- What is Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir)?
- What are the important side effects of Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir)?
- Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir) side effects list for healthcare professionals
- What drugs interact with Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir)?
What is Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir)?
The drugs work in three different ways to help stop HCV from multiplying:
- They block the effect of proteases, which are enzymes HCV uses for making new virus, leading to reduced numbers of HCV copies in the body.
- Ombitasvir blocks HCV NS5A protease, while paritaprevir blocks HCV NS3/4A protease.
- Dasabuvir blocks a viral structure called NS5B palm polymerase which is also needed for replication of HCV.
Ritonavir is not active against the HCV virus. It is used to increase blood levels of paritaprevir by inhibiting the breakdown of paritaprevir.
Common side effects of Viekira Pak when used with ribavirin include:
- skin reactions such as redness or rash,
- sleep problems (insomnia), and
- feeling weak.
Common side effects of Viekira Pak when used without ribavirin include:
Serious side effects of Viekira Pak include:
Drug interactions of Viekira Pak include afluzosin hydrochloride, due to the risk of low blood pressure. Certain anti-seizure medications, rifampin, and St. John's wort may reduce the effectiveness of treatment with Viekira Pak.
Ergot derivatives when used with Viekira Pak can result in ergot toxicity.
Combining certain “statin” drugs with Viekira Pak can increase the risk for serious muscle pain and injury, including rhabdomyolysis. Combining Viekira Pak and pimozide may increase the risk for abnormal heart beats.
Combining efavirenz and Viekira Pak may increase the risk of liver damage.
Viekira Pak has not been evaluated in pregnant women and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When Viekira Pak is administered with ribavirin, the combination regimen should not be used in pregnant women and in men who can father children. Ribavirin is known to cause birth defects and should be avoided during pregnancy.
There is an antiretroviral pregnancy registry that monitors the use of products such as Viekira Pak in HCV/HIV-1 co-infected women. Patients are advised to enroll in this program to help study and understand the safety of antiretroviral therapy during pregnancy.
What are the important side effects of Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir)?
The most common side effects of Viekira Pak when used with ribavirin include:
- skin reactions such as redness or rash,
- sleep problems (insomnia), and
- feeling weak.
The most common side effects of Viekira Pak when used without ribavirin include:
- itching, and
- problems sleeping.
Other side effects include:
- allergic reactions,
- anemia, and
- increases in liver enzymes and bilirubin.
Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir) side effects list for healthcare professionals
If Viekira Pak is administered with ribavirin (RBV), refer to the prescribing information for ribavirin for a list of ribavirin-associated adverse reactions.
The following adverse reaction is described below and elsewhere in the labeling:
- Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
- Increased Risk of ALT Elevations
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of Viekira Pak cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety assessment was based on data from seven clinical trials in more than 2,000 subjects who received Viekira Pak with or without ribavirin for 12 or 24 weeks.
Viekira Pak With Ribavirin In Placebo-Controlled Trials
The safety of Viekira Pak in combination with ribavirin was assessed in 770 subjects with chronic HCV genotype 1 (GT1) infection in two placebo-controlled trials (SAPPHIRE-I and -II). Adverse reactions that occurred more often in subjects treated with Viekira Pak in combination with ribavirin compared to placebo were fatigue, nausea, pruritus, other skin reactions, insomnia, and asthenia (see Table 3).
The majority of the adverse reactions were mild in severity. Two percent of subjects experienced a serious adverse event (SAE). The proportion of subjects who permanently discontinued treatment due to adverse reactions was less than 1%.
Table 3: Adverse Reactions with ≥ 5% Greater Frequency Reported in Subjects with Chronic HCV GT1 Infection Treated with Viekira Pak in Combination with Ribavirin Compared to Placebo for 12 Weeks
|SAPPHIRE-I and -II|
|Viekira Pak + RBV|
N = 770 %
N = 255 %
|*Grouped term 'pruritus' included the preferred terms pruritus and pruritus generalized.|
$Grouped terms: rash, erythema, eczema, rash maculo-papular, rash macular, dermatitis, rash papular, skin exfoliation, rash pruritic, rash erythematous, rash generalized, dermatitis allergic, dermatitis contact, exfoliative rash, photosensitivity reaction, psoriasis, skin reaction, ulcer, urticaria.
Viekira Pak With And Without Ribavirin In Regimen-Controlled Trials
Viekira Pak with and without ribavirin was assessed in 401 and 509 subjects with chronic HCV infection, respectively, in three clinical trials (PEARL-II, PEARL-III and PEARL-IV). Pruritus, nausea, insomnia, and asthenia were identified as adverse events occurring more often in subjects treated with Viekira Pak in combination with ribavirin (see Table 4).
The majority of adverse events were mild to moderate in severity. The proportion of subjects who permanently discontinued treatment due to adverse events was less than 1% for both Viekira Pak in combination with ribavirin and Viekira Pak alone.
Table 4: Adverse Events with ≥ 5% Greater Frequency Reported in Subjects with Chronic HCV GT1 Infection Treated with Viekira Pak in Combination with Ribavirin Compared to Viekira Pak for 12 Weeks
|PEARL-II, -III and||-IV|
|Viekira Pak + RBV|
N = 401 %
N = 509 %
|*Grouped term 'pruritus' included the preferred terms pruritus and pruritus generalized.|
Viekira Pak With Ribavirin In GT1-infected Subjects With Compensated Cirrhosis
Viekira Pak with ribavirin was assessed in 380 subjects with genotype 1 infection and compensated cirrhosis who were treated with Viekira Pak plus ribavirin for 12 (n=208) or 24 (n=172) weeks duration (TURQUOISE-II). The type and severity of adverse events in subjects with compensated cirrhosis was comparable to non-cirrhotic subjects in other phase 3 trials. Fatigue, skin reactions and dyspnea occurred at least 5% more often in subjects treated for 24 weeks.
The majority of adverse events occurred during the first 12 weeks of dosing in both treatment arms. Most of the adverse events were mild to moderate in severity. The proportion of subjects treated with Viekira Pak for 12 and 24 weeks with SAEs was 6% and 5%, respectively and 2% of subjects permanently discontinued treatment due to adverse events in each treatment arm.
Viekira Pak Without Ribavirin In GT1b-infected Subjects With Compensated Cirrhosis
Viekira Pak without ribavirin for 12 weeks was assessed in 60 subjects with genotype 1b infection and compensated cirrhosis (TURQUOISE-III). The type and severity of adverse events and laboratory abnormalities in genotype 1b-infected subjects with compensated cirrhosis were comparable to subjects in other trials without ribavirin.
In PEARL-II, -III and -IV, 7% of subjects receiving Viekira Pak alone and 10% of subjects receiving Viekira Pak with ribavirin reported rash-related events. In SAPPHIRE-I and -II 16% of subjects receiving Viekira Pak with ribavirin and 9% of subjects receiving placebo reported skin reactions. In TURQUOISE-II, 18% and 24% of subjects receiving Viekira Pak with ribavirin for 12 or 24 weeks reported skin reactions.
The majority of events were graded as mild in severity. There were no serious events or severe cutaneous reactions, such as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme (EM) or drug rash with eosinophilia and systemic symptoms (DRESS).
Serum ALT Elevations
Approximately 1% of subjects treated with Viekira Pak experienced post-baseline serum ALT levels greater than 5 times the upper limit of normal (ULN) after starting treatment. The incidence increased to 25% (4/16) among women taking a concomitant ethinyl estradiol containing medication. The incidence of clinically relevant ALT elevations among women using estrogens other than ethinyl estradiol, such as estradiol and conjugated estrogens used in hormone replacement therapy was 3% (2/59).
ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 8-57 days) and most resolved with ongoing therapy. The majority of these ALT elevations were assessed as drug-related liver injury. Elevations in ALT were generally not associated with bilirubin elevations. Cirrhosis was not a risk factor for elevated ALT.
Serum Bilirubin Elevations
Post-baseline elevations in bilirubin at least 2 x ULN were observed in 15% of subjects receiving Viekira Pak with ribavirin compared to 2% in those receiving Viekira Pak alone. These bilirubin increases were predominately indirect and related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced hemolysis. Bilirubin elevations occurred after initiation of treatment, peaked by study Week 1, and generally resolved with ongoing therapy. Bilirubin elevations were not associated with serum ALT elevations.
Across all Phase 3 studies, the mean change from baseline in hemoglobin levels in subjects treated with Viekira Pak in combination with ribavirin was -2.4 g/dL and the mean change in subjects treated with Viekira Pak alone was -0.5 g/dL. Decreases in hemoglobin levels occurred early in treatment (Week 1-2) with further reductions through Week 3. Hemoglobin values remained low during the remainder of treatment and returned towards baseline levels by post-treatment Week 4.
Less than 1% of subjects treated with Viekira Pak with ribavirin had hemoglobin levels decrease to less than 8.0 g/dL during treatment. Seven percent of subjects treated with Viekira Pak in combination with ribavirin underwent a ribavirin dose reduction due to a decrease in hemoglobin levels; three subjects received a blood transfusion and five required erythropoietin. One patient discontinued therapy due to anemia. No subjects treated with Viekira Pak alone had a hemoglobin level less than 10 g/dL.
Viekira Pak In HCV/HIV-1 Co-infected Subjects
Viekira Pak with ribavirin was assessed in 63 subjects with HCV/HIV-1 co-infection who were on stable antiretroviral therapy. The most common adverse events occurring in at least 10% of subjects were fatigue (48%), insomnia (19%), nausea (17%), headache (16%), pruritus (13%), cough (11%), irritability (10%), and ocular icterus (10%).
Elevations in total bilirubin greater than 2 x ULN (mostly indirect) occurred in 34 (54%) subjects. Fifteen of these subjects were also receiving atazanavir at the time of bilirubin elevation and nine also had adverse events of ocular icterus, jaundice or hyperbilirubinemia. None of the subjects with hyperbilirubinemia had concomitant elevations of aminotransferases. No subject experienced a grade 3 ALT elevation.
Seven subjects (11%) had at least one post-baseline hemoglobin value of less than 10 g/dL, and six of these subjects had a ribavirin dose modification; no subject in this small cohort required a blood transfusion or erythropoietin.
Median declines in CD4+ T-cell counts of 47 cells/mm³ and 62 cells/mm³ were observed at the end of 12 and 24 weeks of treatment, respectively, and most returned to baseline levels post-treatment. Two subjects had CD4+ T-cell counts decrease to less than 200 cells/mm³ during treatment without a decrease in CD4%. No subject experienced an AIDS-related opportunistic infection.
Viekira Pak In Selected Liver Transplant Recipients
Viekira Pak with ribavirin was assessed in 34 post-liver transplant subjects with recurrent HCV infection. Adverse events occurring in more than 20% of subjects included fatigue 50%, headache 44%, cough 32%, diarrhea 26%, insomnia 26%, asthenia 24%, nausea 24%, muscle spasms 21% and rash 21%.
Ten subjects (29%) had at least one post-baseline hemoglobin value of less than 10 g/dL. Ten subjects underwent a ribavirin dose modification due to decrease in hemoglobin and 3% (1/34) had an interruption of ribavirin. Five subjects received erythropoietin, all of whom initiated ribavirin at the starting dose of 1000 to 1200 mg daily. No subject received a blood transfusion.
Post-Marketing Adverse Reactions
The following adverse reactions have been identified during post approval use of Viekira Pak. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Hypersensitivity reactions (including angioedema).
Hepatobiliary Disorders: Hepatic decompensation, hepatic failure.
What drugs interact with Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir)?
Potential For Viekira Pak To Affect Other Drugs
Ombitasvir, paritaprevir, and dasabuvir are inhibitors of UGT1A1, and ritonavir is an inhibitor of CYP3A4. Paritaprevir is an inhibitor of OATP1B1 and OATP1B3 and paritaprevir, ritonavir and dasabuvir are inhibitors of BCRP. Co-administration of Viekira Pak with drugs that are substrates of CYP3A, UGT1A1, BCRP, OATP1B1 or OATP1B3 may result in increased plasma concentrations of such drugs.
Potential For Other Drugs To Affect One Or More Components Of Viekira Pak
Paritaprevir and ritonavir are primarily metabolized by CYP3A enzymes. Co-administration of Viekira Pak with strong inhibitors of CYP3A may increase paritaprevir and ritonavir concentrations. Dasabuvir is primarily metabolized by CYP2C8 enzymes. Co-administration of Viekira Pak with drugs that inhibit CYP2C8 may increase dasabuvir plasma concentrations. Ombitasvir is primarily metabolized via amide hydrolysis while CYP enzymes play a minor role in its metabolism. Ombitasvir, paritaprevir, dasabuvir and ritonavir are substrates of P-gp. Ombitasvir, paritaprevir and dasabuvir are substrates of BCRP. Paritaprevir is a substrate of OATP1B1 and OATP1B3. Inhibition of P-gp, BCRP, OATP1B1 or OATP1B3 may increase the plasma concentrations of the various components of Viekira Pak.
Established And Other Potential Drug Interactions
If dose adjustments of concomitant medications are made due to treatment with Viekira Pak, doses should be re-adjusted after administration of Viekira Pak is completed. Dose adjustment is not required for Viekira Pak.
Table 5 provides the effect of co-administration of Viekira Pak on concentrations of concomitant drugs and the effect of concomitant drugs on the various components of Viekira Pak. Refer to the ritonavir prescribing information for other potentially significant drug interactions with ritonavir.
Table 5: Established Drug Interactions Based on Drug Interaction Trials
|Concomitant Drug Class: Drug Name||Effect on Concentration||Clinical Comments|
|ANGIOTENSIN RECEPTOR BLOCKERS e.g.|
|↑ angiotensin receptor blockers||Decrease the dose of the angiotensin receptor blockers and monitor patients for signs and symptoms of hypotension and/or worsening renal function. If such events occur, consider further dose reduction of the angiotensin receptor blocker or switching to an alternative to the angiotensin receptor blocker.|
|↑antiarrhythmics||Therapeutic concentration monitoring (if available) is recommended for antiarrhythmics when co-administered with Viekira Pak.|
|metformin||↔ metformin||Monitor for signs of onset of lactic acidosis such as respiratory distress, somnolence, and non-specific abdominal distress or worsening renal function. Concomitant metformin use in patients with renal insufficiency or hepatic impairment is not recommended. Refer to the prescribing information of metformin for further g uidanc e .|
|ketoconazole||↑ ketoconazole||When Viekira Pak is co-administered with ketoconazole, the maximum daily dose of ketoconazole should be limited to 200 mg per day.|
|voriconazole*||↓ voriconazole||Co-administration of Viekira Pak with voriconazole is not recommended unless an assessment of the benefit-to-risk ratio justifies the use of voriconazole.|
|CALCIUM CHANNEL BLOCKERS|
|↑ calcium channel blockers||Decrease the dose of the calcium channel blocker. The dose of amlodipine should be decreased by at least 50%. Clinical monitoring of patients is recommended for edema and/or signs and symptoms of hypotension. If such events occur, consider further dose reduction of the calcium channel blocker or switching to an alternative to the calcium channel blocker.|
|fluticasone*||↑ fluticasone||Concomitant use of Viekira Pak with inhaled or nasal fluticasone may reduce serum cortisol concentrations. Alternative corticosteroids should be considered, particularly for long term use.|
|furosemide||↑ furosemide (Cmax)||Clinical monitoring of patients is recommended and therapy should be individualized based on patient’s response.|
|atazanavir/ritonavir once daily||↑ paritaprevir||When coadministered with Viekira Pak, atazanavir 300 mg (without ritonavir) should only be given in the morning.|
|darunavir/ritonavir||↓ darunavir (Ctrough)||Co-administration of Viekira Pak with darunavir/ritonavir is not recommended.|
|lopinavir/ritonavir||↑ paritaprevir||Co-administration of Viekira Pak with lopinavir/ritonavir is not recommended.|
|rilpivirine||↑ rilpivirine||Co-administration of Viekira Pak with rilpivirine once daily is not recommended due to potential for QT interval prolongation with higher concentrations of rilpivirine.|
|HMG CoA REDUCTASE INHIBITORS|
|rosuvastatin||↑ rosuvastatin||When Viekira Pak is co-administered with rosuvastatin, the dose of rosuvastatin should not exceed 10 mg per day.|
|pravastatin||↑ pravastatin||When Viekira Pak is co-administered with pravastatin, the dose of pravastatin should not exceed 40 mg per day.|
|IMMUNO SUPPRE SSANTS|
|cyclosporine||↑ cyclosporine||When initiating therapy with Viekira Pak, reduce cyclosporine dose to 1/5th of the patient’s current cyclosporine dose. Measure cyclosporine blood concentrations to determine subsequent dose modifications. Upon completion of Viekira Pak therapy, the appropriate time to resume pre-Viekira Pak dose of cyclosporine should be guided by assessment of cyclosporine blood concentrations. Frequent assessment of renal function and cyclosporine-related side effects is recommended.|
|tacrolimus||↑ tacrolimus||When initiating therapy with Viekira Pak, the dose of tacrolimus needs to be reduced. Do not administer tacrolimus on the day Viekira Pak is initiated. Beginning the day after Viekira Pak is initiated; reinitiate tacrolimus at a reduced dose based on tacrolimus blood concentrations. Typical tacrolimus dosing is 0.5 mg every 7 days. Measure tacrolimus blood concentrations and adjust dose or dosing frequency to determine subsequent dose modifications. Upon completion of Viekira Pak therapy, the appropriate time to resume pre-Viekira Pak dose of tacrolimus should be guided by assessment of tacrolimus blood concentrations. Frequent assessment of renal function and tacrolimus related side effects is recommended.|
|LONG ACTING BETA-ADRENOCEPTOR AGONIST|
|salmeterol*||↑ salmeterol||Concurrent administration of Viekira Pak and salmeterol is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.|
↔mepobramate (metabolite of carisoprodol)
|Increase dose if clinically indicated.|
↓norcyclobenzaprine (metabolite of cyclobenzaprine)
|Increase dose if clinically indicated.|
↑norbuprenorphine (metabolite of buprenorphine)
|Patients should be closely monitored for sedation and cognitive effects.|
|Acetaminophen/ hydro codone||↑ hydrocodone|
|Reduce the dose of hydrocodone by 50% and monitor patients for respiratory depression and sedation at frequent intervals. Upon completion of Viekira Pak therapy, adjust the hydrocodone dose and monitor for signs of opioid withdrawal.|
|PROTON PUMP INHIBITORS|
|omeprazole||↓ omeprazole||Monitor patients for decreased efficacy of omeprazole. Consider increasing the omeprazole dose in patients whose symptoms are not well controlled; avoid use of more than 40 mg per day of omeprazole.|
|alprazolam||↑ alprazolam||Clinical monitoring of patients is recommended. A decrease in alprazolam dose can be considered based on clinical response.|
↓ nordiazepam (metabolite of diazepam)
|Increase dose if clinically indicated.|
|The direction of the arrow indicates the direction of the change in exposures (Cmax and AUC) (↑ = increase of more than 20%, ↓ = decrease of more than 20%, ↔ = no change or change less than 20%).|
Drugs Without Clinically Significant Interactions With Viekira Pak
No dose adjustments are recommended when Viekira Pak is co-administered with the following medications:
Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir) is a combination of antiviral drugs used to treat patients with hepatitis C virus (HCV) genotype 1. Common side effects of Viekira Pak when used with ribavirin include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems (insomnia), and feeling weak. Common side effects of Viekira Pak when used without ribavirin include nausea, itching, and problems sleeping. Serious side effects of Viekira Pak include allergic reactions, anemia, and increases in liver enzymes and bilirubin. Drug interactions of Viekira Pak include afluzosin hydrochloride, certain anti-seizure medications, rifampin, and St. John's wort. Viekira Pak has not been evaluated in pregnant women. It is unknown if any of the drugs contained in Viekira Pak are excreted into human milk.
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Related Disease Conditions
Hepatitis (Viral Hepatitis A, B, C, D, E, G)
Hepatitis is most often viral, due to infection with one of the hepatitis viruses (A, B, C, D, E, F (not confirmed), and G) or another virus (such as those that cause infectious mononucleosis, cytomegalovirus disease). The main nonviral causes of hepatitis are alcohol and drugs. Many patients infected with hepatitis A, B, and C have few or no symptoms of illness. For those who do develop symptoms of viral hepatitis, the most common are flu-like symptoms including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, and aching in the abdomen. Treatment of viral hepatitis is dependent on the type of hepatitis.
Hepatitis C (HCV, Hep C)
Hepatitis C is an inflammation of the liver due to the hepatitis C virus (HCV), which is usually spread by blood transfusion, hemodialysis, and needle sticks, especially with intravenous drug abuse. Symptoms of chronic hepatitis include fatigue, fever, muscle aches, loss of appetite, and fever. Chronic hepatitis C may be cured in most individuals with drugs that target specific genomes of hepatitis C.
Is Hepatitis Contagious?
Hepatitis means "inflammation of the liver," and there are several different types of such as A, B, C, D, and E. Some types of hepatitis are contagious and some types are not. Hepatitis symptoms vary upon the type of disease; however, the following symptoms may develop in someone with hepatitis: fatigue, nausea and vomiting, abdominal pain and discomfort, jaundice (yellowing of the skin and whites of the eyes), and loss of appetite. Treatment for hepatitis depends upon the cause. Some types of hepatitis have a vaccine to prevent spread of disease such as hepatitis A and B.
Hepatitis A and B Vaccinations
Hepatitis A and hepatitis B are the two most commnon viruses that infect the liver. Hepatitis A and Hepatitis B can be prevented and treated with immunizations (vaccinations) such as Havrix, Vaqta, Twinrix, Comvax, Pediarix, and hepatitis b immune globulin (HBIG).
Is Hepatitis B Contagious?
Hepatitis B is a type of liver infection. Hepatitis B is spread through person-to-person contact or through personal items like razors, toothbrushes, etc. Symptoms of hepatitis B include fever, yellowish skin (jaundice), dark urine, fatigue, nausea, and vomiting. There is no drug to cure hepatitis B; however, there is a hepatitis B vaccine available.
Hepatitis B (HBV, Hep B)
The hepatitis B virus (HBV, hep B) is a unique, coated DNA virus belonging to the Hepadnaviridae family of viruses. The course of the virus is determined primarily by the age at which the infection is acquired and the interaction between the virus and the body's immune system. Successful treatment is associated with a reduction in liver injury and fibrosis (scarring), a decreased likelihood of developing cirrhosis and its complications, including liver cancer, and a prolonged survival.
Is Hepatitis C Contagious?
Hepatitis C or hep C causes acute and chronic liver disease. Hep C is a form of liver disease with symptoms like fatigue, jaundice, nausea and vomiting, anorexia, and abdominal discomfort. Hepatitis C is a contagious viral infection caused by people sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
Hepatitis C Cure (Symptoms, Transmission, Treatments, and Cost)
Hepatitis is inflammation of the liver. There are a variety of toxins, diseases, illicit drugs, medications, bacterial and viral infections, and heavy alcohol use can case inflammation of the liver. Hepatitis C viral infection (HCV) is one type of hepatitis. According to the CDC, in 2014 there were an estimated 30,500 cases of acute hepatitis C infections in the US. An estimated 2.7-3.9 million people in the US have chronic hepatitis C. The virus is spread from person-to-person via blood-to-blood contact. Symptoms of HCV infection include joint pain, jaundice, dark urine, nausea, fatigue, fever, loss of appetites, clay colored stool. Hepatitis C can be cured with medications in most people. There is no vaccine against the hepatitis C virus.
Is Hepatitis A Contagious?
Hepatitis means inflammation of the liver. Hepatitis A is one type of hepatitis. Hepatitis is transmitted through person to person contact, contaminated ice, vegetables, fruits, and untreated water. Hepatitis A can be prevented by the hepatitis A vaccine. Symptoms of hepatitis A may include nausea and/or vomiting, fever, loss of appetite, abdominal pain, dark urine, clay-colored stools, jaundice (yellowish color to skin and/or eyes, or joint pain.
Hepatitis E Viral Infection
Hepatitis E (hep E) is a type of hepatitis viral infection that includes hepatitis A, B, C, D, F, which is caused by the hepatitis E virus. Usually, you get (transmitted) hepatitis E from eating or drinking dirty or contaminated water. Hepatitis E can be very serious, especially if a woman is pregnant. Up to ¼ of women who are pregnant with the hep E virus can die from the infection. The signs and symptoms of hepatitis E infection are nausea and vomiting, brown or dark urine, stool changes jaundice (yellow eyes and skin), pain in the right side of the abdomen, dark or brown urine, and light-colored stool. Some people with hep E don’t have any symptoms so they don’t know that they are contagious. It takes about 6 weeks to recover from hep E. A person who has any type of hepatitis, including hepatitis E, should not drink any alcohol. Hep E complications are rare, but when they do occur they include severe (“fulminant”) hepatitis, liver failure, and death. Currently, no specific drugs or treatments are available for hepatitis E. Moreover, the only hepatitis E vaccine currently is available in China. Avoid alcohol, keep hydrated, and getting rest are home remedies for hepatitis E. Talk to your doctor before taking any over-the-counter (medications), especially those containing acetaminophen (Tylenol and others). Usually, the prognosis and life expectancy for hepatitis E after recovery is good. Most people do not have long term liver problems from the infection.
What Type of Drug Is Ombitasvir?
Ombitasvir is a direct-acting antiviral drug that is used to treat hepatitis C. The medication acts as a hepatitis C virus inhibitor and is a dipeptide derivative. It is mostly used as a combination drug containing dasabuvir sodium dihydrate, paritaprevir, and ritonavir under the trade name Viekira Pak, which is FDA-approved. Ombitasvir works by inhibiting the NS5A protein, which helps in the replication of the hepatitis C virus.
Treatment & Diagnosis
Medications & Supplements
- hepatitis A and hepatitis B (recombinant) vaccine (Twinrix)
- hepatitis A vaccine (Havrix, Vaqta)
- hepatitis b vaccine (Recombivax HB)
- Side Effects of Havrix, Vaqta (Hepatitis A vaccine)
- haemophilus b/hepatitis b vaccine - injection, Comvax
- Viekira Pak (ombitasvir, paritaprevir, ritonavir, and dasabuvir)
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.