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 Guide Editors
 Editor In Chief
    Joel E. Gallant, MD, MPH

Pharmacology Editor
    Paul Pham, PharmD, BCPS

Zambia Guideline Team
   Peter Mwaba MMed PhD FRCP
   Alywn Mwinga MMed
   Isaac Zulu MMed MPH
   Velepie Mtonga MMed
   Albert Mwango MBChB
   Jabbin Mulwanda MMed FCS
 

 

 

Drugs>Antiretrovirals>
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Efavirenz

Paul A. Pham, Pharm.D. and John G. Bartlett, M.D.
10-14-2010

Zambia Specific Information

  • Available formulation in Zambia: Capsule: 50 mg; 100 mg; 200 mg; Oral liquid: 150 mg/5 ml; Tablet: 600 mg. EFV600mg/TDF300mg/FTC200mg combination tab.
  • TDF/FTC plus EFV is now the preferred first line regimen due to long-term efficacy and favorable side effect profile.
  • EFV is recommended NNRTI to be used with rifampicin.
  • EFV-based regimen not recommended for the treatment of HIV-2 infection.
  • To prevent NNRTI resistance with treatment discontinuation, discontinue EFV and continue NRTIs for an additional 10 days.
  • Contraindicated in 1st trimester of pregnancy. Birth defects occurred in 5 of 188 live births with 1st trimester exposure and in 0 of 13 live births with 2nd or 3rd trimester exposure.
Zambia Information Author: Paul A. Pham, Pharm. D.

INDICATIONS

FDA

  • Treatment of HIV infection in combination with other ARV agents.

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Sustiva (available in U.S., Canada, and Europe)Efavirenz (EFV)Bristol-Myers Squibb oral
capsule
50 mg
$1.77
      oral
tablet
600 mg
$21.25
      oral
capsule
200 mg
$7.08
     

Stocrin (brand name available in South Africa, Southeast Asia, and other parts of the world)Efavirenz (EFV)Merckoral
capsule
50 mg, 100 mg, 200 mg
variable
      oral
tablet
600 mg
variable
      oral
solution
30 mg/30 mL (180 mL bottle)
variable
Atripla (available in the U.S., Canada, and Europe)EFV/TDF/FTCBristol-Myers Squibb & Gilead Sciencesoral
tablet
EFV600mg/TDF300mg/FTC200mg
$61.09

*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP). AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's information, and the McKesson database.

^Dosage is indicated in mg unless otherwise noted.

USUAL ADULT DOSING

Pill burden: 1 tab per day

  • EFV 600 mg PO once-daily. Evening dosing on an empty stomach recommended initially to decrease side effects.
  • Can be administered as a co-formulated product with TDF/FTC (Atripla) 1 tab PO once-daily.
  • Administration with food, especially with high fat meal, may increase CNS side effects: EFV peak levels increased by 40% (caps) and 80% (tabs).
  • For GI intolerance, consider taking with food after resolution of CNS side effects.
  • Morning CNS side effects may be decreased if taken several hrs before bedtime. Some pts can tolerate morning dosing after resolution of initial CNS side effects.
  • With LPV/r: LPV/r 500/125 mg twice-daily + EFV 600 mg once-daily, especially for PI-experienced pts. In PI-naive pts, standard dose of 400/100 (2 tabs) twice-daily may be adequate.
  • With FPV: FPV 700 mg twice-daily + RTV 100 mg twice-daily OR FPV 1400 mg + RTV 300 mg once-daily plus EFV 600 mg once-daily.
  • With ATV: ATV 400 mg once-daily + RTV 100 mg once-daily + EFV 600 mg once-daily. Consider TDM.
  • With IDV: IDV 800 mg twice-daily + RTV 200 mg twice-daily + EFV 600 mg once-daily.
  • With SQV: SQV 1000 mg twice-daily + RTV 100 mg twice-daily with EFV 600 mg once-daily.
  • With NFV: NFV 1250 mg twice-daily + EFV 600 mg once-daily.
  • With DRV: Dose not established. Consider DRV/r 600/100 mg twice-daily + EFV 600 mg once-daily. With once-daily DRV/r, only 900/100 mg dose has been tested with EFV. Consider DRV/r 800/100 mg or 900/100 mg once-daily plus EFV 600 mg once-daily in PI-naive patients. Consider TDM.
  • With TPV: TPV/r 500/200 mg twice-daily + EFV 600 mg once-daily.
  • With RAL: RAL 400 mg twice-daily + EFV 600 mg once-daily.
  • With MVC: MVC 600 mg twice-daily + EFV 600 mg once-daily. Note: if PIs (i.e LPV/r or SQV/r) contained in regimen, MVC 150 mg twice-daily recommended.
  • With ETR or NVP: avoid co-administration.
  • Planned EFV discontinuation: stop EFV and continue NRTIs for 1-2 wks, but may require up to 4 wks with CYP2B6 polymorphism ("staggered discontinuation") OR substitute PI-based ART for 1 month ("substituted discontinuation"). Substitution associated with less NNRTI resistance than staggered discontinuation in SMART study.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

600 mg once-daily

DOSING FOR GLOMERULAR FILTRATION OF 10-50

600 mg once-daily. Avoid EFV/TDF/FTC co-formulation tab with GFR <50 ml/min.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

600 mg once-daily. Avoid EFV/TDF/FTC co-formulation tab with GFR <50 ml/min.

DOSING IN HEMODIALYSIS

600 mg once-daily (EFV PK not affected by HD). Avoid EFV/TDF/FTC co-formulation tab with GFR <50 ml/min.

DOSING IN PERITONEAL DIALYSIS

600 mg once-daily (limited data). Avoid EFV/TDF/FTC co-formulation tab with GFR <50 ml/min.

DOSING IN HEMOFILTRATION

No data. Consider 600 mg once-daily.

ADVERSE DRUG REACTIONS

Generally well tolerated after resolution of CNS side effects (2-4 wks).

COMMON

  • CNS effects: vivid dreams including nightmares, nocturnal dizziness, morning confusion; depersonalization; usually seen during1st 2-4 wks with gradual resolution in most pts.Dose escalation over 2 wks decreases CNS side effects by approx. 50%, but not recommended due potential risk of resistance.
  • Pts experiencing early CNS toxicity should avoid tasks that require concentration, such as driving, especially in the morning.
  • Pts should be advised of additive effects of alcohol and other psychoactive agents when coadministered with EFV.
  • Morbilliform rash in up to 26% of pts requiring discontinuation in 1.7% (med. onset11 days, duration 16 days); incidence and severity lower than NVP. Generally resolves with continued use of EFV. A meta-analysis of 13 reports with 239 pts indicated 13% of pts developed recurrence of rash when switched from NVP to EFV.
  • False-positive urine toxicology screening test for cannabinoids (w/CEDIA DAU Multilevel THC assay only); confirmatory tests negative.
  • False-positive benzodiazepine screening test (e.g Triage 8, Drug Screen Multi 5)
OCCASIONAL

  • Elevated triglycerides and cholesterol (incidence higher than with NVP).
  • Elevated transaminases (2-8%; incidence and severity lower than with NVP). Frequency increased with concurrent hepatoxic drugs and HCV co-infection.
  • Possible reduction in vitamin D levels
RARE

  • Erythema multiforme and Stevens-Johnson syndrome (0.1%).
  • Gynecomastia.
  • Severe psychiatric disorders, primarily depression reported in 2.4%.

DRUG INTERACTIONS

Substrate of CYP 2B6>CYP3A4; inducer of CYP3A4 and CYP2B6; weak inhibitor of CYP3A4, 2B6, 2C9, and 2C19. Inducers of CYP3A4 and CYP2B6 may decrease EFV serum levels. EFV generally decreases serum levels of CYP3A4 and CYP2B6 substrates.

Drug-to-Drug Interactions

Drug-to-Drug Interaction

DrugEffect of InteractionRecommendations/Comments
NFV NFV AUC: increased 20%. M8 AUC: decreased 37%.No significant interaction. Use standard dose: NFV 1250 mg twice-daily + EFV 600 mg qhs.
NVP EFV AUC: decreased 22%; Cmin: decreased 36%.Co-administration not recommended due to overlapping resistance profile. With co-administration consider increasing EFV to 800 mg once-daily.
Rifampin EFV AUC: decreased 26%; no change in rifampin AUC.Recommended dosing: EFV 800 mg/d with rifampin 600 mg once-daily in pts >60kg (monitor for EFV CNS side effects). May decrease to EFV 600 mg/d if 800 mg dose not easily tolerated. Consider TDM.
RTV RTV AUC: increased 18% EFV AUC: increased 21%.No significant interaction. Use standard dose of RTV and EFV.
SQV SQV/r AUC: decreased 62% (with unboosted SQV) SQV Cmin: decreased 10% (w/ boosted SQV 400 mg/RTV 400 mg); RTV Cmin: no significant change EFV: no significant change.Do not coadminister unboosted SQV with EFV. Recommended dose: SQV 1000 mg + RTV 100 mg twice-daily + EFV 600 mg qhs.
Darunavir DRV Cmin decreased by 31%. EFV AUC and Cmin increased 21% and 17%, respectively (studied with DRV/r 300/100 mg twice-daily). Dose not established. Consider DRV 600/100 mg twice-daily with EFV 600 mg qhs. With once-daily DRV/r, only 900/100 mg dose has been tested with EFV. Based on PK data, either DRV/r 800/100 mg or 950/100 mg once-daily plus EFV 600 mg qhs can be considered in PI-naive patients.
Tipranavir No significant change in TPV and EFV PK parameters with higher TPV/r dose (750mg/200mg twice-daily) Consider TPV/r 500/200 mg twice-daily + EFV 600mg once-daily.
Maraviroc Maraviroc AUC decreased by 45%. Maraviroc 600 mg twice-daily + EFV 600 mg qhs. If PIs (i.e LPV/r or SQV/r) are included in regimen, MVC150 mg twice-daily recommended.
Clarithromycin Clarithromycin AUC decreased 39%. High incidence of rash with co-administration. Consider azithromycin.
Alprazolam May decrease alprazolam concentrations. Titrate to effect or consider lorazepam.
 Amodiaquine Amodiaquine AUC increased with co-administration. Co-administration of EFV with artesunate plus amodiaquine may result in significant LFT elevations. With EFV co-administration, significant increase in amodiaquine AUC (114% and 302%) reported in 2 pts.
Artemether (artemisinin)May decrease serum level of artemetherClose monitoring of artemether therapeutic efficacy (i.e parasite count on blood smear and clinical signs and symptoms of clinical improvement). Co-administration of EFV with artesunate plus amodiaquine may result in significant LFT elevations.
AstemizoleMay significantly increase astemizole serum levelContraindicated due to the potential for cardiac arrhythmias. Recommended alternative antihistamine: loratadine, fexofenadine, desloratidine, or cetirizine.
Atorvastatin Atorvastatin: AUC decreased by 43%.May require atorvastatin dose increase with close monitoring of LFTs and CPK.
ATV ATV AUC: decreased 74%; Cmin: decreased 93% (without RTV co-administration) ATV AUC: increased 241%; Cmin: increased 671% (with RTV co-administration).Recommended dosing: ATV 400 mg + RTV 100 mg once-daily + EFV 600 mg qhs(consider ATV TDM esp. in PI-experienced patients). Unboosted ATV (without RTV) not recommended with EFV.
AzathioprineInteraction unlikelyApplies to all PIs and NNRTIs: Use standard dose.
Azithromycin  Azithromycin AUC unchangedNo significant interaction. Use standard dose.
Bepridil May increase bepridil serum concentrations. May increase risk of QTc prolongation. Contraindicated.
Buprenorphine Buprenorphine AUC and Cmin decreased by 50%. EFV not affected. No withdrawal symptoms noted when buprenorphine Cmin decreased from 0.85 ng/ml to 0.42 ng/ml. It should be noted that withdrawal symptoms may not be seen until a decrease to 0.23 ng/ml. Use standard dose buprenorphine with titration to therapeutic effect.
Bupropion Bupropion AUC decreased 55%. Titrate to therapeutic effect.
CarbamazepineEfavirenz AUC decreased by 34% and carbamazepine AUC decreased by 27%. Avoid co-administration. Consider alternative anticonvulsant (e.g., valproic acid, lamotrigine, levetiracetam, or topiramate). With coadministration, monitor carbamazepine levels and consider efavirenz TDM.
CaspofunginMay decrease caspofungin serum level.Monitor for caspofungin therapeutic failure, may need to increase dose to 70 mg/d.
CetirizineEFV: no significant change cetirizine: no changeNo significant interaction. Use standard dose of both drugs.
CisaprideMay increase cisapride serum level.Contraindicated due to potential for cardiac arrhythmias. Recommended alternative: metoclopramide.
Clarithromycin Clarithromycin AUC: decreased 39%; 14-hydroxyclarithromycin AUC: increased 34%.Clinical significance unknown. High incidence of rash seen in healthy volunteer receiving this combination. Consider alternative macrolide (azithromycin).
CocaineMay theoretically increase serum level of hepatotoxic metabolite.Avoid illicit drugs for obvious reasons.
CyclophosphamideMay decrease serum level of cyclophosphamide.No data. Monitor for chemotherapeutic response. Cyclophosphamide dose may need to be increased.
CyclosporineMay significantly decrease serum level of cyclosporine.Monitor serum level of cyclosporine closely with co-administration. Cyclosporin dose may need to be increased.
Diltiazem (and other dihydropyridines calcium channel blockers: nifedipine, amlodipine)Diltiazem AUC decreased by 69% with co-administration. EFV AUC increased by 11%. Titrate diltiazem dose to effect. Higher diltiazem and other Ca++ channel blocker doses may be needed.
DocetaxelMay decrease serum level of docetaxel.No data. Docetaxel dose may need to be increased.
EchinaceaMay decrease EFV serum level. Echinacea decreased CYP3A4 substrate (midazolam) by 23%.Clinical significance unknown but should avoided until the safety of this combination is further evaluated.
Ergot derivativesMay significantly increase serum level of ergotamine resulting in acute ergot toxicity.Contraindicated. Consider alternative agent for migraine such as sumatriptan but not eletriptan, since it is a CYP3A4 substrate and significant drug-drug interaction occurred with CYP3A4 inhibitor.
Ethinyl EstradiolEthinyl estradiol AUC increased 37%.Clinical significance unknown. No data on progesterone component of oral contraceptive available. Alternative form of birth control should be recommended. Contraceptive failures have been reported with implantable hormonal contraceptive.
EtoposideMay decrease serum level of etoposide.No data. Etoposide dose may need to be increased.
FamotidineNo significant interaction.Use standard dose.
Fatty meal (54% fat) or low fat meal (4%)EFV AUC increased by 50% and 22% with high fat and low fat meal, respectively. Fatty meal increased EFV tabs Cmax by 79% and EFV caps Cmax by 51%. Manufacturer recommends taking EFV on an empty stomach due to the potential for increased CNS side effect from high EFV Cmax. May not be necessary after initial side effects have resolved.
Fluconazole Fluconazole AUC increased 16%.No significant interaction. Use standard dose.
FluoxetineEFV AUC not significantly affected by SSRI (population PK).No significant interaction. Use standard dose.
FPV APV Cmin decreased by 36% (dose used FPV 1400 mg once-daily plus RTV 200 mg once-daily). APV Cmin decreased by 17% (dose used FPV 700 mg twice-daily + RTV100 mg twice-daily).Recommended dosing: FPV 1400 mg + RTV 300 mg once-daily (in PI-naive pts only) or FPV 700 mg twice-daily + RTV 100 mg twice-daily + EFV 600 mg qhs.
Garlic supplement No data.Reduction on SQV serum level. No data with EFV. Avoid co-administration.
Heroin (Diamorphine)Drug interactions unlikely.Interaction unlikely but illicit drug use should be avoided for obvious reasons.
IDV IDV AUC: decreased 19%; Cmin: decreased 48%.Clinically significant: Recommended dose: IDV 1000 mg q8h + EFV 600 mg qhs OR IDV 800 mg twice-daily + RTV 200 mg twice-daily + EFV 600 mg qhs.
IfosphamideMay decrease serum level of ifosphamide.Applies to EFV and NVP: No data. Ifosphamide dose may need to be increased.
Itraconazole  Itraconazole AUC decreased by 39%. EFV AUC not affected. For invasive fungal infections, monitor itraconazole serum levels with co-administration. Consider alternative antifungal (i.e. fluconazole: no significant interaction).
Ketoconazole May decrease ketoconazole serum levels.May need to increase ketoconazole dose (i.e. fluconazole: no significant interaction).
Levonorgestrel Levonorgestrel AUC decreased 56%. Use a second form of contraception with EFV co-administration.
Lorazepam No significant change.Use standard dose.
Lovastatin May decrease lovastatin serum concentrations. No data. Consider atorvastatin.
LPV/r LPV AUC decreased (non-significant); Cmin decreased 39%.Clinically significant: Consider LPV/r600/150 mg (3tabs) twice-daily + EFV 600 mg qhs, especially in PI-experienced pts. Standard dose of 400/100 mg twice-daily may be adequate in PI-naive pts.
Medroxyprogesterone (DMPA) No significant drug interaction. EFV AUC was not significantly affected.DMPA concentrations were not reported.Efficacy of DMPA was not affected by EFV co-administration. Use standard dose of both drugs. Counsel patient on the potential for teratogenicity of EFV.
Mefloquine May decrease serum level of mefloquine.If available consider mefloquine serum level monitoring. Close monitoring of mefloquine therapeutic efficacy (i.e. parasite count on blood smear and clinical signs and sx of clinical improvement).
Methadone Methadone AUC: decreased 57%.Monitor for opiate withdrawal. May need to increase the maintenance dose of methadone.
Midazolam May increase midazolam level.Do not co-administer. Consider lorazepam (not significantly affected by EFV), oxazepam, or temazepam.
Milk thistle No data.Data limited to interaction study with milk thistle and IDV. IDV AUC unchanged; IDV Cmin decreased by 47%. Clinical significance unknown. Avoid co-administration.
MycophenolateInteraction unlikely. No significant interaction observed with NVP.No significant interaction observed with NVP. Use standard dose.
Paclitaxel May decrease serum level of paclitaxel.Applies to EFV and NVP: No data. Monitor for chemotherapeutic response. Paclitaxel dose may need to be increased.
ParoxetineParoxetine AUC not affected.No significant interaction. Use standard dose.
PhenobarbitalEFV and anticonvulsants levels may be decreased.Consider alternative anticonvulsants (i.e. valproic acid, lamotrigine, levetiracetam, or topiramate). With co-administration, monitor anticonvulsants level and consider EFV TDM.
PhenytoinEFV and anticonvulsants levels may be decreased.Consider alternative anticonvulsants (i.e. valproic acid, lamotrigine, levetiracetam, or topiramate). With co-administration, monitor anticonvulsants level and consider EFV TDM.
Pimozide May increase risk of cardiac arrhythmias Contraindicated.
Posaconazole Posaconazole AUC decreased 50%. Avoid co-administration if possible; consider alternative antifungal. With co-administration TDM recommended. For invasive fungal disease, consider posaconazole 400 mg q8h.
Pravastatin Pravastatin AUC decreased 44%.Clinical significance unknown. May need to increase dose of pravastatin.
Raltegravir Raltegravir AUC decreased by 36%, but Cmin not significantly affected. Dose: RAL 400 mg twice-daily + EFV 600 mg qhs.
Rifabutin Rifabutin AUC: decreased 38% No change in EFV AUC.Recommended dosing: Increase rifabutin to 450 mg/d or 600 mg 3x/wk with EFV 600 mg qhs.
Rifapentine EFV serum levels may be significantly decreased.Avoid co-administration. Consider using rifabutin with dose adjustment.
RosiglitazoneEFV Cmin decreased by 6% (non-significant) (n=10).Use standard dose.
Rosuvastatin Other CYP3A4 inhibitor (i.e erythromycin) did not affect rosuvastatin serum level.Rosuvastatin AUC and Cmax unexpectedly increased 2.1 and 4.7-fold at steady state with LPV/r co-administration. Despite increased rosuvastatin exposure, the LDL-lowering effects were attenuated with LPV/r co-administration. Close monitoring recommended due to limited clinical data.
SertralineSertraline AUC decreased 39%.Titrate sertraline to effect.
Simvastatin Simvastatin: AUC decreased by 68%.May require simvastatin dose increase with close monitoring of LFTs and CPK.
SirolimusMay significantly decrease serum level of sirolimus.Applies to EFV and NVP: dose sirolimus based on serum level. May need to increase sirolimus dose.
St. John's wortNot studied, may decrease EFV levels.Contraindicated. Use an alternative (more effective) antidepressant.
TacrolimusMay significantly decrease serum level of tacrolimus.Dose tacrolimus based on serum level. May need to increase tacrolimus dose.
TamoxifenMay decrease serum level of tamoxifen.No data. Monitor for chemotherapeutic response. Tamoxifen dose may need to be increased.
TeniposideMay decrease serum level of teniposide.No data. Monitor for chemotherapeutic response. Teniposide dose may need to be increased.
TerfenadineMay significantly increase terfenadine serum level.Contraindicated due to the potential for cardiac arrhythmias. Recommended alternative antihistamine: loratadine, fexofenadine, desloratidine, or cetirizine.
THCBased on data with NFV and IDV interactions are unlikely.Applies to PIs and NNRTIs: Interactions are unlikely but illicit drug use should be avoided for obvious reasons.
Triazolam May increase triazolam serum level.Contraindicated. Consider lorazepam (not significantly affected by EFV), oxazepam, or temazepam.
VinblastineMay decrease serum level of vinblastine.Applies to EFV and NVP: No data. Monitor for chemotherapeutic response. Vinblastine dose may need to be increased.
VincristineMay decrease serum level of vincristine.Applies to EFV and NVP: No data. Monitor for chemotherapeutic response. Vincristine dose may need to be increased.
Voriconazole EFV (400 mg PO once-daily) decreased steady state voriconazole (200 mg q12h) AUC by 77%. EFV AUC was increased by 44%. No significant change in voriconazole and EFV AUC with voriconazole 400 mg q12h plus EFV 300 mg qhs.EFV should not be co-administered with voriconazole at the standard doses. Dose: EFV 300 mg qhs plus voriconazole 400 mg twice-daily. Monitor voriconazole Cmin (target Cmin >2 mcg/mL). Consider EFV TDM.
WarfarinNot studied; may increase or decrease warfarin effects;monitor INR and adjust warfarin as indicated.Monitor INR and adjust warfarin as indicated.

RESISTANCE

  • K103N: Most common mutation selected by EFV, resulting in high-level resistance to EFV, NVP, DLV.
  • Y181 mutations: 181C/I: resistance to NPV, DLV, low-level resistance to EFV (minimal clinical data on use of EFV with 181C/I). 181C can partially reverse TAM-mediated AZT, TDF resistance to V108I
  • Y188 mutations: 188L high-level resistance to NVP, EFV, intermediate resistance to DLV; 188C: high-level resistance to NVP, low-level resistance to EFV, DLV; 188H: low-level resistance to NVP, EFV, DLV.
  • G190 mutations: 190A: high-level resistance to NVP, intermediate resistance to EFV; 190S: high-level resistance to NPV, EFV; both cause hypersusceptibility to DLV (unknown clinical significance).
  • L100I: intermediate resistance to EFV, DLV; low-level resistance to NVP; can partially reverse TAM-mediated AZT, TDF resistance.
  • V106 mutations: 106A: low-level EFV resistance, high-level NPV resistance, intermediate DLV resistance; 106M: high-level resistance to EFV, NPV, intermediate resistance to DLV; 106I: not associated with resistance .
  • P225H: increases EFV resistance when combined with other NNRTI mutations.
  • V108I: low-level resistance to EFV and other NNRTIs. Clinically insignificant when present as sole mutation.

PHARMACOLOGY

Pharmacology

COMMENTS

  • Pros: Multiple studies demonstrating potency and durability, including in pts with high VL and/or low CD4; convenient (1 pill once-daily), including co-formulation with TDF and FTC (Atripla); generally well tolerated; minimal long-term toxicity; less hepatotoxicity and less severe rash than with NVP; long half-life (forgiving of delayed or missed doses); a preferred agent in DHHS guidelines with more rapid 1st phase virologic decay and superior virologic efficacy compared to LPV/r containing regimen in ACTG 5142;
  • Cons: Early CNS side effects common and require pt education/counseling; more hyperlipidemia than with NVP (though less than with most PIs); low genetic barrier (single point mutation) to resistance; long-half life may increase risk of resistance in pts who interrupt therapy. Lower CD4 increase and more lipoatrophy than with LPV/r in ACTG 5142. (Lipoatrophy difference probably applies only to d4T- or AZT-containing regimens.)

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