atazanavir sulfate
Dosage Form: capsule, gelatin coated
FULL PRESCRIBING INFORMATION
Indications and Usage for Reyataz
Reyataz® (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 96 weeks duration in antiretroviral-naive and 48 weeks duration in antiretroviral-treatment-experienced adult and pediatric patients at least 6 years of age.
The following points should be considered when initiating therapy with Reyataz:
- In Study AI424-045, Reyataz/ritonavir and lopinavir/ritonavir were similar for the primary efficacy outcome measure of time-averaged difference in change from baseline in HIV RNA level. This study was not large enough to reach a definitive conclusion that Reyataz/ritonavir and lopinavir/ritonavir are equivalent on the secondary efficacy outcome measure of proportions below the HIV RNA lower limit of detection [see Clinical Studies (14.2)].
- The number of baseline primary protease inhibitor mutations affects the virologic response to Reyataz/ritonavir [see Clinical Pharmacology (12.4)].
Reyataz Dosage and Administration
General Dosing Recommendations:
- Reyataz Capsules must be taken with food.
- Do not open the capsules.
- The recommended oral dosage of Reyataz depends on the treatment history of the patient and the use of other coadministered drugs. When coadministered with H2-receptor antagonists or proton-pump inhibitors, dose separation may be required [see Dosage and Administration (2.1)].
- When coadministered with didanosine buffered or enteric-coated formulations, Reyataz should be given (with food) 2 hours before or 1 hour after didanosine.
- Reyataz without ritonavir is not recommended for treatment-experienced adult or pediatric patients with prior virologic failure [see Clinical Studies (14)].
- Efficacy and safety of Reyataz with ritonavir in doses greater than 100 mg once daily have not been established. The use of higher ritonavir doses might alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended. Prescribers should consult the complete prescribing information for NORVIR® (ritonavir) when using this agent.
Recommended Adult Dosage
Table 1 summarizes the recommended Reyataz dosing regimen in adults. All Reyataz dosing regimens are to be administered as a single dose with food.
| Treatment-Naive Patients | Reyataz 300 mg with ritonavir 100 mg once daily |
| If unable to tolerate ritonavir | Reyataz 400 mg once daily |
| When combined with any of the following: Tenofovir H2-receptor antagonist Proton-pump inhibitor | Reyataz 300 mg with ritonavir 100 mg once daily |
| • The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 40 mg twice daily. Administer Reyataz and ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist. • If unable to tolerate ritonavir, administer Reyataz 400 mg once daily at least 2 hours before and at least 10 hours after the H2-receptor antagonist. No single dose of the H2-receptor antagonist should exceed a dose comparable to famotidine 20 mg and the total daily dose should not exceed a dose comparable to famotidine 40 mg. • The proton-pump inhibitor dose should not exceed a dose comparable to omeprazole 20 mg daily and must be taken approximately 12 hours prior to Reyataz and ritonavir. | |
| When combined with efavirenz | Reyataz 400 mg with ritonavir 100 mg once daily |
| • Efavirenz should be administered on an empty stomach, preferably at bedtime. | |
| Treatment-Experienced Patients | Reyataz 300 mg with ritonavir 100 mg once daily |
| Do not coadminister with proton-pump inhibitors or efavirenz in treatment-experienced patients. | |
| When given with an H2-receptor antagonist | Reyataz 300 mg with ritonavir 100 mg once daily |
| • The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice daily. Administer Reyataz and ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist. | |
| When given with both tenofovirand an H2-receptor antagonist | Reyataz 400 mg with ritonavir 100 mg once daily |
| • The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice daily. Administer Reyataz and ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist. | |
[For these drugs and other antiretroviral agents for which dosing modification may be appropriate, see Drug Interactions (7).]
Recommended Pediatric Dosage
The recommended daily dosage of Reyataz for pediatric patients (6 to less than 18 years of age) is based on body weight and should not exceed the recommended adult dosage. Reyataz Capsules must be taken with food. The data are insufficient to recommend dosing of Reyataz for any of the following: (1) patients less than 6 years of age, (2) without ritonavir in any pediatric patient less than 13 years of age, and (3) patients less than 40 kg receiving concomitant tenofovir, H2-receptor antagonists, or proton-pump inhibitors.
The recommended dosage of Reyataz with ritonavir in pediatric patients at least 6 years of age is shown in Table 2.
| Body Weight | Reyataz dose | ritonavir dose |
|---|---|---|
| a The Reyataz and ritonavir dose should be taken once daily with food. | ||
| 15 kg to less than 20 kg | 150 mg | 100 mg |
| 20 kg to less than 40 kg | 200 mg | 100 mg |
| at least 40 kg | 300 mg | 100 mg |
For treatment-naive patients at least 13 years of age and at least 40 kg, who are unable to tolerate ritonavir, the recommended dose is Reyataz 400 mg (without ritonavir) once daily with food. For patients at least 13 years of age and at least 40 kg receiving concomitant tenofovir, H2-receptor antagonists, or proton-pump inhibitors, Reyataz should not be administered without ritonavir.
Pregnancy
Dosing During Pregnancy and the Postpartum Period:
- Reyataz should not be administered without ritonavir.
- Reyataz should only be administered to pregnant women with HIV-1 strains susceptible to atazanavir.
- For pregnant patients, no dose adjustment is required for Reyataz with the following exceptions:
- For treatment-experienced pregnant women during the second or third trimester, when Reyataz is
coadministered with either an H2-receptor antagonist or tenofovir, Reyataz 400 mg with ritonavir
100 mg once daily is recommended. There are insufficient data to recommend a Reyataz dose
for use with both an H2-receptor antagonist and tenofovir in treatment-experienced pregnant
women.
- For treatment-experienced pregnant women during the second or third trimester, when Reyataz is
- No dose adjustment is required for postpartum patients. However, patients should be closely monitored for
adverse events because atazanavir exposures could be higher during the first 2 months after delivery. [See
Use in Specific Populations (8.1) and Clinical Pharmacology (12.3).]
Renal Impairment
For patients with renal impairment, including those with severe renal impairment who are not managed with hemodialysis, no dose adjustment is required for Reyataz. Treatment-naive patients with end stage renal disease managed with hemodialysis should receive Reyataz 300 mg with ritonavir 100 mg. Reyataz should not be administered to HIV-treatment-experienced patients with end stage renal disease managed with hemodialysis. [See Use in Specific Populations (8.7).]
Hepatic Impairment
Reyataz should be used with caution in patients with mild-to-moderate hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh Class B) who have not experienced prior virologic failure, a dose reduction to 300 mg once daily should be considered. Reyataz should not be used in patients with severe hepatic impairment (Child-Pugh Class C). Reyataz/ritonavir has not been studied in subjects with hepatic impairment and is not recommended. [See Warnings and Precautions (5.5) and Use in Specific Populations (8.8).]
Dosage Forms and Strengths
- 100 mg capsule with blue cap and white body, printed with white ink “BMS 100 mg” on the cap and with blue ink “3623” on the body.
- 150 mg capsule with blue cap and powder blue body, printed with white ink “BMS 150 mg” on the cap and with blue ink “3624” on the body.
- 200 mg capsule with blue cap and blue body, printed with white ink “BMS 200 mg” on the cap and with white ink “3631” on the body.
- 300 mg capsule with red cap and blue body, printed with white ink “BMS 300 mg” on the cap and with white ink “3622” on the body.
Contraindications
Reyataz (atazanavir sulfate) is contraindicated:
- in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product.
- when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These and other contraindicated drugs are listed in Table 3.
| Drug Class | Drugs within class that are contraindicated with Reyataz | Clinical Comment |
|---|---|---|
| a See Drug Interactions, Table 13 (7) for parenterally administered midazolam. | ||
| b See Drug Interactions, Table 13 (7) for sildenafil when dosed as VIAGRA® for erectile dysfunction. | ||
| Alpha 1-Adrenoreceptor Antagonist | Alfuzosin | Potential for increased alfuzosin concentrations, which can result in hypotension. |
| Antimycobacterials | Rifampin | Rifampin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect and development of resistance. |
| Antineoplastics | Irinotecan | Atazanavir inhibits UGT1A1 and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities. |
| Benzodiazepines | Triazolam, orally administered midazolama | Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with Reyataz may cause large increases in the concentration of these benzodiazepines. Potential for serious and/or life-threatening events such as prolonged or increased sedation or respiratory depression. |
| Ergot Derivatives | Dihydroergotamine, ergotamine, ergonovine, methylergonovine | Potential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues. |
| GI Motility Agent | Cisapride | Potential for serious and/or life-threatening reactions such as cardiac arrhythmias. |
| Herbal Products | St. John’s wort (Hypericum perforatum) | Patients taking Reyataz should not use products containing St. John’s wort because coadministration may be expected to reduce plasma concentrations of atazanavir. This may result in loss of therapeutic effect and development of resistance. |
| HMG-CoA Reductase Inhibitors | Lovastatin, simvastatin | Potential for serious reactions such as myopathy including rhabdomyolysis. |
| Neuroleptic | Pimozide | Potential for serious and/or life-threatening reactions such as cardiac arrhythmias. |
| PDE5 Inhibitor | Sildenafilb when dosed as REVATIO® for the treatment of pulmonary arterial hypertension | A safe and effective dose in combination with Reyataz has not been established for sildenafil (REVATIO®) when used for the treatment of pulmonary hypertension. There is increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, priapism, and syncope). |
| Protease Inhibitors | Indinavir | Both Reyataz and indinavir are associated with indirect (unconjugated) hyperbilirubinemia. |
Warnings and Precautions
Drug Interactions
See Table 3 for a listing of drugs that are contraindicated for use with Reyataz due to potentially life-threatening adverse events, significant drug interactions, or loss of virologic activity. [See Contraindications (4).] Please refer to Table 13 for established and other potentially significant drug interactions [see Drug Interactions (7.3)].
Cardiac Conduction Abnormalities
Atazanavir has been shown to prolong the PR interval of the electrocardiogram in some patients. In healthy volunteers and in patients, abnormalities in atrioventricular (AV) conduction were asymptomatic and generally limited to first-degree AV block. There have been reports of second-degree AV block and other conduction abnormalities [see Adverse Reactions (6.4) and Overdosage (10)]. In clinical trials that included electrocardiograms, asymptomatic first-degree AV block was observed in 5.9% of atazanavir-treated patients (n=920), 5.2% of lopinavir/ritonavir-treated patients (n=252), 10.4% of nelfinavir-treated patients (n=48), and 3.0% of efavirenz-treated patients (n=329). In Study AI424-045, asymptomatic first-degree AV block was observed in 5% (6/118) of atazanavir/ritonavir-treated patients and 5% (6/116) of lopinavir/ritonavir-treated patients who had on-study electrocardiogram measurements. Because of limited clinical experience in patients with preexisting conduction system disease (eg, marked first-degree AV block or second- or third-degree AV block), atazanavir should be used with caution in these patients. [See Clinical Pharmacology (12.2).]
Atazanavir in combination with diltiazem increased diltiazem plasma concentration by 2-fold with an additive effect on the PR interval. When used in combination with atazanavir, a dose reduction of diltiazem by one-half should be considered and ECG monitoring is recommended. In a pharmacokinetic study between atazanavir 400 mg once daily and atenolol 50 mg once daily, no clinically significant additive effect of atazanavir and atenolol on the PR interval was observed. Dose adjustment of atenolol is not required when used in combination with atazanavir. [See Drug Interactions (7) and Clinical Pharmacology (12.2).] Pharmacokinetic studies between atazanavir and other drugs that prolong the PR interval including beta blockers [other than atenolol, see Drug Interactions (7)], verapamil, and digoxin have not been performed. An additive effect of atazanavir and these drugs cannot be excluded; therefore, caution should be exercised when atazanavir is given concurrently with these drugs, especially those that are metabolized by CYP3A (eg, verapamil).
Rash
In controlled clinical trials, rash (all grades, regardless of causality) occurred in approximately 20% of patients treated with Reyataz. The median time to onset of rash in clinical studies was 7.3 weeks and the median duration of rash was 1.4 weeks. Rashes were generally mild-to-moderate maculopapular skin eruptions. Treatment-emergent adverse reactions of moderate or severe rash (occurring at a rate of ≥2%) are presented for the individual clinical studies [see Adverse Reactions (6.1)]. Dosing with Reyataz was often continued without interruption in patients who developed rash. The discontinuation rate for rash in clinical trials was <1%. Reyataz should be discontinued if severe rash develops. Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions have been reported in patients receiving Reyataz. [See Contraindications (4).]
Hyperbilirubinemia
Most patients taking Reyataz experience asymptomatic elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT). This hyperbilirubinemia is reversible upon discontinuation of Reyataz. Hepatic transaminase elevations that occur with hyperbilirubinemia should be evaluated for alternative etiologies. No long-term safety data are available for patients experiencing persistent elevations in total bilirubin >5 times ULN. Alternative antiretroviral therapy to Reyataz may be considered if jaundice or scleral icterus associated with bilirubin elevations presents cosmetic concerns for patients. Dose reduction of atazanavir is not recommended since long-term efficacy of reduced doses has not been established. [See Adverse Reactions (6.1, 6.2).]
Hepatotoxicity
Caution should be exercised when administering Reyataz to patients with hepatic impairment because atazanavir concentrations may be increased. [See Dosage and Administration (2.5).] Patients with underlying hepatitis B or C viral infections or marked elevations in transaminases before treatment may be at increased risk for developing further transaminase elevations or hepatic decompensation. In these patients, hepatic laboratory testing should be conducted prior to initiating therapy with Reyataz and during treatment. [See Adverse Reactions (6.3) and Use in Specific Populations (8.8).]
Nephrolithiasis
Cases of nephrolithiasis were reported during postmarketing surveillance in HIV-infected patients receiving Reyataz therapy. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made. If signs or symptoms of nephrolithiasis occur, temporary interruption or discontinuation of therapy may be considered. [See Adverse Reactions (6.4).]
Diabetes Mellitus/Hyperglycemia
New-onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and hyperglycemia have been reported during postmarketing surveillance in HIV-infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases, diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycemia persisted in some cases. Because these events have been reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between protease inhibitor therapy and these events has not been established. [See Adverse Reactions (6.4).]
Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Reyataz. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia, or tuberculosis), which may necessitate further evaluation and treatment.
Fat Redistribution
Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.
Hemophilia
There have been reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis, in patients with hemophilia type A and B treated with protease inhibitors. In some patients additional factor VIII was given. In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced. A causal relationship between protease inhibitor therapy and these events has not been established.
Resistance/Cross-Resistance
Various degrees of cross-resistance among protease inhibitors have been observed. Resistance to atazanavir may not preclude the subsequent use of other protease inhibitors. [See Clinical Pharmacology (12.4).]
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- cardiac conduction abnormalities [see Warnings and Precautions (5.2)]
- rash [see Warnings and Precautions (5.3)]
- hyperbilirubinemia [see Warnings and Precautions (5.4)]
- nephrolithiasis [see Warnings and Precautions (5.6)]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trial Experience in Adults
Treatment-Emergent Adverse Reactions in Treatment-Naive Patients
The safety profile of Reyataz in treatment-naive adults is based on 1625 HIV-1 infected patients in clinical trials. 536 patients received Reyataz 300 mg with ritonavir 100 mg and 1089 patients received Reyataz 400 mg or higher (without ritonavir).
The most common adverse reactions are nausea, jaundice/scleral icterus, and rash.
Selected clinical adverse reactions of moderate or severe intensity reported in ≥2% of treatment-naive patients receiving combination therapy including Reyataz 300 mg with ritonavir 100 mg and Reyataz 400 mg (without ritonavir) are presented in Tables 4 and 5, respectively.
| 96 weeksc | 96 weeksc | |
|---|---|---|
| Reyataz 300 mg with ritonavir 100 mg (once daily) and tenofovir with emtricitabined | lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir with emtricitabined | |
| (n=441) | (n=437) | |
| * None reported in this treatment arm. | ||
| a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. | ||
| b Based on the regimen containing Reyataz. | ||
| c Median time on therapy. | ||
| d As a fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily. | ||
| Digestive System | ||
| Nausea | 4% | 8% |
| Jaundice/scleral icterus | 5% | * |
| Diarrhea | 2% | 12% |
| Skin and Appendages | ||
| Rash | 3% | 2% |
| Study AI424-034 | Studies AI424-007, -008 | |||
|---|---|---|---|---|
| 64 weeksc Reyataz 400 mg once daily + lamivudine + zidovudinee | 64 weeksc efavirenz 600 mg once daily + lamivudine + zidovudinee | 120 weeksc,d Reyataz 400 mg once daily + stavudine + lamivudine or didanosine | 73 weeksc,d nelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or didanosine | |
| (n=404) | (n=401) | (n=279) | (n=191) | |
| * None reported in this treatment arm. | ||||
| a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. | ||||
| b Based on regimens containing Reyataz. | ||||
| c Median time on therapy. | ||||
| d Includes long-term follow-up. | ||||
| e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily. | ||||
| Body as a Whole | ||||
| Headache | 6% | 6% | 1% | 2% |
| Digestive System | ||||
| Nausea | 14% | 12% | 6% | 4% |
| Jaundice/scleral icterus | 7% | * | 7% | * |
| Vomiting | 4% | 7% | 3% | 3% |
| Abdominal pain | 4% | 4% | 4% | 2% |
| Diarrhea | 1% | 2% | 3% | 16% |
| Nervous System | ||||
| Insomnia | 3% | 3% | <1% | * |
| Dizziness | 2% | 7% | <1% | * |
| Peripheral neurologic symptoms | <1% | 1% | 4% | 3% |
| Skin and Appendages | ||||
| Rash | 7% | 10% | 5% | 1% |
Treatment-Emergent Adverse Reactions in Treatment-Experienced Patients
The safety profile of Reyataz in treatment-experienced adults is based on 119 HIV-1 infected patients in clinical trials.
The most common adverse reactions are jaundice/scleral icterus and myalgia.
Selected clinical adverse reactions of moderate or severe intensity reported in ≥2% of treatment-experienced patients receiving Reyataz/ritonavir are presented in Table 6.
| 48 weeksc Reyataz/ritonavir 300/100 mg once daily + tenofovir + NRTI | 48 weeksc lopinavir/ritonavir 400/100 mg twice dailyd + tenofovir + NRTI | |
|---|---|---|
| (n=119) | (n=118) | |
| * None reported in this treatment arm. | ||
| a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. | ||
| b Based on the regimen containing Reyataz. | ||
| c Median time on therapy. | ||
| d As a fixed-dose combination. | ||
| Body as a Whole | ||
| Fever | 2% | * |
| Digestive System | ||
| Jaundice/scleral icterus | 9% | * |
| Diarrhea | 3% | 11% |
| Nausea | 3% | 2% |
| Nervous System | ||
| Depression | 2% | <1% |
| Musculoskeletal System | ||
| Myalgia | 4% | * |
Laboratory Abnormalities in Treatment-Naive Patients
The percentages of adult treatment-naive patients treated with combination therapy including Reyataz (atazanavir sulfate) 300 mg with ritonavir 100 mg and Reyataz 400 mg (without ritonavir) with Grade 3–4 laboratory abnormalities are presented in Tables 7 and 8, respectively.
| a Based on the regimen containing Reyataz. | |||
| b Median time on therapy. | |||
| c ULN = upper limit of normal. | |||
| d As a fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily. | |||
| Variable | Limitc | 96 weeksb | 96 weeksb |
| Reyataz 300 mg with ritonavir 100 mg (once daily) and tenofovir with emtricitabined | lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir with emtricitabined | ||
| (n=441) | (n=437) | ||
| Chemistry | High | ||
| SGOT/AST | ≥5.1 x ULN | 3% | 1% |
| SGPT/ALT | ≥5.1 x ULN | 3% | 2% |
| Total Bilirubin | ≥2.6 x ULN | 44% | <1% |
| Lipase | ≥2.1 x ULN | 2% | 2% |
| Creatine Kinase | ≥5.1 x ULN | 8% | 7% |
| Total Cholesterol | ≥240 mg/dL | 11% | 25% |
| Hematology | Low | ||
| Neutrophils | <750 cells/mm3 | 5% | 2% |
| Variable | Limitd | Study AI424-034 | Studies AI424-007, -008 | ||
|---|---|---|---|---|---|
| 64 weeksb | 64 weeksb | 120 weeksb,c | 73 weeksb,c | ||
| Reyataz 400 mg once daily + lamivudine + zidovudinee | efavirenz 600 mg once daily + lamivudine + zidovudinee | Reyataz 400 mg once daily + stavudine + lamivudine or + stavudine + didanosine | nelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or + stavudine + didanosine | ||
| (n=404) | (n=401) | (n=279) | (n=191) | ||
| * None reported in this treatment arm. | |||||
| a Based on regimen(s) containing Reyataz. | |||||
| b Median time on therapy. | |||||
| c Includes long-term follow-up. | |||||
| d ULN = upper limit of normal. | |||||
| e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily. | |||||
| Chemistry | High | ||||
| SGOT/AST | ≥5.1 x ULN | 2% | 2% | 7% | 5% |
| SGPT/ALT | ≥5.1 x ULN | 4% | 3% | 9% | 7% |
| Total Bilirubin | ≥2.6 x ULN | 35% | <1% | 47% | 3% |
| Amylase | ≥2.1 x ULN | * | * | 14% | 10% |
| Lipase | ≥2.1 x ULN | <1% | 1% | 4% | 5% |
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