REYATAZ (Page 5 of 21)

6.1 Clinical Trial Experience

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.

Adverse Reactions in Treatment-Naive Adult Subjects

The safety profile of REYATAZ in treatment-naive adults is based on 1625 subjects with HIV-1 infection in clinical trials. 536 subjects received REYATAZ 300 mg with ritonavir 100 mg and 1089 subjects 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 subjects 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 Subjects with HIV-1 Infection,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 Administered as a fixed-dose.e As a fixed-dose product: 300 mg tenofovir DF, 200 mg emtricitabine once daily.

96 weeksc REYATAZ 300 mg with ritonavir 100 mg (once daily) and tenofovir DF/emtricitabined (n=441)

96 weeksc lopinavir/ritonavird 400 mg/100 mg (twice daily) and tenofovir DF/emtricitabinee (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 Subjects with HIV-1 Infection,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 product: 150 mg lamivudine/300 mg zidovudine twice daily.

Study AI424-034

Studies AI424-007, -008

64 weeksc

REYATAZ 400 mg (once daily) with lamivudine/ zidovudinee (n=404)

64 weeksc

efavirenz 600 mg (once daily) with lamivudine/ zidovudinee (n=401)

120 weeksc,d

REYATAZ 400 mg (once daily) with stavudine and lamivudine or didanosine (n=279)

73 weeksc,d

nelfinavir 750 mg TID or 1250 mg BID with stavudine and lamivudine or didanosine (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%

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