"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
The following adverse reactions are discussed in other sections of the labeling:
- Lactic acidosis/severe hepatomegaly with steatosis [See BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Severe acute exacerbations of Hepatitis B [See BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Immune reconstitution syndrome [See WARNINGS AND PRECAUTIONS].
Adverse Reactions from Clinical Trials Experience
Clinical Trials in Adult Subjects
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. The most common adverse reactions (incidence greater than or equal to 10%, any severity) identified from any of the 3 large controlled clinical trials include headache, diarrhea nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.
Studies 301A and 303– Treatment Emergent Adverse Reactions: The most common adverse reactions that occurred in subjects receiving EMTRIVA with other antiretroviral agents in clinical trials 301A and 303 were headache, diarrhea, nausea, and rash, which were generally of mild to moderate severity. Approximately 1% of subjects discontinued participation in the clinical trials due to these events. All adverse reactions were reported with similar frequency in EMTRIVA and control treatment groups with the exception of skin discoloration which was reported with higher frequency in the EMTRIVA treated group.
A summary of EMTRIVA treatment-emergent clinical adverse reactions in Studies 301A and 303 is provided in Table 2.
Table 2 : Selected Treatment-Emergent Adverse
Reactions (All Grades, Regardless of Causality) Reported in ≥ 3% of
EMTRIVA-Treated Subjects in Either Study 301A or 303 (0–48 Weeks)
|EMTRIVA + ZDV/d4T + NNRTI/PI
|Lamivudine + ZDV/d4T + NNRTI/PI
|EMTRIVA + didanosine + efavirenz
|Stavudine + didanosine + efavirenz
|Body as a Whole|
|Abnormal dreams||2%||< 1%||11%||19%|
|a Rash event includes rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, and allergic reaction.|
Studies 301A and 303– Laboratory Abnormalities: Laboratory abnormalities in these trials occurred with similar frequency in the EMTRIVA and comparator groups. A summary of Grades 3-4 laboratory abnormalities is provided in Table 3 below.
Table 3 : Treatment-Emergent Grades 3-4 Laboratory
Abnormalities Reported in ≥ 1% of EMTRIVA-Treated Subjects in
Either Study 301A or 303
|EMTRIVA + ZDV/d4T + NNRTI/PI
|Lamivudine + ZDV/d4T + NNRTI/PI
|EMTRIVA + Didanosine + Efavirenz
|Stavudine + Didanosine + Efavirenz
|Percentage with grade 3 or grade 4 laboratory abnormality||31%||28%||34%||38%|
|ALT ( > 5.0 x ULNa)||2%||1%||5%||6%|
|AST ( > 5.0 x ULN)||3%||< 1%||6%||9%|
|Bilirubin ( > 2.5 x ULN)||1%||2%||< 1%||< 1%|
|Creatine kinase ( > 4.0 x ULN)||11%||14%||12%||11%|
|Neutrophils ( < 750 mm³)||5%||3%||5%||7%|
|Pancreatic amylase ( > 2.0 x ULN)||2%||2%||< 1%||1%|
|Serum amylase ( > 2.0 x ULN)||2%||2%||5%||10%|
|Serum glucose < 40 or > 250 mg/dL)||3%||3%||2%||3%|
|Serum lipase ( > 2.0 x ULN)||< 1%||< 1%||1%||2%|
|Triglycerides ( > 750 mg/dL)||10%||8%||9%||6%|
|a ULN = Upper limit of normal|
Study 934– Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviralna´ve subjects received either VIREAD® + EMTRIVA administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254). Adverse reactions observed in this trial were generally consistent with those seen in previous trials in treatment-experienced or treatment-na´ve subjects (Table 4).
Table 4 : Selected Treatment-Emergent Adverse
Reactionsa (Grades 2–4) Reported in ≥ 5% in Any Treatment Group in
Study 934 (0–144 Weeks)
|TDFb + EMTRIVA + EFV
|AZT/3TC + EFV
|General Disorders and Administration Site Condition|
|Infections and Infestations|
|Upper respiratory tract infections||8%||5%|
|Nervous System Disorders|
|Skin and Subcutaneous Tissue Disorders|
|a Frequencies of adverse reactions are based
on all treatment-emergent adverse events, regardless of relationship to study
b From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
c Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.
Study 934 – Laboratory Abnormalities: Significant laboratory abnormalities observed in this trial are shown in Table 5.
Table 5 : Significant Laboratory Abnormalities
Reported in ≥ 1% of Subjects in Any Treatment Group in Study 934
|TDFa + EMTRIVA + EFV
|AZT/3TC + EFV
|Any ≥ Grade 3 Laboratory Abnormality||30%||26%|
|Fasting Cholesterol ( > 240 mg/dL)||22%||24%|
|Creatine Kinase (M: > 990 U/L) (F: > 845 U/L)||9%||7%|
|Serum Amylase ( > 175 U/L)||8%||4%|
|Alkaline Phosphatase ( > 550 U/L)||1%||0%|
|AST (M: > 180 U/L) (F: > 170 U/L)||3%||3%|
|ALT (M: > 215 U/L) (F: > 170 U/L)||2%||3%|
|Hemoglobin ( < 8.0 mg/dL)||0%||4%|
|Hyperglycemia ( > 250 mg/dL)||2%||1%|
|Hematuria ( > 75 RBC/HPF)||3%||2%|
|Glycosuria (3+)||< 1%||1%|
|Neutrophils ( < 750/mm )||3%||5%|
|Fasting Triglycerides ( > 750 mg/dL)||4%||2%|
|a From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of VIREAD + EMTRIVA with efavirenz.|
Clinical Trials in Pediatric Subjects
Assessment of adverse reactions is based on data from Study 203, an open label, uncontrolled trial of 116 HIV-1-infected pediatric subjects who received emtricitabine through 48 weeks. The adverse reaction profile in pediatric subjects was generally comparable to that observed in clinical trials of EMTRIVA in adult subjects. Hyperpigmentation was more frequent in children. Additional adverse reactions identified from this trial include anemia.
Selected treatment-emergent adverse events, regardless of causality, reported in subjects during 48 weeks of treatment were the following: infection (44%), hyperpigmentation (32%), increased cough (28%), vomiting (23%), otitis media (23%), rash (21%), rhinitis (20%), diarrhea (20%), fever (18%), pneumonia (15%), gastroenteritis (11%), abdominal pain (10%), and anemia (7%). Treatment-emergent grades 3-4 laboratory abnormalities were experienced by 9% of pediatric subjects, including elevated amylase ( > 2.0 x ULN) (n=4), decreased neutrophils ( < 750/mm³) (n=3), elevated ALT ( > 5 x ULN) (n=2), elevated CPK ( > 4 x ULN) (n=2) and one subject each with elevated bilirubin ( > 3.0 x ULN), elevated GGT ( > 10 x ULN), elevated lipase ( > 2.5 x ULN), decreased hemoglobin ( < 7 g/dL), and decreased glucose ( < 40 mg/dL).
Read the Emtriva (emtricitabine) Side Effects Center for a complete guide to possible side effects
The potential for drug interactions with EMTRIVA has been studied in combination with zidovudine, indinavir, stavudine, famciclovir, and tenofovir disoproxil fumarate. There were no clinically significant drug interactions for any of these drugs. Drug interactions trials are described elsewhere in the labeling [See CLINICAL PHARMACOLOGY].
Read the Emtriva Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/22/2013
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