Viekira Pak Side Effects
Generic Name: dasabuvir / ombitasvir / paritaprevir / ritonavir
Note: This document contains side effect information about dasabuvir / ombitasvir / paritaprevir / ritonavir. Some of the dosage forms listed on this page may not apply to the brand name Viekira Pak.
For the Consumer
Applies to dasabuvir / ombitasvir / paritaprevir / ritonavir: oral tablet extended release
Other dosage forms:
Along with its needed effects, dasabuvir / ombitasvir / paritaprevir / ritonavir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking dasabuvir / ombitasvir / paritaprevir / ritonavir:Incidence not known
- Blistering, peeling, or loosening of the skin
- dark-colored urine
- general feeling of tiredness or weakness
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- red skin lesions, often with a purple center
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain, continuing
- unusual tiredness or weakness
- yellow eyes or skin
Some side effects of dasabuvir / ombitasvir / paritaprevir / ritonavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, scaly skin
- hives or welts, or skin rash
- increased sensitivity of the skin to sunlight
- lack or loss of strength
- redness or other discoloration of the skin
- severe sunburn
- trouble sleeping
For Healthcare Professionals
Applies to dasabuvir / ombitasvir / paritaprevir / ritonavir: oral kit, oral tablet extended release
Side effects reported more often with this product in combination with ribavirin compared to placebo were fatigue, nausea, pruritus, other skin reactions, insomnia, and asthenia; most were mild to moderate in severity. Less than 1% of patients permanently discontinued therapy (with or without ribavirin) due to side effects.
In patients with genotype 1 hepatitis C virus (HCV) infection (including those with cirrhosis) using this product, the most common side effects were fatigue and nausea. Therapy was permanently discontinued due to side effects in 1.2% of patients; 1.3% interrupted therapy due to side effects. Ribavirin dose was reduced due to side effects in 7.7% of patients.
In patients with genotype 1 HCV infection using ombitasvir/paritaprevir/ritonavir plus dasabuvir without ribavirin, pruritus was the only side effect reported in at least 5% of patients when compared to studies including placebo and ombitasvir/paritaprevir/ritonavir plus dasabuvir and ribavirin. Therapy was permanently discontinued due to side effects in 0.3% of patients; 0.5% interrupted therapy due to side effects.
In patients with compensated cirrhosis using this product with ribavirin, fatigue, skin reactions, and dyspnea were reported more often in those treated for 24 weeks than for 12 weeks. Most side effects occurred during the first 12 weeks. Therapy was permanently discontinued due to side effects in 2% of patients.
The most common side effects reported with this product in combination with ribavirin in HCV/HIV-1 coinfected patients on stable antiretroviral therapy were fatigue, insomnia, nausea, headache, pruritus, cough, irritability, and ocular icterus.
The most common side effects reported with this product in combination with ribavirin in 34 post-liver transplant patients with recurrent HCV infection were fatigue, headache, cough, diarrhea, insomnia, asthenia, nausea, muscle spasms, and rash.
If applicable, the manufacturer product information for ribavirin should be consulted for ribavirin-associated side effects.[Ref]
Very common (10% or more): Elevated total bilirubin (up to 54%), elevated ALT (up to 25%)
Frequency not reported: Drug-related liver injury, jaundice, hyperbilirubinemia
Postmarketing reports: Hepatic decompensation, hepatic failure[Ref]
Grade 3 (greater than 3 to 10 times the upper limit of normal [3 to 10 x ULN]) and grade 4 (greater than 10 x ULN) total bilirubin elevations have been reported in up to 9.7% and 0.1% of patients, respectively. Grade 3 (greater than 5 to 20 x ULN) and grade 4 (greater than 20 x ULN) ALT elevations have been reported in up to 1.1% and up to 0.5% of patients, respectively.
Post-baseline bilirubin elevations (at least 2 x ULN) occurred in 15% of patients using this product with ribavirin compared to 2% of those using this product alone. These increases were primarily indirect and associated with inhibition of OATP1B1/1B3 (bilirubin transporters) by paritaprevir and ribavirin-induced hemolysis. Bilirubin elevations occurred after therapy initiation, peaked by week 1 of the study, and usually resolved with ongoing therapy. Elevated bilirubin was not associated with elevated serum ALT.
Elevations in total bilirubin greater than 2 x ULN (mostly indirect) were reported in 34 of 63 HCV/HIV-1 coinfected patients using this product with ribavirin. At the time of bilirubin elevation, 15 of these patients were also using atazanavir and 9 patients also reported ocular icterus, jaundice, or hyperbilirubinemia. No concurrent elevations of aminotransferases occurred with hyperbilirubinemia.
About 1% of patients had post-baseline serum ALT levels greater than 5 times the upper limit of normal (5 x ULN) during therapy; incidence increased to 25% (4/16) in women concurrently using a product containing ethinyl estradiol. Clinically relevant ALT elevations were reported in 2 of 59 women using estrogens other than ethinyl estradiol (e.g., estradiol, conjugated estrogens [hormone replacement therapy]).
ALT elevations were usually asymptomatic, occurred during the first 4 weeks of therapy (20 days [mean]; range: 8 to 56 days), and resolved with continued use. Most ALT elevations were assessed as drug-related liver injury. Elevated ALT was usually not associated with elevated bilirubin. Cirrhosis was not a risk factor for elevated ALT.
Hepatic decompensation and hepatic failure (including liver transplantation or fatal outcomes) have been reported in patients using ombitasvir/paritaprevir/ritonavir (with and without dasabuvir and with and without ribavirin). Most patients with these severe outcomes had evidence of advanced/decompensated cirrhosis before starting therapy. Cases were generally reported within 1 to 4 weeks of starting therapy and characterized by acute onset of rising direct serum bilirubin levels without increases in ALT together with clinical signs/symptoms of hepatic decompensation.[Ref]
Very common (10% or more): Fatigue (up to 50%), asthenia (up to 24%)[Ref]
Fatigue was reported in 48% of HCV/HIV-1 coinfected patients using this product with ribavirin.
Fatigue (50%) and asthenia (24%) were reported in post-liver transplant patients using this product with ribavirin.[Ref]
Headache was reported in 16% of HCV/HIV-1 coinfected patients and 44% of post-liver transplant patients using this product with ribavirin.[Ref]
Very common (10% or more): Headache (up to 44%)
Common (1% to 10%): Dizziness[Ref]
Cough was reported in 11% of HCV/HIV-1 coinfected patients and 32% of post-liver transplant patients using this product with ribavirin.[Ref]
Very common (10% or more): Cough (up to 32%)
Common (1% to 10%): Dyspnea[Ref]
Very common (10% or more): Diarrhea (26%), nausea (up to 24%)
Common (1% to 10%): Vomiting[Ref]
Nausea was reported in 17% of HCV/HIV-1 coinfected patients using this product with ribavirin.
Diarrhea (26%) and nausea (24%) were reported in post-liver transplant patients using this product with ribavirin.[Ref]
Pruritus was reported in 13% of HCV/HIV-1 coinfected patients using this product with ribavirin.
Rash was reported in 21% of post-liver transplant patients using this product with ribavirin.[Ref]
Very common (10% or more): Skin reactions (includes rash, erythema, eczema, maculopapular rash, macular rash, dermatitis, papular rash, skin exfoliation, pruritic rash, erythematous rash, generalized rash, allergic dermatitis, contact dermatitis, exfoliative rash, dermatitis, photosensitivity reaction, psoriasis, skin reaction, ulcer, urticaria; up to 24%), pruritus (includes pruritus, generalized pruritus; up to 18.7%)
Common (1% to 10%): Rash-related events, dry skin[Ref]
Muscle spasms were reported in 21% of post-liver transplant patients using this product with ribavirin.[Ref]
Very common (10% or more): Muscle spasms (21%)[Ref]
Insomnia (19%) and irritability (10%) were reported in HCV/HIV-1 coinfected patients using this product with ribavirin.
Insomnia was reported in 26% of post-liver transplant patients using this product with ribavirin.[Ref]
Very common (10% or more): Insomnia (up to 19%), irritability (10%)
Common (1% to 10%): Sleep disorder[Ref]
Very common (10% or more): Ocular icterus (10%)[Ref]
Ocular icterus was reported in 10% of HCV/HIV-1 coinfected patients using this product with ribavirin.[Ref]
Grade 2 (8 to less than 10 g/dL), grade 3 (6.5 to less than 8 g/dL), and grade 4 (less than 6.5 g/dL) hemoglobin decreases have been reported in up to 7.9%, up to 0.8%, and up to 0.3% of patients, respectively.
In phase 3 trials, the change from baseline in hemoglobin levels averaged -2.4 g/dL in patients using this product with ribavirin and -0.5 g/dL in patients using this product alone. Hemoglobin level decreased early in therapy (week 1 or 2) with further decreases through week 3. Low hemoglobin values persisted throughout therapy and returned towards baseline levels by 4 weeks after therapy. Less than 1% of patients using this product with ribavirin had hemoglobin levels decrease to less than 8 g/dL during therapy and 7% had their ribavirin dose reduced due to decreased hemoglobin levels; 3 patients received a blood transfusion and 5 required erythropoietin. Therapy was discontinued due to anemia in 1 patient. No patients using this product alone had hemoglobin levels less than 10 g/dL.
At least 1 post-baseline hemoglobin value less than 10 g/dL was reported in 7 of 63 HCV/HIV-1 coinfected patients using this product with ribavirin. Ribavirin dose was modified in 6 of these patients; no patient required a blood transfusion or erythropoietin.
In HCV/HIV-1 coinfected patients using this product with ribavirin, CD4+ T-cell count decreases averaged 47 cells/mm3 and 62 cells/mm3 by the end of 12 and 24 weeks of therapy, respectively; most returned to baseline levels posttreatment. During therapy, CD4+ T-cell counts decreased to less than 200 cells/mm3 (without a decrease in CD4%) in 2 patients. No AIDS-related opportunistic infection occurred.[Ref]
Common (1% to 10%): Anemia, hemoglobin decreased
Frequency not reported: Decreased CD4+ T-cell counts[Ref]
Postmarketing reports: Hypersensitivity reactions (including angioedema/tongue and lip swelling)[Ref]
Common (1% to 10%): Decreased appetite
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir)." AbbVie US LLC, North Chicago, IL.
Some side effects of Viekira Pak may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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- Drug class: antiviral combinations
Other brands: Viekira XR
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