The Role of the Primary Care Clinician in HIV Care

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1 The Role of the Primary Care Clinician in HIV Care Jeffrey Kwong, DNP, ANP-BC, AAHIVS, ACRN, FAANP Columbia University School of Nursing New York, NY New York Nurse Practitioner Association Annual Meeting 2015

2 Disclosures I have no relevant disclosures.

3 Learning Objectives 1. Discuss the epidemiology of HIV/AIDS. 2. Explain the modes of HIV transmission. 3. Describe the signs and symptoms of HIV infection. 4. Explain antiretroviral treatment for HIV infection.

4 Stage 3 (AIDS) Classifications and Deaths of Persons with HIV Infection Ever Classified as Stage 3 (AIDS), among Adults and Adolescents, United States and 6 Dependent Areas Note. All displayed data have been statistically adjusted to account for reporting delays, but not for incomplete reporting. Deaths of persons with HIV infection, stage 3 (AIDS) may be due to any cause.

5 Diagnoses of HIV Infection among Adults and Adolescents, by Transmission Category, United States and 6 Dependent Areas Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays and missing transmission category, but not for incomplete reporting. a Heterosexual contact with a person known to have, or to be at high risk for, HIV infection. b Includes hemophilia, blood transfusion, perinatal exposure, and risk factor not reported or not identified.

6 Diagnoses of HIV Infection among Adults and Adolescents, by Sex and Transmission Category, 2013 United States and 6 Dependent Areas Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays and missing transmission category, but not for incomplete reporting. a Heterosexual contact with a person known to have, or to be at high risk for, HIV infection. b Includes hemophilia, blood transfusion, perinatal exposure, and risk factor not reported or not identified.

7 Rates of Diagnoses of HIV Infection among Adults and Adolescents, 2013 United States and 6 Dependent Areas N = 47,958 Total Rate = 18.0 Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays, but not for incomplete reporting.

8 Rates of Diagnoses of HIV Infection among Adults and Adolescents, by Sex and Race/Ethnicity, 2013 United States Note. Data include persons with a diagnosis of HIV infection regardless of stage of disease at diagnosis. All displayed data have been statistically adjusted to account for reporting delays, but not for incomplete reporting. a Hispanics/Latinos can be of any race.

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11 Perinatal Infections - NYS Source: New York State, Department of Health AIDS Institute

12 HIV Infection AIDS

13 HIV Transmission Blood Semen Vaginal Secretions Breast Milk Sex Injection Drug Use Blood Transfusion Occupational exposure Mother to Child

14 Awareness of Serostatus Among People with HIV and Estimates of Transmission ~14 % Unaware of Infection Accounting for: ~54% of New Infections ~86% Aware of Infection ~46% of New Infections People Living with HIV/AIDS: 1,039,000-1,185,000 New Sexual Infections Each Year: ~56,000** (may be higher) CDC (2014) HIV at a glance

15 HIV Testing and Screening Centers for Disease Control & Prevention (2006) years old Persons initiating treatment for TB Persons seeking treatment for STIs Pregnant women U.S. Preventive Services Task Force (2013) Grade A recommendation years old Persons at high-risk screen annually Pregnant women CDC, MMWR (2006) 55(RR14);1-17 USPSTF Ann Intern Med (2013);30 Apr

16 Testing and Diagnosis 4 th generation HIV antigen/antibody testing Decreased window period Improves ability to detect early HIV infection

17 HIV RNA Typical Course of Acute HIV infection 1 mil 100,000 10,000 1, Exposure WINDOW PERIOD 4 th generation testing HIV RNA WINDOW PERIOD early generation testing Symptoms Ab HIV-1 Antibodies Ab positive Ab negative Days

18 CDC, Laboratory Testing for Diagnosis of HIV infection

19 Rapid Testing Saliva or blood Results in 20 minutes Available over the counter Many rapid tests are 2 nd or 3 rd generation. Be aware window period is different Only 1 FDA approved 4 th generation rapid tests available

20 HIV Then HIV NOW

21 Rationale for ART Improves and preserves immune function in most patients Reduction in AIDS- and non-aidsassociated morbidity and mortality Reduce risk of HIV transmission

22 Evolution of DHHS Guidelines Factor Recommendation / AIDS Treat Treat Treat Treat Treat Treat Treat Treat Treat Treat CD4 count (cells/ mm 3 ) Viral load (copies /ml) Other factors Treat <500 >20,000 Trea t <200 Offe r <350 Indi v. >350 Trea t <200 Offer <350 Indiv. >350 >55,00 0 Treat <200 Offer <350 Indiv. >350 > 100,000 Treat <350 Risks/be nefits if >350 No specific viral load Pregnant women HBV coinfected HIVAN Treat <350 Rec >500 optional No specific viral load Pregnant women HBV coinfected HIVAN Treat <350 Rec >500 optional (panel split) No specific viral load Pregnant women HBV coinfected HIVAN Rec for all <350 (AI) (AII) >500 (BIII) No specific viral load Pregnant women HBV coinfected HIVAN < 350 (AI) (AII) > 500 (BIII) No viral load Treat to control disease and prevent infection ANY (AI) No viral load Treat to control disease and prevent infection

23 2015 DHHS Guidelines HIV treatment should be offered to ALL individuals to prevent disease progression AND to prevent transmission of HIV. (AI) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

24 Considerations Patients should be willing and able to: commit to treatment understand benefits, risks understand importance of adherence Patients or providers may elect to defer ART Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

25 Laboratory & Diagnostic Evaluation Complete blood count (AIII) Comprehensive metabolic panel (AIII) CD4+ T cell count (AI) HIV plasma RNA (AI) HIV genotype (AII) Hepatitis serologies STI screen (GC, Chlamydia, RPR) Fasting lipids & glucose (AIII) Urinalysis G6PD Toxoplasma IgG IGRA or PPD Chest Radiograph Cervical cytology Aberg et al. (2013). Primary care guidelines for the management of persons infected with HIV: 2009 update by the HIV Medicine Association of the Infectious Disease Society of America DHHS (2015). Guidelines for use of antiretrovirals agent in HIV-1-infected adults and adolescents

26 CD4+ (T4) Cell Count Indicator of immune function Determines urgency of ART or need for OI prophylaxis Assess TRENDS over time In virologically suppressed patients (2+ years) cells/mm 3 (assess annually) (BII) > 500 cells/mm 3 (optional) (CIII) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

27 HIV RNA Critical in determining response to ART Goal is HIV RNA below limit of detection

28 Source: CDC.gov

29 HIV RNA Check at baseline & before initiating ART 2-4 weeks after start or change of ART Every 3-4 months with stable patients; Consider every 6 months for stable, adherent patients with VL suppression >2 years (AIII) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

30 Resistance Assays Genotype Identifies drug resistance mutations Phenotype Measures virus ability to grow in various concentrations of drugs

31 Resistance (%) Transmitted HIV Antiretroviral Drug Resistance ( ) 10 HIV Surveillance Areas in US % 17.9%* 15.5% Overall (n=18,144) Recent infection (n=3904) Long-standing infection (n=11,953) % 7.0% 6.5% 8.1% 10.5%* 7.3% 5 4.5% 4.5% 4.1% 0 Any Class NRTI NNRTI PI Total sample size: 77,887 newly diagnosed HIV-positive patients. *P<0.01 Kim versus D, et al. long-standing 20 th CROI. Atlanta, infection Abstract 149. Kim D, Ziebell R, Saduvala N, et al. Trend in transmitted HIV- 1 ARV drug resistance- associated mutations: 10 HIV surveillance areas, US, Program and abstracts of the 20 th Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta, GA. Abstract 149.

32 HLA-B*5701 Testing Human Leukocyte Antigen Testing Predicts allergic reaction to abacavir Abacavir hypersenstivity can be fatal. Patients who test HLAB*5701 POSITIVE should have ABACAVIR listed as an allergy.

33 Treating HIV.the principle At least 3 different DRUGS At least 2 different CLASSES Try for 1 time a day DOSING

34

35 Antiretroviral Therapy NRTI Abacavir (ABC) Didanosine (ddi) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4t) Tenofovir (TDF) Zidovudine (AZT, ZDV) NNRTI Delavirdine (DLV) Efavirenz (EFV) Etravirine (ETR) Nevirapine (NVP) Rilpivirine (RPV) PI Atazanavir (ATV) Darunavir (DRV) Fosamprenavir (FPV) Indinavir (IDV) Lopinavir (LPV) Nelfinavir (NFV) Ritonavir (RTV) Saquinavir (SQV) Tipranavir (TPV) Integrase Inhibitor Dolutegravir (DTG) Elvitegravir* (EVG) Raltegravir (RAL) Entry Inhibitors Fusion Inhibitor Enfuvirtide (ENF, T-20) CCR5 Antagonist Maraviroc (MVC) Boosting Agent Cobicistat (COB)

36 Nuceloside Analogues (NRTI) ADVANTAGES Established backbone of combination therapy Minimal drug interactions DISADVANTAGES Lactic acidosis, hepatic steatosis, lipoatrophy Renal, bone density Cardiovascular risk

37 Integrase Inhibitors ADVANTAGES Fewer adverse events than with EFV Rapid drop in VL RAL, DTG have fewer drug-drug interactions than with PIs or NNRTIs (not true of EVG/COBI) Virologic response noninferior to EFV NNRTIs and PIs preserved for future use DISADVANTAGES Lower genetic barrier to resistance than PIs COBI has many drug-drug interactions COBI may cause or worsen renal impairment

38 Protease Inhibitors ADVANTAGES Higher genetic barrier to resistance PI resistance uncommon with failure (boosted PI) NNRTIs and Integrase preserved for future use DISADVANTAGES Metabolic complications (fat maldistribution, dyslipidemia, insulin resistance) GI intolerance Potential for drug interactions (CYP450), especially with RTV

39 Non-Nucleosides (NNRTIs) ADVANTAGES Long half-lives Less metabolic toxicity (dyslipidemia, insulin resistance) than with some PIs PIs and Integrase preserved for future use DISADVANTAGES Low genetic barrier to resistance single mutation Cross-resistance Rash; hepatotoxicity Potential drug interactions (CYP450) Transmitted resistance to NNRTIs more common than resistance to PIs Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

40 Initial Treatment: Constructing an ART regimen Nucleoside (NRTI) #1 Nucleoside (NRTI) #2 Non-Nucleoside Protease Integrase Inhibitor (NNRTI)(INSTI) (PI) Fusion inhibitor & CCR5 antagonist not recommended in initial ART Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

41 The Nucleoside (NRTI) Backbone TDF/FTC Once-daily dosing High virologic efficacy Active against HBV Potential for renal and bone toxicity ABC/3TC Once-daily dosing Must be HLA-B*5701 negative Possible risk of cardiovascular events** Possible inferior efficacy if baseline HIV RNA >100,000 copies/ml Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

42 Initial Regimens: Recommended (Regardless of baseline HIV RNA or CD4 count) PI based INSTI based Darunavir +ritonavir (QD) + Tenofovir/Emtricitabine( AI) Dolutegravir + Abacavir/Lamivudine (AI) Dolutegravir + Tenofovir/Emtricitabine (AI) Elvitegravir/Cobicistat/Tenofovir/Emtricitabine (AI) Raltegravir + Tenofovir/Emtricitabine (AI) Notes: 3TC can be used in place of FTC and vice versa; TDF: caution if renal insufficiency 1. Consider alternative to EFV in women who plan to become pregnant or are not using effective contraception. 2. ATV/r should not be used in patients who take >20 mg omeprazole per day. 3. ABC should be used only if HLA-B*5701 is negative; caution if high risk of CV disease. 4. EVG/COBI should be started only if CrCl <70 ml/min. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

43 Initial Regimens: Alternative NNRTI based PI based Efavirenz/Tenofovir/Emtricitabine (BI) Rilpivirine/Tenofovir/Emtricitabine (BI) ** Atazanavir+Ritonavir³ + Tenofovir/Emtricitabine (BI) # Atazanavir/cobicistat + Tenofovir/Emtricitabine (BI) Darunavir/ritonavir (BII) or Darunavir/Cobicistat (BIIII) + Abacavir/Lamivudine ## Darunavir/cobicistat + Tenofovir/Emtricitabine (BII) # Notes: ** only in patients with baseline viral load <100,000 copies/ml and CD4> 200 cells/m3 # only in patients with baseline CrCl>70 ml/min ## only in patients who are HLAB5701 negative Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

44 Potential Advantages and Disadvantages of Single-Tablet Regimens Advantages Simplicity Convenience Fewer copays Reduces selective nonadherence Disadvantages Inability to adjust dosages Not available for all ART regimens Not available for all NRTI pairings

45 Preference Side Effects Drug-Drug Interactions Resistance Antiretroviral Regimen Cost Co- Morbidities Adherence /Dosing

46 Adherence High rates of adherence correlate with: viral suppression (goal=undetectable) reduced rates of resistance improved survival Adherence assessment and counseling should be done at every visit

47 Initiating and monitoring patients Follow closely until virologically suppressed. Then monitor every 3-4 months. Stable patients can be monitored every 6 months. For patients not on treatment, monitor every 3-4 months or more frequently as needed Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Dept of Health and Human Services; 2015

48 Recommended OI prophylaxis Opportunistic Infection CD4+ at which to initiate prophylaxis Recommended Prophylaxis P. Jiroveci < 200 TMP-SMX Toxoplasma IgG < 100 TMP-SMX Mycobacterium Avium < 50 Azithromycin

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50 Co-morbidities: Similar Age but Increased Frequency Outcome Adjusted Mean Difference in Age, Yrs Higher rate of MI, ESRD, HIV-associated cancers vs HIV-uninfected adults Risk airr (95% CI) Myocardial Infarction (-0.62 to 0.54) 1.81 ( ) End Stage Renal Disease (-0.69 to 0.23) 1.43 ( ) HIV-associated cancers* (-0.93 to -0.21) 1.84 ( ) Other cancers (-0.78 to -0.12) 0.95 ( ) HIV-associated cancer diagnoses occurred ~ 7 months earlier in HIV-infected adults vs HIVuninfected adults *Included anal, Hodgkin s lymphoma, liver, lung, oral cavity and pharyngeal cancers. Althoff K, et al. CROI Abstract 59.

51 Traditional Factors Are the Biggest Contributor to CVD in HIV Population FAMILY HX GENDER AGE CARDIOVASCULAR DISEASE DIET OBESITY TOBACCO USE DIABETES HTN HIV Infection ART LIPIDS

52 Recommended Screenings Component Blood Pressure Check Digital Prostate Exam Frequency Annually Annually Ophthalmologic Exam Every 6-12 months in CD4 < 50 cells/mm 3 Depression Screening Fasting glucose Fasting Lipids Colonoscopy Annually Mammography Age 50 Cervical Cancer Every 6-12 months Every 6-12 months Age 50 and every 10 years, earlier or more frequent in persons at risk After 2 normal Paps 6 months apart may perform annually Bone Densitometry Post-menopausal women 65 years or older and in persons > 50 with >1 risk factor for premature bone loss Abdominal Aortic Aneurysm Men who have ever smoked Aberg, et al. (2013). Primary care guidelines for the management of persons infected with Human Immunodeficiency Virus:

53 Mental Health Providers should assess the presence of depression and domestic violence by means of direct questioning or validated screening tools (B-III) Aberg et al. (2013). Primary care guidelines for the management of persons infected with HIV: 2009 update by the HIV Medicine Association of the Infectious Disease Society of America

54 An ounce of prevention..

55 Non-Occupational Post-Exposure Prophylaxis

56 PrEP Candidates PrEP is recommended as one prevention option for the following adults at substantial risk of HIV acquisition Sexually active MSM Heterosexually active men and women Injection drug users MSM Heterosexual Women and Men Injection Drug Users Potential indicators of substantial risk of acquiring HIV infection HIV-positive sexual partner Recent bacterial STI High number of sex partners History of inconsistent or no condom use Commercial sex work HIV-positive sexual partner Recent bacterial STI High number of sex partners History of inconsistent or no condom use Commercial sex work In high-prevalence area or network HIV-positive injecting partner Sharing injection equipment Recent drug treatment (but currently injecting) CDC. PrEP Guideline

57 HPTN 052: Treatment 96% reduction in HIV transmission if partner is treated with ART SOURCE: NIAD (may 12, 2011)

58 Photo: J. Kwong

59

60 Summary HIV treatment options have improved. Selection of treatment includes consideration for adherence, potential side effects, and co-morbidities. NPs play a critical role in managing chronic co-morbidities and supporting health promotion and wellness interventions to ensure healthy aging with HIV.

61 QUESTIONS? Contact Information Jeffrey Kwong, DNP, MPH, ANP-BC

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