September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV) SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT ALL HIV INFECTED PATIENTS MUST BE MANAGED BY A CCHCS HIV SPECIALIST GOALS • Offer HIV screening to all • Ensure a sexual history and appropriate risk reduction counseling is performed • Refer all patients with HIV to HIV specialists as by a primary care team member for every patient with HIV at least annually. soon as possible • Initiate antiretroviral therapy (ART) for all patients with HIV as soon as possible • Identify newly diagnosed cases of HIV/Acquired • Screen and evaluate the patients with substance use disorder as a Immunodeficiency Syndrome (AIDS) transmission risk factor (see CCHCS Substance Use Disorder Care Guide) • Identify acute HIV seroconversion

ALERTS Inappropriate or suboptimal treatment regimens Red Flags • Patients receiving only one HIV medication rather than a multi-drug ANY CD4 CD4 <200 CD4 <100 combination (note that some co-formulations exist) • New onset fevers • Dyspnea • Headache • Patients on treatment for months with a persistently detectable viral • Weight loss >10% • Cough • Blurry or lost load • Fatigue • Fevers vision • Patients with CD4 <200 cells/mm3 who are not on Pneumocystis • Skin lesions • Diarrhea jiroveci (PCP) prophylaxis (see page 6) • Night sweats

DIAGNOSTIC CRITERIA/EVALUATION (SEE PAGE 2 FOR HIV TESTING ALGORITHM) D Consider HIV in the following circumstances: • Patients with known high risk behaviors prior to or during incarceration (tattoos, injection drug use, sexual exposure) • Patients with symptoms suggesting immunocompromised state (e.g., unexplained weight loss (>10%), recurring fevers, rashes, diarrhea, enlarged lymph nodes, recurrent infections, thrush) I E • Date of diagnosis • Current (OI) • Vaccination history • Transmission risk factors prophylaxis (if applicable) • Smoking/substance use history • History of AIDS related conditions • HIV medication history • Thorough review of systems • Lowest (nadir) CD4 count • HIV resistance history • Transmission and risk reduction • History of opportunistic infections • History of /Sexually Transmitted strategies Diseases/Rapid Plasma Reagin • Baseline Labs (See page 4) TREATMENT OPTIONS - INITIATING TREATMENT: GUIDELINES FOR WHEN TO START AND WHAT TO USE Do not initiate, change, or discontinue HIV medications without first consulting an HIV specialist WHEN TO START HIV TREATMENT: • ART is recommended for all HIV infected individuals as soon as possible, regardless of CD4 counts. ART should be initiated ONLY in consultation with an HIV specialist. The patients starting ART must be willing to commit to treatment and understand the risks and benefits of treatment and the importance of adherence. The patients and/or providers may elect to defer therapy based on clinical or psychosocial factors. WHAT TO USE: • Monotherapy is NEVER acceptable for HIV treatment. In general, three agents are used in combination. See page 5 for recommended initial HIV combination treatment regimens. See pages 8-11 for treatment precautions and side effects: noting specific contraindications and interactions between HIV medications and the patient’s existing medications. • Ensure a sexual history is performed annually and provide risk reduction counseling and education. Order ART and confirm eligibility in CCHCS’ 340b program as documented in the Electronic Health Record System (EHRS). Education for health care staff on conducting a sexual history can be found on the Center for Disease Control’s website: https://www.cdc.gov/hiv/pdf/clinicians/screening/cdc-hiv-php- discussing-sexual-health.pdf

MONITORING (See page 4 for monitoring details) Clinic visits are recommended as clinically indicated during TABLE OF CONTENTS treatment: HIV TESTING ALGORITHM ...... PAGE 2 • Components of the clinical evaluation include: NONOCCUPATIONAL POST‐EXPOSURE PROPHYLAXIS (nPEP) ...... PAGE 3 Review of systems (fever, weight loss, cough, diarrhea, etc.), MONITORING HIV PATIENTS ...... PAGE 4 Physical examination (vitals, oropharynx, lymph nodes, skin, etc.), ANTIRETROVIRAL TX REGIMENS ...... PAGE 5 Assessment: date of diagnosis, note CD4, viral load, h/o OI, HIV OPPORTUNISTIC INFECTION PROPHYLAXIS...... PAGE 6 medication regimen, previous medications, RECOMMENDED IMMUNIZATIONS ...... PAGE 7 Education: discuss risk reduction, adherence. MEDICATIONS ...... PAGE 8‐12 PATIENT EDUCATION ...... PE‐1 & 2

Contact the HIV Program mailbox with questions: [email protected] InformaƟon contained in the Care Guide is not a subsƟtute for a health care professional's clinical judgment. EvaluaƟon and treatment should be tailored to the individual paƟent and the clinical circumstances. Furthermore, using this informaƟon will not guarantee a specific outcome for each paƟent. Refer to “Disclaimer Regarding Care Guides” for further clarificaƟon. hp://www.cchcs.ca.gov/clinical‐resources/

1 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)

SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT HIV TESTING

Clinical Routine HIV testing is offered to new arrivals. See Opt Out* HIV screening policy, Patient reports a presentation Health Care Department Operations Manual (HCDOM) Section 3.1.8, Reception Cen- history of HIV suspicious ter. HIV testing is also available on patient request and should be considered routine- disease, but no for acute ly in patients at high risk for acquiring HIV (persons who inject drugs and their sex documentation of versus chronic partners, persons who exchange sex for money or drugs, sex partners of person with a positive HIV HIV: offer HIV HIV infection, persons or their partners who have had more than one sex partner antibody in the testing since their most recent HIV test, and transgender women). health record

Patient agrees to HIV test Patient agrees to HIV test No Yes Document reasons Is Acute HIV suspected? (any of the following for ≥ 6 weeks): for refusal of test • Fevers/Myalgia • Pharyngitis • Diarrhea • Lymphadenopathy • Rash • Headache

Yes No

Order HIV-1/2 antigen/antibody 4th generation Order HIV-1/2 antigen/antibody 4th generation screening test screening test AND quantitative HIV viral load positive negative Screening test and Screening test and/or viral load negative viral load positive Patient Tests HIV Positive: Patient is HIV Negative: Confirmatory HIV-1 and Consider retesting HIV-2 antibodies performed annually and as automatically clinically indicated Patient is HIV Patient is HIV Positive: Negative: Consider retesting 1. Order baseline labs (Page 4) HIV-1 positive or Both HIV-1 annually and as 2. Perform clinical evaluation (Page 1) HIV-2 positive And HIV-2 clinically indicated 3. Refer to a CCHCS HIV specialist Or both positive negative onsite or via telemedicine. 4. Ensure the patient is transferred out of a restricted-cocci area 1 or 2 in- stitution. Qualitative HIV viral load 3 5. If CD4 <200 cells/mm , start PCP positive (automatically performed) negative prophylaxis (Pages 6, 12) 6. If CD4 <50 cells/mm3, start Mycobacterium avium complex Note: Western Blot is NO longer recommended as (MAC) prophylaxis (Pages 6, 12) a confirmatory HIV screening test 7. Do not attempt to initiate HIV *Patient has the option to decline HIV test. Signed consent/refusal not required. Patient declination HIV Screening Test Result Interpretation recorded in progress notes. HIV-1/2 antigen/ Reflex Qualitative Reflex HIV-1 and HIV-2 antibodies Diagnosis: antibody 4th generation HIV viral load

Positive HIV-1 positive and/or HIV-2 positive Not performed HIV Positive

Positive HIV-1 and HIV-2 negative Positive HIV Positive; Acute HIV False Positive HIV test. No further Positive HIV-1 and HIV-2 negative Negative workup recommended. HIV Negative; no further testing Negative Not performed Not performed recommended

• Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines

2 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)

SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT PATIENT NONOCCUPATIONAL POST-EXPOSURE PROPHYLAXIS (nPEP) For employee occupational exposures, contact employee’s supervisor (do not use this Care Guide) NOTE: Protocols for the patient occupational and non-occupational exposures are the same. D C/E R L HIGHER LOWER NEGLIGIBLE RISK

• Percutaneous injury • Receptive or insertive • Kissing from non-bloody vaginal or anal intercourse • Receptive and insertive • Mouth to mouth Exposure sharps • Bites with blood exposure oral-vaginal, oral-anal, or resuscitation • Mutual masturbation • Needle sharing oral-penile contact • Non bloody human bites without blood or skin • Hollow-bore needle sticks • Solid bore needle sticks breakdown

Source HIV Evaluate case-by case: Positive or unknown Any negative, positive or unknown status Yes if: • HIV positive and HIV viral load is elevated* • Mucosa is not intact (gingival disease, oral lesions) nPEP YES • Blood exposure noted NO warranted? • Genital ulcer disease

Otherwise: No T O *S PEP 72 28 P R P E P (PEP) ( ) Medication (2 pill regimen) Sig Prescribe This Quantity Notes Tenofovir disoproxil fumarate/ 1 PO daily Prescribe 28 Include: Do not exceed 28 days or emtricitabine (Truvada®) for post-exposure. *See pages 8-11 for side effects and dosing. with Raltegravir (Isentress®) 400mg 1 PO BID Prescribe 56 Include: Do not exceed 28 days or *See pages 8-11 for side effects and dosing. for post-exposure. or Dolutegravir (Tivicay®) 50mg 1 PO daily Prescribe 28 Include: Do not exceed 28 days or *See pages 8-11 for side effects and dosing. for post-exposure.

M Recommended Laboratory evaluation for the patients who receive nPEP for HIV exposure Test Baseline Week 2 Week 4 Week 12 Week 24 HIV 4th gen Antigen/Antibody test E, S* E E E¥ Serum liver enzymes E E Blood Urea Nitrogen (BUN)/creatinine E E STD screen (gonorrhea, chlamydia, syphilis) E,S E E€ Hepatitis B Virus (HBV) serology (HBVsAb, E¶,S E***¶ E∞ HBVsAg, HBVcAb) Hepatitis C Virus (HCV) serology E,S Eα Pregnancy test (for women of reproductive age) E E*** HIV viral load S E** E** HIV resistance testing S E** E** E=Exposed S=Source *HIV testing of source is indicated for sources of unknown **If determined to be HIV positive on follow up testing ***Additional testing for pregnancy, STDs and HBV should be performed as clinically indicated ¶Start HBV vaccination if evidence of non-immunity. ¥Only if HCV infection is acquired during the original exposure. €Syphills only unless clinically indicated. αIf exposed person is susceptible to Hep C at baseline. ∞If exposed person is susceptible to Hep B at baseline. Centers for Disease Control and Prevention. Updated Guidelines for Antiretroviral Post-exposure Prophylaxis After Sexual, Injection Drug Use, or Other Non-occupational Exposure to HIV United States, 2016: https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf 3 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV) SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT

MONITORING HIV PATIENTS Pre Treatment On Treatment Treatment Failure At time Q 3–6 Starting 2-8wks Q4-8 Q3-4 Q 6 If clinically of Test Baseline Q yr after 1 Q yr treat- mos treatment start wks mos mos indicated ment failure HIV antibody test 9 (HIV 1/2 Antigen/Antibody 4th generation)  3 CD4 count (lymphocyte subset panel 5)        2 2 2 HIV viral load (HIV-1 RNA Quantitative PCR)         HIV genotype 1 1   4 HIV Tropism Test (HIV-1 Coreceptor Tropism)   CBC with differential and PLT    5 5 5 5  Comprehensive Metabolic Panel         Pregnancy Test14 11,14 11,14  Random or Fasting Glucose  7 7 7 Random or Fasting Lipid Panel  6 6 6 Urinalysis   8, 13 8 13 Rapid Plasma Reagin (RPR)     Serum Phosphorus 14 14 14 14 14 14

Gonorrhea/chlamydia (NAAT)   16,17 16, 17 Trichomoniasis screen (NAAT)  17 Hepatitis A Antibody total  11 19 Hepatitis B Core Antibody Total (Not IGM)   Hepatitis B Surface Antibody Immunity Quantitative  10,19 Hepatitis B Surface Antigen19  19 Hepatitis B Viral Load  12,19 Hepatitis C Antibody with Reflex to Viral Load     Varicella-Zoster Antibody, IgG  10 Toxoplasma Antibody, IgG  15 Glucose-6-phosphate dehydrogenase (G6PD)  HLA-B5701  TB Screening     PA and lateral CXR if not in health record  Cryptococcal Serum Antigen 15 15 Measles Titer 18 Anal Cancer Screening: The Department of Health and Human Services HIV Guidelines for Adult and Adolescent Opportunistic Infections do not provide recommendations for routine screening for anal cancer, but do acknowledge that some specialists and organizations recommend annual anal pap smears in patients living with HIV. They only recommend screening for anal cancer if referral for high resolution anoscopy (HRA) is available (CCHCS has HRA available in select regions). CCHCS’ prevalence of anal dysplasia and/or anal cancer in patients living with HIV since 2016 is less than 1% and providers can consider annual screening with anal pap smears for their patients living with HIV. At the present time there is no national guidance on the management based on HRA results and the follow-up plans will be determined by the HRA provider.

1. Obtain an HIV genotype if no previous genotype is or other cardiovascular risk factors are present, repeat tenofovir containing regimens. noted in the health record. annually; otherwise repeat every 5 years. 14. In women of childbearing potential and planning to 2. Obtain HIV viral load every 4-8 weeks after starting 7. Repeat fasting if abnormal, non-fasting, and no history initiate dolutegravir. treatment until it is undetectable, then obtain every 3-4 of diabetes. Repeat annually to screen for diabetes. 15. Consider in patients newly diagnosed with HIV without months if consistently undetectable x2 years, may 8. UA pre-treatment and every 6 months while on signs of meningitis if the CD4 <100 increase interval to every 6 months. treatment if regimen contains tenofovir (Atripla, 16. Offer annual 3-site testing (urogenital/pharyngeal/ 3. Obtain CD4 every 3-6 months during 1st 2 years of Complera, Genvoya, Stribild, Truvada, Viread); monitor rectal) for gonorrhea/chlamydia if clinically indicated. HIV treatment. After 1st 2 years, if CD4 300-500, may glucose and protein. 17. Offer all patients with vaginal sex in the past 12 months increase interval to every 12 months, if CD4 >500, CD4 9. Repeat serology if previously negative and clinical and then annually if ongoing. re-check is optional. If CD4 <300, continue checking suspicion of disease or prophylaxis is indicated. 18. Not needed if born in US prior to 1957 or every 3-6months. 10. Repeat serology post vaccination if applicable. documentation of previous vaccination. 4. Only obtain tropism testing if considering in 11. In women of childbearing potential. 19. Offer to all patients sexually active with high risk next HIV regimen 12. If HBV Core Antibody is Positive and HBV Surface partners, men who have sex with men, intravenous 5. Obtain CBC after ~4 weeks on treatment if on AZT; Antibody is negative or if HBV Surface Antigen drug abuse, sex in exchange for money, and/or check CBC if CD4 ordered. Positive. multiple partners 6. Repeat fasting if abnormal and non-fasting. If abnormal 13. In patients with chronic kidney disease who are on

• Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines • Sexually Transmitted Diseases Treatment Guidelines, 2021. Centers for Disease Control and Prevention. https://www.cdc.gov/std/treatment-guidelines/STI-Guidelines-2021.pdf • Thompson, M & Horberg, et al. Primary Care Guidance for Persons with Human Immunodeficiency Virus: 2020 Update by the HIV Medicine Assoc. of the IDSA. Clin Infect Dis 2020. 4 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)

SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT

ANTIRETROVIRAL (ARV) REGIMENS RECOMMENDED FOR TREATMENT - NAÏVE PATIENTS

DO NOT initiate, change, or discontinue HIV medications without first consulting an HIV specialist [email protected]

R R - Those with optimal and durable C efficacy, favorable tolerability and toxicity profile, and ease of use I S T I R Abacavir and Abacavir/lamivudine and Dolutegravir/ Abacavir/lamivudine:

® • Should not be used in the patients who test positive for • Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ) HLA-B5701. Atazanavir: • Dolutegravir (Tivicay®) and tenofovir alafenamide/ • Should not be used in the patients who require >20mg emtricitabine (Descovy®) or tenofovir disoproxil fumarate/ omeprazole equivalent per day. emtricitabine (Truvada®) Cobicistat: • Should not be started in the patients with a pretreatment estimated CrCl <70ml/min. ® • Dolutegravir/lamivudine (Dovato ) • Cobicistat is a potent CYP3A inhibitor. It can increase the concentration of other drugs metabolized by this pathway. Multiple drug-drug interactions exist. • Dolutegravir/abacavir/lamivudine (Triumeq®) Darunavir: • Treatment experienced patients with a history of • Raltegravir (Isentress®) and tenofovir alafenamide/ resistance to HIV medications require twice daily emtricitabine (Descovy®) or tenofovir disoproxil fumarate/ darunavir boosted with ritonavir. emtricitabine (Truvada®) • Consult an HIV specialist for dosing requirements. Dolutegravir: • Recommended as a preferred regimen in pregnant P R P women regardless of trimester (updated data show a C O C O reduced risk of neural tube defects over time and the difference is no longer significant compared with other ART regimens). Dolutegravir/lamivudine: • Abacavir/lamivudine • Atazanavir ® ® • Except in the patients with HIV RNA >500,000 copies/mL, (Epzicom ) (Reyataz ) boosted HBV coinfection or in whom ART would be started before with ritonavir the results of a HIV Genotype or HBV testing are ® • Tenofovir disoproxil (Norvir ) available. fumarate/ PLUS Efavirenz: ® emtricitabine (Truvada ) • Darunavir • Now considered safe to use in pregnancy (Prezista®) boosted • Screen and monitor for antepartum depression in • Tenofovir disoproxil with ritonavir pregnancy. fumarate (Viread®) and Elvitegravir/cobicistat/tenofovir/emtricitabine: ® lamivudine (Epivir ) • Dolutegravir • Should not be started in the patients with a pretreatment (Tivicay®) estimated CrCl <70ml/min and should be changed to an alternative regimen if the patient’s CrCl falls below 50 ml/min. • Raltegravir ® • Cobicistat is a potent CYP3A inhibitor. It can increase the (Isentress ) concentration of other drugs metabolized by this pathway. Multiple drug-drug interactions exist. Emtricitabine (Emtriva®): • May be substituted by lamivudine (Epivir®) and vice versa. Tenofovir: • Use with caution in the patients with renal insufficiency.

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. February 10, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new-guidelines Saag, M., et al. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults, 2020 Recommendations of the International Antiviral Society-USA Panel. JAMA. 2020;324(16):1651-1669.

Dental Management of HIV infected Patients

• HIV infected patients do not require special precautions or prophylaxis for dental care beyond standard precautions and the routine standard of care. • Check patient’s dental history for evidence of a routine comprehensive dental examination. Advise HIV infected patients to request a dental comprehensive exam once a year.

Bold = Formulary 5 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV) SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT PROPHYLAXIS TO PREVENT THE FIRST EPISODE OF OPPORTUNISTIC INFECTION (OI) C I P A CD4 count <200 cells/mm3 Pneumocystis Trimethoprim- jiroveci sulfamethoxazole TMP-SMX, orally one double strength CD4 % <14% or history of AIDS defining illness three times a week pneumonia (TMP-SMX), one or (PCP) CD4 count >200 but <250 cells/mm3 and monitoring CD4 double strength orally dapsone 100mg orally once daily or count at least every three months is not possible daily (first choice) 50mg orally twice daily or or Indication for Discontinuing Primary Prophylaxis: one single strength dapsone 50mg orally daily and CD4 count increased from <200 cells/mm3 to ≥200cells/ 3 orally daily pyrimethamine 50mg orally weekly mm for ≥3 months in response to ART. and leucovorin 25 mg orally weekly or Can consider when CD4 count is 100–200 cells/mm3 and Aerosolized pentamidine 300mg via HIV RNA remains below limit of detection of the assay Respirgard II® nebulizer every month used for ≥3 months to 6 months or atovaquone 1,500mg orally daily Indication for Restarting Primary Prophylaxis: or CD4 count <100 cells/mm3 regardless of HIV RNA atovaquone 1,500mg and pyrimethamine 25mg and CD4 count 100–200 cells/mm3 and HIV RNA above leucovorin 10mg orally daily detection limit of the assay used

Toxoplasma Toxoplasma IgG positive patients with CD4 count TMP-SMX, one TMP-SMX orally one double strength gondii <100 cells/mm3 double strength orally three times a week encephalitis daily or TMP-SMX orally one single strength Seronegative patients receiving PCP prophylaxis daily not active against toxoplasmosis should have or dapsone 50mg orally daily and toxoplasma serology retested if CD4 count declines pyrimethamine 50mg orally weekly to <100cells/mm3 and leucovorin 25mg orally weekly or dapsone 200mg and pyrimethamine Prophylaxis should be initiated if toxoplasmosis lgG 75mg and leucovorin 25mg orally weekly or seroconversion occurs Atovaquone 1,500mg with/without pyrimethamine 25mg and leucovorin 10 mg orally daily

Rifampin (RIF) 600mg orally daily for Mycobacterium No evidence of active TB disease and: Isoniazid (INH) 300mg (+) diagnostic test for LTBI, and no prior history orally daily and four months tuberculosis pyridoxine 50mg orally or infection of treatment for active or latent TB daily for nine months Rifabutin (RFB) (dose adjusted based (Treatment of (-) diagnostic test for LTBI, but close contact or on concomitant ART) for four months latent TB with a person with infectious pulmonary TB INH 900mg orally twice Rifapentine (RPT) (weight-based, 900 infection or a week and pyridoxine mg max) PO weekly + INH 15mg/kg LTBI) history of untreated or inadequately treated 50mg orally daily for weekly (900 mg max) + pyridoxine 50mg healed TB (i.e., old fibrotic lesions) regardless nine months weekly x12 weeks – in patients receiving of diagnostic tests for LTBI For persons exposed to an EFV- or RAL-based ART regimen drug-resistant TB, (32.1–49.9 kg 750 mg ≥ 50.0kg 900mg) selection of drugs after *Multiple drug-drug interactions exist consultation with public between RIF, RPT, and HIV medications health authorities is advised *Consultation with HIV specialist or pharmacist strongly advised Disseminated Not on ART or remain viremic on ART with no options for Azithromycin RFB 300mg orally daily (dosage Mycobacterium a suppressive ART regimen 1,200mg orally once adjustment based on drug-drug avium weekly AND: interactions with ART); rule out complex or active TB before starting RFB (MAC) CD4 count <50 cells/mm3 after ruling out active MAC Clarithromycin disease infection 500mg orally twice a day Indication for Discontinuing Primary Prophylaxis: or Azithromycin 600mg Initiation of effective ART orally twice weekly Indication for Restarting Primary Prophylaxis: CD4 count <50 cells/mm3 (only if not on fully suppressive ART) In general, primary prophylaxis against the following conditions is not recommended: • CMV • Cryptococcal disease • Histoplasmosis • Candidiasis • Coccidioidomycosis

HIV expert consultation required prior to any prophylaxis initiation, dosage change, or discontinuation

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults. 2018 Recommendations of the International Antiviral Society-USA Panel. JAMA. July, 24 2018. Available at https://jamanetwork.com/journals/jama/article-abstract/2688574 6 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV) UMMARY ECISION UPPORT ATIENT DUCATION ELF ANAGEMENT S D S P E /S M Recommended Immunizations for HIV Positive Adults Please note that vaccinations can cause a transient increase in HIV viral load within a few weeks after administration. This increase should resolve over time and does not usually indicate the development of antiretroviral drug resistance.

Immunization Dosage Comments and Warnings Name Recommended for All HIV Positive Adults *There is limited data on vaccine efficacy in patients living with HIV, but due to the COVID-19 pandemic and Two injections 21-28 subsequent large outbreaks in CDCR with significant morbidity and mortality, all patients should have a COVID-19 days apart (Pfizer or discussion with their primary care provider and HIV specialist about the risks and benefits of the vaccine. (mRNA) Modena vaccine) Current data do not demonstrate an increased risk of susceptibility, severity of disease or mortality in pa- tients living wit h HIV if controlled for co-morbidities. Recommended unless: 1. Already immune (Hepatitis BsAb positive), 2. Chronic active HBV (Hepatitis BsAg Hepatitis B Virus Three injections over positive). Consider vaccination if isolated HBV cAb positive and HBV viral load negative. Check Hepatitis (HBV) a six month period BsAb 1-2 months after completion of immunization series. Additional injections (regular dose or double dose) may be necessary if antibody levels are < 10 after completion of an initial series. Should be given every year. Only injectable flu vaccine should be given to those who are HIV positive. Influenza One injection The nasal spray vaccine (FluMist/LAIV) is contraindicated. Meningococcal Two injections; two Recommended also for college students, military recruits, people who do not have a spleen, and people (MenACWY) months apart traveling to certain parts of the world. Revaccinate every 5 years. Pneumococcal Give single dose of PCV13 one or more years after PPSV23. Give PPSV23 no sooner than 8 weeks after 13-valent One injection dose of PCV13. conjugate PCV13) Should be given soon after HIV diagnosis, unless vaccinated within the previous five years. If CD4 count is Pneumococcal One or two < 200 cells/mm3 when the vaccine is given, immunization should be repeated when CD4 count is > 200 Polysaccharide injections cells/mm3. See above regarding timing of PPSV23 doses with PCV13. Repeat every 5 years if 64 years of (PPSV23) age or younger. At 65 years of age or older, only 1 dose at least 5 years after most recent dose. Tetanus and Diphtheria One injection Repeat vaccine every ten years. Toxoid (Td) Tetanus, Recommended for adults 64 years of age or younger and should be given in place of next Td booster one Diphtheria, and One injection time only. Pertussis (Tdap) Recommended for Some HIV Positive Adults Hepatitis A Virus Two injections over a Recommended for all non-immune (Hepatitis A lgG negative) HIV infected patients. (HAV) one year period Hepatitis A/ Three injections over Hepatitis B a six month period or Can be used in those who require both HAV and HBV immunization. Combined Vaccine four injections over a (Twinrix) one year period Can be used in those with functional or anatomical asplenia, sickle cell disease, undergoing elective Haemophilus splenectomy (administer 2 weeks prior to surgery). One injection* influenzae Type B *Recipients of hematopoietic stem cell transplants should receive 3 doses 4 weeks apart 6-12 months after a successful transplant regardless of Hib vaccination history. Human Three injections over Recommended for HIV infected men and women under 26 years of age. Routine vaccination is not recom- Papillomavirus 24 weeks (0, 1-2mo, mended for patients living with HIV between 26-45 years old but can be considered after shared decision (HPV) 6mo) making. The two dose regimen is not recommended in patients living with HIV. Measles, Mumps, People born before 1957 do not need to receive this vaccine. HIV positive adults with CD4 counts < 200 and Rubella One or two injections cells/mm3 or clinical symptoms of HIV should not get the MMR vaccine. Each component can be given (MMR) separately if needed to achieve adequate antibody titer levels. People born before 1980 do not need to receive this vaccine. Recommended for all others unless there is Two injections; three Varicella evidence of immunity (IgG) or CD4 count is 200 cells/mm3 or below. Not recommended to be given during months apart pregnancy. Recommended for adults > 50 regardless of previous herpes zoster or history of Zostavax (ZVL). Do not Two injections; 2-6 Zoster (Shingrix)^ give during an acute episode of herpes zoster. Consider delaying vaccination until the patient is virologically months apart suppressed on ART and CD4 count >200 cells/mm3 to maximize response to vaccine. *Recommended Adult Immunization Schedule - United States, 2021. Centers for Disease Control Website. Available at: https://www.cdc.gov/vaccines/schedules/easy-to-read/adult.html.

^Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV. Department of Health and Human Services. September 5, 2019. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection/varicella- zoster-virus-disease?view=full

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines 7 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)

SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT Medications (NOTE: Do not initiate, change or discontinue HIV medications without first consulting an HIV specialist)

• Current recommended minimum effective combination consists of three antiretroviral medications from a minimum of two classes. DO NOT PRESCRIBE MONOTHERAPY FOR HIV. If any medication is discontinued due to toxicity or other reason, discontinue combination. • Monitor for hepatotoxicity; use with caution in the patients with chronic hepatitis B or C or end stage liver disease. All Classes • The data on antiretroviral medication associated weight gain are insufficient to the recommendations. It is advised to counsel patients on the potential for weight gain. • Monitor for renal dysfunction and consult with an HIV specialist for dosing in renal dysfunction. • Multiple concerns regarding drug-drug interactions exist. (See page 12 for more information) Nucleoside/ Many NRTIs are associated with: Nucleotide • Hepatic steatosis Reverse • Lactic acidosis (rare but potentially fatal): look for nausea, vomiting, abdominal pain, fatigue, weakness, dyspnea with an Transcriptase associated metabolic acidosis. Discontinue all potential offending agents immediately Inhibitors (NRTI) • Lipodystrophy

Medication Formulation Side Effects Special Notes Tablet: • Hypersensitivity reaction; • Hypersensitivity associated with positive (Z®, ABC) 300 mg potentially FATAL if re-challenged HLA-B5701: screen prior to initiation $$$ Solution: • Hypersensitivity reaction: look for fever, rash, GI 20mg/ml symptoms, cough, dyspnea, pharyngitis • Adjust dose for hepatic dysfunction • Avoid in treatment naïve patient if HIV viral load >100,000 copies/ml

Delayed release • Peripheral neuropathy • Weight based dosing (V®, ) capsule: • Pancreatitis • Adjust dose for renal dysfunction $$$ 200mg, 250mg • Lactic acidosis– See above • Adjust dose if given with tenofovir 400mg • Avoid in combination with stavudine Powder for • Contraindicated with ribavirin solution: • Prolonged exposure associated with noncirrhotic 2gm, 4gm portal hypertension with esophageal varices

Capsule: • Severe acute exacerbation of • Active against chronic hepatitis B (E®, FTC) 200mg chronic hepatitis B can occur with • Dose adjustment for renal dysfunction $$$$$ abrupt discontinuation in the • Contraindicated for use with lamivudine patients coinfected with chronic hepatitis B Tablet: • Severe acute exacerbation of • Active against chronic hepatitis B (E®, 3TC) 100mg, 150mg, chronic hepatitis B can occur with • Adjust dose for renal dysfunction $$$ 300mg abrupt discontinuation in the • Contraindicated with emtricitabine Solution: patients coinfected with chronic 10mg/ml hepatitis B Capsule: • Peripheral neuropathy • Weight based dosing (Z®, D4T) 15mg, 20mg • Pancreatitis • Dose adjustment for renal dysfunction $$$ 30mg, 40mg • Lactic acidosis– See above • Avoid in combination with didanosine • Hyperlipidemia • Contraindicated with zidovudine

Tablet: • Severe acute exacerbation of • Active against chronic hepatitis B 150mg, chronic hepatitis B can occur with • Adjust dose for renal dysfunction 200mg, abrupt discontinuation in the • Adjust dose if given in combination with didanosine (V®, TDF) 250mg, patients co-infected with chronic and/or atazanavir $$$$$ 300mg hepatitis B Powder: • Renal impairment 40mg/gm • Fanconi's Syndrome • Decreased bone mineral density Tablet: 300mg • Bone marrow suppression • Contraindicated for use with stavudine (R®, AZT) Syrup: 50mg/ml • Anemia (usually macrocytic) • Caution in use with other agents that cause bone $$$ Capsule: 100mg • Myopathy marrow suppression • Nausea • Adjust dose for renal dysfunction

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines Saag, M., et al. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults, 2020 Recommendations of the International Antiviral Society-USA Panel. JAMA. Bold = Formulary 8 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)

SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT Medications (NOTE: Do not initiate, change or discontinue HIV medications without first consulting an HIV specialist) Non-nucleoside Many NNRTIs are associated with: Reverse • Rash and potential Stevens Johnson Syndrome: monitor for rash during initiation of these medications and discontinue if Transcriptase severe or accompanied by mucous membrane involvement. Less severe rash may be treated with antihistamines and Inhibitors followed closely (NNRTI) • Hyperlipidemia • Cross class resistance; if history of prior NNRTI use and poor virologic response, consult HIV specialist prior to initiation of second NNRTI • Long half life: consult HIV specialist if possible prior to discontinuation to avoid the emergence of resistant mutations • Multiple concerns regarding drug-drug interactions. (See page 12 for more information) Medication Formulation Side Effects Special Notes Tablet: • CNS side effects: • Potentially teratogenic especially in the first trimester: obtain (S®, EFV) 600mg dizziness, bizarre dreams pregnancy test prior to starting in women of child bearing $$$$$ Capsule: • False positive with certain potential. 50mg types of cannabinoid testing • Avoid taking with a high fat meal 200mg • Immediate evaluation is recommended for psychiatric symptoms such as severe depression or suicidal ideation Tablet: • Nausea (P®, ) 100mg • Dizziness $$$$$ • Abnormal Dreams Tablet: • Hepatotoxicity (I®, ETR) 25mg • Hypersensitivity reaction $$$$$ 100mg, 200mg Tablet: • Hepatotoxicity • Avoid starting nevirapine in women with CD4 >250 cells/mm3 (V®, NVP) 200mg • Monitor LFTs baseline, two or men with CD4 >400 cells/mm3. Once the patients on NVP $$$ Solution: weeks after initiation, and reach a CD4 cell count higher than these 50mg/5 ml monthly for the first 18 weeks cut-offs, they are not required to discontinue unless XR tablet: of therapy; discontinue if otherwise indicated 100mg clinical hepatitis or severe • Dose escalation with initiation: 200mg daily for two weeks, 400mg rash occurs and do not then 200mg, one twice daily or two once daily re-challenge. Tablet: • Depression • Requires an acid environment for optimal absorption. Con- (E®, RPV) 25mg • Insomnia traindicated for use with proton pump inhibitors; $$$$$ • Headache specific dosing recommendations for use with other acid • Rash lowering agents. Consult an HIV specialist or package insert for specifics • Use with caution in the patients with baseline HIV viral load >100,000 copies/ml Integrase Strand Transfer Inhibitor (INSTI) Tablet: • Hypersensitivity reaction: • Not recommended for Child Pugh Class C patients. (T, DTG) 10mg rash, constitutional findings • Recommended as a preferred regimen in pregnant women $$$$$ 25mg • Diarrhea regardless of trimester (updated data show a reduced risk of 50mg neural tube defects over time and the difference is no longer significant compared with other ART regimens). Tablet: • Asthenia (I®, RAL) 400mg, • Nausea $$$$$ 600mg • Diarrhea Chew: • Headache 25mg • CPK elevation 100mg Suspension: 100mg/ml Cabotegravir Tablet: • Dizziness • Requires HIV specialist review and approval. (Vocabria®, CAB) 30mg • Fever • Oral Cabotegravir and rilpivirine should be taken for one $$$$$ • Headache month prior to starting the extended-release injectable • Insomnia formulation (see Cabenuva information). • Myalgias • Contraindicated if used with phenytoin, phenobarbital, • Nausea oxcarbazepine, carbamazepine, rifampin, rifapentine. • Rash

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines Saag, M., et al. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults, 2020 Recommendations of the International Antiviral Society-USA Panel. JAMA. 2020;324(16):1651-1669.

Bold = Formulary 9 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV) SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT Medications (NOTE: Do not initiate, change or discontinue HIV medications without first consulting an HIV specialist) Protease Many PIs are associated with: • GI intolerance: nausea, vomiting, • Increased bleeding in hemophiliacs Inhibitor (PI) • Hyperlipidemia diarrhea • Most PIs are prescribed in combination with ritonavir in order to • Hyperglycemia • Hepatotoxicity especially in the patients with achieve more optimal drug levels • Lipodystrophy/fat redistribution underlying liver disease or • Multiple concerns regarding drug-drug interactions • Elevated transaminases coinfection with hepatitis B or C (See page 12 for more information) Medication Formulation Side Effects Special Notes Capsule: • Indirect hyperbilirubinemia: jaun- • Requires an acidic environment for optimal ab- (R®, ATV) 100mg dice, scleral icterus rarely a cause for sorption; specific dosing recommendations for use $$$$$ 150mg discontinuation with proton pump inhibitors, H2 200mg • PR prolongation blockers, antacids: Consult an HIV specialist or 300mg • Nephrolithiasis, cholelithiasis package insert for specifics Powder for oral suspension: • Adjust dose for hepatic dysfunction 50mg • Adjust dose for renal dysfunction • Adjust dose if given with tenofovir Tablet: • Rash; caution if sulfonamide allergy, • Should always be used with ritonavir or (P,® DRV) 75mg Stevens Johnson cobicistat $$$$$ 150mg Syndrome has been reported 600mg • Headache 800mg Suspension: 100mg/ml Tablet: 700mg • Rash; caution if sulfonamide allergy • Dose adjustment for hepatic dysfunction (L®, LEX) Suspension: 50mg/ml • Nephrolithiasis (rare) $$$$$ Capsule: • Headache • Dose adjustment for hepatic dysfunction ® • Asthenia; Metallic taste (C , IND) 200mg • Alopecia $$$$$ 400mg • Hemolytic anemia • Thrombocytopenia • Indirect hyperbilirubinemia • Nephrolithiasis / Tablet: 200mg - 50mg • Asthenia • Co-formulated with ritonavir 100mg - 25mg • PR and QT prolongation • Avoid once daily dosing in patients on HD (K®, LPV) Solution: • GI Intolerance: nausea, vomiting, diar- $$$$$ 80mg - 20mg/ml rhea Tablet: • Diarrhea • Do not use with ritonavir (V®, NLF) 250mg $$$$$ 625mg Tablet: 500mg • Headache • Requires co-administration of ritonavir (I®, SQV) Capsule: 200mg • PR and QT prolongation • Pretreatment EKG is recommended $$$$$ Capsule: 250mg • Rash; caution if sulfonamide allergy • Requires co-administration of ritonavir (A® , TPV) Solution: • Potentially fatal hepatotoxicity $$$$$ 100mg/ml • Intracranial hemorrhage Pharmacologic Boosters Tablet: 100mg • Paresthesia – circumoral and • Full dose ritonavir poorly tolerated (N®, RTV) Capsule: 100mg extremities • Refrigeration required with capsule $$$$$ Solution: 80mg/ml • Asthenia; taste perversion C Tablet: • Jaundice (studied with atazanavir) • Avoid if Clcr <70ml/min and in combination with (T) 150mg • Nausea tenofovir $$$$$ Fusion Inhibitor E For injection: • Injection site reactions • Subcutaneous injection twice daily (F®, T20) 90mg/vial • Increased bacterial pneumonia $$$$$ • Hypersensitivity reaction Entry Inhibitor I For IV infusion: • Diarrhea • Monoclonal antibody for extensive multidrug re- (T®) 200mg/vial • Dizziness sistant HIV-1 with limited alternatives $$$$$$ • Nausea • Subcutaneous injection or IV infusion every 2 weeks • Rash • No data in pregnancy Entry & Attachment Inhibitor FOSTEMSAVIR ER-Tablet: 600mg (with or • Nausea (≥5% of patients) • Gp120 attachment inhibitor (LERONLIMAB®) without food) • Diarrhea • Heavily treatment-experienced adults only $$$$$$ • Headache • Pretreatment EKG is recommended • Elevated liver function tests • Caution in patients with Hepatitis B or C co- • QT prolongation infections • Significant drug-drug interactions; consult an HIV specialist, pharmacist or https://aidsinfo.nih.gov/ contentfiles/lvguidelines/ adultandadolescentgl.pdfprior to initiation. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines

Bold = Formulary 10 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)

SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT

Medications (NOTE: Do not initiate, change, or discontinue HIV medications without first consulting an HIV specialist) • Only active against CCR5 tropic strains of HIV: must obtain tropism assay prior to initiation. CCR5 Inhibitor • Multiple concerns regarding drug-drug interactions exist. (See page 12 for more information) Medication Formulation Side Effects Special Notes Tablet: • Abdominal pain • Many drug-drug interactions; consult an HIV specialist, pharmacist or ® (S , MVC) 25mg/75mg/ • Cough https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf prior to initiation • Dizziness $$$$$ 150mg/300mg • Rash • Adjust dose for renal dysfunction Solution: • Hepatotoxicity • Tropism testing required prior to starting 20mg/ml • Orthostatic hypotension Co-formulations of medication classes listed above // Tablet: • Headache • Recommended for initial therapy or switch therapy (please consult with an HIV specialist). 50mg/200mg/ • Nausea • Not recommended in the patients with a Cr/Cl of <30mL/min, those with severe liver impairment, or ® pregnant women. (B ) 25mg • Diarrhea • Significant drug-drug interactions; consult an HIV specialist, pharmacist or $$$$$ https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf prior to initiation. // Tablet: See information regarding • See information regarding each individual component, listed above 600mg/ each individual (A®) 200mg/300mg component, listed above $$$$$ E/T Tablet: See information regarding • See information regarding each individual component, listed above (®) 200mg/25mg each individual $$$$$ component, listed above / Tablet: See information regarding • See information regarding each individual component, listed above (E®, EPZ) 600mg/300mg each individual $$$$$ component, listed above E// Tablet: See information regarding • Many drug-drug interactions; consult an HIV specialist, pharmacist or / 150mg/50mg/ each individual https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf prior to initiation A (G®) 200mg/10mg component, listed above $$$$$ E// Tablet: See information regarding • See information regarding each individual component, listed above 200mg/25mg/25 each individual (®) mg component, listed above $$$$$ D// Tablet: See information regarding • See information regarding each individual component, listed above (T®) 50mg/600mg/ each individual $$$$$ 300mg component, listed above C// Tablet: See information regarding • Many drug-drug interactions; consult an HIV specialist, pharmacist or / 150mg/150mg/ each individual https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf prior to initiation. 200mg/ 300mg component, listed above (S®) $$$$$ L/ Tablet: See information regarding • See information regarding each individual component, listed above (C®,CMB) 150mg/300mg each individual $$$$$ component, listed above E// Tablet: See information regarding • See information regarding each individual component, listed above 200mg/25mg/ each individual (C®) 300mg component, listed above $$$$$ / T: See information regarding • Many drug-drug interactions; consult an HIV specialist, pharmacist or ® (E ) 300mg/150mg each individual component, https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf prior to initiation. $$$$$ listed above / Tablet: See information regarding • See information regarding each individual component, listed above (J®) 50mg/25mg each individual $$$$$ component, listed above / T: See information regarding • Many drug-drug interactions; consult an HIV specialist, pharmacist or ® (P ) 800mg/50mg each individual https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf prior to initiation. $$$$$ component, listed above // Tablet: See information regarding • See information regarding each individual component, listed above (T®,TZV) 300mg/ each individual $$$$$ 150mg/300mg component, listed above Tablet: See information regarding • See information regarding each individual component, listed above / 200mg/300mg each individual (T®, TVD) component, listed above $$$$$ // Tablet: • Headache • Recommended for initial therapy or switch therapy (please consult with an HIV specialist). / 800mg/150mg/ • Nausea • Not recommended in the patients with a Cr/Cl of <30mL/min, those with severe liver impairment, (S®) 200mg/10mg • Diarrhea or pregnant women. $$$$$ • Abdominal Discomfort • Significant drug-drug interactions; consult an HIV specialist, pharmacist or • Rash https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf prior to initiation. / Tablet: See information regarding • See information regarding each individual component, listed above / 100mg/300mg/ each individual (D®) 300mg component, listed above $$$$$ D/ Tablet: See information regarding • Except in the patients with HIV RNA >500,000 copies/mL, HBV coinfection or in whom ART would ®) (Dovato ) 50mg/300mg each individual be started before the results of a HIV Genotype or HBV testing are available. $$$$$ component, listed above • See information regarding each individual component, listed above Cabotegravir/Rilpivirine Suspension: • Injection site reactions • Requires HIV specialist review and approval. The patient needs to be virally suppressed on a ® (Cabenuva , CAB/RPV) 600mg/300mg • Dizziness stable anti-retroviral regimen, no history of treatment failure, and no known resistance to cabo- $$$$$$ per 3ml, gluteal • Fever tegravir or rilpivirine. intramuscular • Oral Cabotegravir and rilpivirine should be taken for one month prior to starting the extended- use only • Headache • Insomnia release injectable formulation. • Myalgias • Requires cold-chain supply and storage, a loading dose of 600mg/900mg and then a maintenance dose of 400mg/600mg every 4 weeks (+/- 7days). • Nausea • Contraindicated if used with phenytoin, phenobarbital, oxcarbazepine, carbamazepine, rifampin, • Rash rifapentine. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines Bold = Formulary Page 11 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)

SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT Medications (NOTE: Do not initiate, change or discontinue HIV medications without first consulting an HIV specialist)

P O I P M

C OR [email protected]

Medication Formulation Side Effects Special Notes (M®) Suspension: • Rash $$$$$ 750mg/5ml • GI intolerance

A Tablet: • Rash • Recommended use criteria: treatment of (Z®) 250mg • Diarrhea community acquired pneumonia, STDs, $$ 500mg • Nausea opportunistic infections in HIV or acute 600mg • Abdominal pain exacerbations of chronic bronchitis Tablet: • Rash • Recommended use criteria: treatment of (B®) 250mg • Diarrhea opportunistic infections in the patients with HIV $ 500mg • Nausea or H. Pylori or as prescribed by ID specialist • Abdominal pain • Pseudomembranous colitis Tablet: • Rash, hypersensitivity reaction • Contraindicated in G6PD deficiency $ 25mg • Hematologic abnormalities 100mg • Hemolytic anemia (G6PD related) • Neuropathy Solution: 300mg • Rash • Given via nebulizer for prophylaxis (®) • Renal impairment • Dose adjustment for renal dysfunction $$$$ • Bronchospasm • Arrhythmia • Hematologic abnormalities Tablet: • Neutropenia • Contraindicated in folate deficiency and (D®) 25mg • Thrombocytopenia hypersensitivity to pyrimethamine $$$$ • Megaloblastic anemia • Use with caution if G6PD deficient, renal • Rash dysfunction, hepatic dysfunction or history of seizure disorders - Tablet: • Rash, Stevens Johnson Syndrome • Dose adjustment for renal dysfunction 160mg/800mg • Hematologic abnormalities • Use with caution if G6PD deficient (rare) (TMP-SMX SS DS, B SS® DS®) $

Drug-Drug Interactions Multiple drug-drug interactions exist between many antiretroviral medications and other medication classes including, but not limited to, certain antimicrobials, analgesics, antiarrhythmics, oral contraceptives, anxiolytics, lipid lowering agents, acid lowering agents, herbal preparations, corticosteroids, and anticonvulsants. Prior to adding to or adjusting the medication profile of an HIV patient, consider consulting:  An HIV specialist or pharmacist  http://www.hiv-druginteractions.org/Interactions.aspx  https://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf or contact the CCHCS HIV Warmline at [email protected]

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. August 16, 2021. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines Bold = Formulary

12 September 2021 CCHCS Care Guide: Human Immunodeficiency Virus (HIV)

SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT

H I V (HIV) W HIV: • You can have HIV for years and not feel sick.

• HIV can cause sores in your mouth. These sores may be a sign of a serious condition. Please see your dentist if you develop sores in your mouth.

• HIV can cause your gums to swell or bleed. If you have swollen or bleeding gums, they can be treated by your dentist.

• HIV can cause white or red spots which may be painless in your mouth and your tongue. These spots may be a sign of a serious condition. Please see your dentist if you develop white or red spots in your mouth or on your tongue.

• Brushing your teeth and flossing is especially important for someone living with HIV. You can reduce your risk of tooth loss by brushing and flossing in the morning and evening. • There is no cure or vaccine for HIV, but treatment can help you live longer and prevent other painful and serious problems. • AIDS (Acquired Immunodeficiency Syndrome) often occurs in the patients with untreated HIV. • If HIV is not treated, it can slowly destroy your immune system. You may get other serious and maybe deadly infections. • Early treatment can save your life. KNOW YOUR STATUS Ask your health care provider for an HIV test if you have never been tested. HIV may take up to six months to show up in your blood.

PROTECT YOURSELF HIV can be spread through unprotected sexual contact or sharing needles with someone who is HIV infected. You should avoid these risky behaviors.

KNOW HOW HIV IS NOT SPREAD HIV is not spread by dry kissing, shaking hands, hugging, sharing utensils or food, or sharing toilets.

IF YOU THINK YOU HAVE BEEN EXPOSED, SEE YOUR HEALTH CARE PROVIDER. Especially if you have any of the following:  Diarrhea  Swollen lymph glands  Oral thrush (white patches in your mouth)  Vaginal yeast infections  Flu-like symptoms Night sweats  Fevers  Weight loss Request a dental examination once a year

IF YOU ARE ON HIV MEDICINES, BE SURE TO TAKE THEM EVERY DAY.

Missed doses may cause your medicine to stop working to control your HIV. Tell your health care provider if you are not able to take your HIV medicines due to bad side effects or other reasons. PE-1 Anal Cancer Screening TEST YOURSELF Self-collected Rectal Swab

Wash your hands Remove the tube Place your label Wet the tip of the 1 with soap and water 2 and swab from 3 on the tube. 4 swab with tap for at least 20 the packaging. water. seconds.

Get into a comfortable position Gently insert the swab 2-3 inches into the anus. Move 5 that allows you to access your 6 the swab ONCE in a large circle, pressing gently anus. against the inside.

Slowly pull the Wash your 7 swab out over a 10 hands with period of 15 to 30 Swish the swab Throw away swab. soap and seconds, moving in 8 around in the liquid 9 Place cap back on water and a circle. several times. the tube and twist it return to lab. closed. PE-2 Septiembre de 2021 Guía de CCHCS para los Cuidados del Virus de Inmunodeficiencia Humana (VIH)

RESUMEN APOYO PARA TOMAR DECISIONES EDUCACIÓN PARA EL PACIENTE/CONTROL PERSONAL DEL CASO

V I H (VIH) L VIH: • Se puede tener VIH durante años sin sentir ningún malestar.

• El VIH puede causar llagas en la boca. Estas llagas pueden ser un signo de una afección grave. Consulte a su dentista si presenta llagas en la boca.

• El VIH puede hacer que sus encías se inflamen o sangren. Si tiene las encías hinchadas o sangrantes, su dentista puede tratarlas.

• El VIH puede causar manchas blancas o rojas que pueden ser indoloras en la boca y la lengua. Estas manchas pueden ser un signo de una afección grave. Consulte a su dentista si desarrolla manchas blancas o rojas en la boca o en la lengua.

• Cepillarse los dientes y usar hilo dental es especialmente importante para alguien que vive con el VIH. Puede reducir el riesgo de pérdida de dientes cepillándose y usando hilo dental por la mañana y por la noche. • No existe cura ni vacuna contra el VIH, pero el tratamiento puede ayudarle a vivir más y prevenir otras complicaciones dolorosas y graves. • El SIDA (Síndrome de Inmunodeficiencia Adquirida) ocurre principalmente en pacientes cuyo VIH no ha recibido tratamiento.

• Si el VIH no se trata, puede destruir lentamente el sistema inmunológico; por lo que se pueden contraer otras infecciones graves e incluso mortales. • Recibir tratamiento a tiempo puede salvarle la vida. CONOZCA SU SITUACIÓN

Solicite a su proveedor de atención médica una prueba para detectar el VIH si nunca se ha realizado este examen. El VIH puede demorar hasta seis meses para ser detectado en la sangre.

PROTÉJASE A SÍ MISMO

El VIH se puede contagiar a través del contacto sexual sin protección o por intercambio de jeringas con una persona portadora de VIH. Estos comportamientos arriesgados se deben evitar. SEPA CÓMO NO SE CONTAGIA EL VIH El VIH no se contagia a través de un beso, apretón de manos, abrazos, compartir utensilios o alimentos, ni por compartir el baño.

SI CREE QUE HA SIDO EXPUESTO, ACUDA A SU PROVEEDOR DE CUIDADOS DE SALUD Especialmente si presenta alguno de los siguientes:  Diarrea  Inflamación en las glándulas linfáticas  Candidiasis bucal (parches blancos dentro de la boca)  Infecciones vaginales por hongos  Síntomas parecidos a una gripe  Sudoración nocturna  Fiebre  Pérdida de peso Solicite un examen dental una vez al año SI USTED SE ENCUENTRA BAJO TRATAMIENTO CONTRA EL VIH, ASEGÚRESE DE TOMAR SUS MEDICINAS TODOS LOS DÍAS.

Saltar alguna dosis podría ocasionar que la medicina pierda la capacidad de controlar el VIH. Hable con su proveedor de cuidados de salud si no puede tomar sus medicinas contra el VIH debido a efectos secundarios perjudiciales o por otra razón.

PE-3 SPANISH Prueba de cáncer anal PRUEBA PERSONAL

Hisopo rectal de recolección personal

Lávese las manos con Saque el tubo y el Pegue su etiqueta Humedezca la 1 agua y jabón durante 2 hisopo del empaque. 3 en el tubo. 4 punta del hisopo al menos 20 segundos. con agua del grifo.

Colóquese en una posición cómoda, Inserte suavemente el hisopo 2-3 pulgadas en el ano. 5 que le permita llegar al ano. 6 Mueva el hisopo UNA VEZ haciendo un círculo grande y presionando suavemente contra el interior.

Retire lentamente el Lávese las 7 hisopo durante 15 a 10 manos con

30 segundos, Agite el hisopo en el Deseche el hisopo. agua y jabón. moviéndolo en círcu- 8 líquido varias veces. 9 Coloque la tapa al Envíe al los. tubo y gírela para laboratorio. cerrar. PE-4 SPANISH