From Drug Holidays to 100% Adherence- The Role of the Pharmacist in HIV Drug Therapy - FL APPROVED -

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2 From Drug Holidays to 100% Adherence- The Role of the Pharmacist in HIV Drug Therapy - FL APPROVED - ACTIVITY DESCRIPTION In the mid 1990 when multiple drug regimens HIV cocktails became available, drug holidays were used to help the body recover. With the advent of more tolerable HIV regimens, 100% adherence is necessary to achieve maximum durable viral load suppression. Join community based pharmacist Professor Peter Kreckel in a review of the drug regimens, as well as the newer boosted combinations and their impact on medication adherence. TARGET AUDIENCE The target audience for this activity is pharmacists, pharmacy technicians, and nurses in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacist will be able to: Describe the pharmacist s critical role in counseling and educating HIV patients to improve the patient outcomes and medication adherence. Provide an update on antiretroviral therapy (ARV) for HIV to include the six categories of HIV medications to include their mechanisms of action, efficacy, dosing, safety, and tolerability profiles, and first line combination therapy. State the current Florida Law on AIDS and its impact on testing, confidentiality of test results, and treatment. After completing this activity, the pharmacy technicians will be able to: Describe the pharmacist s critical role in counseling and educating HIV patients to improve the patient outcomes and medication adherence, and the role of the technician to assist the pharmacist. Provide an update on antiretroviral therapy (ARV) for HIV to include the six categories of HIV medications to include their mechanisms of action, efficacy, dosing, safety, and tolerability profiles, and first line combination therapy. State the current Florida Law on AIDS and its impact on testing, confidentiality of test results, and treatment. ACCREDITATION Pharmacy PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Nursing PharmCon, Inc. is approved by the California Board of Registered Nursing (Provider Number CEP 13649) and the Florida Board of Nursing (Provider Number ). Activities approved by the CA BRN and the FL BN are accepted by most State Boards of Nursing. CE hours provided by PharmCon, Inc. meet the ANCC criteria for formally approved continuing education hours. The ACPE is listed by the AANP as an acceptable, accredited continuing education organization for applicants seeking renewal through continuing education credit. For additional information, please visit: Universal Activity No.: H02-P Credits: 1.0 contact hour (0.1 CEU) Release Date: 01/22/2016 freece Expiration Date: 5/1/2018 ACPE Expiration Date: 5/1/2018 ACTIVITY TYPE Knowledge-Based Live Webinar FINANCIAL SUPPORT BY PharmCon

3 Pete Kreckel, RPh Adjunct Assistant Professor, Saint Francis university ABOUT THE AUTHOR "Professor Pete" Kreckel is a practicing retail pharmacist who works in Altoona Pennsylvania. Both he and his wife, Denise are 1981 graduates of the University of Pittsburgh School of Pharmacy. He has worked independent retail pharmacy for over 30 years. He has been teaching Pharmacology in the Physician Assistant program at St. Francis University since He has been a regular PharmCon favorite since 2008 covering topics of primary interest to the retail pharmacist. He was inducted into Pi Alpha the Physician Assistant honorary fraternity, and was named as "Preceptor of the Year" by the Pennsylvania Pharmacists Association for his dedicated work to the education of pharmacy students from Duquesne University, and from his Alma mater the University of Pittsburgh. Professor Kreckel was recently named the 2014 Preceptor of the Year by the NCPA! FACULTY DISCLOSURE It is the policy of PharmCon, Inc. to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer of any commercial product(s) and/or service(s) discussed in an educational activity. Peter Kreckel reports no actual or potential conflict of interest in relation to this activity. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Reviewers unanimously found that the activity is fair balanced and lacks commercial bias. Please Note: PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced and objective. Occasionally, faculty may express opinions that represent their own viewpoint. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not intended as a substitute for the participant s own research, or for the participant s own professional judgement or advice for a specific problem or situation. Conclusions drawn by participants should be derived from objective analysis of scientific data presented from this activity and other unrelated sources. Neither freece/pharmcon nor any content provider intends to or should be considered to be rendering medical, pharmaceutical, or other professional advice. While freece/pharmcon and its content providers have exercised care in providing information, no guarantee of it s accuracy, timeliness or applicability can be or is made. You assume all risks and responsibilities with respect to any decisions or advice made or given as a result of the use of the content of this activity.

4 From Drug Holidays To 100% Adherence - The Role of The Pharmacist in HIV Drug Therapy Activity ACCREDITATION Universal Activity Number L02 Activity INSTRUCTION Faculty Credits 1.0 contact hour(s) Peter Kreckel, RPh Adjunct Asst. Prof. of Pharmacology, St. Francis University Faculty Disclosure Prof. Kreckel has no actual or potential conflicts of interest in relation to this activity. Learning OBJECTIVES Describe the pharmacist s critical role in counseling and educating HIV patients to improve the patient outcomes and medication adherence Provide an update on antiretroviral therapy (ARV) for HIV to include the six categories of HIV medications to include their mechanisms of action, efficacy, dosing, safety, and tolerability profiles, and first line combination therapy State the current Florida Law on AIDS and its impact on testing, confidentiality of test results, and treatment Legal DISCLAIMER The material presented here does not necessarily reflect the views of PharmCon, Inc. or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. FACULTY: Peter Kreckel, RPh 1/21/ Learning Objectives Describe the pharmacist s critical role in counseling and educating HIV patients to improve the patient outcomes and medication adherence. Provide an update on antiretroviral therapy (ARV) for HIV to include the six categories of HIV medications to include their mechanisms of action, efficacy, dosing, safety, and tolerability profiles, and first line combination therapy. State the current Florida Law on AIDS and its impact on testing, confidentiality of test results, and treatment. Stage 3 (AIDS) Classifications among Adults and Adolescents with HIV Infection, by Sex and Transmission Category, 2011 United States and 6 Dependent Areas Males Females N=24,443 N=8,102 15% 10% 1% 6% 69% Note. 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. 20% 2% 78% 1/21/ /21/

5 Stage 70 3 (AIDS) Classifications among Adults and Adolescents with Diagnosed HIV Infection, by Race/Ethnicity, United States and 6 Dependent Areas Diagnoses of HIV Infection and Population among Adult and Adolescent Males, by Race/Ethnicity 2013 United States Diagnoses of HIV Infection N=37,887 < 23% 1% < 1% 2% 2% 42% Male Population, United States N=128,717,938 16% 12% 2% 1% < 1% 5% % 65% Note. 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. b Includes Asian/Pacific Islander legacy cases. White Hispanic/Latino(a) Asian(b) Black/African American Multiple Races American Indian/Alaska Native Note. Data include persons with a disgnosis 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 1/21/ /21/ DRUG HOLIDAYS: Or Why Even the HIV/AIDS Orthodoxy Isn't All Bad By Peter Duesberg: 25 June 2000 Until recently all those who question the HIV/AIDS hypothesis had every right to blame the proponents of this hypothesis for disregarding the fatal biochemical toxicity of DNA chain terminators like AZT, in view of the hypothetically fatal HIV. But this is no longer true. In the face of the inevitable toxicity of anti-hiv drugs (Duesberg & Rasnick, 1998; Christensen, 2000), the HIV-AIDS orthodoxy is now softening its stand. According to Science News, AIDS doctors do now implement "drug holidays" for all those HIVpositives suffering "from the nasty side effects and the rigors of the treatment" (Christensen, 2000). Thus even mainstream, Durban Declaration-signing AIDS doctors now recommend "drug holidays" to their patients to recover from their prescriptions DRUG HOLIDAYS: Or Why Even the HIV/AIDS Orthodoxy Isn't All Bad By Peter Duesberg: 25 June 2000 This is a very promising development, one that could unite us all at last! Certainly neither side of the AIDS debate would consider insulin-holidays for diabetes patients, or dialysis holidays for kidney patients. Therefore the recommended anti-hiv drug holidays are a significant step away from the "hit hard and early" days of the International AIDS conference in Vancouver in Perhaps we could all agree at our next meeting in Johannesburg to extend drug holidays for all HIV-positives and AIDS patients for a very, very long time. 1/21/ /21/

6 SMART STUDY Says STOP Drug Holidays NEW YORK, Dec., (2006) -- HIV patients should not take drug holidays. That's the unambiguous warning from researchers involved in the large, randomized Strategies for Management of Antiretroviral Therapy (SMART) study. The trial was halted early this year because patients in the drug holiday arm were doing significantly worse than those on continual treatment HIV Prevention Through Care and Treatment (2011) Of the estimated 942,000 persons with HIV who were aware of their infection, approximately 77% were linked to care, and 51% remained in care. Among HIV-infected adults in care, 45% received prevention counseling, and 89% were prescribed ART, of whom 77% had viral suppression. Thus, an estimated 28% of all HIV-infected persons in the United States have a suppressed viral load. Conclusions: Prevalence of HIV testing and linkage to care are high but warrant continued effort. Increasing the percentages of HIV-infected persons who remain in HIV care, achieve viral suppression, and receive prevention counseling requires additional effort. 1/21/ /21/ Typical Reasons for Non Adherence British Columbia Study Failure to fill the prescription(s) Failure to understand dosing instructions Complexity of regimen (e.g., pill burden, size, dosing schedule, food requirements) Pill aversion Pill fatigue Adverse effects Inadequate understanding of drug resistance and its relationship to adherence Cost-related issues Depression, drug and alcohol use, homelessness, poverty Stigma Adherence was estimated using pharmacy refill data in 886 treatment-naive individuals in British Columbia followed prospectively for a median of 19 months after starting ART Adherence Rate % 1 dose/month 84% suppression 90-95% 2-3 doses/month 64% suppression (doses per month based on single dose regimen) % with viral load under 500copies/ml Conclusion: this study also found that near-perfect levels of adherence are required for reliable viral suppression. 1/21/ /21/

7 San Francisco Adherence Study In a cross-sectional analysis of 34 HIV-positive, homeless individuals taking ART including a PI over 3 months, adherence was assessed using patient report, unannounced pill counts, and MEMS caps. In a multivariate analysis, controlling for drug resistance, duration of therapy, and CD4 count Each 10% decrease in adherence was found to result in a doubling of the viral load. Adherence alone explained between 40-60% of the variation in viral load. The study suggests that small differences in adherence can result in major differences in virologic control and that adherence may be the predominant factor determining virologic outcomes. Stacking the Deck The Clinicians Role - Factors Governing Adherence: Assess patient s social situation Assess the clinical condition (CD4, viral load) The prescribed regimen (including dosing schedule and potential side effects) The importance of strict adherence to ART and potential development of drug resistance as a consequence of suboptimal adherence, The patient-provider relationship: critical that each patient receives and understands information about HIV disease including the goals of therapy Achieving and maintaining viral suppression Decreasing HIV-associated morbidity and mortality Preventing sexual transmission of HIV 1/21/ /21/ Stacking the Deck The Patients Role - Factors Governing Adherence Social status Depression and other mental illnesses, neurocognitive impairment Low health literacy; denial?; social stigma? Low levels of social support, Stressful life events, high levels of alcohol consumption and active substance use, Homelessness, poverty, nondisclosure of HIV serostatus, Inconsistent access to medication- insurance coverage and cost issues Patient s Age Readiness to start therapy Stacking the Deck : Role of Drug Regimens Simple, once-daily regimens Including those with low pill burden Without a food requirement Few side effects or toxicities Select right regimen for patient- if poor adherence is predicted, a PI/r regimen might be more forgiving for missed doses 1/21/ /21/

8 Drug Therapy Review Primary Goals for HAART Therapy Effective treatment of HIV-infected individuals with ART is highly effective at preventing transmission to sexual partners. However, less than one-third of HIV-infected individuals in the United States have suppressed viral loads, which is mostly a result of: Undiagnosed HIV infection and failure to link or retain diagnosed patients in care. Despite remarkable improvements in HIV treatment and prevention, economic and social barriers that result in continued morbidity, mortality, and new HIV infections persist. Reduce HIV-associated morbidity and prolong the duration and quality of survival Decrease likelihood of AIDS defining illnesses Restore and preserve immunologic function Maximally and durably suppress plasma HIV viral load Prevent HIV transmission. NOTE: Adoption of treatment strategies recommended in these guidelines has reduced HIV-related morbidity and mortality and has reduced perinatal and, probably, behaviorassociated transmission of HIV. Source: Downloaded from 1/21/ /21/ AIDS Defining Illness Bacterial infections, multiple or recurrent* Candidiasis of bronchi, trachea, or lungs Candidiasis of esophagus Cervical cancer, invasive Coccidioidomycosis, disseminated or extrapulmonary Cryptococcosis, extrapulmonary Cryptosporidiosis, chronic intestinal (>1 month's duration) Cytomegalovirus disease (other than liver, spleen, or nodes), onset at age >1 month Cytomegalovirus retinitis (with loss of vision) Encephalopathy, HIV related Herpes simplex: chronic ulcers (>1 month's duration) or bronchitis, pneumonitis, or esophagitis (onset at age >1 month) Histoplasmosis, disseminated or extrapulmonary Isosporiasis, chronic intestinal (>1 month's duration) 1/21/ AIDS Defining Illness Kaposi sarcoma Lymphoid interstitial pneumonia or pulmonary lymphoid hyperplasia complex* Lymphoma, Burkitt (or equivalent term) Lymphoma, immunoblastic (or equivalent term) Lymphoma, primary, of brain Mycobacterium avium complex or Mycobacterium kansasii, disseminated or extrapulmonary Mycobacterium tuberculosis of any site, pulmonary, disseminated, or extrapulmonary Mycobacterium, other species or unidentified species, disseminated or extrapulmonary Pneumocystis jirovecii pneumonia Pneumonia, recurrent Progressive multifocal leukoencephalopathy Salmonella septicemia, recurrent Toxoplasmosis of brain, onset at age >1 month Wasting syndrome attributed to HIV 1/21/

9 Simplifying HIV Therapy Domino s and HIV Drugs that prevent entry of the HIV virus into the CD4 cell Blocks the attachment or fusing of virus to cell membrane. (fusion inhibitors) Keeps virus from entering the cell. (entry inhibitors) Drugs that inactivate enzymes necessary for replication. Reverse transcriptase : NRTI and NNRTI Integrase: INSTI Protease: PI Backbone Therapy: most always see two NRTI s (usually Truvada ) + (NNRTI) or (INSTI) or (PI) Think of a row of dominos Removing any one domino and the last domino will be standing. Similar to the steps of HIV replication. If the last domino remains standing no infectious virons are spread! 1)Attachment 2) Entry 3)Reverse transcriptase 4)Integrase 5)Protease 1/21/ /21/ When to Start HAART???? Highly Active Anti Retroviral Therapy FUSION and ENTRY Inhibitors HIV symptoms? CD4 count Start Treatment? Comments VIRAL FUSION INHIBITOR: Mechanism: Blocks the fusion of the HIV virus into the host cell. Yes Any Yes ANY AIDS defining illness, start treatment. No <500 Yes Newest recommendations No >500 Yes * Patients with greater than 350 are likely to benefit from ART. Especially if Hep-B, pregnant, or HIVAN Current use: salvage therapy Injection site reactions, recurrent pneumonia, diarrhea, nausea, fatigue Fuzeon Enfuvirtide T-20 dose 90mg SQ BID CCR5 Co-Receptor Antagonist Mechanism: Binds to a receptor called CCR5 on CD4 cell. Current use: Merit study- got FDA approval for treatment naïve patients Selzentry Maraviroc MVC 300mg BID (adjust for P450) 1/21/ /21/

10 NRTI: Nucleoside/tide Reverse Transcriptase Inhibitor ADVANTAGES Established backbone of combination therapy (2 drugs from this category) Minimal drug interactions Renally eliminated- doses need adjusted for all except abacavir (alcohol dehydrogenase) and zidovudine (glucuronidation) DISADVANTAGES Lactic acidosis and hepatic steatosis reported with most NRTIs (rare) Brand Generic Abbr Dosage Emtriva Emtricitabine FTC 200mg daily Viread Tenofovir DF TDF 300mg/day Epivir Lamivudine 3TC 150mg BID or 300/day Ziagen Abacavir (must be HLA- B*5701 negative) ABC Retrovir Zidovudine AZT 300mg BID 1/21/ interfere with viral-rna dependent DNA-polymerase resulting in chain termination and inhibition of viral replication 300mg BID or 600mg/day NNRTI Non Nucleoside Reverse Transcriptase Inhibitor Class effects: Long half lives Potential for cross resistance (K103mutation***) Skin rash P450 drug interactions Brand Generic Abbr dose Viramune *** Nevirapine NVP 200mg daily x14 days, then 200q12 Sustiva *** Efavirenz EFZ 600mg HS Rescriptor *** Delaviridine DLV mg every 8 hours Intelence Etravirine TMC mg (2x100mg) BID pc Edurant Rilpivirine RPV 25mg daily with a meal (viral 1/21/ highly selective, noncompetitive inhibitors of HIV- 1 reverse transcriptase load must be less than 100K, and CD4 over 200.) INSTI: Integrase Strand Inhibitors Minimal CYP450 drug interactions. No dosage adjustments needed. Well tolerated- Preferred as of 4/8/2015 May take with or without food. Preferred option for treatment naïve patients. Also for Protease inhibitor intolerant patients Mechanism: Interferes with enzyme needed to integrate viral DNA into host cell DNA. It transports the proviral DNA into the host cell nucleus. There it is integrated into the target cells' DNA. Isentress Raltegravir RAL 400mg BID + or - food Stribild Elvitegravir JTK303 Once daily with food +cobicistat Tivicay Dolutegravir DTG 50mg- 1/day QUAD Therapy : Stribild Stribild (elvitegravir + cobicistat + tenofovir + emtricitabine) Approved by FDA August 27, 2012 Elvitegravir: integrase strand inhibitor Cobicistat (GS-9350) : boosts the blood levels and effectiveness of elvitegravir. Cobicistat, itself, does not have any antiviral activity. DOSE: one tablet daily with food Avoid if CrCl is less than 70ml/min. D/C if CrCl is under 50 EFFICACY: compared to- Atripla: 84% undetectable HIV versus 88% Stribild Reyataz/rit: 87% undetectable HIV versus 90% Stribild 1/21/ /21/

11 Protease Inhibitors (PI) ADVANTAGES Higher genetic barrier to resistance PI resistance uncommon with failure (boosted PI) NNRTI options preserved for future use DISADVANTAGES Metabolic complications (fat maldistribution, dyslipidemia, insulin resistance) GI intolerance Potential for drug interactions (CYP450), especially with RTV Prezista darunavir DRV/r 800mg + 100mg ritonavir Reyataz Atazanavir TAZ 400mg daily Lexiva fosamprenivir FPR 1.4gm BID Kaletra Lopinavir LPV/r 200mg/50mg BID /Ritonavir Norvir Ritonavir RTV mg (booster) 1/21/ Mechanism: reversible inhibitors of HIV aspartyl protease, a viral enzyme responsible for the cleavage of the viral polyprotein into a number of essential enzymes and several structural proteins. Poll question #1 Which of the following HIV medications is administered by injection only? a) Tivicay (dolutegravir) b) Retrovir (zidovudine) c) Fuzeon (enfuvirtide) d) Selzentry (Maraviroc) e/ /2/stock-photo questions-about-the-vote.jpg 1/21/ Answer to Poll question #1 Answer C Fuzeon (enfuvirtide) Ritonavir Boosting Ritonavir (Norvir ) by Abbvie Labs (AWP=$308/30) (available at capsules or tablets) Is the most potent inhibitor of the Cytochrome P450 enzyme system ALL PI are substrates of CYP450-3A4 so their metabolic rate may be altered in the presence of CYP inducers or inhibitors Kaletra (lopinavir + ritonavir) (all in one tablet) Dose: 2 bid if experienced. (4) single dose first time treatment e/ /2/stock-photo questions-about-the-vote.jpg 1/21/ /21/

12 Boosting with Cobicistat (TYBOST ) Combos Boosted with Cobistat Manufactured by Gilead Sciences- AWP=$ Mechanism: CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection. Considered to be a pharmacokinetic enhancer. NO HIV ACTIVITY Also boosts elvitegravir (INSTI) in Stribild Considered to be non-inferior to ritonavir Cobicistat does not appear to improve the gastrointestinal or lipid side effects of ritonavir Brand Generic Category Dose Stribild (elvitegravir + cobicistat + tenofovir + emtricitabine) INSTI Once daily with food Evotaz (atazanavir + cobicistat) PI Once daily-light meal Prezcobix (darunavir + cobicistat) PI Once daily with food 1/21/ /21/ One and Done!! What's New EVERYTHING! Preferred Regimens (April 8, 2015) SIG: Take one (1) tablet once daily Brand Name Category Contains Contains 2 NRTI Atripla NNRTI efavirenz tenofovir + emtricitabine Complera NNRTI rilpivirine tenofovir + emtricitabine Stribild INSTI elvitegravir/cobistat tenofovir + emtricitabine Triumeq INSTI dolutegravir abacavir + lamivudine COLUMN A (INSTI or PI options in alphabetical order) Darunavir + ritonavir Dolutegravir Dolutegravir Elvitegravir/ cobicistat Raltegravir COLUMN B (Dual-NRTI options- in alphabetical order) Tenofovir/emtricitabine (coformulated) Tenofovir/emtricitabine (coformulated) Abacavir +Lamivudine (must be HLA- B*5701 negative) Tenofovir/emtricitabine (coformulated) Tenofovir/emtricitabine (coformulated) How to prescribe Prezista + Ritonavir + Truvada Tivicay + Truvada Triumeq Stribild Isentress + Truvada 1/21/ /21/

13 PREGNANCY and HIV- MORE new stuff! As of August 6, 2015 An HIV-infected pregnant woman can transmit the virus to her infant during pregnancy, at labor and delivery, or through breastfeeding. Risk of infection is 30%, if untreated. Risk drops to between 0.7% - 2% if treated. Preferred protease inhibitors (PI): darunavir/ritonavir (Prezista/Norvir) : promoted to a preferred protease inhibitor for ARV-naive pregnant women; atazanavir/ritonavir (Reyataz/Norvir) remains a Preferred PI. Alternative PI: lopinavir/ritonavir has been changed from Preferred to Alternative PI. (may cause nausea) Preferred NNRTI: NNRTI): efavirenz remains a preferred NNRTI when initiated after the first 8 weeks of pregnancy 1/21/ Post Exposure Prophylaxis If you experienced a needle stick or sharps injury or were exposed to the blood or other body fluid of a patient during the course of your work, immediately follow these steps: Wash needle sticks and cuts with soap and water Flush splashes to the nose, mouth, or skin with water Irrigate eyes with clean water, saline, or sterile irrigants Report the incident to your supervisor Immediately seek medical treatment PEPLINE: /21/ Post Exposure Prophylaxis Pregnant Patients: Florida Law Average risk for HIV transmission after percutaneous exposure of HIV infected blood is 0.3% Average after a mucous membrane exposure risk is about 0.09% RECOMMENDATIONS as of DECEMBER 2013 CDC recommends prophylaxis for ALL occupational exposures to HIV. Start PEP STAT, continue for 4 weeks. (May stop if negative) SHOULD contain 3 medications for all exposures. Three drug combination therapy Raltegravir (Isentress-Merck) PLUS Tenofovir/emtricitabine (Truvada ) 1/21/ Florida law (s , F.S.) requires a health care provider who attends a pregnant woman for conditions relating to her pregnancy to offer testing for HIV and counsel her on the availability of treatment if she tests positive. Document in writing if the pregnant woman objects to HIV testing, and keep in her chart. Still encourage testing. If pregnant women tests HIV negative: offer follow up testing 6 months later. Exposure window is 6 months from time of infection until detectable antibodies. If HIV positive, support is available thru Healthy Start Care Coordination System. Contact the Family Health Line at BABY 1/21/

14 Florida Law: Consent Florida Statutes Title XXIX Chapter Florida Law: Notification No person in this state shall order a test designed to identify the human immunodeficiency virus, or its antigen or antibody, without first obtaining the informed consent of the person upon whom the test is being performed. Informed consent shall be preceded by an explanation of the right to confidential treatment of information identifying the subject of the test and the results of the test to the extent provided by law. Information shall also be provided on the fact that a positive HIV test result will be reported to the county health department with sufficient information to identify the test subject and on the availability and location of sites at which anonymous testing is performed. As required in paragraph E Each county health department shall maintain a list of sites at which anonymous testing is performed, including the locations, phone numbers, and hours of operation of the sites. Consent need not be in writing provided there is documentation in the medical record that the test has been explained and the consent has been obtained. The person ordering the test or that person s designee shall ensure that all reasonable efforts are made to notify the test subject of his or her test result. Notification of a person with a positive test result shall include information on the availability of appropriate medical and support services, on the importance of notifying partners who may have been exposed, and on preventing transmission of HIV. Notification of a person with a negative test result shall include, as appropriate, information on preventing the transmission of HIV. When testing occurs in a hospital emergency department, detention facility, or other facility and the test subject has been released before being notified of positive test results, informing the county health department for that department to notify the test subject fulfills this responsibility. 1/21/ /21/ Exceptions if Positive Result Poll question #2 A positive preliminary test result may not be revealed to any person except in the following situations: 1. Preliminary test results may be released to licensed physicians or the medical or nonmedical personnel subject to the significant exposure. 2. Preliminary test results may be released to health care providers and to the person tested when decisions about medical care or treatment of, or recommendation to, the person tested and, in the case of an intrapartum or postpartum woman, when care, treatment, or recommendations regarding her newborn, cannot await the results of confirmatory testing. Positive preliminary HIV test results may not be characterized to the patient as a diagnosis of HIV infection. 1/21/ Which of the following is a pharmacokinetic enhancer with NO viral activity? A. Lamivudine (Epivir ) B. Raltegravir (Isentress ) C. Ritonavir (Norvir ) D. Cobicistat (Tybost ) 1/21/ e/ /2/stock-photo questions-about-the-vote.jpg 11

15 Answer to poll question #2 D Cobicistat (Tybost ) e/ /2/stock-photo questions-about-the-vote.jpg 1/21/ Can We Talk?? When I asked the local HIV outreach program what barriers they saw with their clients: Depression Drug and alcohol abuse Co$t Privacy Group originally met at the library, then a church hall, anywhere that was not hospital related Patients hide meds so they won t be discovered by roommates, relatives, friends, etc. Out of sight out of mind 1/21/ Depression source: HIV patients will respond in a similar way to TCA, SSRI, SNRI. Risk of suicide is higher than general population. A person distressed by an HIV diagnosis may need treatment, for an adjustment reaction, but the distress will respond to supportive and other types of psychotherapy rather than medications HIV can damage subcortical areas of the brain and produce HIV dementia, resulting in states that are mistaken for clinical depression. HIV+ patients can also experience other medical and endocrine abnormalities that can create mood disturbances. Drug and Alcohol Abuse (source: Injection drug use is one of the causes of HIV in the United States and is responsible for approximately 10% of HIV cases annually. Injecting drugs: HIV risk from sharing drug preparation or injecting equipment ( works ) with a person who has HIV. Can then pass HIV to sex and drug-using partners. Drinking alcohol or taking other drugs can increase risk for HIV and other sexually transmitted diseases (STDs), due to lowered inhibitions. 1/21/ /21/

16 Methamphetamine Abuse (source: There is a strong link between meth use and HIV transmission for men who have sex with men (MSM). Studies show that MSM who use meth may increase their sexual AND drug-use risk factors. They may: Use condoms less often Have more sex partners Engage in unprotected anal sex (as the receptive partner, which is the highest risk behavior) Inject meth instead of smoking or snorting it Alcohol Abuse (source: Being drunk lowers ability to make safe choices and lowers inhibitions- risk for unprotected sex Alcohol use and abuse may make it difficult to follow your HIV treatment plan. Alcohol abuse can contribute to health conditions such as liver disease that have an impact on the progression of HIV infection Alcohol may lead to malnourishment, which makes it more difficult to defend the body against HIV. 1/21/ /21/ Addressing the Co$ts NNRTI Truvada #30 ($ ) 1/21/ Total per month Total Per year Isentress #60 ($ ) $ $ Truvada Sustiva ($ ) $ $ Truvada Reyataz-boosted ($ $308.60) $ $ Truvada Prezista- boosted ( ) $ $ Complera $ $ Atripla $ $ Privacy (source: Congress enacted important legal protection, the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Designed to protect the privacy of patients medical records and other health information. Provides patients with access to their medical records and with significant control over how their personal health information is used and disclosed. HIPAA has proven to be very effective in preventing discrimination against people living with HIV/AIDS by preventing others from knowing their HIV status 1/21/

17 What You Can Do: Questions? Follow all privacy rules, in your annual HIPAA training Enforce privacy especially with staff. No discussion about patients Florida pharmacists/techs: be familiar with Florida specific statutes Know your own state statutes Have a private area to discuss treatment with HIV positive patients. 1/21/ /21/

18 Exam Questions: 1) Which of the following was the findings of the Adherence Study conducted in British Columbia? a. Drug holidays are useful in limiting side effect complaints b. Drug holidays had minimal effect on viral loads c. Reliable viral suppression is best achieved with near-perfect adherence d. Viral suppression calculated at 65% and over provides reliable viral suppression 2) According to the San Francisco Adherence Study which of the following was found when adherence rates decreased by 10% a. Minimal effect on CD4+ counts b. Viral suppression decreased 20% c. CD4 count doubled d. The viral load doubled 3) All of the following enzymes are necessary for HIV replication, EXCEPT: a. DNA decarboxylase b. Integrase c. Protease d. Reverse transcriptase 4) Which of the following HIV drugs works by antagonizing the CCR5 receptor a. Raltegravir b. Enfuviritide c. Cobicistat d. Maraviroc

19 5) Which of the following mechanisms of action is NOT represented by one of the drugs in the quad therapy drug (Stribild) a. A booster b. NRTI (nucleoside/tide) reverse transcriptase inhibitor c. NNRTI (non-nucleoside) reverse transcriptase inhibitor d. Integrase strand inhibitor 6) Which of the following drugs has the highest genetic barrier to resistance? a. Mariviroc b. Darunavir c. Nevirapine d. Efavirenz 7) Which of the following is first line treatment for post exposure prophylaxis? a. Atazanavir/cobistat + tenofovir/emtrictabine b. Efavirenz + tenofovir/emtrictabine c. Raltegravir + tenofovir/emtrictabine d. Dolutegravir + abacavir/lamivudine 8) Which of the following drugs is a pharmacokinetic enhancer with NO intrinsic anti-viral activity? a. Ritonavir b. Cobicistat c. Efavirenz d. Abacavir 9) All of the following are barriers to treatment of patients as observed by a local HIV outreach program, EXCEPT? a. Depression b. Drug abuse c. Lack of effective anti-virals d. Privacy

20 10) Which of the following HIV drugs is first line treatment of a newborn? a. Raltegravir b. Zidoduvidine c. Nevirapine d. Efavirenz