abnormalities
Ø If 4-week HCV VL undetectable, continue treatment and consider rechecking at end of
treatment (recommendations are not firm)
Ø If 4-week HCV VL detectable, recheck at 6 weeks
¡ Stop treatment if 6-week HCV
VL has increased 10-fold from 4-week level
¡ Some experts recommend stopping treatment if 6-week HCV
VL is higher than 4-week HCV VL, even if not 10-fold higher
Ø 12-week post-treatment HCV
VL:
¡ if undetectable = SVR = 99% chance of durable cure
Ø 24-week post-treatment HCV
VL is optional; order if risk is higher, such as:
¡ Viremia present on 4-week HCV VL check ¡ Adherence problems identified ¡ Patients who have received a liver transplant
Ø If viremia reappears at 12 or 24 weeks, consider rechecking HCV genotype to see if
patient may have been dually infected with a different minority genotype
ØHCC screening with every 6-month liver ultrasound if F3-F4 fibrosis or
ØAlso includes:
¡ Counseling to prevent reinfection ¡ Screening for reinfection ¡ Behavior modifications ¡ See Lesson 2.4 (preventing reinfection) for additional information
Ø HCV can suppress HBV in vivo, so HBV may flare when HCV is treated
¡ More common in HBV sAg+ patients, but also can occur in isolated HBV cAb+ patients from
latent cccDNA
¡ Risk is much lower in HIV co-infected patients who are on tenofovir, lamivudine, or
emtricitabine
Ø Stage chronic HBV patients with eAg/eAb/ALT/VL before treatment for HCV
(along with the fibrosis assessment), then check ALT and HBV VL during and immediately after HCV treatment
Ø Treat if HBV treatment criteria are met (see Resources)
ØAnnual assessment of fibrosis progression – labs and vibration-controlled
ØHCC screening with liver ultrasound every 6 months in patients with
ØWork to resolve barriers to treatment
Ø DAA resistance and re-treatment strategies are areas of ongoing research; consult AASLD-
IDSA guidelines7
Ø General approach – do two of the following if cirrhosis is not present8:
¡ Switch regimen ¡ Add ribavirin ¡ Lengthen treatment
Ø With all patients, assess adherence and work to resolve adherence barriers Ø May also wait for new therapies if re-treatment is not urgent
ØNon-hepatologists can and should provide HCV treatment to confront
ØThe AASLD-IDSA HCV Guideline website is the definitive source for
ØOther websites provide helpful clinical tools and opportunity to practice
ØThe main challenge in HIV/HCV co-infection treatment is managing drug
1.
AASLD-IDSA. When and in whom to initiate HCV therapy. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy. Accessed April 17, 2017.
2.
Box TD. Hepatitis C Update for Primary Care. Clinical Care Options. February 21, 2017. Accessed July 7, 2017 at http://review.clinicaloptions.com/Hepatitis/Treatment%20Updates/Primary%20Care.aspx
3.
AASLD-IDSA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full- report/hcv-testing-and-linkage-care. Accessed April 17, 2017.
4.
AASLD-IDSA. Monitoring patients who are starting hepatitis C treatment, are on treatment, or have completed therapy. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are- treatment-or-have. Accessed April 17, 2017.
5.
AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. July 7, 2017.
6.
AASLD-IDSA. Retreatment of Persons in whom prior therapy has failed. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed. Accessed April 17, 2017.
7.
Feld JJ. How I manage patients with HCV after DAA treatment failure. Clinical Care Options Hepatitis. http://review.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Resistance%20Alert/Clinical%20Thoughts/CT2.aspx. Posted 11/19/2016.
Accessed April 17, 2017.
ØA portion of this presentation are from slides prepared by Philip J.
ØDr. Bolduc’s presentation is part of a curriculum developed by the AETC
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