REYATAZ (Page 5 of 20)

6.1 Clinical Trial Experience

Adverse Reactions in Treatment-Naive Adult 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 were 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 7 and 8, respectively.

Table 7: Selected Adverse Reactionsa of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Naive Patients,b Study AI424-138
* 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.

96 weeksc REYATAZ 300 mg with ritonavir100 mg (once daily) and tenofovirwith emtricitabined (n=441)

96 weeksc lopinavir 400 mg with ritonavir100 mg (twice daily) and tenofovirwith emtricitabined (n=437)

Digestive System

Nausea

4%

8%

Jaundice/scleral icterus

5%

*

Diarrhea

2%

12%

Skin and Appendages

Rash

3%

2%

Table 8: Selected Adverse Reactionsa of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Naive Patients,b Studies AI424-034, AI424-007, and AI424-008
* 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.

Study AI424-034

Studies AI424-007, -008

64 weeksc

REYATAZ400 mg once daily+ lamivudine +zidovudinee (n=404)

64 weeksc

efavirenz600 mg once daily+ lamivudine +zidovudinee (n=401)

120 weeksc,d

REYATAZ400 mg once daily+ stavudine +lamivudine ordidanosine(n=279)

73 weeksc,d

nelfinavir750 mg TID or1250 mg BID +stavudine +lamivudine ordidanosine(n=191)

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%

Adverse Reactions in Treatment-Experienced Adult 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 9.

Table 9: Selected Adverse Reactionsa of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Experienced Patients,b Study AI424-045
* 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.

48 weeksc REYATAZ/ritonavir 300/100 mgonce daily + tenofovir + NRTI(n=119)

48 weeksc lopinavir/ritonavir 400/100 mgtwice dailyd + tenofovir + NRTI(n=118)

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%

*

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