Transcript IHS/CCUIH HIV and HCV Clinical Consultation Service

Clinician Consultation Center
Indian Health Services
California Consortium for Urban Indian Health
Hepatitis C Warmline
Joanna Eveland, MD
Brenda Goldhammer, MPH
Clinician Consultation Center
The Clinician Consultation Center (CCC) at the University of California at San
Francisco provides immediate, state-of-the-art HIV/AIDS clinical consultation to
health care providers (physicians, nurse practitioners, physician assistants,
pharmacists and other health care professionals) across the country through four
telephone and online consultation services:
HIV/AIDS Management Consultation Service: 6:00 a.m.-5:00 p.m. PST
Perinatal HIV Consultation and Referral Service: 24/7
Post-Exposure Prophylaxis Consultation Service(PEPline): 6:00 am – 11:00 pm PST
Pre-Exposure Prophylaxis Consultation Service (PrEPline): 6:00 a.m.-5:00 p.m. PST
Health Resources and Services Administration (HRSA) HIV/AIDS Bureau
AIDS Education and Training Centers (AETCs)
and
Centers for Disease Control and Prevention (CDC)
IHS/CCUIH HIV and HCV Clinical Consultation Service
For HIV Consultation: 1-800-933-3413
For Hepatitis C Consultation: 1-844-437-4636
What it is:
A national, cost-free telephone service providing confidential expert advice on HCV mono- and co-infection for
CCUIH/IHS clinicians. Up-to-date, clinically supported options and advice on testing, prevention, and treatment,
including follow-up advice for challenging or ongoing clinical management scenarios.
Who it’s for:
IHS/CCUIH clinicians of any experience level who provide primary care and specialty HIV and/or HCV care, and who
have general informational or patient-specific questions on HIV or HCV management.
What to expect:
Consultation from clinicians, hepatologists, and clinical pharmacists with expertise in HIV and HCV care. Advice is
based on Federal treatment guidelines, current medical literature, and clinical best practices.
When it’s available:
6 a.m. – 5 p.m. PST, Monday through Friday. Initial responses will be provided within one business day of the call. On
nights, weekends, and holidays, calls will be routed to a voice mail system and returned the next business day.
CCC Consultations
Clinical team blend of…
• Expert knowledge
• Primary care foundation
• Non-judgmental consultation
• Multidisciplinary approach
Consultation Goals
• Answer caller’s questions with evidence-based
responses.
• Share expert opinion in cases where gray area
exists in guidelines.
• Provide useful references and resources.
• Build caller’s capacity to manage similar cases
in the future.
What can the HCV Clinical Consultation Service
offer you?
Help in a changing treatment landscape
• Expanded HCV screening
• Treatment is evolving
quickly
• More treatment options,
more complexity
• New issues around cost
and access
History of HCV Treatment: In a New Era
Helping you to stay aware of new HCV
Treatments
Topics for the HCV Clinical Consultation
Service: Before Treatment
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Screening for HCV (and interpreting tests)
Determining liver disease severity
Preparing for treatment
Choosing a regimen
Topics for the HCV Clinical Consultation
Service: During Treatment
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Dosing and duration
Monitoring
Drug interactions
Access
Complications
Topics for the HCV Clinical Consultation Service:
Care for Complex Patients
• Management of Liver Cirrhosis
• Treatment of Special Populations
• HIV co-infected
• Pregnancy
• Kidney failure
• Substance abuse
Cultural Competency
• Awareness of unique issues faced by Native
Populations
• An understanding of HCV as a “broken spirit
disease”
• Clinical experience working with
underserved/minority communities
• Able to discuss addiction, trauma, poverty as
related to HCV treatment
Topics for the HCV Clinical Consultation Service:
Sample Questions
My patient’s HCV antibody
test just came back positive.
What do I do next?
What treatment do I pick
for my patient with HCV
and cirrhosis?
My patient is 4 weeks into
treatment and the HCV viral
load is still detectable! Should
I stop treatment?
Topics for the HCV Clinical Consultation Service:
Sample Consult
Consult with
Clinical Pharmacist
on drug
interactions with
diabetes and HCV
medications
Share treatment
guidelines and
other
educational
resources
What HCV
treatment
regimen should I
pick for my
newly diagnosed
patient? He also
has diabetes.
Consult with
HCV specialist
on treatment
options
Discuss the
“question behind
the question”:
Does this patient
have liver
cirrhosis?
Information for a Productive Consult
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Patient demographics
Treatment history
HCV genotype and viral load
Other recent labs and imaging for staging
PMHx, Meds, Allergies, SHx
Questions for us
Recent Case
• 58 y.o. male with GT 1a infection and
compensated cirrhosis
• Treated from March-June 2015 with
Sofosbuvir/Ledipasvir + Ribavirin X 12 weeks
• Failed treatment: HCV Viral load became
undetectable 8 wks into treatment but then
relapsed 12 wks post treatment
Case Continued
Labs
HCV VL 128,000 IU/ml
AST 168
ALT 131
INR 1.1
T. bili 1.5
Platelets 62K
Questions from Caller
• Should this patient be retreated with combo
of Sofosbuvir/Simeprevir?
• When will next generation of HCV medications
be available?
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“The Questions behind the Question”
• How do we interpret HCV resistance testing?
• How do we manage treatment failure with
HCV Direct Acting Agents (DAAs)?
• Does this patient need to be treated right
away?
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Clinician Response: Managing Resistance
• The Y93C mutation confers resistance to NS5A
inhibitors Ledipasvir and Daclatasvir.
• Check for Q80K (NS3 inhibitor Resistant
Associated Variant- RAV) before considering
Simepravir.
• Re-check his HCV genotype as minor species
variants may have appeared after treatment.
Clinician Response: Treatment Regimen
Per AASLD/IDSA guidelines, for cirrhotic patients
requiring urgent treatment who have NS5A
inhibitor RAVs detected and who do not have
NS3 inhibitor RAVs detected, treatment with
Simeprevir/Sofosbuvir/Riba for 24 weeks is
recommended.
Clinician Response Continued: Caveats
• However, if the patient fails this regimen with
NS3 resistance, his future treatment options
will be very limited.
• If no evidence of decompensation, may be
reasonable to defer treatment awaiting more
data.
• Another option is retreatment through a
clinical trial- referred caller to local trial
currently enrolling patients with DAA failure.
When Will New Drugs be Out?
• Spoke directly with Merck headquarters.
• Fixed dose combination of
Grazoprevir/Elbasvir has received
breakthrough therapy designation and FDA
should rule by Jan. 2016
• However, this combo has not been evaluated
in DAA treatment failures other than a small
Phase II trial called C-EDGE.
Newer New Drugs
• Drugs in the pipeline more relevant to this patient
are actually earlier in development.
• Both Gilead and Merck are developing "triplet
combinations" consisting of a HCV nucleoside
inhibitor, second generation NS5a inhibitor, and 3rd
or 4th generation HCV Protease Inhibitor.
• Second gen NS5a inhibitors (i.e. Gilead’s 5816) will
hopefully will retain activity against resistant virus
• The earliest likely approval is late 2016.
Questions? Comments? Concerns?
Thank you!