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Table 5 First Generation INSTIs: Selected drug-related adverse events after week 48 recorded in 2% or more patients in either treatment group

From: A clinical review of HIV integrase strand transfer inhibitors (INSTIs) for the prevention and treatment of HIV-1 infection

 

Raltegravir(RAL + FTC/TDF)

Elvitegravir(EVG/COBI/FTC/TDF)

STARTMRKa

ONCEMRKa

GS-236-0102b

GS-236-0103b

GS-292–0104/0111d

Adverse Reaction

RAL n = 281

EFV n = 282

RAL 1200 mg QD n = 531

RAL 400 mg BID n = 266

EVG/ COBI FTC/ TDF n = 348

EFV/ FTC/ TDF n = 352

EVG/ COBI/ FTC/ TDF n = 353

ATV/ RTV + FTC/ TDF n = 355

EVG/ COBI/ FTC/ TAF N = 866

EVG/ COBI/ FTC/ TDF N = 867

Diarrhea

1%

3%

2%

3%

23%

19%

22%

27%

17%

19%

Nausea

3%

4%

7%

7%

21%

14%

20%

19%

15%

17%

Vomiting

-

-

2%

1%

-

-

-

-

7%

6%

Fatigue

1%

3%

-

-

11%

13%

14%

13%

8%

8%

Upper respiratory infection

-

-

-

-

14%

11%

15%

16%

11%

13%

Dizziness

1%

6%

2%

3%

7%

24%

-

-

5%

4%

Headache

4%

5%

3%

5%

14%

10%

15%

12%

14%

13%

Insomnia

4%

3%

-

-

9%

14%

-

-

7%

6%

Depression

-

-

-

-

9%

11%

-

-

-

-

Rash

-

-

-

-

6%

12%

-

-

6%

5%

Discontinuations due to drug-related clinical adverse events

1%

4%

0%

1%

4%c

5%c

4%c

5%c

1%

1%

References

[90]

[63]

[91]

[11]

[65]

  1. Dash (-) indicates that information regarding this adverse effect was not reported in the study results
  2. ATV atazanavir, COBI cobicistat, EFV efavirenz, EVG elvitegravir, FTC emtricitabine, RAL raltegravir, RTV ritonavir, TDF tenofovir disoproxil fumarate
  3. aReported as drug-related clinical adverse events of moderate-severe intensity
  4. bReported as adverse events in ≥ 10% of patients in either group
  5. cDiscontinuations reported as patients with any treatment-emergent adverse event leading to premature discontinuation of study drug; whether they were deemed to be drug-related was not distinguished
  6. dReported as adverse events in ≥ 5% of patients in either group