GUIDELINES FOR ANTIRETROVIRAL TREATMENT

 

 The decision to start a patient on ARV will be based on the clinical findings and/or CD4 level determination. The benefits, toxicity, adherence issues and costs of the treatment must be a component of counseling.

Criteria for Initiation of ARV

WHO Clinical Staging	CD4 Testing NOT AVAILABLE	CD4 Testing  AVAILABLE
STAGE 1 – ASYMPTOMATIC	DO NOT TREAT	TREAT if CD4 is BELOW 200 cells/mm3
STAGE 2 – MILD	DO NOT TREAT	TREAT if CD4 is BELOW 200 cells/mm3
STAGE 3 – ADVANCED	TREAT	Consider TREATMENT if CD4 is BELOW 350 cells/mm3 and initiate TREATMENT before CD4 falls below 200 cells/mm3
STAGE 4 – SEVERE	TREAT	TREAT irrespective of CD4 Count

 

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WORLD HEALTH ORGANIZATION

CLINICAL STAGING OF HIV and AIDS

CLINICAL STAGE 1

Asymptomatic
Persistent Generalized Lymphadenopathy

CLINICAL STAGE 2

Unexplained moderate weight loss (under 10% of presumed or measured body weight)
Recurrent Upper Respiratory Tract Infections (Sinusitis, Tonsillitis, Otitis Media, Pharyngitis)

Herpes Zoster
Angular Cheilitis
Recurrent Oral Ulcerations
Papular Pruritic Eruptions
Seborrheic Dermatitis
Fungal Nail Infection

CLINICAL STAGE 3

Unexplained severe weight loss ( over 10% of presumed or measured body weight)
Unexplained Chronic Diarrhea for longer than one month
Unexplained Persistent Fever (intermittent or constant for longer than one month)
Persistent Oral Candidiasis
Oral Hairy Leukopakia
Pulmonary Tuberculosis (current)
Severe Bacterial Infections (e.g. Pneumonia, Empyema, Pyomyositis, Bone or Joint Infection, Meningitis, Bacteremia, Severe Pelvic Inflammatory Disease)
Acute Necrotizing Ulcerative Stomatitis, Gingivitis, Periodontitis
Unexplained Anemia (below 8g/dl), Neutropenia (below 0.5 x 10⁹ / 1) and/or Chronic Thrombocytopenia (below 50 x 10⁹ / 1)

CLINICAL STAGE 4

HIV Wasting Syndrome
Pneumocystis Pneumonia
Recurrent Bacterial Pneumonia
Chronic Herpes Simplex infection (Orolabial, Genital or Anorectal for more than one month’s duration or visceral at any site)
Esophageal Candidiasis (or Candidiasis of Trachea, Bronchi or Lungs)
Extrapulmonary Tuberculosis
Kaposi Sarcoma
Cytomegalovirus Infection (Retinitis or Infection of other organs)
Central Venous System Toxoplasmosis
HIV Encephalopathy
Extrapulmonary Cryptococci's incliding Meningitis
Disseminated Non-Tuberculosis Mycobacterial Infection
Progressive Multifocal Leukoencephalopathy
Chronic Cryptosporidiosis
Chronic Isosporiasis
Disseminated Mycosis (Coccidiomycosis or Histoplasmosis)
Recurrent Septicemia (including Non-Typhoidal Salmonella)
Lymphoma (Cerebral or B Cell Non-Hodgkin)
Invasive Cervical Carcinoma
Atypical Disseminated Leishmaniasis
Symptomatic HIV-Associated Neuropathy or HIV-Associated Cardiomyopathy

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ANTIRETROVIRAL DRUGS: DOSES, INSTRUCTIONS, ADMINISTRATION, IMPORTANT ADVERSE REACTION

DRUG

DOSE

ADMINISTRATION

IMPORTANT ADVERSE REACTIONS

NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTI’s)

Zidovudine (ZDV or AZT) 300mg Tablets	300mg every 12 hours	take without regard to meals	Anemia, Leukopenia, Lactic Acidosis (rare)
Lamivudine (3TC) 150mg Tablets	150mg every 12 hours or 300mg once daily	take without regard to meals	Well tolerated
Stavudine (d4T) 30mg Tablets	30mg every 12hours irrespective of body weight	take without regard to meals	Pancreatitis Lactic Acidosis Severe Hepatomegally with Steatosis Rapidly Progressing Ascending Neuromuscular Weakness
Didanosine (ddI) 200mg Entric Coated Capsules 250mg Entric Coated Capsules 400mg Entric Coated Capsules	Body weight: >60kg 400mg once daily with TDF: 250mg once daily Body weight: <60kg 250mg once daily with TDF: 200mg once daily	Must be taken on an empty stomach	Pancreatitis Lactic Acidosis

NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTI)

Tenofovir (TDF) 300mg Tablets

300mg once daily

take without regard to meals

Nephrotoxicity

NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NNRTIs)

Efavirenz (EFV) 600mg Tablets	600mg once daily	Take on an empty stomach and before bedtime as severe dizziness is possible upon initiation of therapy that resolves or becomes tolerable after a few days	Rash Hepatitis
Nevirapine (NVP) 200mg Tablets	As severe hypersensitivity may develop during initiation, trial period should be done by giving 200mg once a day x 14days together with the full dose of NRTI. If there is no sign of hypersensitivity, then give full dose at 200my every 12hours.	Take without regard to meals Not recommended to be co-administered with Rifampicin.	STOP if any of these are observed: 1. Fever or Feverish Sensation 2. Flu-like Symptoms such as muscle or body pains 3. Disseminated Macular or Maculopapular or Urticarial rashes In case of mild skin rashes such as discreet papular or nodular rashes that are limited in number, without other signs, continue NVP and observe for any progression. Serious hepatic events have been reported among treatment-naïve with pre-Nevirapine CD4 counts >250 cells/mm3 or in treatment-naïve male patients with pre-Nevirapine CD4 counts >400 cells/mm3

PROTEASE INHIBITORS (PI’s)

Indinavir (IDV) 400mg Capsules	800mg every 12hours to be given with Ritonavir 100mg every 12hours	For RTV-boosted IDV take with or without food Take with plenty of water to avoid Nephrolithiasis. Not recommended to be co-administered with Rifampicin	Nephrolithiasis
Ritonavir (RTV) 100mg Capsules	100mg every 12hours to be given with Indinavir 800mg every 12hours or Sauinavir 1000mg every 12hours	For RTV-boosted IDV take with or without food For RTV-boosted SQV take within 2hours of a meal Not recommended to be co-administered with Rifampicin	Hepatitis Lipodystrophy
Lopinavir / Ritonavir (LPV/r) Lopinavir 200mg/Ritonavir 50mg Tablets	2 tablets every 12hours	Take without regard to meals Not recommended to be co-administered with Rifampicin	Gastro Intestinal Intolerance Lipodystrophy
Nelfinavir (NFV) 250mg Tablets 625mg Tablets	1250mg every 12hours 750mg every 8hours	Take with meal or snack Not recommended to be co-administered with Rifampicin	Gastro Intestinal Intolerance Lipodystrophy
Saquinavir (SQV) 500mg Tablets	1000mg every 12hours to be given with Ritonavir 100mg every 12hours	Take within two hours of a meal Not recommended to be co-administered with Rifampicin	Gastro Intestinal Intolerance Lipodystrophy

FIXED DRUGS COMBINATIONS

Lamivudine (3TC) + Stavudine (d4T) 3TC 150mg + d4T 30mg Tablets	1 Tablet every 12hours	Take without regard to meals	See Lamivudine and Stavudine above
Zidovudine (ZDV) + Lamivudine (3TC) ZDV 300mg + 3TC 150mg Tablets	1 Tablet every 12hours	Take without regard to meals	See Zidovudine and Lamivudine above
Zidovudine (ZDV) + Lamivudine (3TC) + Nevirapine (NVP) ZDV 300mg + 3TC 150mg + NVP 200mg Tablets	1 Tablet every 12hours	Take without regard to meals Not recommended to be co-administered with Rifampicin	See Zidovudine, Lamivudine and Nevirapine above
Emtricitabine (FTC) + Tenofovir (TDF) + Efavirenz (EFV) FTC 200mg + TDF 300mg + EFV 600mg Tablets	1 Tablet once daily	Take on an empty stomach and before bedtime	See Tenofovir and Efavirenz above. Emtricitabine – minimal toxicity, rare cases of lactic acidosis

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IMPORTANCE OF ADHERENCE COUNSELING

HIV can develop resistance to ARV’s. The success of ARV Therapy largely depends on patient’s adherence to treatment. A 95% adherence rate is required to prevent the development of drug resistance.

LABORATORY TESTS PRIOR TO INITIATING ARV TREATMENT

Complete Blood Count (CBC)
Chest X-Ray, Sputum Acid Fast Bacilli (AFB) and Sputum Culture to rule out Active Tuberculosis
Pregnancy Test for Females of Reproductive Age
Baseline Urinalysis, Fasting Blood Sugar (FBS), Liver Function Tests, Creatinine, and Lipid Profile when indicated

MONITORING FOR ARV TOXICITY

For Zidovudine (AZT) + Lamivudine (3TC) + Efavirenz (EFV) / Nevirapine (NVP)

Complete Blood Count (CBC) – every month for the first 3 months and every 4-6 months thereafter
SGPT, SGOT, Alkaline Phosphatase, Amylase – after 1 month, after 6 months and every 12 months thereafter

For Tenofovir (TDF) + Lamivudine (3TC) + Efavirenz (EFV) / Nevirapine (NVP)

Creatinine and Urinalysis – Annually
SGPT, SGOT, Alkaline Phosphatase, Amylase – after 1 month, after 6 months and every 12 months thereafter

For Stavudine (d4T) + Lamivudine (3TC) + Efavirenz (EFV) / Nevirapine (NVP)

Complete Blood Count (CBC) – Annually
SGPT, SGOT, Alkaline Phosphatase, Amylase – after 1 month, after 6 months and every 12 months thereafter
Total Cholesterol, Triglyceride, Low Density Lipoprotein (LDL) – after 6 months and every 12 months thereafter

For Tenofovir (TDF) + Lamivudine (3TC) + Lopinavir / Ritonavir (LPV/r)

Creatinine and Urinalysis – Annually
Total Cholesterol, Triglyceride, Low Density Lipoprotein (LDL) – after 6 months and every 12 months thereafter
Fasting Blood Sugar (FBS) – after 6 months and every 12 months thereafter

For Zidovudine (AZT) + Lamivudine (3TC) + Lopinavir / Ritonavir (LPV/r)

Complete Blood Count (CBC) – after 1 month, after 6 months and avery 12 months thereafter
Total Cholesterol, Triglyceride, Low Density Lipoprotein (LDL) – after 6 months and every 12 months thereafter
Fasting Blood Sugar (FBS) – after 6 months and every 12 months thereafter

For Stavudine (d4T) + Lamivudine (3TC) + Lopinavir / Ritonavir (LPV/r)

Complete Blood Count (CBC) – Annually
SGPT, SGOT, Alkaline Phosphatase, Amylase – after 1 month, after 6 months and every 12 months thereafter
Total Cholesterol, Triglyceride, Low Density Lipoprotein (LDL) – after 6 months and every 12 months thereafter
Fasting Blood Sugar (FBS) – after 6 months and every 12 months thereafter

MONITORING RESPONSE TO TREATMENT

Trial of therapy for at least 6 to 12 months should be given before concluding that an ARV regimen is failing. For patients with good compliance to ART, clinical response is recommended to be used together with CD4 Count and Viral Load Determination (whenever available) to detect treatment failure.

CHANGE OF TREATMENT REGIMEN

Drug Toxicity and Side Effects

ARV Drugs are associated with side effects and long term toxicities. Although life threatening side effects had been reported, many side effects can be managed symptomatically. the ARV component causing toxicity should be identified and changed if necessary. The General Principle is that single-drug substitution because of toxicity should involve drugs belonging to the same ARV class.
It is also important to ask patients of intake of other medications because ARV’s may interact with these medications.

Treatment Failure

It is very important to regularly assess patients for treatment failure, determine the reasons for these and institute appropriate management immediately. If poor compliance is the cause of treatment failure then counseling for adherence must be intensified and the current regimen continued. Determination of CD4 Count should be performed after 3 months to reassess response to treatment.
Patients who are candidates for second-line ARV’s must be managed in close coordination with the Research Institute of Tropical Medicine or San Lazaro Hospital.

THESE INFORMATION IS JUST TO GIVE YOU AN IDEA ABOUT ARV TREATMENT. IT IS STILL BEST TO CONSULT YOUR DOCTOR ABOUT IT.

 JaKe Positive. BE SAFE! +)