HIV/AIDS Treatment and Care : Clinical protocols for the European ...

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186 HIV/AIDS TREATMENT AND CARE CLINICAL PROTOCOLS FOR THE WHO EUROPEAN REGION • organize adherence support • adjust treatment regimens so they are safe, effective and acceptable • minimize the risk of drug resistance because of poor adherence. Early in the course of HAART, mild side-effects such as headache, nausea, diarrhoea and fatigue are common. They may often be managed simply with support, reassurance and symptomatic treatment such as analgesics or anti-diarrhoeal agents. These interventions are very useful in helping individuals to cope with side-effects without stopping or changing their HAART regimens. Side-effects can vary from mild to very serious and can affect many organ systems. Major side-effects of ARVs by drug class and organ system (114) are shown in Protocol 1, Patient evaluation and antiretroviral treatment for adults and adolescents. Careful clinical assessment is required to exclude other possible causes of signs and symptoms that might be mistaken as ARV side-effects, for example opioid withdrawal syndrome is characterized by headaches, anxiety, diarrhoea and headaches. In cases where the symptomatic measures are not sufficient or the toxicity is too severe it may be necessary to replace a side-effect-causing ARV drug with another ARV drug within the existing HAART regimen (please see Table 2 above). Please also see Protocol 1, Patient evaluation and antiretroviral treatment for adults and adolescents. 4.4 Drug-drug interactions in IDUs Health care providers should counsel every patient on all possible interactions of ARVs with other drugs administered, including substitution therapy drugs (see Table 3), illicit/recreational drugs and medications for TB, HCV, HBV and other opportunistic infections. Awareness of interactions and reporting and management of symptoms is critical for the patient’s well-being, treatment adherence and effectiveness, and management of drug interactions. 4.4.1. Methadone and ARVs • Methadone is metabolized in the liver by several cytochrome P450 (CYP) enzymes (especially CYP3A4). Its level may drop when used in conjunction with drugs that induce cytochrome enzymes, and an increased dosage may be required. When used in conjunction with drugs that inhibit cytochrome enzymes, its level may increase and a dose reduction may be needed. • Methadone itself inhibits the metabolism of ZDV, thus possibly elevating ZDV levels by as much as 43%; although no empiric dose reduction is currently recommended, signs of toxicity should be closely monitored (115). • Methadone can decrease ddI levels by up to 60%, leading to ddI underexposure, incomplete viral suppression and development of resistance. • Nevirapine, efavirenz and ritonavir decrease methadone concentrations (116, 117) and produce withdrawal symptoms. • NNRTIs are significantly more likely to interact with methadone than PIs, therefore IDUs on OST require careful monitoring. • The PI LPV/r has also been shown to produce an increase of methadone metabolism necessitating dosage increases in some cases (118).
Table 3. Interactions between ARV drugs and methadone a Antiretroviral agent Agent’s effect on methadone NRTIs Abacavir (ABC) Methadone levels mildly decreased. Risk of opiate withdrawal low. Dosage adjustments unlikely but some patients might require methadone dose increase. Didanosine (ddI) Buffered tablet Enteric coated capsule None reported. No dosage adjustments necessary. HIV/AIDS TREATMENT AND CARE FOR INJECTING DRUG USERS Methadone’s effect on ARV agent Peak concentration reduced (34%). Time to peak increased. Concentrations decreased (60%) in buffered tablet but not in enteric coated (EC) capsule. Comments Data sparse – although one study showed an increase of 22% in oral methadone clearance. Risk of opiate withdrawal low. Methadone dose adjustment might be needed. Only studied with twicedaily administration of buffered tablets. Hypothesized due to reduced bioavailability of didanosine in the setting of slower transit through the acidic environment of the stomach in patients taking methadone. Great inter-individual variability in didanosine pharmacokinetic data. No effect on enteric coated (EC) capsule Enteric coated (EC) capsule therefore preferred. Empricintamin (FTC) Not studied Not studied No known interactions Lamivudine (3TC) None reported None reported No known interactions Stavudine (d4T) None reported. No dosage adjustments necessary. Concentrations decreased (18–27%). Clinical significance unclear. Clinical significance of effect unclear. Tenofovir (TDF) None reported None reported No known interactions Zidovudine (ZDV) None reported No dosage adjustments necessary. NNRTIs Efavirenz (EFV) Methadone concentrations significantly decreased (60%). Methadone withdrawal common. Significant methadone dose increase (50%) usually required. Concentrations significantly increased (43%). Clinical significance unclear. Adverse events possible. Monitor for ZDV adverse events. Watch for anaemia, nausea, myalgia, vomiting, asthenia, headache and bone marrow suppression in recipients. If methadone trough levels are normal, suspect that problem is ZDV toxicity. Unknown Observe closely for signs of methadone withdrawal and increase dosage as necessary. Symptoms of withdrawal may be delayed for up to 2 or 3 weeks. 187
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HIV/AIDS TREATMENT AND CARE Clinica
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© World Health Organization 2007 A
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iv Acknowledgements The editors wou
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vi Marco Vitoria (WHO headquarters)
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viii CRP C-reactive protein CS caes
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x LFT liver function test LGE linea
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xii TDM therapeutic drug monitoring
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xiv Introduction HIV is a chronic i
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Annex 7. Glossary .................
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HIV/AIDS TREATMENT AND CARE CLINICA
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10 HIV/AIDS TREATMENT AND CARE CLIN
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1 HIV/AIDS TREATMENT AND CARE CLINI
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I. Principles management of opportu
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management of opportunistic infecti
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palliative care for people living w
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III. Initial evaluation palliative
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IV. Treatment palliative care for p
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Type of pain or treatment Usual sta
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Type Symptoms Possible causes Disea
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References palliative care for peop
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ManageMent of Hepatitis C and HiV C
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3.2. Considerations regarding treat
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278 hiv/aids tReatment and caRe cLi
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I. Prevention strategies Prevention
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Prevention of HePatitis a, B, C and
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Prevention of HePatitis a, B, C and
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5. Contraceptive methods for women
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I. Policy issues Prevention of Hiv
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Annex 3. Rabies vaccines ..........
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442 hIv/aIds tReatment and caRe clI
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I. Policy issues post-exposure prop
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post-exposure prophylaxis for hiv i
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° condom use ° presence of STIs (
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History of antiretroviral treatment
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Test results: HBV: HCV: HIV: Post-t
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The World Health Organization (WHO)
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