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Improving Quality of Life in the Treatment-Experienced Patient With HIV Management of Treatment-Related Toxicities

Improving Quality of Life in the Treatment-Experienced Patient With HIV Management of Treatment-Related Toxicities. Valery Hughes, RN, MS, C-FNP Research Nurse Practitioner/Sub-investigator Weill Medical College of Cornell University Division of Infectious Diseases New York, NY.

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Improving Quality of Life in the Treatment-Experienced Patient With HIV Management of Treatment-Related Toxicities

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  1. Improving Quality of Life in the Treatment-Experienced Patient With HIV Management of Treatment-Related Toxicities Valery Hughes, RN, MS, C-FNP Research Nurse Practitioner/Sub-investigator Weill Medical College of Cornell University Division of Infectious Diseases New York, NY

  2. HIV TreatmentThe Good and the Bad • Impact of combination antiretrovirals: good • Treatment of the newly diagnosed: pretty good • Choices for experienced patients: maybe not so good, certainly more complicated • The purpose of this talk will be to review some of these issues and discuss ways to address them

  3. Case Discussion #1FYG Darunavir, C202 • Diagnosed in 1995, presented with PCP • History of cryptococcal meningitis, seizures, wasting, thrush, zoster • CD4 nadir ~21 cells/mm3 in 2001 • 4 class exposure (had been in T1249/T20 study in early 2001) • History of: • Immune reconstitution • Abacavir hypersensitivity reaction

  4. Case Discussion #1FYG Darunavir, C202 • Social • Employed full time as RN • Lives with daughter in Manhattan apartment • Close, supportive family • Good understanding of HIV life cycle and need for strict adherence

  5. Case Discussion #1FYG Darunavir, C202 • Presented for screening in December 2003 • Medications at that time: lopinavir-based regimen • Baseline HIV RNA 1.7 million copies/mL

  6. Case Discussion #1FYG Darunavir, C202 • Started DRV-based regimen including ZDV and ENF on 2/17/04 • Week 2 HIV RNA 14,653 copies/mL • Hemoglobin: 6.1 g/dL by week 2 • Grade 4 anemia • Reported fatigue • Epoetin alfa 40,000 U/mL 1 mL weekly started • Hgb increased and stabilized at just over 11

  7. Case Discussion #1FYG Darunavir, C202 HIV-RNA Hgb

  8. Anemia • Lower than normal levels of Hgb • Normal Hgb • Female: 12 to 16 g/dL • Males: 14 to 18 g/dL • Causes of anemia • Decreased RBC production • infection, medication (AZT-containing), HIV disease itself • Increased RBC destruction/loss (i.e., hemolysis) • Blood loss (bleeding ulcer, menstrual cycle) • Ineffective RBC production • Nutritional deficiency: vitamin B12, folic acid Volberding PA, et al. Clin Infect Dis. 2004 May 15;38(10):1454-1463.

  9. Common Symptoms of Anemia • Fatigue • Weakness • Shortness of breath • Dizziness or fainting • Pale skin, including decreased pinkness of the lips, gums, lining on the eyelids, nail beds and palms • Rapid heart beat (tachycardia) • Feeling cold • Sadness or depression • Decreased sexual function • Difficulty sleeping • Decreased appetite • Impaired cognitive function Volberding PA, et al. Clin Infect Dis. 2004 May 15;38(10):1454-1463.

  10. Signs and Symptoms of Anemia Immune System • Impaired T-cell and macrophage function Cardiorespiratory System • Exertional dyspnea • Tachycardia, palpitations • Cardiac enlargement, hypertrophy • Increased pulse pressure, systolic ejection murmur • Risk of life-threatening cardiac failure Genital Tract • Menstrual problems • Loss of libido CNS • Debilitating fatigue • Dizziness, vertigo • Depression, sadness • Impaired cognitive function Gastrointestinal System • Anorexia • Nausea Vascular System • Low skin temperature • Pallor of skin, mucous membranes, and conjunctivae Volberding PA, et al. Clin Infect Dis. 2004 May 15;38(10):1454-1463.

  11. WHO Criteria for Assessment of Therapy-Induced Toxicity: Anemia WHO = World Health Organization

  12. Risk Factors Currently Associated With Anemia in HIV Infection • History of clinical AIDS • CD4 cell count of <200 cells/µL • Plasma viral load • Female Gender • African-American race • Zidovudine (AZT) use • Increasing age • Lower body mass index (BMI) • History of bacterial pneumonia • Oral candidiasis • History of fever Volberding PA, et al. Clin Infect Dis. 2004 May 15;38(10):1454-1463.

  13. Drugs That Commonly Cause Anemia in HIV-Infected Patients • Antiretrovirals • Zalcitabine • AZT-containingtherapy(Retrovir®,Combivir®,Trizivir®) • AntiviralAgents • Flucytosine • Amphotericin • Anti-PneumocystisCarinii(Pneumocystisjiroveci)Agents • Sulfonamides • Trimethoprim • Pyrimethamine • Pentamidine • AntineoplasticAgents • Cyclophosphamide,doxorubicin,methotrexate,paclitaxel,vinblastine • ImmuneResponseModifiers • IFN-α Volberding PA, et al. Clin Infect Dis. 2004 May 15;38(10):1454-1463.

  14. 39% 31% 19% 12% *Anemia was defined as <12 g/dL for women and < 13 g/dL for men Prevalence of Anemia* by Race Levine AM, et al. J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):28-35. Semba RD, et al. Clin Infect Dis. 2002 Jan 15;34(2):260-266.

  15. 64% 54% 52% 47% 46% 35% 1.5% 1.2% 0.6% * No anemia: > 12 g/dL women; >14 g/dL men Mild anemia: 8-12 g/dL women; 8-14 g/dL men Severe anemia: <8 g/dL for both women and men Prevalence of Anemia* During HAART Levine AM, et al. J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):28-35. Semba RD, et al. Clin Infect Dis. 2002 Jan 15;34(2):260-266.

  16. As low as could be As high as could be As low as could be As high as could be As low as could be As high as could be Anemia Linear Analog Scale Assessment Questions about how you felt during the past week are listed below. Place a vertical mark somewhere between the two extremes to reflect how you feel. • How would you rate your energy level during the past week? • How would you rate your ability to do your daily activities over the past week? • How would you rate your overall quality of life during the past week? Volberding PA, et al. Clin Infect Dis. 2004 May 15;38(10):1454-1463.

  17. Anemia Patient Self-Assessment For each statement, which answer best describes how you're feeling? • I lack the strength to do the everyday things I used to do.All the timeMost of the timeOccasionally • I feel tired and weak more quickly than usual. All the time Most of the timeOccasionally • I feel dizzy after climbing stairs or walking short distances. All the timeMost of the timeOccasionally • I am short-of-breath after simple tasks like cooking meals or getting dressed. All the time Most of the timeOccasionally • I find it difficult to concentrate during activities like reading. All the time Most of the timeOccasionally

  18. Treatment of HIV and Treatment-related Anemia • Transfusion • Epoetin alfa (PROCRIT®) Volberding PA, et al. Clin Infect Dis. 2004 May 15;38(10):1454-1463.

  19. Treatment of HIV and Treatment-related Anemia • Epoetin alfa • 40,000 Units QW or 10,000 Units TIW • Allow at least 4 weeks to assess dose response • ± Iron supplementation as indicated* • If no response at 4 weeks • Increase from 10,000 Units TIW to 20,000 Units TIW • Increase from 40,000 Units QW to 60,000 Units QW • Optimal Hgb: ≥13 g/dL men, ≥12 g/dL women • Maintain Hgb by titrating dose or increasing dosing interval *Ferritin <100ng/mL, transferrin saturation <20% TIW = three times weekly; QW = once weekly Volberding PA, et al. Clin Infect Dis. 2004 May 15;38(10):1454-1463.

  20. Case Discussion #1FYG Darunavir, C202 • Enfuvirtide injection site reactions • Increased risks include decreased overall subcutaneous fat • No hard data regarding traditional injections vs. the Biojector®2000 • Anecdotes are about 70/30 in favor of the Biojector®2000 in my practice • FYG used traditional injections and had the classic reactions worse on thighs than on abdomen

  21. Injection Site Reactions • Ice before • Ice after • Heat after • Pressure after • Results?

  22. Adherence • Multiple factors influence adherence • Readiness to start or continue treatment • This needs to be evaluated fully in the context of the patient’s life: a full social history is important • Belief in treatment efficacy • Fear of side effects • Psychiatric disorders

  23. Predictors of Good Adherence • Availability of emotional and practical life supports • Ability to fit the medications into daily routine • Understanding that poor adherence leads to resistance • Recognition that taking all medication doses is important • Feeling comfortable taking medications in front of people Willard S. J Assoc Nurses AIDS Care. 2006 Mar-Apr;17(2):16-26.

  24. Predictors of Poor Adherence • Poor clinician-patient relationship • Active drug and alcohol use • Active mental illness, particularly depression • Lack of patient education • Inability of patients to identify their medications • Lack of reliable access • Domestic violence and discrimination • Medication side effects Willard S. J Assoc Nurses AIDS Care. 2006 Mar-Apr;17(2):16-26.

  25. SIDE EFFECTS

  26. Case Discussion #2TLR • Found to be positive after becoming septic post-hysterectomy • Single mother, disclosure issues, very angry about how she was infected • Started naïve study (A5095, in fact) and quickly became undetectable • Ultimately failed 3 regimens: why?

  27. Case Discussion #2TLR • Disclosure issues • She never told her mother or her children, and did not want to be seen “taking pills” • Often missed evening and weekend doses • Anger issues • Had only had sex with one man, and found later that he knew he was HIV positive • Would not discuss this with social worker, MD, psychiatrist, sister, anyone; but, anger and grief often erupted during visits about adherence

  28. Case Discussion #2TLR • What did we do? • Presented a united message • We all said the same thing: “take all your doses or choose to stay off treatment” • Supported her choice to stay off medications • Encouraged her to disclose to her family to help get family support • Restarted regimen when she felt she could be adherent

  29. Lipodystrophy • No generally accepted case definition of syndrome(s) • Initial reports suggested clustering of: • Central fat accumulation • Lipoatrophy • Dyslipidemia • Insulin resistance/type 2 diabetes mellitus • One syndrome or several?

  30. Lipodystrophy as a Metabolic Syndrome • Compared with age and BMI matched controls from the Framingham Offspring Study, HIV+ patients with lipodystrophy had: • Higher diastolic blood pressure • Elevated triglycerides, total cholesterol (not LDL) • Lower HDL • Elevated tPA and PAI-1 levels (markers of impaired fibrinolysis) Hadigan C, et al. Clin Infect Dis. 2001 Jan;32(1):130-139. Hadigan C, et al. J Clin Endocrinol Metab. 2001 Feb;86(2):939-943.

  31. Case Discussion #3DWC Darunavir, C202 • 36-year-old African American found to be HIV+ in 1993 • Cryptococcal meningitis in 1994 • No other OIs • Peripheral neuropathy • Triple-class exposure starting in 1993 • Type 2 Diabetes, 2002 • Hypertension, 2003 • Hyperlipidemia, 2003

  32. Case Discussion #3DWC Darunavir, C202 • Presented with moderate lipoaccumulation: • In dorsocervical area • +Gynecomastia with band of fatty tissue extending bilaterally and symmetrically laterally into the axilla* • Otherwise very muscular • Very aggressive about managing his body shape as much as possible • 5 x per week: 30 min cardio and 45 min weight training *As described by Palella FJ Jr, et al. JAMA. 2006 Aug 16;296(7):766-768.

  33. Palella FJ Jr, et al. JAMA. 2006 Aug 16;296(7):766-768.

  34. Psychological Impact of Morphologic Changes • Conflicting data on whether there is a negative impact on QOL or association with depression • Poor body image reported in men and women • Decreased social contact, self-esteem, sexual function in majority of subjects in one study • Twice as likely to feel recognizable as HIV+ person Steel, AIDS Pt Care STDs 2006; Huang, AIDS Res 2006;Goetzenich, IAS 2000; Falutz, Forum Nutr 2003; Oette AIDS Pt Care STDs 2002; Corless AIDS Pt Care STDs 2005; Guaraldi G HIV Clin Trials 2003; Collins AIDS Behav 2006; Ammassari, JAIDS 2002

  35. Valantin MA, et al. AIDS 2003 Nov 21;17(17):2471-2477.

  36. Risk Factors for Lipoatrophy • Older age • Duration of HIV • Lower pre-treatment BMI • Hypertriglyceridemia • Low nadir CD4 • TNF- promoter polymorphisms • Use of NRTIs, especially d4T • PIs may be synergistic Lichtenstein KA, et al. AIDS. 2001 Jul 27;15(11):1389-1398. McComsey G, et al. AIDS Read. 2003 Nov;13(11):539-542, 559. Nolan D, et al. AIDS. 2003 Jan 3;17(1):121-123. Mallal SA, et al. AIDS. 2000 Jul 7;14(10):1309-1316. Dube MP, et al. AIDS 2005 Nov 4;19(16):1807-1818.

  37. Lipodystrophy Summary • Morphologic complications of HIV/antiretroviral therapy are more than cosmetic concerns • Associated metabolic syndrome with insulin resistance, dyslipidemia • Psychological impact • Accelerated atherosclerosis is a long-term concern • Metabolic factors appear to be associated with hepatic steatosis • Associated with fibrosis and decreased treatment response in the setting of HCV coinfection • Promising therapeutic approaches are under study • Until then, patient teaching regarding diet and exercise are still valuable

  38. Gastrointestinal – Diarrhea • Associated with many meds • If so, can be treatment limiting • May have an indeterminate cause • Problem in quality of life

  39. Case Discussion #4JOG • 39-year-old white male • HIV+ 1992 • Presented with triple-class failure • History of adherence issues • HIV RNA 248,712 copies/mL (5.39 log10) • CD4 299 cells/mm3

  40. Case Discussion #4JOG • Started new regimen 7/30/03 on RESIST-1, using 500 mg TPV and 200 mg RTV BID • Developed loose stools 4-5 times a day almost immediately • Loose stools attributed to PI regimen because of temporal relationship

  41. Case Discussion #4JOG • Started Imodium with improvement • Other options might include fiber such as psyllium husks or other OTC remedies if stool was watery • If CD4 count was lower, it would warrant work up including stool studies and GI consult • Self-discontinued all ARVs despite excellent virologic and immunologic response

  42. Summary • In a perfect world, ARVs would be an invisible patch placed annually and with no side effects • We are not there yet • In a perfect world, all patients would be ready to start treatment, have great support, unlimited access and fabulous families • But think how far we have come in 25 years • Nursing interventions continue to be key in maintaining the quality of life for people living with HIV

  43. Our research subjects, particularly those discussed today! Cornell HIV Clinical Trials Unit Trip Gulick Marshall Glesby Joanne Grenade Glenn Sturge Tim Wilkin Kristen Marks Kirsis Ham Todd Stroberg Christina Megill Natacha Joseph Marisol Valentin Eduardo Baez Luis Lopez-Detres Thanks to:

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