Running head: DUNBAR CASE ANALYSIS Dunbar: Case Analysis Presentation Whitney L. Dunbar Wright State University Nursing 7103 Dr. Kristine A. Scordo 1 DUNBAR CASE ANALYSIS 2 Dunbar: Case Analysis Presentation History and Physical Source Patient, a reliable source Chief Complaint “I have a lump in my neck with flu-like symptoms.” History of Present Illness This patient is a 25-year old pleasant African American female who presents to the infectious disease office with complaints of “a lump in my neck with flu-like symptoms” and was referred by her primary care physician (PCP). The patient stated she began to have a sore throat, fever, headache 6/10, and joint pain 3/10 with fatigue and a lack of appetite nine days ago. She made an appointment to see her PCP that day. Her nasal swab result was negative for influenza and her throat culture for streptococcal was negative. She was told by her PCP to rest in addition to taking over the counter medication for her sore throat and headache. The patient stated she had been taking Tylenol to help relieve her headache, sore throat, and fever. Her symptoms continued and she found a couple of lumps on the right side of her neck two days ago while changing her clothes. She saw her PCP again and they implemented further laboratory tests. Her PCP called her yesterday and told her to make an appointment at the infectious disease office due to a possible viral infection. She denies any neck pain, chest pain, cough, nausea, vomiting, or diarrhea. Medical History Genital chlamydia ten months ago Genital gonorrhea 2011 DUNBAR CASE ANALYSIS 3 Appendicitis 2009 Three-pack year smoking Surgical History Appendectomy 2009 Family History Family medical history is significant for hypertension, hypercholesterolemia, hypertriglyceridemia, chronic obstructive pulmonary disorder, and coronary artery disease. Social History The patient is single with no children and lives in a one-bedroom apartment in a safe and quiet neighborhood. She works full-time at Wal-Mart as a supervisor in customer service and has health insurance through Anthem. Currently, she is enrolled in two classes at her local community college to obtain a business management degree. She denies smoking or any recreational drugs. She drinks three to six alcohol beverages almost every weekend socially and her last drink was ten days ago. The patient expresses that she has a great support system with her family and friends. Obstetric History Gravida 0/Para 0/ Abortion 0. Immunizations Childhood immunizations up to date. No tuberculosis skin test and tetanus booster shot nine years ago. Last Examination Date: Last physical exam two days ago. Last pelvic examination ten months ago with results of chlamydia. Last dental examination two years ago and last vision examination four years ago. DUNBAR CASE ANALYSIS 4 Allergies No known allergies Medications The current medication prescribed for the patient is Junel FE 1mg-20mcg tablet by mouth (PO) daily and states she takes this medication every morning. Over the counter medication the patient is currently taking is Tylenol 650mg PO two to three times a day for management of her current symptoms. Reports Tylenol was last taken eight hours ago. She denies any herbal medication or use of any complementary alternative medicines. Review of Systems General: Patient denies weight loss but reports a decrease in appetite, fatigue, and weakness for the last nine days. She reports fevers as high as 102 degrees Fahrenheit for the last nine days, but temperatures have decreased to 99 degrees Fahrenheit since taking Tylenol. Patient denies chills, but reports having night sweats twice in the last week. Skin: Patient reports areas of a pink, dry, round, small, and flat rash on her anterior upper chest that appeared five days ago. Denies rash and skin color changes, pruritus, bruising, or lesions. She reports no history of skin disease, no recent work-related skin hazards, and on no medication for the rash. HEENT: Complains of a headache that started nine days ago. She reports an aching pain that gradually gets worse over a couple of hours to a moderate pain of 6/10 and the pain is behind both of her eyes. The pain gets worse with eye movement or increased activity. Her headaches last for an hour with rest and after taking Tylenol to relieve the headache to a 0/10. No history of head injury, dizziness, or DUNBAR CASE ANALYSIS 5 syncope. Denies any visual changes, eye pain, or discharge. She denies wearing correction lenses. Denies any hearing loss or earaches. Denies nasal discharge, sinus pain, or epistaxis. Complains of a sore throat that started nine days ago. The pain 5/10 is intermittent and lasts for five minutes after any kind of swallowing and worse in the morning. She reports gargling salt water twice a day and drinking hot tea and broth to help relieve the pain. Neck: Reports a lump on the right side of her neck that appeared two days ago. Denies any tenderness, change in size since this morning, or any recent infections. Denies neck stiffness and any limitation of motion. Denies any thyroid problem or history of prior irradiation of head, neck, or upper chest. Denies neck pain or swollen glands. Breast: Denies any pain, lumps, nipple discharge, or swelling. Denies breast-self examination. Respiratory: Denies any history of lung disease, chest pain with breathing, shortness of breath, wheezing, cough, or productive sputum. CV: Denies any palpitations, chest pain, irregular heartbeat, cyanosis, dyspnea on exertion, dyspnea with exertion, orthopnea, or edema in extremities. GI: Reports decrease in appetite for the last week but no weight loss. Denies any food intolerance, indigestion, nausea, vomiting, dysphagia, diarrhea, constipation, or abdominal pain. Reports history of appendicitis with appendectomy in 2009. Last bowel movement two days ago. GU: Denies pain on urination, frequency, urgency, hesitancy, nocturia, or straining. Urine is yellow. DUNBAR CASE ANALYSIS Genitalia: 6 Last menstrual period 17 days ago. Cycle is 28 days with duration three to five days, flow moderate, no dysmenorrhea. Denies any vaginal discharge, sores, lesions, or itching. Sexual health: Reports being heterosexual with multiple sexual partners. She takes birth control pills to prevent pregnancy, but reports that only some of her partners use a form of contraception. She reports her last sexual encounter was a month ago and denies using any protection. She denies planning to have children at this time. She has a history of treated chlamydia and gonorrhea, but has never been tested for human immunodeficiency virus (HIV). M/S: Reports generalized weakness and some generalized joint pain 3/10 that started nine days ago. It is an aching pain that is worse with activity and relieved by rest and Tylenol. The joint pain is tolerable and the duration is as long as the activity. Denies any joint swelling, deformity, or decreased range of motion. Denies muscle pain. Neurological: Denies any sensory changes, mood changes, fainting, confusion or memory problems, poor coordination or history of seizures. Psychosocial: Reports of stress from working full time and taking two college classes. She reports having the inability to sleep well this last week due to nighttime awakenings from a headache or night sweats. Denies any depression, anxiety, or any suicidal ideations. Physical Exam General: Patient is awake, alert, pleasant, articulates clearly, and appropriately responds to stimuli. Her hygiene is clean and she is dressed appropriate for her age, setting, DUNBAR CASE ANALYSIS 7 and gender. She is in no distress. Her weight is 72 kilograms with a height of five feet and five inches. Vital Signs: Temperature of 101.6 degrees Fahrenheit, heart rate of 92 beats per minute, blood pressure of 108/64 mmHg, respiratory rate of 12 breaths per minute, and oxygen saturation of 97% on room air. Skin: Warm, dry, intact, and skin turgor good. Small well-circumscribed fivemillimeter pink macule generalized rash on anterior upper thorax and collar region. Normal hair distribution and texture. No clubbing or discoloration of nails and nail beds pink. HEENT: Head is normocephalic with no lesions, lumps, parasites, or tenderness on palpitation. Face is symmetric without weakness, swelling, or involuntary movements. Eye acuity by Snellen chart with 20/20 vision in both eyes. No abnormalities in fields with confrontation and corneal light reflex symmetric bilaterally. Extra-ocular movements are intact. Conjunctiva clear and sclera white. No lesions, discharge, swelling, or ptosis. Pupils are equal, round, reactive to light, and accommodate. The pinna of the ear has no lesions, mass, discharge, or tenderness bilaterally. The ear canals are clear and tympanic membranes are pearly gray with no perforations and landmarks intact. Bilaterally heard whispered words. Nose has no deformities or tenderness on palpitation. Nares patent with septum midline and mucosa pink with no lesions. No tenderness of sinuses. Mouth mucosa and gingivae is pink with no lesions or bleeding. Tongue is midline with midline protrusion. Tonsils are 2+. Pharyngeal wall bright red with edema and no exudate on pharyngeal or tonsils. DUNBAR CASE ANALYSIS Neck: 8 Smooth movement with full range of motion. Symmetric. Two palpable cervical lymph nodes, two centimeters, soft, mobile, no tenderness, and no erythema or warmth. Trachea midline. No jugular vein distention at 45 degrees. Carotids two plus bilaterally with no bruits. Breast: Symmetric with no lesions, discharge, masses, tenderness, or lymphadenopathy. Respiratory: Anteroposterior to transverse diameter one to two and no lesions. Respirations are even and relaxed with no use of accessary muscles. Symmetric chest expansion. Vesicular breath sounds clear in all lung fields. No adventitious sounds. Capillary refill less than one second and no cyanosis. CV: Regular rate, rhythm, and S1 and S2 present. No murmurs, clicks, or rubs. No visible pulsations, no heave or lift, and no thrill. Pulses are two plus in upper and lower extremities bilaterally. Abdomen: Skin is smooth with no lesions or striae. One-centimeter scar at midline umbilicus, one-centimeter scar midline suprapubic, and one-centimeter scar right upper quadrant at mid-clavicle. Contour is flat and symmetric. Bowel sounds present with no bruits. Tympany in all four quadrants. Soft, no masses, no organomegaly, no tenderness, and no inguinal lymphadenopathy. M/S: Symmetric with no swelling, deformity, or masses. Smooth full range of motion of joints with no crepitus, but generalized joint pain with movement. No deformity or curvature of vertebral column. Strength four out of five bilaterally in upper and lower extremities. No muscle tenderness. Neurological: Behavior and speech appropriate. Alert and oriented to person, place, and time. Recent and remote memory intact. Cranial nerves two through twelve intact. No DUNBAR CASE ANALYSIS 9 atrophy or tremors, but generalized weakness. Gait is smooth and coordinated. Negative Romberg. Light touch, pinprick, and vibration intact. Deep tendon reflexes two plus. Negative Kernig and Brudzinski. Genitalia: No lesions or discharge from external genitalia. A specimen for a Papanicolaou smear, gonorrhea, chlamydia, trichomoniasis, moniliasis collected. Laboratory Findings According to AIDSinfo (2012) and Infectious Disease Society of America (IDSA) (2009), the succeeding laboratory tests help determine the diagnosis, stage of the disease, and assist in selection of the drug regimen for the patient. Table 1 Basic Metabolic Panel (BMP) and Complete Blood Count (CBC) BMP Results Normal CBC Results Normal Sodium 2.8 mm3 4.5-10.5 mm3 3% 3-6% 44% 1% 0% 48% 4% 50-62% 0-3% 0-1% 25-40% 3-7% 144 mEq/L 136-145 mEq/L White blood cell count (WBC) Neutrophil Bands/Stab (%) Neutrophil Segs/Polys (%) Eosinphils (%) Basophils (%) Lymphocytes (%) Monocytes (%) Red blood cell count (RBC) Hemoglobin 4.3 mm3 24 mEq/L 3.5-5.2 mEq/L 96-106 mEq/L12 22-30 mEq/L Hematocrit 43.8% 97 mg/dL 70-110 Mean corpuscular volume (MCV) 88 fL 3.6-5.0 mm3 (female) 12.0-16.0 g/dL (female) 36%-48% (female) 82-98 fL Mean corpuscular hemoglobin 29 pg/cell 26-34 pg/cell Potassium 3.6 mEq/L Chloride 99 mEq/L Carbon Dioxide Glucose 14.6 g/dL mg/dL Blood urea nitrogen 10 mg/dL 6-20 mg/dL DUNBAR CASE ANALYSIS 10 (BUN) Creatinine 1.1 mg/dL 0.6-1.2 mg/dL Calcium 9.1 mg/dL 8.8-10.4` mg/dL (MCH) Mean corpuscular hemoglobin concentration (MCHC) RBC distribution width (RDW) Platelet Mean platelet volume (MPV) Note. Normal laboratory values (Fischback & Dunning, 2009). Table 2 Other Laboratory Tests and Results Lipid Profile Result Normal Total Cholesterol 178 mg/dL 140-199 mg/dL High Density Lipoprotein (HDL) Low Density Lipoprotein (LDL) Triglyceride 55 mg/dL 35-80 mg/dL 98 mg/dL <130mg/dL 125 mg/dL <150 mg/dL Lab Test Alanine Transaminase (ALT) Aspartate Transaminase (AST) Fasting Blood Glucose 34% 32%-36% 12.2% 11.5%-14.5% 135 mm3 140-400 mm3 8.0 fL 7.4-10.4 fL Result Normal 38 unit/L 7-35 unit/L 40 unit/L 10-36 unit/L 97 mg/dL 70-110 mg/dL Note. Normal laboratory values (Fischback & Dunning, 2009). Table 3 Serologies for Hepatitis A, B, and C Viruses Lab Test Result Hepatitis A Virus: Hepatitis A Antibody (HAV IgG) Hepatitis B: Core Antibody (AntiHBc,IgG) Antibody (Anti-HBs) Surface Antigen (HBsAg) Hepatitis C: Normal Negative Negative-Offer hepatitis vaccine Positive- Immune Anti-HBc,IgG Negative Negative Negative: No chronic infection, offer vaccine Anti-HBs: If positive, patient is immune by previous infection or immunization Anti-HBs Negative HBsAg Negative DUNBAR CASE ANALYSIS 11 Antibody (HCV IgG) HCV IgG negative Note. Normal laboratory values (Fischback & Dunning, 2009). Table 4 Labs for HIV Lab Test HCV Negative Result Normal Enzyme-linked immunoabsorbent assay (ELISA) Western Blot Negative Negative Negative Negative CD4 T-cell count and Percentage Plasma HIV RNA (Viral Load) P24 antigen capture assay 740 cells/mm3 and 34% 500-1000 cells/mm3 562,000 copies/mL Not detectable Reactive Negative HIV Genotypic Resistance Testing Coreceptor Tropism Test Low-level resistance Low-level resistance Negative Negative HLA-B*5701 Negative Negative Aptima HIV-1 Qualitative Positive Negative Assay; GenProbe Glucose-6-phosphate Negative Negative dehydrogenase Note. Normal laboratory values (Fischback & Dunning, 2009; IDSA, 2009). Table 5 Papanicolaou Test and other Sexually Transmitted Infection (STI) Tests Test Result Normal Papanicolaou Nucleic Acid Amplification Test for Cervix swab: /Gonorrhea and Chlamydia No abnormal or atypical cells; No inflammation, no infection, no partially obscuring blood; Major cell types within normal limits Negative and Negative Vaginal Swab: Trichomoniasis Negative No abnormal or atypical cells; No inflammation, no infection, no partially obscuring blood; Major cell types within normal limits Negative Negative DUNBAR CASE ANALYSIS Vaginal Swab: Moniliasis 12 Negative Negative Note. Normal laboratory values (Fischback & Dunning, 2009). Table 6 Urinalysis General Characteristics and Measurements Test/Normal Result Chemical Determinants Test/Normal Result Color: pale yellow to amber Amber Glucose: negative Negative Specific gravity: 1.005-1.025 with a normal fluid intake pH: 4.5-8.0 1.022 Blood: negative Negative 5.5 Protein: negative Negative Volume 6002,500 mL/24/h Appearance: clear to slightly hazy 700 mL/24h Ketones: negative Negative Clear Bilirubin: Negative negative Urobilinogen: 0.5-4.0 mg/d 0.7 mg/dL Nitrite for bacteria: Negative negative Leukocyte esterase: Negative negative Note. Normal laboratory values (Fischback & Dunning, 2009). Table 7 Other Tests Test Lymph Node Biopsy Epstein-Barr Virus (EBV) Microscopic Examination of Sediment Test/Normal Result Casts Casts negative: negative occasional hyaline casts Red blood Negative cells: negative or rare White blood Negative cells: negative or rare Crystals: Negative negative Epithelial cells: few; hyaline casts 0-1/lpf Few Result Normal Hyperplasia and multinucleated syncytia of T cells with damaged follicular dendritic network No abnormalities DUNBAR CASE ANALYSIS 13 Antibodies to viral load (antiVCA) Antibodies to EBV nuclear antigen using ELISA Blood Cultures Negative Negative Negative Negative Pending Negative Urine Cultures Pending Negative Purified protein derivative Negative, induration 3mm skin testing for tuberculosis (TB) Cytomegalovirus (CMV) Negative for CMV-specific antibody test IgG and IgM by ELISA Syphilis Nonreactive, negative for Venereal Disease Research syphilis Laboratory Test Anti-Toxoplasma antibody by Titer <1:16: no previous indirect fluorescent antibody infection by IFA (IFA) Pregnancy Test Negative Note. Normal laboratory values (Fischback & Dunning, 2009). Negative for cutaneous hypersensitivity- area of induration <10mm Negative for CMV-specific IgG and IgM by ELISA Nonreactive, negative for syphilis Titer <1:16: no previous infection by IFA Positive or Negative Diagnostic Findings Usually, the diagnosis of HIV is by serologic tests that validate the presence of antibodies to HIV. The recommended initial tests for HIV-type 1 infection diagnosis are a rapid HIV test or an ELISA. If the initial test is reactive, it should be confirmed by a western blot or indirect immunofluorescence assay. Also, if a person seems to be involved in high-risk activity in the past three months and HIV-seronegative, the person should have repeated serologic testing at weeks six, 12, and 24 because there may be delayed appearance of HIV antibodies in recent infected persons. In addition, if a person who is reporting involvement in high-risk behavior and presents with signs and symptoms of acute retroviral syndrome, implement testing for plasma viral load in addition to HIV antibody testing. However, the Federal Drug Administration (FDA) does not approve quantitative plasma viral load for HIV diagnosis and necessitates validation by following serologic testing in order to document seroconversion. The qualitative HIV-1 RNA DUNBAR CASE ANALYSIS 14 test aptima HIV-1 qualitative assay has been approved for diagnosing HIV infection and helps diagnosing the acute or primary HIV-1 infected person. A positive result in this test can be considered confirmatory, but a western blot serology should be implemented two to four months after the initial indeterminate or negative test for confirmation (IDSA, 2009). Differential Diagnosis The differential diagnoses for a patient presenting with flu-like symptoms and lymphadenopathy incorporate mononucleosis from Epstein-Barr virus (EBV) or cytomegalovirus, toxoplasmosis, syphilis, viral hepatitis, other viral infections, meningitis, and lymphoma (AIDSinfo, 2012; IDSA, 2012; Lexi-Comp, 2013). The diagnosis of HIV infection can be attained from the patients’ clinical presentation, diagnostic findings, sexual history, and medical history. First, the patient presents with a fever, pharyngitis, arthralgia, rash, and lymphadenopathy after having unprotected sex a month ago. Around 50% of individuals experience the acute HIV syndrome with similar presenting symptoms that occur three to six weeks after exposure to HIV. Abnormal diagnostic results that help diagnose HIV infection include leukopenia with lymphocytosis, thrombocytopenia, elevated liver enzymes, viral load of 562,000 copies/mL, and a reactive P24 antigen capture assay. The positive aptima HIV-1 qualitative assay confirms the diagnosis of HIV infection. The patients’ sexual and medical history entail risk factors associated with the diagnosis of HIV infection. The risk factors include a history of chlamydia and gonorrhea, multiple sexual partners, and not using any form of protection during the sexual encounters (AIDSinfo, 2012; IDSA, 2012; Lexi-Comp, 2013). DUNBAR CASE ANALYSIS 15 Plan According to AIDinfo (2012) guidelines, the primary treatment goals for starting antiretroviral therapy (ART) are to decrease HIV-associated illnesses and lengthen the duration and quality of survival, reestablish and preserve immunologic function, maximally and strongly overpower plasma HIV viral load, and inhibit HIV transmission since HIV infection cannot be eradicated. Antiretroviral (ARV) regimens should have at least, desirable three, active drugs from two or more drug classes in order to attain viral suppression. Around the initial 12 to 24 weeks of therapy, the viral load is usually decreased to below limits of assay detection in the ART-naive patient. The provider and patient must work together to define individualized strategies in order to improve adherence, develop long-term treatment achievement, and attain treatment goals. The initial ARV regimen should be customized and based on virologic efficacy, pill burden, dosing frequency, potential of drug-to-drug interactions, anticipated side effects, convenience, genotypic resistance testing, and comorbidities. Drug Therapy Within six mechanistic classes there are over 20 permitted ARV drugs accessible for design combination regimens. The six classes include nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), fusion inhibitors (FIs), CCR5 antagonists, and integrase strand transfer inhibitors (INSTIs). The initial ARV regimen usually entails two NRTIs in combination with a NNRTI, a PI, an INSTI, or a CCR5. The following two tables provide information about the recommended and alternative initial ARV combination regimens for the ARV naïve patient (AIDsinfo, 2012). DUNBAR CASE ANALYSIS 16 Table 8 Recommended and Alternative Initial Combination Regimens for the ARV Naïve Patient Preferred Alternative NNRTI-Based Regimen Efavirenz/Tenofovir/Emtricitabine PI-Based Regimens Ritonavir-Boosted Atazanavir + Tenofovir/Emtricitabine Ritonavir-Boosted Darunavir + Tenofovir/Emtricitabine INSTI-Based Regimen Raltegravir + Tenofovir/Emtricitabine Note. Recommendations (AIDSinfo, 2012). NNRTI-Based Regimens Efavirenz + Abacavir/Lamivudine Rilpivirine/Tenofovir/Emtricitabine Rilpivirine + Abacavir/Lamivudine PI-Based Regimens -Atazanavir/ritonavir + Abacavir/Lamivudine -Darunavir/ritonavir + Abacavir/Lamivudine Fosamprenavir/ritonavir (once or twice daily) + Abacavir/Lamivudine or Tenofovir/Emtricitabine Lopinavir/ritonavir (once or twice daily) + Abacavir/Lamivudine or Tenofovir/Emtricitabine INSTI-Based Regimen Raltegravir + Abacavir/Lamivudine Running head: DUNBAR CASE ANALYSIS 17 Table 9 Information on Preferred and Alternative ARV Medication for the ARV Naïve Patient Drug and Cost Drug-to-Drug Interactions Adverse Effects/Precautions Follow Up Monitoring Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Drugs that increase effects of NRTIs: Ribavirin, GanciclovirValganciclovir, Atazanavir, Ethanol, Lopinavir, Telaprevir, and Protease Inhibitors may increase Tenofovir, Common Side Effects: headache, nausea, diarrhea, pancreatitis, neutropenia, transaminase increased, myalgia, neuropathy, musculoskeletal pain, nasal signs and symptoms, cough, sore throat, infections, weakness, and hyperpigmentation Monitor CBC with differential, reticulocyte count, renal and hepatic function tests, serum phosphorus, CD4 count, HIV RNA plasma levels, serum transaminases, amylase, bilirubin, triglycerides; HLA-B*5701 genotype status prior to initiation of therapy, signs and symptoms of hypersensitivity Abacavir and Lamivudine (Epzicom®) Abacavir 600mg and Lamivudine 300mg; (30): $977.61) once daily Tenofovir and Emtricitabine (Truvada®) Tablets Emtricitabine 200mg and Tenofovir 300mg; 200-300 mg (30): $1149.01 once daily Drugs that decrease effects of NRTIs: Acyclovir-Valacyclovir, Food, Adefovir, Protease Inhibitors decrease Abacavir, and Trimethoprim NRTIs increase effects of other drugs: Emtricitabine NRTIs decrease effects of other drugs: Atazanavir, Didanosine, Dabigatran Etexilate, Linagliptin, P-glycoprotein/ABCB1 Substrates, Vincristine, and Tenofovir may decrease Protease Inhibitors Severe Side Effects: Evaluate for risk factors lactic acidosis, for heart disease prior to hepatomegaly, treatment myocardial infarction, anaphylaxis, paresthesia, neuropathy, red cell aplasia, splenomegaly, steatosis, rhabdomyolysis, hyperbilirubinemia, Advanced Practice Nurse (APN) May Prescribe No, physician initiated or physician consult DUNBAR CASE ANALYSIS 18 anemia, Precautions: chronic hepatitis B, coronary heart disease, renal impairment, preexposure prophylaxis, decreased bone mineral density, hypersensitivity, and immune reconstitution syndrome, fat redistribution Abacavir: Positive for the presence of the HLA-B*5701 allele are at an increased risk for hypersensitivity reactions and use with caution in patients with plasma HIV RNA levels ≥100,000 copies/mL Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Drugs that increase effects of NNRTIs: Boceprevir, Darunavir, Mifepristone, Saquinavir, Common Side Effects: hypercholesterolemia, dizziness, depression, Testing for hepatitis B virus prior to the initiation of antiretroviral therapy No physician initiated or physician consult DUNBAR CASE ANALYSIS Efavirenz (Sustiva®) Capsules 200mg (90): $633.96; Tablets 600mg (30): $643.97 once daily Rilpivirine (Edurant®) Tablet 25mg (30): $804.38 once daily Efavirenz, Emtricitabine, and Tenofovir (Atripla®) Tablets Efavirenz 600mg, Emtricitabine 200mg, and Tenofovir 300mg (30): $1878.96 once daily Rilpivirine, Tenofovir, and Emitricitabine (CompleraTM) Tablets Rilpivirine 25mg, Tenofovir 300mg, and Emtricitabine 200mg (30): $2,195.83 Voriconazole, Food, Ethanol, Ketoconazole, and Lopinavir Drugs that decrease effects of NNRTIs: Rifampin, St Johns Wort, Antacids, Carbamazepine, Dexamethasone, Didanosine, Fosphenytoin (Rilpivirine), H2Antagonists, OXcarbazepine, Phenobarbital, Phenytoin (Ripivirine), Primidone, Proton Pump Inhibitors, and Rifamycin Derivatives, NNRTIs increase effects of other drugs: Bepridil, Cisapride, CYP3A4 inhibitors, substrates, inducers, CYP2C9 inhibitors, CYP2C19 inhibitors, CYP2B6 inducers, Dihydroergotamine, Ergoloid Mesylates, Ergonovine, Ergotamine, Fosphenytoin, Methadone, Methylergonovine, Midazolam, Nevirapine, Phenytoin, Pimozide, Rilpivirine, Ritonavir, and Triazolam NNRTIs decrease effects of other drugs: Atazanavir, Atorvastatin, Atovaquone, Apixaban, Aripiprazole, Apixaban, Buprenorphine, Bupropion, Cyclosporine, CYP3A4 inducers 19 insomnia, anxiety, headache, rash, diarrhea, and ALT increased Monitor CBC with differential, reticulocyte count, CD4 count, HIV RNA plasma levels, Severe Side Effects: renal and hepatic allergic reaction, function tests, ataxia, pancreatitis, cholesterol, seizures, suicidal triglycerides, bone ideation, neuropathy, density (long-term), dyspnea, lactic serum phosphorus, acidosis, body fat serum transaminases, accumulation, signs of skin rash, signs abdominal discomfort, and symptoms of anxiety, cholecystitis, infection glomerulonephritis, nephrotic syndrome, Monitor for CNS vomiting, and effects, redistribution of somnolence body fat, hyperglycemia, Precautions: hyperlipidemia, and chronic hepatitis B, cushings appearance, hepatomegaly, hepatic and review patient’s and renal impairment, medications seizure disorder, hypercholesterolemia, central nervous system (CNS) effects, decreased bone mineral density, depressive disorders, hypersensitivity, and immune reconstitution DUNBAR CASE ANALYSIS Protease Inhibitors (PIs) Atazanavir (Reyataz®) Tablets 150mg (30): $557.97; 200mg (60): $1064.94; 300mg (30): $1067.99 once daily Darunavir (Prezista®) Tablets 400mg (60): $1,086.03; 600mg (60): $1,129.04 once daily Fosamprenavir (Lexiva®) Tablets 700mg (30): $439.98 once or twice daily Lopinavir/ritonavir (Kaletra®) Solution and inhibitors, CYP2C19 substrates inhibitors, CYP2B6 inhibitors, CYP2C9 substrates, Etonogestrel, Etravirine, Everolimus, Active metabolite of Fosamprenavir, Indinavir, Itraconazole, Lopinavir, Lovastatin, Norgestimate, PACLitaxel, Posaconazole, Pravastatin, Proguanil, Raltegravir, Rifabutin, Sertraline, Simvastatin, Tacrolimus, Telaprevir, and Vitamin K Antagonists Drugs that increase effects of PIs: Carbamazepine, Cyclosporine, Delavirdine, Enfuvirtide, Posaconazole, Other PIs, and Food Drugs that decrease effects of PIs: Antacids, Boceprevir, Efavirenz, Garlic, Fusidic Acid, H2Antagonists, Minocycline, Proton Pump Inhibitors, Rifampin, Tenofovir, and St Johns Wort PIs increase effects of other drugs: Alfuzosin, Alprazolam, Atorvastatin, Bosentan, Buprenorphine, Cisapride, CYP3A4 inhibitors, CYP2D6 inhibitors, Digoxin, Ergot derivatives, Etravirine, Indinavir, Irinotecan, Meperidine, Midazolam, Nefazodone, Nefazodone, 20 syndrome Efavirenz should not be used during first trimester of pregnancy, women trying to conceive, or not using efficient and regularly taking contraception Common Side Effects: rash, cholesterol increased, nausea, amylase increased, bilirubin increase, cough, liver enzymes increased, vomiting, hypertriglyceridemia, weakness, creatine phosphokinase (CPK) increased, and diarrhea Severe Side Effects: alopecia, angioedema, AV block, cholecystitis, edema, stroke, nephrolithiasis, pancreatitis, left bundle branch block, Monitor viral load, CD4, serum glucose, liver function tests, cholesterol, electrolytes, triglycerides, bilirubin, drug levels (with certain concomitant medications), CPK level, uric acid, serum amylase and lipase, electrocardiogram monitoring in patients with prolonged PR interval or with concurrent AV nodal blocking drugs Monitor for hypersensitivity reaction, gastrointestinal disturbance, No, physician initiated or physician consult DUNBAR CASE ANALYSIS 400mg-100mg/5mL (160): $419.98 Tablets 100mg-25mg (30): $103.99; 200mg50mg (30): $199.99 once or twice daily Ritonavir (Norvir®) Capsules 100mg (30): $290.98; Solution 80mg/mL (240): $1508.58; 100mg (30): $289.99 once or twice daily Integrase Strand Transfer Inhibitor (INSTI) Raltegravir (Isentress®) Tablets 400mg (60): Nevirapine, Pitavastatin, Rifabutin, Rosuvastatin, Sildenafil, Simvastatin, Sirolimus, Temsirolimus, Tenofovir, Trazodone, Triazolam, Tricyclic Antidepressants, Vardenafil, and Warfarin PIs Decrease effects of other drugs: Abacavir, Amiodarone, Calcium channel blockers, Clarithromycin, Contraceptives, CYP3A4 inducers, Didanosine, Divalproex, Eplereone, Pimozide, Quinidine, Tacrolimus, Telaprevir, Theophylline derivatives, Valproic Acid, and Zidovudine, Drugs that increase effects of NNRTIs: Proton Pump Inhibitors Drugs that decrease effects of NNRTIs: Rifampin, Tipranavir, Rifabutin, Fosamprenavir, 21 QT prolongation, Stevens-Johnson syndrome, torsades de pointes, lymphoma, metabolic acidosis, seizures, acute respiratory distress syndrome, myocardial infarction, lactic acidosis hyperlipidemia, rash, CNS effects, and electrolyte imbalance Precautions: renal and hepatic impairment, hemophilia A or B, conduction abnormalities, diabetes, fat redistribution, hypersensitivity, diabetes, pancreatitis, sulfonamide allergy, increased cholesterol, nephrolithiasis, hemolytic anemia, immune reconstitution syndrome, cardiovascular disease Common Side Monitor viral load, CD4 Effects: headache, count, and lipid profile insomnia, glucose increased, Severe Side Effects: No, physician initiated or physician consult DUNBAR CASE ANALYSIS $1030.04 twice daily Efavirenz, and St John’s Wort Increase effects of other drugs: None listed Decrease effects of other drugs: None listed 22 abdominal pain, anemia, cerebellar ataxia, depression, drug rash with eosinophilia and systemic symptoms, hepatic failure, hepatitis, herpes simplex, hypersensitivity, myopathy, nephrolithiasis, renal failure, StevensJohnson syndrome, suicidal ideation, thrombocytopenia, toxic epidermal necrolysis, vomiting, and weakness Precautions: immune reconstitution syndrome, myopathy, and skin and hypersensitivity reactions Note: Drug information (AIDSinfo, 2012; Lexi-Comp, 2013; Ohio Board of Nursing, 2011). Running head: DUNBAR CASE ANALYSIS 23 Even though the patients CD4 count is above 500 cells/mm3, the patient should be started on ART because the viral load is >100,000 copies/mL and the patient is at high risk for transmitting HIV to any future sexual partner due to her high viral load level. Also, there has been an increasing attentiveness to untreated HIV infection or uncontrolled viremia could be related to the development of cardiovascular disease, kidney disease, liver disease, neurologic complications, and malignancies (AIDSinfo, 2012). Before initiating ART, the patient should be agreeable and committed to treatment, comprehend the risks and benefits of therapy, and the importance of adherence. Once there is informed consent, the patient will be started on Atripla (Efavirenz 600mg, Emtricitabine 200mg, and Tenofovir 300mg) tablet PO daily for life-long treatment. The medication should be taken on an empty stomach and usually at nighttime. Atripla is the medication of choice because Abacavir and Rilpivirine are to be used in caution with patients who have a pretreatment viral load >100,000 copies/mL. This eliminated all of the alternative recommended regimens and one of the preferred regimens. Also, the patient is busy working full-time and taking two college courses. Therefore, it would be beneficial for the patient to have a medication with lower frequency and lower pill burden. Atripla is only one pill once a day versus the PI-based regimens of more than one pill. Even though the patient has health insurance with Anthem, cost is still a factor on deciding what ART to initiate because Anthem will only cover 90% of total cost per month of ARV medications. The cost of Atripla is $1878.96 ($188 after insurance coverage) a month (thirty tablets) compared to over $2,000 for the PI-based regimens (AIDSinfo, 2012; Lexi-Comp, 2013). All of the drug-to-drug interactions, side effects, follow-up monitoring, and precautions of Atripla are noted in table nine, but there specific issues from these topics that should be DUNBAR CASE ANALYSIS 24 addressed for this patient. The common side effect of Atripla is hypercholesterolemia and with the patients’ strong family history of hypercholesterolemia, there should be close monitoring of the patients lipid panel once Atripla is initiated. Also, there are two drug-to-drug-interactions that need to be addressed specifically with the patient. Alcohol increases the effects of Atripla and the patient admits to drinking alcohol. Therefore, the patient should be educated on the effects alcohol has with their new medication and the importance of alcohol cessation. The patient is currently taking Junel FE 1mg-20mcg tablet PO daily and Atripla decreases the effectiveness of the hormonal contraceptive. Therefore, the patient should be educated on using an alternative or additional contraceptive method to prevent pregnancy. The patient needs to be educated on notifying the ANP if she is ever pregnant or thinking of having a child due to the adverse effects of Efavirenz during pregnancy. A pregnancy test should be drawn at the initiation of Atripla. Follow-up monitoring for this patient includes a viral load, BMP, liver enzymes and bilirubin, CBC with differential, and fasting lipid panel at two to eight weeks post Atripla initiation. Every three to six months a CD4 count, viral load, BMP, CBC with differential, and liver enzymes with bilirubin should be measured. A fasting lipid panel should be monitored every twelve months and a urinalysis and fasting glucose should be monitored every six months. Serologic testing should be performed over the next three months for confirmation (AIDSinfo, 2012; Lexi-Comp, 2013). In addition to ART, it is vital that the patient be educated on HIV infection, importance of adherence to medication, prevention of secondary transmission, offered different support groups, and government programs. The patient should be educated about HIV infection at diagnosis and understand that there is no cure for HIV infection. Educating on the importance of adherence includes that ART has been significantly associated with HIV viral suppression, decreased rates DUNBAR CASE ANALYSIS 25 of resistance, an increase in survival, and a better quality of life. When providing education on the importance of adherence to ART, the consequences of not adhering to ART should also be discussed (AIDSinfo, 2012). In addition, the patient should be educated on how HIV is transmitted and how to prevent transmitting HIV to other people. It would be important to educate this patient on the different contraceptive methods available in order to have safe sex and not transmit HIV. Counseling and related behavior interventions, for example, Partnership for Health, Options, and Positive Choice, have proven to be effective interventions in decreasing behaviors associated with secondary transmission of HIV for people living with HIV. These three interventions can be provided in the treatment setting and by the APN. It is important to educate the patient on different support groups that can be provided. Support groups that would be applicable for this patient include Sister to Sister and Women Involved in Life Learning from Other Women (WILLOW). These support groups involve behavioral interventions and education for adult sexually active women in order to reduce sexual risk behaviors and prevent transmission of HIV (Center for Disease Control and Prevention, 2012). The patient should be educated on the different government programs that can offer HIV-related services and financial assistance. The APN could recommend the patient to apply for the Ryan White HIV/AIDS Program that provides HIV-related services and could financially assist with medical costs after insurance coverage (AIDS.gov, 2013). Advanced Practice Nurse Authority to Prescribe Ohio APNs who hold a valid Certificate to Prescribe have the authority to prescribe any of the ARV medications from the recommended regimens only if it is physician initiated or a physician consult (Ohio Board of Nursing, 2013). DUNBAR CASE ANALYSIS 26 Clinical Study Efavirenz (EFV) has been studied and compared to other NNRTIs, PIs, and INSTIs in combination regimens including two NRTIs and still no other regimen has demonstrated to be better than EFV-based regimens for virologic responses. Findings from large randomized, controlled trials and cohort studies of ART-naïve patients have exhibited effective viral suppression in EFV-treated patients, where a significant percentage of these patients have plasma viral loads <50 copies/mL up to seven years of follow-up (AIDSinfo, 2012). A randomized double blind, double-dummy, active-controlled trials assessed the efficacy and safety between rilpivirine (RIL) and EFV with tenofovir and emtricitabine in treatment-naïve adults with HIV-1 infection at 112 sites across 21 countries. The inclusion criteria for the population were 18 years or older, viral sensitivity to every studied drug, had a plasma viral load at screening of 5,000 copies/mL or greater, and no previous treatment of ARV medications. The method consisted of a computer-generated interactive web response system to randomly assign patients to take either once-daily 25mg RIL PO or once-daily 600mg PO and everyone took a fixed-dose regimen of once-daily 300mg tenofovir PO and one-daily 200mg emtricitabine PO. The population was stratified with the screening viral load (<100,000 copies/mL, >100,000 to ≤500,000 copies/mL, and >500,000 copies/mL and randomized. The RIL or matching placebo was to be taken with a meal, while EFV or matching placebo was to be taken at night on an empty stomach in order to achieve the double-dummy design. There was a six-week screening period, a 96-week treatment period, and a four-week follow-up period for the trial. The findings included 287 of the 346 (83%) patients who received RIL and 285 of the 344 (83%) patients who received EFV attained an established response (viral load less than 50 copies/mL) at week 48. Even though RIL demonstrated to be non-inferior to EFV overall, the incidence of virological DUNBAR CASE ANALYSIS 27 failure (VF) (failure to attain or maintain a serum viral load <50 copies/mL) consisted of 45 (13%) patients who received RIL and only 13 (6%) patients who received EFV. Also, only 62% (21 of 34) of the patients who received RIL that started with a baseline viral load >500,000 copies/mL attained an established response compared to 81% (38 of 47) of patients who received EFV. In addition, patients who were taking RIL and experienced VF were more likely to have genotypic resistance to other NNRTIs and to their prescribed NRTIs compared to patients taking EFV and experiencing VF. The issues of concern incorporate that the findings cannot be applied to the general population because it did not include patients who had HIV-2, patients with more than one NNRTI resistance-associated mutation, or had a clinically significant disease. Also, the trial only used one NRTI regimen. There were no legal or ethical implications present in the study when reviewed (Molina et al., 2011). Issues There are important considerations when determining what medication to prescribe for this patient. First, the consideration of effectiveness of the medication because the patients plasma viral load is 562,000 copies/mL and it is important to choose the best drug that will effectively bring the patients plasma viral load to not detectable in a short period of time. Through research atripla is the most effective medication to bring the plasma viral load to not detectable. Second, drug-to-drug interactions were a consideration in medication choice. The patient is currently taking Junel FE 1mg-20mcg tablet PO daily and through research, atripla could decrease the effectiveness of the oral contraceptive, but no other interactions noted. The patient could either switch to a new contraceptive method, for example, an intrauterine device, or add another contraceptive method, for example, condoms, to the oral contraceptive (AIDSinfo, 2012). Third, patient compliance is an important factor in considering what medication to DUNBAR CASE ANALYSIS 28 prescribe because this patient will be on ART for the rest of her life and the patient lives a stressful life with working full-time and taking college courses. Therefore, it is important to have a simple ARV regimen and atripla is only one pill a day that can be taken on an empty stomach. Fourth, there will be necessary follow-up appointments throughout the patients’ life once the medication is started. There will be laboratory tests implemented in order to make sure atripla is effective. Fifth, financial cost is another consideration because atripla is $188.00 a month after insurance coverage and is the least expensive of the recommended or alternative ARV regimens available (Lexi-Comp, 2013). The patient can apply to government programs that can assist with the rest of the monthly cost. The patients’ education level, ability to understand the importance of taking atripla, compliance with current medication, and making the appointment at the infectious disease office soon after her appointment with her PCP, allows the APN to gain confidence that the patient will be adherent with taking atripla and making followup appointments. Legal and Ethical Considerations The legal and ethical considerations that need to be taken into account when prescribing atripla include autonomy, beneficence, nonmaleficence, and justice. First, the right to autonomy consists of the patient being able to decline the medication regimen or be noncompliant while the APN respects the patients’ decision. The APN has the responsibility of providing all of the education the patient should have in order to make an informed decision on adhering to the medication regimen. This includes education on the use, side effects, cost, benefits, and the treatment goals of atripla. Also, the consequences of not taking atripla should be discussed with the patient. The APN needs to have the patient agree to taking atripla before prescribing the medication. Second, the right to beneficence includes the APN believing the prescribed DUNBAR CASE ANALYSIS 29 medication regimen will benefit the patients’ health, improve quality of life, and lengthen the duration of life. Applying the right to beneficence for this patient includes the APN believing atripla will decrease the patients’ plasma viral load to a not detectable level and decrease risks for opportunistic infections in order to enhance her quality and length of life. Third, the right to nonmaleficence includes the APN prescribing the medication regimen with the intent of doing no harm or causing adverse effects. The intent for prescribing atripla should not be to cause the patients plasma viral load to increase, CD4 count to drop, cause an opportunistic infection, or decline quality and length of life. Last, the right to justice includes the APN treating all persons fairly and equally (American Nurses Association, 2013). Right to justice for this patient includes the APN treating this patient the same whether they were or were not diagnosed with HIV. Discussion Questions 1. It has been two years since the patient first started taking atripla and she has been adhering to her ARV regimen and follow-up appointments with you. She is coming into the office today for a follow-up appointment regarding her laboratory results and treatment plan. You review with her that her CD4 count is now 842 cells/mm3 and her plasma viral load is not detectable. When discussing the treatment plan, she tells you that she is getting married in a month and her fiancé and her would like to start a family soon after their wedding. As her healthcare provider and using the AIDSinfo ART guidelines for adults, would you change her ARV regimen knowing that she is planning to have a child soon? Why or why not? If you decide to change her ARV regimen, what would you change her ARV regimen to and why? 2. Discuss the HIV infection classification system for adults. What clinical category is this patient and why? How will you know if this patient moves to a different clinical category? Please explain. DUNBAR CASE ANALYSIS 30 References AIDS.gov. (2013). Federal resources. Washington, DC: Author. Retrieved February, 11, 2013, from http://www.aids.gov/federal-resources/ AIDSinfo. (2012). Guidelines for the use of antiretroviral agents in hiv-1-infected adults and adolescents. Rockville, MD: Author. Retrieved February 2, 2013, from http://www.aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf American Nurses Association. (2013). Code of ethics for nurses. Silver Spring, MD: Author. Retrieved February, 16, 2013, from http://nursingworld.org/MainMenuCategories/EthicsStandards/CodeofEthicsforNurses Fischbach, F. & Dunning, M. (2003). A manual of laboratory and diagnostic tests (8th ed.). Philadelphia, PA: Wolters Kluwer/Lippincott Williams & Williams. Center for Disease Control and Prevention. (2012). HIV/AIDS. Atlanta, GA: Author. Retrieved February, 6, 2013, from http://www.cdc.gov/hiv/ Infectious Disease Society of America. (2009). Primary care guidelines for the management of persons infected with human immunodeficiency virus: 2009 update by the hiv medicine association of the infectious disease society of america. Clinical Infectious Disease, 49, 651-681. Retrieved February 2, 2013, from http://www.idsociety.org/uploadedFiles/IDSA/GuidelinesPatient_Care/PDF_Library/HIV%20Primary%20Care.pdf Lexi-Comp, Inc. (2013). Lexi-DrugsTM. Lexi-Comp, Inc. Accessed February 8, 2013. Molina, J., Cahn, P., Grinsztejn, B., Lazzarin, A., Mills, A., Saag, M.,… Boven, K. (2011). Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naïve adults infected with hiv-1 (echo): A phase 3 randomised double-blind active-controlled trial. DUNBAR CASE ANALYSIS 31 Lancet, 378, 238-246. Retrieved February 8, 2013, from http://journals.ohiolink.edu.ezproxy.libraries.wright.edu:2048/ejc/pdf.cgi/Molina_JeanMichel.pdf?issn=01406736&issue=v378i9787&article=238_rvewtap3rdat Ohio Board of Nursing (2013). The formularly developed by the Committee on Prescriptive Governance. Retrieved February 9, 2013, from http://www.nursing.ohio.gov/PDFS/AdvPractice/1-20-13_Formulary.pdf