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APPENDIX C. Basic and Expanded HIV Postexposure Prophylaxis Regimens
BASIC REGIMEN
Zidovudine (RETROVIR™; ZDV; AZT) + Lamivudine (EPIVIR™;
3TC); available as COMBIVIR™
--- ZDV: 600 mg per day, in two or three divided doses, and
--- 3TC: 150 mg twice daily.
Advantages --- ZDV is associated with decreased risk of HIV transmission in the
CDC case-control study of occupational HIV infection.
--- ZDV has been used more than the other drugs for PEP in HCP.
--- Serious toxicity is rare when used for PEP.
--- Side effects are predictable and manageable with antimotility
and antiemetic agents.
--- Probably a safe regimen for pregnant HCP.
--- Can be given as a single tablet (COMBIVIR™) twice daily.
Disadvantages
--- Side effects are common and might result in low adherence.
--- Source patient virus might have resistance to this regimen.
--- Potential for delayed toxicity (oncogenic/teratogenic) is unknown.
ALTERNATE BASIC REGIMENS
Lamivudine (3TC) + Stavudine (ZERIT™; d4T)
--- 3TC: 150 mg twice daily, and
--- d4T: 40 mg (if body weight is <60 kg, 30 mg twice daily) twice daily.
Advantages
--- well tolerated in patients with HIV infection, resulting in good
adherence,
--- serious toxicity appears to be rare, and
--- twice daily dosing might improve adherence.
Disadvantages
--- Source patient virus might be resistant to this regimen.
--- Potential for delayed toxicity (oncogenic/teratogenic) is unknown.
Didanosine (VIDEX™, chewable/dispersable buffered tablet;
VIDEX™ EC, delayed-release capsule; ddI) + Stavudine (d4T) --- ddI: 400 mg (if body weight is <60 kg, 125 mg twice daily) daily,
on an empty stomach.
--- d4T: 40 mg (if body weight is <60 kg, 30 mg twice daily) twice daily.
Advantages
--- Likely to be effective against HIV strains from source patients who
are taking ZDV and 3TC.
Disadvantages
--- ddl is difficult to administer and unpalatable.
--- Chewable/dispersable buffered tablet formulation of ddI interferes
with absorption of some drugs (e.g., quinolone antibiotics, and indinavir).
--- Serious toxicity (e.g., neuropathy, pancreatitis, or hepatitis) can
occur. Fatal and nonfatal pancreatitis has occurred in HIV-positive,
treatment-naive patients. Patients taking ddI and d4T should be
carefully assessed and closely monitored for pancreatitis, lactic
acidosis, and hepatitis.
--- Side effects are common; anticipate diarrhea and low adherence.
--- Potential for delayed toxicity (oncogenic/teratogenic) is
unknown.
EXPANDED REGIMEN Basic regimen plus one of the following:
Indinavir (CRIXIVAN™; IDV) --- 800 mg every 8 hours, on an empty stomach.
Advantages
--- Potent HIV inhibitor.
Disadvantages
--- Serious toxicity (e.g., nephrolithiasis) can occur; must take 8
glasses of fluid per day.
--- Hyperbilirubinemia common; must avoid this drug during late pregnancy.
--- Requires acid for absorption and cannot be taken simultaneously with
ddI in chewable/dispersable buffered tablet formulation (doses must be
separated by at least 1 hour).
--- Concomitant use of astemizole, terfenadine, dihydroergotamine,
ergotamine, ergonovine, methylergonovine, rifampin, cisapride, St.
John's Wort, lovastatin, simvastatin, pimozide, midazolam, or
triazolam is not recommended.
--- Potential for delayed toxicity (oncogenic/teratogenic) is unknown.
Nelfinavir (VIRACEPT™; NFV) --- 750 mg three times daily, with meals or snack, or
--- 1250 mg twice daily, with meals or snack.
Advantages
--- potent HIV inhibitor, and
--- twice dosing per day might improve
adherence.
Disadvantages
--- Concomitant use of astemizole, terfenadine,
dihydroergotamine, ergotamine, ergonovine, methylergonovine, rifampin, cisapride, St.
John's Wort, lovastatin, simvastatin, pimozide, midazolam, or
triazolam is not recommended.
--- Might accelerate the clearance of certain drugs, including oral
contraceptives (requiring alternative or additional contraceptive
measures for women taking these drugs).
--- Potential for delayed toxicity (oncogenic/teratogenic) is unknown.
Efavirenz (SUSTIVA™; EFV) --- 600 mg daily, at bedtime.
Advantages --- Does not require phosphorylation before activation and might be
active earlier than other antiretroviral agents (note: this might be only a
theoretical advantage of no clinical benefit.)
--- One dose daily might improve
adherence.
Disadvantages
--- Drug is associated with rash (early onset) that can be severe
and might rarely progress to Stevens-Johnson syndrome.
--- Differentiating between early drug-associated rash and
acute seroconversion can be difficult and cause extraordinary concern for
the exposed person.
--- Nervous system side effects (e.g., dizziness, somnolence, insomnia,
and/or abnormal dreaming) are common. Severe psychiatric symptoms
are possible (dosing before bedtime might minimize these side effects).
--- Should not be used during pregnancy because of concerns
about teratogenicity.
--- Concomitant use of astemizole, cisapride, midazolam, triazolam, ergot
derivatives, or St. John's Wort is not recommended because inhibition
of the metabolism of these drugs could create the potential for
serious and/or life-threatening adverse events (e.g., cardiac
arrhythmias, prolonged sedation, or respiratory depression).
--- Potential for oncogenic toxicity is
unknown.
Abacavir (ZIAGEN™; ABC); available as TRIZIVIR™, a combination of
ZDV,
3TC, and ABC
--- 300 mg twice daily.
Advantages --- potent HIV inhibitor, and
--- well tolerated in patients with HIV infection.
Disadvantages
--- Severe hypersensitivity reactions can occur, usually within the first
6 weeks of treatment.
--- Potential for delayed toxicity (oncogenic/teratogenic) is unknown.
ANTIRETROVIRAL AGENTS FOR USE AS PEP ONLY WITH EXPERT CONSULTATION
Ritonavir (NORVIR™; RTV)
Disadvantages --- difficult to take (requires dose escalation),
--- poor tolerability, and
--- many drug interactions.
--- potent HIV inhibitor, and
--- well tolerated in patients with HIV infection.
Disadvantages
--- Concomitant use of flecainide, propafenone, astemizole, terfenadine,
dihydroergotamine, ergotamine, ergonovine, methylergonovine, rifampin,
cisapride, St. John's Wort, lovastatin, simvastatin, pimozide,
midazolam, or triazolam is not recommended because inhibition of the
metabolism of these drugs could create the potential for serious
and/or life-threatening adverse events (e.g., cardiac arrhythmias,
prolonged sedation, or respiratory depression).
--- May accelerate the clearance of certain drugs, including oral
contraceptives (requiring alternative or additional contraceptive measures for women
taking these drugs).
--- Potential for delayed toxicity (oncogenic/teratogenic) is unknown.
ANTIRETROVIRAL AGENTS GENERALLY NOT RECOMMENDED FOR USE
AS PEP
Nevirapine (VIRAMUNE™; NVP) --- 200 mg daily for 2 weeks, then 200 mg twice daily.
Disadvantages
--- Associated with severe hepatotoxicity (including at least one case
of liver failure requiring liver transplantation in an exposed person
taking PEP),
--- Associated with rash (early onset) that can be severe and progress
to Stevens-Johnson syndrome,
--- Differentiating between early drug-associated rash and
acute seroconversion can be difficult and cause extraordinary concern for
the exposed person, and
--- Concomitant use of St. John's Wort is not recommended because this
might result in suboptimal antiretroviral drug
concentrations.
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