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Ombitasvir / paritaprevir / ritonavir Side Effects

For the Consumer

Applies to ombitasvir / paritaprevir / ritonavir: oral tablet

As well as its needed effects, ombitasvir / paritaprevir / ritonavir may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking ombitasvir / paritaprevir / ritonavir, check with your doctor immediately:

Less common:
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • dizziness
  • fever
  • headache
  • itching or rash
  • loss of appetite
  • nausea
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin
Incidence not known:
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Minor Side Effects

Some ombitasvir / paritaprevir / ritonavir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry, or scaly skin
  • increased sensitivity of the skin to sunlight
  • lack or loss of strength
  • redness or other discoloration of the skin
  • severe sunburn
  • skin rash, encrusted, scaly, and oozing
  • swelling
  • trouble sleeping

For Healthcare Professionals

Applies to ombitasvir / paritaprevir / ritonavir: oral tablet

General

The most common side effects reported in patients with genotype 1 hepatitis C virus (HCV) infection using this drug in combination with dasabuvir and ribavirin were fatigue and nausea. The most common side effects reported in patients with genotype 4 HCV infection using this drug with ribavirin were asthenia, fatigue, nausea, and insomnia; the most common side effect reported in such patients using this drug without ribavirin was asthenia.

The manufacturer product information for dasabuvir and/or ribavirin should be consulted.[Ref]

Other

Very common (10% or more): Asthenia (up to 29%), fatigue (up to 15%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 14%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 13%)[Ref]

Dermatologic

Pruritus was common during combination therapy with dasabuvir (without ribavirin) and very common during combination therapy with dasabuvir and ribavirin.

Most skin reactions were of mild severity.[Ref]

Very common (10% or more): Pruritus (includes pruritus, generalized pruritus)
Common (1% to 10%): 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, photosensitivity reaction, psoriasis, skin reaction, ulcer, urticaria)[Ref]

Hepatic

Common (1% to 10%): Elevated ALT, elevated total bilirubin, hyperbilirubinemia
Postmarketing reports: Hepatic decompensation, hepatic failure[Ref]

Combination therapy with dasabuvir and ribavirin for 12 weeks: ALT greater than 5 to 20 times the upper limit of normal (5 to 20 x ULN), ALT greater than 20 x ULN, total bilirubin greater than 3 to 10 x ULN, and total bilirubin greater than 10 x ULN were reported in 0.8%, 0.4%, 2.5%, and 0.1% of patients, respectively.

Combination therapy with dasabuvir (without ribavirin) for 12 weeks: ALT greater than 5 to 20 x ULN and total bilirubin greater than 3 to 10 x ULN were reported in 0.2% and 0.4% of patients, respectively.

Combination therapy with dasabuvir and ribavirin for 12 or 24 weeks: ALT greater than 5 to 20 x ULN, ALT greater than 20 x ULN, and total bilirubin greater than 3 to 10 x ULN were reported in 1.1%, 0.5%, and 9.7% of cirrhosis patients, respectively.

In clinical trials with this drug and dasabuvir (with and without ribavirin), about 1% of patients had post-baseline serum ALT levels greater than 5 x ULN during therapy; incidence increased to 26% in women concurrently using a product containing ethinyl estradiol. No increase in incidence of ALT elevations was reported with estrogens other than ethinyl estradiol (e.g., estradiol, conjugated estrogens).

ALT elevations were usually asymptomatic, occurred during the first 4 weeks of therapy (20 days [mean]; range: 8 to 57 days), and resolved with continued use. Elevated ALT was usually not associated with elevated bilirubin. Cirrhosis was not a risk factor for elevated ALT.

Transient serum bilirubin elevations were reported in patients using combination therapy with dasabuvir and ribavirin. 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 aminotransferase elevations.

Transient elevations in total bilirubin greater than 3 x ULN (mostly indirect) were reported in 17 (27%) HCV/HIV-1 coinfected patients using combination therapy with dasabuvir and ribavirin; 15 of these patients were also using atazanavir. No concurrent elevations of aminotransferases occurred with hyperbilirubinemia.

None of the patients infected with genotype 4 HCV reported post-baseline ALT levels greater than 5 x ULN after starting this drug.

Post-baseline bilirubin elevations (at least 2 x ULN) occurred in 5% of HCV genotype 4-infected patients using this drug with ribavirin. These increases were primarily indirect and associated with inhibition of OATP1B1/1B3 (bilirubin transporters) by paritaprevir and possibly ribavirin-induced hemolysis. Bilirubin elevations occurred soon after the start of therapy, peaked by week 1 of the study, and usually resolved with ongoing therapy. Elevated bilirubin was usually not associated with elevated serum 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 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]

Hematologic

Common (1% to 10%): Anemia, decreased hemoglobin (Hgb)[Ref]

Combination therapy with dasabuvir and ribavirin for 12 weeks: Hgb 8 to less than 10 g/dL and Hgb 6.5 to less than 8 g/dL were reported in 5.4% and 0.1% of patients, respectively.

Combination therapy with dasabuvir and ribavirin for 12 or 24 weeks: Hgb 8 to less than 10 g/dL, Hgb 6.5 to less than 8 g/dL, and Hgb less than 6.5 g/dL were reported in 7.9%, 0.8%, and 0.3% of cirrhosis patients, respectively.

At least 1 post-baseline Hgb value less than 10 g/dL was reported in 10 of 34 post-liver transplant patients using combination therapy with dasabuvir and ribavirin. Ribavirin dose was modified in 10 patients due to decreased Hgb; ribavirin was interrupted in 1 patient. Five patients (ribavirin starting dose of 1000 to 1200 mg/day) required erythropoietin; no patient required a blood transfusion.

The change from baseline in Hgb levels averaged -2.1 g/dL in patients using this drug with ribavirin and -0.4 g/dL in patients using this drug alone. Hgb level decreased early in therapy (week 1 or 2) with further decreases through week 3. Low Hgb values persisted throughout therapy and returned towards baseline levels by 4 weeks after therapy. At least 1 patient using this drug with ribavirin had a single Hgb level decrease to less than 8 g/dL during therapy and 4% had their ribavirin dose reduced due to anemia/decreased Hgb levels; no patient received a blood transfusion or erythropoietin. No patients using this drug alone had Hgb levels less than 8 g/dL.[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including angioedema)[Ref]

References

1. "Product Information. Technivie (ombitasvir / paritaprevir / ritonavir)." AbbVie US LLC, North Chicago, IL.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

It is possible that some side effects of ombitasvir / paritaprevir / ritonavir may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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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