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Dasabuvir / ombitasvir / paritaprevir / ritonavir Side Effects

For the Consumer

Applies to dasabuvir / ombitasvir / paritaprevir / ritonavir: oral tablet

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by dasabuvir / ombitasvir / paritaprevir / ritonavir. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking dasabuvir / ombitasvir / paritaprevir / ritonavir:

Less common:
  • Abdominal or stomach pain
  • bloating of the abdomen or stomach
  • dark urine
  • light-colored stools
  • nausea and vomiting
  • yellow eyes or skin
Incidence not known:
  • Blistering, peeling, or loosening of the skin
  • chills
  • cough
  • diarrhea
  • itching
  • joint or muscle pain
  • 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
  • unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with dasabuvir / ombitasvir / paritaprevir / ritonavir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Itching skin or rash
  • lack or loss of strength
  • trouble sleeping

For Healthcare Professionals

Applies to dasabuvir / ombitasvir / paritaprevir / ritonavir: oral kit, oral tablet extended release

General

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]

Hepatic

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]

Other

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]

Nervous system

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]

Respiratory

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]

Gastrointestinal

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]

Dermatologic

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]

Musculoskeletal

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]

Psychiatric

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]

Ocular

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]

Hematologic

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]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including angioedema/tongue and lip swelling)[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir)." AbbVie US LLC, North Chicago, IL.

Not all side effects for dasabuvir / ombitasvir / paritaprevir / ritonavir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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