HIV Treatment & Adherence Update 2014

Transcription

1 NORTHWEST AIDS EDUCATION AND TRAINING CENTER HIV Treatment & Adherence Update 2014 Lara Strick, MD, MS Infectious Disease Physician, WA DOC Corrections Program Director, Northwest AETC Clinical Assistant Professor, University of Washington Oregon Corrections Conference May 10, 2014

2 Topics Antiretroviral Therapy Guidelines Importance of Adherence Patient Barriers to Adherence Monitoring Adherence

3 HIV 2014 UPDATE 2014 HHS Antiretroviral Therapy Guidelines

4 US Health and Human Services (HHS) May 1, 2014 Antiretroviral Therapy Guidelines Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents Developed by the HHS Panel on Antiretroviral Guidelines for Adults and Adolescents A Working Group of the Office of AIDS Research Advisory Council (OARAC) Source: 2014 HHS Antiretroviral Therapy Guidelines. AIDS Info (

5 Updated HIV Care Cascade in United States 100% 82% 66% 37% 33% 25% Source: Hall HI, et al XIX IAC; July 22-27, Washington DC. Abs FRLBX05

6 Initiating Antiretroviral Therapy

7 At what CD4 cell count would you consider HAART? A. < 100 cells/mm 3 B. < 200 cells/mm 3 C. < 350 cells/mm 3 D. < 500 cells/mm 3 E. Any CD4 cell count

8 HHS Antiretroviral Therapy Guidelines: May 2014 Initiating Therapy in Treatment-Naïve Patients 1000 CD4 Cell Count ! 500 Recommend: Moderate 200 Recommend: Strong 0 Source: 2014 HHS Antiretroviral Therapy Guidelines. AIDS Info (

9 ANTIRETROVIRAL THERAPY: DHHS GUIDELINES DHHS Antiretroviral Therapy Guidelines: May 2014 Factors Affecting Decision on When to Initiate Therapy More effective regimens More convenient regimens Better tolerated therapy Less long-term toxicity Better immune recovery Lower rates of resistance More treatment options Concerns for uncontrolled viremia Decrease HIV transmission Earlier Therapy Lack of RCT data supporting early Rx Potential drug toxicity Drug and monitoring cost Potential negative impact on QOL Later Therapy

10 PREVENTION OF OPPORTUNISTIC INFECTIONS CD4 Cell Progression (without Antiretroviral Therapy) 1000 CD4 Cell Count AIDS 0 Year (expanded) Years

11 PREVENTION OF OPPORTUNISTIC INFECTIONS Chronic Immune Activation and Inflammation CD4 Cell Count Immune Activation & Inflammation Year (expanded) Years

12 HIV Prevention Trials Network (HPTN) Study 052 1,763 HIV Serodiscordant Couples (97% heterosexual) n = 872 n = 853 n = 37 n = 1 Source: Cohen M, et al. N Engl J Med. 2011;36:

13 ANTIRETROVIRAL THERAPY: DHHS GUIDELINES HIV Prevention Trials Network (HPTN) Study ,763 HIV Serodiscordant Couples (97% heterosexual) CD4 Cell Count Early Therapy CD cells/mm ! Deferred Therapy CD4 < 250 cells/mm 3 or AIDS Related Event Source: Cohen M, et al. N Engl J Med. 2011;36:

14 HIV Prevention Trials Network (HPTN) Study % Reduction Early Therapy (n = 886) 1 P < Deferred Therapy (n = 877) Linked Transmissions Source: Cohen M, et al. N Engl J Med. 2011;36:

15 PARTNER Study 767 HIV Serodiscordant Couples Heterosexual MSM n = 445 n = 282 Source: Rodger A, et al. Abstract 153LB. 21st CROI, March 4-6, 2014.

16 PARTNER Study HIV+ partner on HAART and VL <200 copies/ml Only data from couples who reported sex without condoms were included in analysis Grand total of 44,439 sex acts HIV transmission did occur, but only from OUTSIDE partners None were phylogenetically linked to the original HIV+ in any couple Transmission rate = 0 However, longer-term transmission risk with suppressive ART may NOT be zero Source: Rodger A, et al. Abstract 153LB. 21st CROI, March 4-6, 2014.

17 HIV 2014 UPDATE Importance of Adherence

18 Adherence v. Non-Adherence Medication adherence = extent patient takes a medication in the way intended by health care provider Non-adherence is meant to be non-judgmental, not an expression of blame Typical adherence rates for long-term medications are 50-75% 100% adherence often the expectation in prison/jail HIV viral suppression require good adherence

19 How would you estimate your adherence?

20 How would you estimate your adherence? A. 20% B. 50% C. 70% D. 80% E. 90% F. 95% G. 100%

21 Predictors of Adherence Treatment Regimen: - #pills, dosing frequency, food requirements, med side effects Disease Characteristics: - Stage & duration of HIV, opportunistic infections, HIV symptoms Patient Provider Relationship - Overall satisfaction & trust Clinical Setting - Perceived confidentiality - Prior experiences with correctional health care system Patient Variables - Sociodemographic factors - Psychosocial factors: MH, substance use, lack of knowledge

22 MAXIMIZING ADHERENCE DURING INCARCERATION Maximizing Adherence in Corrections Medication dispensation Medication access Dealing with custodial barriers Minimizing patient barriers

23 MAXIMIZING ADHERENCE DURING INCARCERATION Keep on Person (KOP) vs. Pill Line (DOT) KOP! Avoids waiting time in line Doesn t interrupt activities You aren t seen on the line and questioned by others Develops self-sufficiency which may facilitate adherence upon release Pill Line! Helps some to remember More interaction with medical staff Distrust of cellie Avoids issues with cell and strip searches Can track adherence

24 Which method of medication dispensation leads to better adherence? A. Keep on Person (KOP) B. Pill Line

25 MAXIMIZING ADHERENCE DURING INCARCERATION Adherence and Method of Medication Dispensation % ART Adherence Overall DOT SAT/KOP MEMS Pill Count Adherence overall was high compared to the community Directly observed therapy (DOT) did not improve adherence Majority (68%) reported they prefer self-administered therapy (SAT) to DOT Source: Wohl DA, et al. Clin Infect Dis. 2003;36(12):

26 HIV 2014 UPDATE Patient Barriers to Adherence

27 Patient Barriers Distrust of the system Concern about confidentiality Frequency of dosing & pill burden Side effects Co-morbidities - Mental health issues (& stigma) - Addiction - Viral hepatitis

28 Distrust of the System

29 You suggest patient start HAART & they say, I ain t taking any of those meds in prison. I don t want to be a guinea pig for some experimental drugs. I ll never get the same stuff Magic Johnson takes anyway.

30 You respond 1. I m not going to waste my time seeing you, if you aren t interested in following what I recommend. Don t come back until you change your attitude. 2. It s your choice, but you ll have to sign this refusal of treatment form. Kite me if you change your mind. 3. I m glad to see you care about your health. I would like to continue discussing the possible med options available & will see you back regularly to answer any questions you have.

31 Establish Trust Trust is earned and takes time, especially for offenders Build rapport Educate!!! - Illiteracy & low reading level common - Use diagrams & pictures - Consider peer support Collaborate allow the offender as much control of the situation as possible

32 Confidentiality

33 Maximize Confidentiality Avoid segregating HIV offenders Avoid having an HIV provider Don t group on a call out list When possible, have auditory privacy - Close doors - Have officers stand out of ear shot - Don t talk about patients in hallways or public places - Use no contact rooms Maintain privacy of records - No papers with patient info on desk - Angle computer screens - Proper use (e.g. forwarding indentifying info) Instruct not to disclose personal info in kites Use professional translators

34 Recommended Antiretroviral Regimens

35 HHS Antiretroviral Therapy Guidelines: 2014 Recommended Regimens Regardless of Viral Load for ARV-Naïve Patients Class Therapy Pill Burden NNRTI-Based PI-Based Efavirenz-Tenofovir-Emtricitabine Atazanavir + Ritonavir + Tenofovir-Emtricitabine Darunavir + Ritonavir + Tenofovir-Emtricitabine Raltegravir + Tenofovir-Emtricitabine INSTI-Based Elvitegravir-Cobicistat-Tenofovir-Emtricitabine Dolutegravir + Abacavir-Lamivudine* Dolutegravir + Tenofovir-Emtricitabine * Abacavir recommended only if HLA-B5701 negative Source: 2014 HHS Antiretroviral Therapy Guidelines. AIDS Info (

36 HHS Antiretroviral Therapy Guidelines: 2014 Recommended Regimens Only if Viral Load <100,000 copies/ml Class Therapy Pill Burden Ŧ Rilpivirine-Tenofovir-Emtricitabine NNRTI-Based Efavirenz + *Abacavir-Lamivudine PI-Based Atazanavir + Ritonavir + *Abacavir-Lamivudine Ŧ Recommended only if CD4 count >200 cells/ml *Abacavir recommended only if HLA-B5701 negative Source: 2014 HHS Antiretroviral Therapy Guidelines. AIDS Info (

37 HHS Antiretroviral Therapy Guidelines: March 2012 Factors to Consider for HIV Treatment Regimen selection should be individualized & based on many factors: Comorbid conditions - (e.g., cardiovascular, liver or renal disease, drug use, mental illness, TB) Potential adverse drug effects Potential drug interactions with other medications Pregnancy or pregnancy potential Genotypic drug-resistance testing Specific drug issues Patient adherence potential Convenience (e.g., pill burden, dosing freq, & food considerations) Source: 2012 HHS Antiretroviral Therapy Guidelines. AIDS Info (

38 Single Tablet Regimens

39 Single Tablet Antiretroviral Regimens AWP (Monthly) Efavirenz-Tenofovir-Emtricitabine Atripla $2402 Rilpivirine-Tenofovir-Emtricitabine Complera $2463 Elvitegravir-Cobicistat-Tenofovir-Emtricitabine Stribild $2949 AWP = Average Wholesale Price (Monthly): 2014 HHS Antiretroviral Therapy Guidelines

40 Future Single Tablet Regimen Dolutegravir-Abacavir-Lamivudine

41 Antiretroviral Side Effects

42 Match Drug with Most Common Side Effect Efavirenz (contained in Atripla) Jaundice Atazanavir Diarrhea Darunavir Dizziness & weird dreams Raltegravir Insomnia Dolutegravir Muscle pains

43 Jaundice - Atazanavir Most persons on have a benign mild elevation of indirect bilirubin, but only 5% get jaundiced Concern that it will identify as HIV or Hepatitis infected Reversible

44 CNS Side Effects Efavirenz (Rilpivirine) Vivid dreams, trouble sleeping, dizziness, drowsiness Concern it will decrease awareness & response time Use precaution if severe depression, mania, aggression or PTSD Take at night, but consider work schedule & when goes to sleep Take on an empty stomach food increases absorption & thus side effects Educate on what to expect Reassure that symptoms improve over time & usually resolve after 1 st month

45 Diarrhea Darunavir & other PIs, Stribild Lack of full control of bathroom privileges Wet cell? Cellie? Yard, work, school or other activities? Consider empiric loperamide for 1-2 months after starting HAART, especially if on a protease inhibitor Diarrhea is a big deal in prison/jail

46 Co-Morbidities

47 Mental Health & Chemical Dependency Stabilize mental health issues prior to initiating HAART when possible Better mental health care often means better adherence (not just Axis I) Address chemical dependency Even if patient not actively using now, it may be an issue upon release

48 HIV MEDICATION ADHERENCE Monitoring Adherence During Incarceration

49 Ways to Monitor Adherence 1. You take them off HAART immediately They don t deserve it 2. You make all his HIV medications pill line until he can prove he can take them regularly 3. You make him LWOP 4. You call out patient & discuss barriers to taking the meds daily & ways to minimize them

50 MONITORING ADHERENCE DURING INCARCERATION Ways to Monitor Adherence Patient self-report - Accurate self-reporting requires collaborative and non-judgmental relationship - Example conversation: Taking pills every day is really hard. Most people have problems taking their pills at some point during treatment. I would like to know if you have had any problems with taking your pills, missing pills, or taking them late. I am asking because I want to help figure out ways to make it easier for you to take them. Unannounced pill count in cell - If done by custody, this may not engender trust Pill line - Monitors adherence, but does not necessarily improve adherence

51 Monitoring CD4 Cell Count Initiation of therapy Need for prophylaxis against OI Once suppressed for 2 years - CD cells: Every 12 months - CD4 > 500 cells: Optional Virologic rebound HIV-associated clinical symptoms Development of conditions that may reduce CD4 count Source: 2014 HHS Antiretroviral Therapy Guidelines. AIDS Info (

52 Questions?!