1 Side Effects of Anti-retroviral Therapy HAIVN Harvard Medical School AIDS Initiative in Vietnam

2 By the end of this session, participants will be able to: List the side effects of ARVs used in Vietnam Recognize the side effects when caring for patients Educate patients to recognize and monitor side effects of ARVs Learning Objectives

3 Side Effects of ARVs: Light side effects: occur in first weeks of ARV commence, and improve gradually (nausea, vomit) In more severer cases, may required: Symptom treatment or Change medications Some side effects are related to: Dosage and/or Interactive with other medications Overview: Side Effects of ARVs (1)

4 Patients should be carefully educated so that they can: Recognize side effects of medications Inform health workers to have timely management Better adherence Overview: Side Effects of ARVs (2)

ARV Drugs Currently Available in Vietnam Nucleoside/ Nucleotide RTI AZT / Zidovudine d4T / Stavudine 3TC / Lamivudine ddI / didanosine ABC / Abacavir TDF / Tenofovir Non-nucleoside RTI NVP /Nevirapine EFV / Efavirenz Protease Inhibitor Lopinavir/r (Aluvia)

6 AZT + 3TC LAMZIDIVIR, Combivir D4T + 3TC + NVP D4T-FDC, NEVITRIO 30, Triamune, GPOvir AZT + 3TC + NVP AZT-FDC, LAMZITRIO AZT + 3TC + ABC ABATRIO, Trizivir Combination Pills Available in Vietnam

7 Side Effects of First-line ARVs

8 Side Effects of d4T

9 This is a common side effect of d4T Symptoms: Pain or tingling in hands and feet Stocking and glove distribution Symmetrical Peripheral Neuropathy: Symptoms

10 Nurses can: Ask patients on each visit about the symptoms Educate patients: Loose shoes/sandals Light bedding Walk a little, not a lot! Cool water soaks Try Ibuprofen for pain Peripheral Neuropathy: How to Manage?

Dorsocervical enlargement (humpback) Lipodystrophy (1)

Abdominal (visceral) adiposity Lipodystrophy (2)

Lipodystrophy (3) sunken cheeksprominent veins

14 This is a serious side effect of d4T Symptoms: Abdominal pain Nausea, and vomiting More common among patients who use alcohol Pancreatitis: Symptoms

15 Must STOP the medication Patients should come to clinic May need to be hospitalized Pancreatitis: Management

16 Side Effects of AZT

17 Very common at start of therapy Often improves with time: Provide reassurance Nausea and Vomiting: Symptoms

18 In minor cases, educate patients to: Take the AZT with a little food Eat small frequent meals Avoid spicy or fried foods Replace fluids (tea, broth) Anti-nausea medications as needed Nausea and Vomiting: Management (1)

19 Educate patients to go to the clinic or hospital if : There is blood in the vomit Pain in your stomach Fever Vomiting persists more than 1 day Be thirsty, but can not eat or drink properly Nausea and Vomiting: Management (2)

20 Usually declines in frequency 2-4 weeks after beginning AZT Patient education in minor cases: Try paracetamol Rest in quiet, dark room Cool cloth over eyes Avoid caffiene (coffee, strong tea, soda) Headache (1)

21 Educate patients to go to clinic if: Vision changes Paracetamol doesn’t relieve the pain Headaches are very severe and frequent Difficulty with walking or balance Confusion Headache (2)

22 Bone marrow suppression: Anemia Severe reduction in red blood cells Fatigue, shortness of breath Neutropenia: Low white blood count Diminished ability to fight infections Serious Side Effects (1)

23 Closely monitor patients to recognize symptoms of serious side effects May need to swap for D4T or TDF Serious Side Effects : Management

24 Side Effects of Nevirapine (NVP)

25 Rash caused by NVP usually appears 2-6 first wks of treatment, but could be later Rash: Symptoms Symptoms MildScattered rashes with or without itching Moderate Generalized rashes with or without itching No systemic symptoms SevereGeneralized maculopapular rashes, allergic edema, itching, high fever Very severe Generalized blisters, erosion of mucus membranes, red face, conjunctivitis, high fever ( above 400C)

Mild Rash (1)

Mild Rash (2)

28 Educate patients: Note when rashes developed and report to nurses and doctors Avoid soaps, shower cream Do not taking bath with hot water Avoid direct sunlight Use Antihistamines tablet or cream Come to clinic or hospital: if blisters, sores in mouth, painful rash swelling in face, hands, feet. Mild Rash: Management

Moderate Rashes

30 Moderate rashes: Usually improves with symptomatic treatment Less frequent when begin with : NVP 200 mg tablet once a day for 14 days and then increase to 200 mg tablet twice a day Treatment of moderate rash Antihistamines Close monitoring for developing of worsening symptoms If no improvement after a few weeks, may need to change medication Moderate Rashes: Management

Severe and Very Severe Rash (1)

Severe and Very Severe Rash (2)

33 Confluent erythema Facial edema or central facial involvement Skin pain Palpable purpura Skin necrosis Blisters or epidermal detachment Mucous membrane erosions Urticaria Swelling of tongue Symptoms that Indicate Serious Rash

34 Stop the medications May need hospitalization and intensive care Provide nursing care as for a burn patient Strict hand-washing & careful patient handling to prevent infection of skin Fluid and electrolyte management, nutritional support, pain control Daily evaluation of % of body surface area involved Severe and Very Severe Rash: Management

35 This is a serious side effect : Greater risk for patients with hepatitis B or C Greater risk for women with CD4 counts over 250 Patient education: Important to come to clinic for regular blood tests Report any nausea, abdominal pain, change in color of urine or stool Liver Injury

36 Common side effects: Rash similar to nevirapine rash Sleep disturbances Difficulty sleeping Vivid dreams (may be good or bad) Serious side effects Mental illness Fetal abnormalities (teratrogenic) Side Effects of Efavirenz

37 Difficulty sleeping May have very vivid dreams – sometimes nightmares Usually goes away in a few weeks Sleep Disturbances: Symptoms

38 Patient education: Try taking efavirenz in morning, unless it causes dizziness. Avoid alcohol and drugs Avoid fatty food because fat increase EFV absorption Sleep Disturbances: Management

39 Feelings of sadness may occur with efavirenz. Usually goes away in a few weeks. EFV can also cause severe mental illness, including: Psychosis Depression: May be mild or severe Mental Illness: Symptoms

40 Educate patients: Talk to someone about how you feel Go to the Clinic if: Your feelings are very severe and prevent you from daily life You are thinking of hurting yourself You are easy to be anger or super agitated Mental Illness: Management

41 Side Effects of Second Line ARVs

42 If the first regimen doesn’t work, other combinations of medications might include some of the following: Abacavir Lopinavir/ritonavir Tenofovir DDI Side Effects of Second Line ARVs

43 3-5% of patients Fever Malaise, Myalgias Rash GI symptoms Dyspnea, pulmonary infiltrates Usually within first 6 weeks of therapy, although late cases reported ABC - Hypersensitivity: Symptoms

44 Educate patients: Watch for: any fever skin rash Fatigue nausea, vomiting, diarrhea, abdominal pain, or respiratory symptoms See nurse or doctor ASAP Discontinue drug as directed. Restart ABC can cause cardiovascular collapse and death ABC - Hypersensitivity: Management DO NOT RESTART EVER

45 GI intolerance: nausea, vomiting diarrhea Hyperglycemia (insulin resistance) Fat redistribution and abnormal lipids Occasional rash and headace Side Effects of Lopinavir/r (LPV/r, Kaletra)

46 If patients develops vomiting or diarrhea, educate them: Tell your nurse or doctor Replace fluids Eat foods that provide nutrients and absorb liquid Small, more frequent meals Avoid: skins of fruits and vegetables, milk, greasy food, sweets Side Effects of Lopinavir/r: Management (1)

47 Educate patients to go to clinic if: : Vomiting or diarrhea occurs more than 4 times/day There is blood in the diarrhea There is a fever You are thirsty but cannot eat or drink properly You are dizzy when you stand up Side Effects of Lopinavir/r: Management (2)

48 Usually well tolerated Mild side effects: nausea, vomiting, diarrhea. Serious side effect: kidney damage Should be used with caution in people with history of kidney problems Side Effects of Tenofovir

49 Common side effects: Peripheral neuropathy Rash: usually mild, but severe also reported Severe side effects: pancreatitis Severe hepatitis, especially if taken with d4T Educate patients to take ddI: 1 hour before meals or 2 hours after meals (If not EC) Side Effects of ddI

50 Nurses should educate patients and their families: How to recognize side effects How to manage at home on their own That they should not stop ARVs arbitrarily That they should go to clinic if the side effect is severe Remember

51 Adherence counseling for patients about side effects is really important for good adherence To recognize side effects is the key to care and manage Common side effects: Peripheral neuropathy Nausea, vomit, diarrhea Rash… Key Points

52 Thank You! Question?