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. 2011 Jan;9(1):40–53. doi: 10.2174/157016211794582650

Table 4.

Summary of Specific Safety Issues, Phase III Studies

STARTMRK BENCHMRK

Raltegravir N=281 Efavirenz N=282 Raltegravir N=462; PYR=708 Placebo N=237; PYR=244

% % % Rate % Rate

Rash in Overall Population

 All 9.6 20.9 11.3 7.3 6.3 6.1
 Drug-related 1.8 13.8 2.6 1.7 3.8 3.7
 Serious 0.0 0.0 0.0 0.0 0.0 0.0
 Discontinued 0.0 1.1 0.0 0.0 0.0 0.0

Rash in Patients Who Received OBT with Darunavir

 All NA NA 17.4 10.9 4.8 3.8
 Drug-related NA NA 3.9 2.4 2.9 2.3
 Serious NA NA 0.0 0.0 0.0 0.0
 Discontinued NA NA 0.0 0.0 0.0 0.0

Rash in Patients Who Received OBT without Darunavir

 All NA NA 6.3 4.2 7.5 8.8
 Drug-related NA NA 1.6 1.1 4.5 5.3
 Serious NA NA 0.0 0.0 0.0 0.0
 Discontinued NA NA 0.0 0.0 0.0 0.0

Depression/Suicidality

 All 7.5 8.9 3.7 2.4 5.5 5.3
 Drug-related 2.5 3.9 0.6 0.4 0.8 0.8
 Serious 0.7 0.7 0.4 0.3 0.8 0.8
 Discontinued 0.0 0.4 0.0 0.0 0.0 0.0

IRIS

 All 6.8 4.6 0.4 0.3 0.4 0.4
 Drug-related 3.2 1.1 0.0 0.0 0.4 0.4
 Serious 1.8 0.7 0.4 0.3 0.0 0.0
 Discontinued 0.4 0.0 0.0 0.0 0.0 0.0

Lipodystrophy

 All 0.0 0.7 5.6 3.7 3.0 2.9
 Drug-related 0.0 0.4 4.8 3.1 3.0 2.9
 Serious 0.0 0.0 0.0 0.0 0.0 0.0
 Discontinued 0.0 0.0 0.0 0.0 0.0 0.0

Increased CK with Clinical Manifestations (Myopathy, Myositis, or Rhabdomyolysis)

 Grade 3 or 4 CK NA NA 6.7 4.4 3.4 3.3
 Discontinued Due to Laboratory AE 0.0 0.0 0.0 0.0 0.0 0.0
 Myopathy, Myositis or Rhabdomyolysis 0.4 0.0 0.2 0.1 0.4 0.4

PYR = Person Years at Risk.

N = Number of patients in each treatment group.

Events per 100 person-years, with person-years at risk (PYR) calculated based on the overall endpoint.

Determined by the investigator to be possibly, probably, or definitely drug related.

NA = Not Applicable.

Note: For BENCHMRK Studies Raltegravir and Placebo were administered with Optimized Background Therapy (OBT). For STARTMRK Raltegravir and Efavirenz were administered with tenofovir/ emtricitabine.

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