What the Primary Care Provider Should Know Carolyn K Burr EdD RN CoClinical Director NYNJ AETC LPS Deputy Director FrançoisXavier Bagnoud Center December 17 th 2013 Support for this program is provided in part through an educational training grant from the New Jersey Departmen ID: 736851
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Diagnosis and Initial Management of HIV/AIDS:What the Primary Care Provider Should Know
Carolyn K. Burr, EdD, RNCo-Clinical Director NY/NJ AETC LPSDeputy Director François-Xavier Bagnoud CenterDecember 17th, 2013
Support for this program is provided in part through an educational training grant from the New Jersey Department of Health (NJDOH), Division of HIV,STD and TB Services.Slide2
ObjectivesDescribe two ways HIV can be transmittedIdentify two laboratory tests used to assess HIV disease
Describe the clinical progression of HIVDiscuss the purpose of antiretroviral treatmentSlide3
What is HIVH
umanImmunodeficiencyVirusHIV is a retrovirus that attacks the immune system.Its genetic material, RNA, must be converted in to DNA during replication.Over time, the immune system and the body loses its ability to fight the virus.Slide4
HIV and the Immune SystemThe CD4 cells coordinate a body’s immune response to an invader (bacteria, virus, etc.)
BUT, when HIV enters CD4 cells for reproduction, it damages the CD4 cell, eventually killing it. The body’s immune system works hard making more CD4 cellsOvertime, HIV destroys the CD4 cells faster than the immune system can make new onesSo, HIV damages the very system that usually protects the body from infection.Slide5
HIV Life CycleSlide6Slide7
HIV in New Jersey36,648 people are living with HIV
78%Minorities
79%
40 years or older
34%
Women
(53% between 20-49)
159 perinatal exposures
3% infectedSlide8
HIV TransmissionBloodSemen Vaginal Secretions
Breast milkComes into contact with: mucous membranes, damaged tissue, or is injected into the bodyThrough:Vaginal, anal, or oral sexContaminated needlesIV drug useSlide9Slide10
HIV TransmissionPerinatal transmission during pregnancy, labor and deliver, or breastfeeding
Occupational exposure via needle stick or exposure to eyes, nose, or open woundSince 1981 there have been 57 documented cases of occupational transmission in the USBlood transfusion or organ donation from an HIV infected donor (rare in US)Slide11
HIV TransmissionHIV is NOT transmitted by casual contactWorking or playing with an HIV positive person
Closed mouth kissingShaking handsPublic poolsHuggingPublic toiletHIV is not transmitted by air, food, or mosquito and does not survive long outside the body.Slide12
HIV TestingCDC recommends
routine HIV testing for ALL patients:Aged 13-64Initiating TB treatmentSeeking treatment for STI’sWho are pregnant
Repeat Screening RecommendedAnnually people at high riskBefore beginning a new sexual relationship
When clinically indicated
After an occupational exposureSlide13
HIV TestingBenefits of routine opt-out
HIV testingReduces the stigma of testingReduces transmissionMajority of people aware of their HIV status reduce behaviors that transmit infectionPerinatal transmission can be prevented if mother’s HIV status is knownImproves patient outcomes (with early diagnosis of HIV)Slide14
Sequence of HIV Assay Reactivity During Early HIV Infection relative to Western Blot*
0
-20
- 15
-10
- 5
-25
Estimated #
of days HIV assay is reactive before a positive Western
blot
result is obtained
Gen-Probe
Aptima
(26
)**
Abbott Architect
Ag/
Ab
Combo
(20)
Clearview
Statpak
/Complete
(5)
Trinity
Uni
-gold
Recombigen
(2)
WB POSITIVE
BioRad
GS +
O
(12
)
Medmira
Reveal G3
(6)
Ortho
Vitros
Eci
/
ECiQ
(13)
OraSure
Oraquick
Advance
(1)
Bayer ADVIA Centaur
(14)
Bio-Rad Ag/
Ab
combo (19)
BioLytical
Insti
(9)
Adapted from Owen et al J
Clin
Micro 2008 and Masciotra et al J
Clin
Virol
2011
Bio-Rad
Mulltispot
(
7)
Avioq
(6)
*Assay sensitivity above is based on frozen plasma only. Whole-blood and oral fluid has not been
characterized for early infection.
**Current data suggests that the Gen-Probe
Aptima can detect HIV-1 RNA ~9-11 days after infection.
NAT
4
th
gen IA
3
rd
gen Lab IA
1
st gen WB
2
nd
gen IA
3
rd
gen POC IA
DPP HIV1/HIV-2(6)Slide15
HIV Laboratory Tests – CD4 CountCD4 count –measures state of a person’s immune function
Adult values are approximately 500-1300Used to determine stage of HIV progressionDetermines risk of opportunistic infectionHistorically guided decisions about antiretroviral therapy (ART)Slide16
HIV Laboratory Tests – Viral LoadDetects the amount of virus
presentHigh viral loads increase risk for disease progression and HIV transmission Monitors effectiveness of ARTGoal of therapy is an undetectable viral loadUsed during acute infection to detect virus
Measured by HIV-1 RNA PCR Slide17
Clinical ProgressionAcute Retroviral SyndromeTwo thirds of all patients experience symptoms
Occurs 2-6 weeks after initial infectionSymptoms last 2-4 weeksMay be mistaken for influenza, mononucleosis, or other viral processDuring this period HIV virus is replicating rapidly and CD4 count decreases until the body’s immune response recovers CD4 cells and decreases viral loadSlide18
Clinical ProgressionClinical LatencyVirus is replicating at low levels
CD4 cells are maintained at a healthy levelVirus is transmittableThis period may last for several yearsSlide19
Clinical ProgressionClinical symptoms will begin to develop at the end of this period as CD4 count falls and viral load increases. May include
Bacillary angiomatosis (lesion on skin caused by infection with gram negative organismPersistent or resistant vulvovaginal candidiasisPID Cervical DysplasiaHairy leukoplakiaHerpes ZosterFever or diarrhea lasting longer than one monthSlide20
AIDSAIDS is characterized by certain infections that take advantage of the body’s weakened immune system. A diagnosis of AIDS is made when an HIV positive patient has a CD4 count of less that 200 or 14% or the patient is diagnosed with an AIDS defining condition
Progression from initial infection with HIV to advanced HIV/AIDS varies among people and can take several months to up to 10 years or more.Slide21
Opportunistic InfectionsOpportunistic infections are infections that take advantage of a weakened immune system to cause more frequent or severe illness
CDC identifies 29 infectionsProphylactic drugs may be given to prevent illness for some conditionsOther clinical options includeEffective ARTVaccination
Avoiding exposure to certain pathogensDisease treatment
Preventing disease recurrence (secondary prophylaxis or chronic maintenance therapy)Slide22
Clinical ProgressionSlide23
What can we do?Slide24
Antiretroviral TherapyRecommended for all HIV-positive people
To prevent disease progressionTo prevent transmission of infectionsStrength of recommendation based on CD4 countTransmission riskSee
Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents available at http://www.aidsinfo.nih.gov
/
for more infoSlide25
Confusing terminology?
ART = Anti Retroviral T
herapyARV = Anti
R
etro
V
irals
HAART =
H
i
ghly
A
ctive
A
nti
R
etroviral
T
herapy
Triple Therapy = Three Antiretrovirals
“The Cocktail”Slide26
Basic Facts about ARVs
Always use 3 or more different ARV medications for therapy.Regimen should be selected by an experienced HCW. Other medications interact with ARVs.
ARVs are divided into
classes
, e
ach of which attacks HIV in a different way.
New classes becoming available through clinical trials.Slide27
HIV as a Chronic Disease
ARVs change HIV from a terminal (fatal) disease to a “chronic disease”Examples of chronic diseases:DiabetesHigh blood pressure
AsthmaSchizophreniaSlide28
Advantages of ARV TherapyImproved patient health
Reduced illness Reduced hospitalisationsFewer deaths from AIDSSlide29
Goals of TreatmentImprove quality of life
Reduce HIV-related morbidity and mortality Restore and/or preserve immunologic functionMaximally and durably suppress HIV viral loadPrevent HIV transmissionSlide30
How do ARVs control HIV?
ARVs reduce the ability of the HIV virus to replicateIn turn, this increases the ability of the body to fight diseaseReduces the risk of HIV transmission
HIVReplication
Immune
Response
Slide31
The Ideal ARV
Good tolerability
No toxicities
Complete viral suppression
No resistanceSlide32
Initial Treatment: Choosing Regimens3 main categories:
1 NNRTI + 2 NRTIs1 PI + 2 NRTIs1 II + 2 NRTIsCombination of NNRTI, PI, or II + 2 NRTIs preferred for most patientsFusion inhibitor, CCR5 antagonist not recommended in initial ART
Advantages and disadvantages to eachtype of regimenIndividualize regimen choiceSlide33
Achievable…..?YES
ARVs are able to significantly reduce viral load, allowing the immune system to recover followed by an increase in quality of life and reduction in morbidity and mortalityBUT they are not perfect……….Slide34
Managing Side Effects
‘Acceptable’ (transient, manageable)Versus
‘Unacceptable’ (severe, adverse reactions)
…..but,
ALL
must be reported so that they can be managed appropriatelySlide35
Basic Facts about Adherence and ARV Therapy
ARV blood concentrations must remain constant; low concentrations allow HIV to mutate. HIV mutations cause drug resistance.ARV medications must be taken every day otherwise they will not work.Things that can lower drug concentrations:
Missing 1 or 2 ARV medication doses regularlyTaking ARV medication late Taking ARVs with certain foods or other medications Slide36
Treatment AdherenceA patient’s ability to follow a prescribed treatment regimen
Major factor in success of drug regimenSignificant determinant of survivalWillingness to start treatment and take medications exactly as directedLevel of adherence affects how well ART decreases the HIV viral loadAverage US ART adherence rate is about 70%Slide37
Treatment AdherenceFactors associated with poor adherenceDepression
Active alcohol or drug useLow literacyLack of social support (unstable social situation, chaotic lifestyle)Lack of support from partnerAdvance HIV infectionYoung ageDisbelief in treatment efficacyUnstable housingCognitive impairmentCompeting priorities
Childcare, food and workSlide38
Treatment AdherenceComplexity of medication regimenAdverse drug effects
Poor patient provider relationshipsLack of resourcesPoor literacySubstance abuseStigmaTravel away from homeSleeping through dosesTreatment fatigueAdherence should be assessed at each visitSlide39
Treatment AdherenceStrategies to improve adherenceChoose once daily dosing if possible
Avoid complex or poorly tolerated regimesUse fixed dose combinations if possibleUse multidisciplinary approachProvide tools and supportReminder alarmsText message remindersEducation and counselingPill boxesSlide40
ResistanceSkipping doses of medications may cause the virus to mutate leading to strains of HIV that are resistant to medications
Drug resistant strains can be transmitted Viral fitness: Ability of a virus to enter and destroy CD4 cell (caused by the number resistant mutations developed)Slide41
Resistance TestingGenotype
Amplifies and sequences HIV to look for mutations known to correlate with drug resistance. Most successful if viral load is above 1000 copies/mlRecommended as initial form of resistance testingUse to select effective ARTPhenotypeHIV reverse transcriptase and protease genes are spliced and created into a laboratory strainThe strain is grown in the presence of escalating concentrations of ARV drugsProcess takes 2-3 weeks and is costlyRecommended for patients with complicated multidrug resistance patternsSlide42
Take Home Messages: HIV 101HIV infection is a treatable, chronic illnessRoutine HIV testing is essential not only for treatment of HIV but also for prevention
ART improves quality of life and decreasesMortalityMorbidityRisk of transmission to partnersAdherence is key to ARV effectivenessSlide43
ResourcesAIDS Education and Training Center National Resource Center www.aidsetc.orgNY/NJ AETC
http://www.nynjaetc.org/index.htmlNY/NJ AETC Trainings On-Demand Online Courses http://www.nynjaetc.org/on-demand/index.html#CMENational Clinicians Consultation Center www.nccc.ucsf.eduAIDSInfo Clinical Guidelines http://
aidsinfo.nih.gov/guidelinesFrançois-Xavier Bagnoud Center http://fxbcenter.org/Slide44
THANK YOU!