09. HLibman HIV Sept 2012

• Overview and epidemiology • HIV diagnostic testing • Initial evaluation of new patient • General principles of antiretroviral therapy • Long term treatment complications • Prophylaxis

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HIV Infection: What Does the General Doctor Need to Know?

Howard Libman, M.D.

Beth Israel Deaconess Medical Center

Harvard Medical School

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• Overview and epidemiology

• HIV diagnostic testing

• Initial evaluation of new patient

• General principles of antiretroviral therapy

• Long term treatment complications

• Prophylaxis of opportunistic infections

• Health care maintenance issues

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Months | Years

Seropositive

HIV Disease/AIDS Acute HIV Syndrome

HIV Disease/AIDS Clinical Latency

(cells/

mm 3 )

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Spectrum of HIV Infection

• CD4 cell count > 500/mm3

Most patients asymptomatic

Bacterial infections, TB, shingles

• CD4 cell count 500-200/mm3

Many patients asymptomatic

Generalized lymphadenopathy, KS, thrush

• CD4 cell count < 200/mm3

PCP, cryptococcosis, toxoplasmosis

• CD4 cell count < 50/mm3

CMV and MAC infections

Increased risk of lymphoma

Mortality highest

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Reported Cumulative Cases of HIV, AIDS, and Deaths in Vietnam by Year

AIDS Patients Death HIV infection

Vietnam MoH, 2010.

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0.3% 2.3%

Distribution of HIV Infection

in Vietnam by Age

VAAC/Vietnam MoH, 2010.

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73.5%

Women 26.5%

Distribution of HIV Infection in

Vietnam by Gender

VAAC, 2010.

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Distribution of HIV Cases in Vietnam by Risk Behaviors

• Over 50% from injection-drug use

• 40% likely from sexual transmission

(heterosexual and homosexual)

• 5% of cases unknown risk behavior

VAAC/Vietnam MoH, 2010.

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Traditional Historical Indications for

HIV Antibody Testing

• Men who have sex with men

• Persons with multiple sexual partners

• Current or past injection drug users

• Recipients of blood products between 1978

and 1985

• Persons with current or past STD's

• Commercial sex workers and their contacts

• Pregnant women and women of child-bearing age

• Children born to HIV-infected mothers

• Sexual partners of those at risk for HIV infection

• Donors of blood products, semen, or organs

• Persons who consider themselves at risk

or request testing

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Traditional Clinical Indications for

• Tuberculosis

• Syphilis

• Recurrent shingles

• Chronic constitutional symptoms

• Chronic generalized adenopathy

• Chronic diarrhea or wasting

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CDC Recommendations for

“Routine” HIV Antibody Testing

• Screen all healthy patients after notification

that an HIV test will be performed unless theydecline (“opt-out” testing)

• Specific informed consent is unnecessary

• Persons at high risk for HIV infection should be

screened at least annually

• Prevention counseling should be not required

as part of routine HIV testing, but it is strongly encouraged for persons at high risk

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WHO Recommendations for

• HIV screening should be voluntary,

confidential, and undertaken with consent

• Recommended in all patients presenting for care in countries with a generalized

HIV epidemic

• In countries with concentrated or low-level epidemics, recommended in patients

presenting for care in antenatal,

tuberculosis, and sexual health clinics

• Specific HIV screening policies vary by

country

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• In the US, HIV antibody testing is performed

by using enzyme-linked immunosorbent

assay (ELISA), which is highly sensitive

• If result is negative, the test is reported as

negative

• If result is positive, a Western blot (WB)

assay is performed for confirmation

• If WB assay result is positive, the test is

reported as positive

• WB results are occasionally described as

indeterminate; supplemental testing may be recommended

Diagnostic Tests for HIV Infection

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MOH Testing Strategies

Testing Strategy I: At the blood banks

• Positive test with one of these test: ELISA, SERODIA, rapid test

• One positive screening test is sufficient to

reject blood for safe transfusion

Testing Strategy II: Routine screening in high prevalence areas

• Two different ELISA tests

• Positive result if both ELISAs are positive

Testing Strategy III: HIV diagnosis

• Three different ELISA tests

• Positive result if all three tests are positive

Guidelines for Diagnosis and Treatment of HIV/AIDS, Ministry of Health, Vietnam August, 2009

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• General health issues

• Syphilis, other STDs, TB, hepatitis

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Physical Examination

• Integument: seborrhea, psoriasis,

EF, onychomycosis, HSV, VZV, KS,generalized adenopathy

• HEENT: CMV retinitis, CWS,

thrush, OHL, ANUG

• Pulmonary: PCP

• Gastrointestinal: organomegaly

• Genitourinary: vaginitis, PID, HPV,

cervical and anal dysplasia/carcinoma

• Neurological: mental status,

focal central/peripheral findings

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Pulmonary Tuberculosis

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Extrapulmonary Tuberculosis

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Pneumocystis Pneumonia

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Penicillium Infection

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Cytomegalovirus Retinitis

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Baseline Laboratory Evaluation in US

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CD4 Cell Count

• Surrogate marker for HIV disease progression

• Normal value > 350/mm3

Average decline of 50-100 per year

Variability between patients

• Intercurrent illnesses may affect value

• Care in comparing values from different labs

• Main clinical uses are to determine need for

antiretroviral therapy and prophylaxis againstopportunistic pathogens

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Viral Load Testing

• Measurement of viral RNA by PCR or bDNA

• Level correlates with CD4 cell count

decline and clinical progression; the lower,the better

• Normal variability of 0.3 log (3- to 5-fold)

• Intercurrent illnesses and immunizations

may affect value

• Main clinical use is to assess effectiveness

of antiretroviral therapy

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Baseline Laboratory Evaluation

in Vietnam

• All patients:

- HIV antibody test (for confirmation)

- CD4 cell count (if available)

- If any suspicion of TB: CXR, sputum AFB, other tests for diagnosis of extrapulmonary disease

• If available:

- ALT, AST, HBsAg, HBsAb, anti-HCV,

RPR/VDRL

- Creatinine, glucose, lipid profile

- Pregnancy testing, Pap smear (in women)

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Syphilis in HIV Infection

• Unusual clinical presentations, disease

progression, serologic results, and

response to therapy have been described

• False-positive RPR/VDRL in drug users

• Indications for lumbar puncture?

CDC: Evidence of neurologic disease

Some authorities are more aggressive

• What is appropriate therapy?

CDC recommendations: Unchanged

• Follow clinically and serologically

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Viral Hepatitis in HIV Infection

• Hepatitis B is very common in patients with HIV disease; majority show evidence of prior infection

• Clinical course may be accelerated

• Exacerbation of chronic hepatitis B infection may occur with initiation of combination antiretroviral therapy or discontinuation of 3TC, FTC, or TDF

• Hepatitis C is common in IDUs; the majority have chronic infection

• HCV progression is accelerated in patients with HIV disease

• Treatment of chronic hepatitis C infection in the context of HIV disease is less likely to be effective

• Hepatitis A is common in MSM

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PPD Interpretation in HIV Infection

• Positive PPD is defined as > 5 mm induration

• Use of control panel is no longer recommended

• Frequency of anergy is high is patients with

CD4 cell count < 200/mm3

• Isoniazid treatment of latent TB is indicated in

HIV-infected patients with +PPD regardless of

age; it is not recommended in anergic,

high-risk patients

• Hold INH if transaminases > 5 times normal or

if clinical evidence of hepatitis

• Total duration of prophylaxis is 9 months

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Antiretroviral Drugs Available in Vietnam

• Nucleoside RT inhibitors (NRTIs)

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DHHS Recommended Regimens for

Pregnant women ZDV/3TC + LPV/r (bid)

EFV should not be used during the first trimester of pregnancy or in women trying to conceive or not using effective and consistent contraception.

3TC can be used in place of FTC and vice versa.

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First-line ARV Regimens in Vietnam

Guidelines for Diagnosis and Treatment of HIV/AIDS, Ministry of Health,

Vietnam Modification and Supplement, November, 2011

d4T is no longer recommended

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Antiretroviral Therapy: General Usage Guidelines

• Potent combination therapy is necessary,

and effect is durable in majority of patients

• Initial options include NRTI x 2 plus NNRTI,

* coinfection with HBV (where Rx indicated)

• About three-quarters of patients achieve

virologic suppression with first regimen

• Indications for modification of regimen:

* increase in viral load

* drug toxicity

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When to Start Antiretroviral Therapy

in Vietnam

• Patients with CD4 cell count < 350 cells/mm3

regardless of clinical stage

• Patients with WHO clinical stage 3 or 4

regardless of CD4 cell count

Vietnam Modification and Supplement, November, 2011.

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Fat atrophy

face, extremities, buttocks

Lactic acidemia/acidosisOsteopenia/osteoporosisAvascular necrosis of hipsPeripheral neuropathy

Long Term Treatment Complications

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Facial Lipoatrophy

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Hyperlipidemia,

insulin resistance

Switch therapy

PI  NNRTI d4T TDF or ABC

Insulin-sensitizing drugs

Local injection Rx

(polylactic acid, calcium

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Clinical Syndromes

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Lactic Acidemia and Acidosis

• Lactic acidemia is common in patients on NRTIs, but symptomatic acidosis is not

• Related to mitrochondrial toxicity from interference with DNA polymerase-gamma

• Clinical manifestations are variable and

nonspecific

• Management consists of discontinuation of NRTI drugs in symptomatic patients with high lactate

level

• Routine lactate monitoring in the absence of

symptoms is unlikely to be helpful

• However, if symptoms are present and an

increased lactate level is confirmed, modification

of ARV regimen is warranted

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Peripheral Neuropathy

• HIV infection itself and certain ARV drugs (ddI, d4T, ddC) are likely responsible

• Manifests with sensory symptoms

involving the lower extremities

• Diagnosis is made clinically after

excluding other common causes of

peripheral neuropathy

• Management consists of discontinuation

of the offending drug and control of HIV infection

• If necessary, analgesics and

antidepressants and /or anticonvulsants can be used for chronic pain management

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OI Prophylaxis in HIV Infection in US

Stratified by CD4 Cell Count

Red font indicates secondary prophylaxis only.

* In patients with positive PPD

** Alternative Rx: dapsone/pyrimethamine

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Primary Prophylaxis for Select OIs in Vietnam

Disease/Agent Indication Primary

disease

Cotrimoxazole (960

mg tab) once daily

CD4 > 200 cells/mm 3 for more than 6 months

Toxoplasma

gondii

WHO Stage IV or CD4 < 100

cells/mm 3

Cotrimoxazole (960

mg tab) once daily

CD4 > 200 cells/mm 3 for more than 6 months

Vietnam August, 2009

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HIV Routine Health Care Maintenance in US

* In HBV-seronegative patients; ** In at risk patients and those with chronic

hepatitis; *** Especially in patients at risk for exposure to or morbidity from

influenza; + Annually after first year; ++ In PPD-negative patients.

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