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Table 7 Second 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

 

Dolutegravir

Bictegravir

Cabotegravir

SPRING-2a

SINGLE

GEMINI-1 and -2b – Pooled Analysis

GS-US-380–1489a

GS-US-380–1490a

FLAIR and ATLAS – Pooled Analysis

Adverse reaction

DTG n = 411

RAL n = 411

DTG n = 414

EFV n = 419

DTG/3TC n = 716

DTG and FTC/ TDF n = 717

DTG n = 315

BIC n = 314

DTG n = 325

BIC n = 320

CAB n = 591

CAR n = 591

Diarrhea

11%

11%

17%

18%

9%

11%

13%

13%

12%

12%

–

–

Nausea

14%

13%

14%

14%

4%

7%

23%

10%

9%

8%

3%

1%

Vomiting

–

–

5%

5%

–

–

5%

4%

–

–

–

–

Fatigue

5%

4%

13%

12%

-

-

9%

6%

8%

6%

5%

 < 1%

Upper respiratory infection

6%

6%

9%

10%

8%

6%

11%

6%

7%

5%

–

–

Dizziness

6%

6%

9%

35%

–

–

–

–

1%

2%

2%

 < 1%

Headache

12%

12%

13%

13%

10%

10%

14%

11%

12%

13%

4%

 < 1%

Insomnia

5%

4%

15%

10%

4%

6%

6%

4%

4%

5%

–

–

Depression

5%

3%

6%

6%

–

–

–

–

–

–

-

–

Rash

–

–

3%

14%

–

–

–

–

–

–

2%

0%

Pyrexia

–

-

-

-

-

-

–

–

–

–

8%

0%

Injection site reactions

–

–

–

–

–

-

–

–

-

–

83%

0%

Discontinuations due to drug-related clinical adverse events

2%

2%

2%

10%

1%

1%

1%

0%

 < 1%

2%

80%

–

References

[92]

[93]

[96]

[97]

[98]

[99, 100]

  1. Dash (-) indicates that information regarding this adverse effect was not reported in the study results or was reported as < 2% for both groups
  2. 3TC lamivudine, BIC bictegravir, CAB cabotegravir, CAR current antiretroviral regimen, DTG dolutegravir, EFV efavirenz, FTC emtricitabine, RAL raltegravir, RPV rilpivirine, TDF tenofovir disoproxil fumarate
  3. aAdverse events reported as adverse events with ≥ 5% incidence in either group
  4. bAdverse events reported as adverse events with ≥ 4% incidence in either group