What is Lesovir?
Lesovir are antiviral medications that prevent hepatitis C virus (HCV) cells from multiplying in your body.
Lesovir is a combination medicine used to treat hepatitis C in adults.
Lesovir may also be used for purposes not listed in this medication guide.
Lesovir indications
See also: Lesovir
Adult Patients:
Lesovir Tablets are indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) :
- genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
- genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin
- genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin
Pediatric Patients:
Lesovir Tablets are indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kg with HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
How should I use Lesovir?
Use Lesovir as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Lesovir. Talk to your pharmacist if you have questions about this information.
- Take Lesovir by mouth with or without food.
- Do not take an antacid that has aluminum or magnesium in it within 4 hours of Lesovir.
- If you take cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine, ask your doctor or pharmacist how to take it with Lesovir.
- Lesovir works best if it is taken at the same time each day.
- Continue to take Lesovir even if you feel well. Do not miss any doses.
- If you miss a dose of Lesovir, take it as soon as you remember the same day and go back to your regular dosing schedule. Do not take more than 1 dose of Lesovir in the same day. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Lesovir.
Uses of Lesovir in details
This medication is a combination of Lesovir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin). These drugs work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.
It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.
How to use Lesovir
Read the Patient Information Leaflet if available from your pharmacist before you start taking Lesovir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily.
This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.
Tell your doctor if you vomit within 5 hours after taking this medication. You may need to take another dose.
Continue to take Lesovir for the full length of time prescribed, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.
Antacids lower the absorption of Ledipasvir (Lesovir). If you are taking an antacid, take it at least 4 hours before or 4 hours after this medication.
Other acid-lowering medications for indigestion, heartburn, or ulcers (such as prescription or over-the-counter medications including famotidine, omeprazole) may prevent Ledipasvir (Lesovir) from working. Ask your doctor or pharmacist how to use these medications safely.
Lesovir description
Lesovir is a 2-drug fixed-dose combination product containing Ledipasvir (Lesovir) 90 mg and Sofosbuvir (Lesovir) 400 mg in a single tablet, for oral administration.
Each tablet contains Ledipasvir (Lesovir) 90 mg and Sofosbuvir (Lesovir) 400 mg.
It also includes the following excipients: Colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Film-Coating: FD&C yellow no. 6/sunset yellow FCF aluminum lake, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
Ledispavir is a hepatitis C virus (HCV) nonstructural protein 5A (NS5A) inhibitor and Sofosbuvir (Lesovir) is a nucleotide analog inhibitor of HCV NS5B polymerase.
Ledipasvir (Lesovir) is methyl [(2S)-1-{(6S)-6-[5-(9,9-difluoro-7-{2-[(1R,3S,4S)-2-{(2S)-2-[(methoxycarbonyl)amino]3 methylbutanoyl}-2-azabicyclo(2.2.1)hept-3-yl)-1H-benzimidazol-6-yl}-9H-fluoren-2-yl)-1H-imidazol-2-yl]-5-azaspiro(2.4)hept-5-yl}-3-methyl-1-oxobutan-2-yl]carbamate. It has a molecular formula of C49H54F2N8O6 and a molecular weight of 889.
Ledipasvir (Lesovir) is practically insoluble (<0.1 mg/mL) across the pH range of 3-7.5 and is slightly soluble below pH 2.3 (1.1 mg/mL).
Sofosbuvir (Lesovir) is (S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy (phenoxy)phosphorylamino)propanoate. It has a molecular formula of C22H29FN3O9P and a molecular weight of 529.45.
Sofosbuvir (Lesovir) is a white to off-white crystalline solid with a solubility of ≥2 mg/mL across the pH range of 2-7.7 at 37°C and is slightly soluble in water.
Lesovir dosage
Recommended Dosage
The recommended dosage of Lesovir is one tablet taken orally once daily with or without food.
Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups.
Table 1 shows the recommended Lesovir treatment regimen and duration based on patient population.
For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in Table 1. Refer to DRUG INTERACTIONS for dosage recommendations for concomitant HIV-1 antiviral drugs.
Table 1 : Recommended Treatment Regimen and Duration for Lesovir in Patients with Genotype 1, 4, 5 or 6 HCV
| Patient Population | Treatment Regimen and Duration | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Genotype 1 | Treatment-naive without cirrhosis or with compensated cirrhosis (Child-Pugh A) | Lesovir 12 weeks* | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment-experienced** without cirrhosis | Lesovir 12 weeks | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment-experienced** with compensated cirrhosis (Child-Pugh A) | Lesovir 24 weeks† | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment-naive and treatment-experienced** with decompensated cirrhosis (Child-Pugh B or C) | Lesovir + ribavirin‡ 12 weeks | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Genotype 1 or 4 | Treatment-naive and treatment-experienced** liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A) | Lesovir + ribavirin§ 12 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Genotype 4, 5 or 6 | Treatment-naive and treatment-experienced**, without cirrhosis or with compensated cirrhosis (Child-Pugh A) | Lesovir 12 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
* Lesovir for 8 weeks can be considered in treatment-na
Lesovir interactionsSee also: Potential for Drug Interaction: As Lesovir contains Lesovir, any interactions that have been identified with these agents individually may occur with Lesovir. After oral administration of Lesovir, Sofosbuvir (Lesovir) is rapidly absorbed and subject to extensive first-pass hepatic extraction. In clinical pharmacology studies, both Sofosbuvir (Lesovir) and the inactive metabolite GS-331007 were monitored for purposes of pharmacokinetic analyses. Ledipasvir (Lesovir) is an inhibitor of the drug transporters P-gp and BCRP and may increase intestinal absorption of co-administered substrates for these transporters. Lesovir are substrates of drug transporters P-gp and BCRP while GS-331007 is not. P-gp inducers (eg, rifampin or St. John’s wort) may decrease Lesovir plasma concentrations, leading to reduced therapeutic effect of Lesovir, and the use with P-gp inducers is not recommended with Lesovir. Established and Potentially Significant Drug Interactions: Table 12 provides a listing of established or potentially clinically significant drug interactions. The drug interactions described are based on studies conducted with either Lesovir, the components of Lesovir (Lesovir) as individual agents, or are predicted drug interactions that may occur with Lesovir. Drugs without Clinically Significant Interactions with Lesovir: Based on drug interaction studies conducted with the components of Lesovir (Ledipasvir (Lesovir) or Sofosbuvir (Lesovir)) or Lesovir, no clinically significant drug interactions have been either observed or are expected when Lesovir is used with the following drugs individually : Abacavir, atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, efavirenz, emtricitabine, lamivudine, methadone, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, tenofovir disoproxil fumarate, or verapamil. See Table 12 for use of Lesovir with certain human immunodeficiency virus antiretroviral regimens. Lesovir side effectsSee also: The following serious adverse reactions are described below and elsewhere in labeling:
Clinical Trials ExperienceBecause 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. If Lesovir is administered with ribavirin, refer to the prescribing information for ribavirin for a description of ribavirin-associated adverse reactions. The safety assessment of Lesovir was based on pooled data from three randomized, open-label Phase 3 clinical trials (ION-3, ION-1 and ION-2) of subjects with genotype 1 HCV with compensated liver disease (with and without cirrhosis) including 215, 539, and 326 subjects who received Lesovir once daily by mouth for 8, 12 and 24 weeks, respectively. The proportion of subjects who permanently discontinued treatment due to adverse events was 0%, less than 1%, and 1% for subjects receiving Lesovir for 8, 12, and 24 weeks, respectively. The most common adverse reactions (at least 10%) were fatigue and headache in subjects treated with 8, 12, or 24 weeks of Lesovir. Table 2 lists adverse reactions (adverse events assessed as causally related by the investigator, all grades) observed in at least 5% of subjects receiving 8, 12, or 24 weeks treatment with Lesovir in clinical trials. The majority of adverse reactions presented in Table 2 occurred at severity of grade 1. The side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs. Table 2 : Adverse Reactions (All Grades) Reported in ≥ 5% of Subjects Receiving 8, 12, or 24 Weeks of Treatment with Lesovir
The safety assessment of Lesovir was also based on pooled data from three open-label trials (Study 1119, ION-4 and ELECTRON-2) in 118 subjects with chronic HCV genotype 4, 5 or 6 infection with compensated liver disease (with or without cirrhosis). The subjects received Lesovir once daily by mouth for 12 weeks. The safety profile in subjects with chronic HCV genotype 4, 5 or 6 infection with compensated liver disease was similar to that observed in subjects with chronic HCV genotype 1 infection with compensated liver disease. The most common adverse reactions occurring in at least 10% of subjects were asthenia (18%), headache (14%) and fatigue (10%). Adverse Reactions In Subjects With CirrhosisThe safety assessment of Lesovir with or without ribavirin was based on a randomized, double-blind and placebo-controlled trial in treatment-experienced genotype 1 subjects with compensated cirrhosis and was compared to placebo in the SIRIUS trial. Subjects were randomized to receive 24 weeks of Lesovir once daily by mouth without ribavirin or 12 weeks of placebo followed by 12 weeks of Lesovir once daily by mouth + ribavirin. Table 3 presents the adverse reactions, as defined above, that occurred with at least 5% greater frequency in subjects treated with 24 weeks of Lesovir or 12 weeks of Lesovir + ribavirin, compared to those reported for 12 weeks of placebo. The majority of the adverse reactions presented in Table 3 were Grade 1 or 2 in severity. Table 3 : Adverse Reactions with ≥ 5% Greater Frequency Reported in Treatment-Experienced Subjects with Cirrhosis Receiving Lesovir for 24 Weeks or Lesovir + RBV for 12 Weeks Compared to Placebo for 12 weeks
Adverse Reactions In Subjects Co-infected With HIV-1The safety assessment of Lesovir was based on an open-label clinical trial in 335 genotype 1 or 4 subjects with HCV/HIV-1 co-infection who were on stable antiretroviral therapy in Study ION-4. The safety profile in HCV/HIV-1 co-infected subjects was similar to that observed in HCV mono-infected subjects. The most common adverse reactions occurring in at least 10% of subjects were headache (20%) and fatigue (17%). Adverse Reactions In Liver Transplant Recipients And/Or Subjects With Decompensated CirrhosisThe safety assessment of Lesovir with ribavirin (RBV) in liver transplant recipients and/or those who had decompensated liver disease was based on pooled data from two Phase 2 open-label clinical trials including 336 subjects who received Lesovir plus RBV for 12 weeks. Subjects with Child-Pugh-Turcotte (CPT) scores greater than 12 were excluded from the trials. The adverse events observed were consistent with the expected clinical sequelae of liver transplantation and/or decompensated liver disease, or the known safety profile of Lesovir and/or ribavirin. Decreases in hemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were observed in 38% and 13% of subjects treated with Lesovir plus RBV for 12 weeks, respectively. Ribavirin was permanently discontinued in 11% of subjects treated with Lesovir plus RBV for 12 weeks. Liver Transplant Recipients With Compensated Liver DiseaseAmong the 174 liver transplant recipients with compensated liver disease who received Lesovir with RBV for 12 weeks, 2 (1%) subjects permanently discontinued Lesovir due to an adverse event. Subjects With Decompensated Liver DiseaseAmong the 162 subjects with decompensated liver disease (pre-or post-transplant) who received Lesovir with RBV for 12 weeks, 7 (4%) subjects died, 4 (2%) subjects underwent liver transplantation, and 1 subject ( < 1%) underwent liver transplantation and died during treatment or within 30 days after discontinuation of treatment. Because these events occurred in patients with advanced liver disease who are at risk of progression of liver disease including liver failure and death, it is not possible to reliably assess the contribution of drug effect to outcomes. A total of 4 (2%) subjects permanently discontinued Lesovir due to an adverse event. Less Common Adverse Reactions Reported in Clinical Trials (less than 5%): The following adverse reactions occurred in less than 5% of subjects receiving Lesovir in any one trial. These events have been included because of their seriousness or assessment of potential causal relationship. Psychiatric disorders: depression (including in subjects with pre-existing history of psychiatric illness). Depression (particularly in subjects with pre-existing history of psychiatric illness) occurred in subjects receiving Sofosbuvir (Lesovir) containing regimens. Suicidal ideation and suicide have occurred in less than 1% of subjects treated with Sofosbuvir (Lesovir) in combination with ribavirin or pegylated interferon/ribavirin in other clinical trials. Laboratory AbnormalitiesBilirubin Elevations: Bilirubin elevations of greater than 1.5xULN were observed in 3%, less than 1%, and 2% of subjects treated with Lesovir for 8, 12, and 24 weeks, respectively. Bilirubin elevations of greater than 1.5xULN were observed in 3%, 11% and 3% of subjects with compensated cirrhosis treated with placebo, Lesovir + ribavirin for 12 weeks and Lesovir for 24 weeks, respectively, in the SIRIUS trial. Lipase Elevations: Transient, asymptomatic lipase elevations of greater than 3xULN were observed in less than 1%, 2%, and 3% of subjects treated with Lesovir for 8, 12, and 24 weeks, respectively. Transient, asymptomatic lipase elevations of greater than 3x ULN were observed in 1%, 3% and 9% of subjects with compensated cirrhosis treated with placebo, Lesovir + ribavirin for 12 weeks and Lesovir for 24 weeks, respectively, in the SIRIUS trial. Creatine Kinase: Creatine kinase was not assessed in Phase 3 trials ION-3, ION-1 or ION-2 of Lesovir. Creatine kinase was assessed in the ION-4 trial. Isolated, asymptomatic creatine kinase elevations of greater than or equal to 10xULN was observed in 1% of subjects treated with Lesovir for 12 weeks in the ION-4 trial and has also been previously reported in subjects treated with Sofosbuvir (Lesovir) in combination with ribavirin or peginterferon/ribavirin in other clinical trials. Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of Lesovir. Because postmarketing 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. Cardiac DisordersSerious symptomatic bradycardia has been reported in patients taking amiodarone who initiate treatment with Lesovir. Skin And Subcutaneous Tissue DisordersSkin rashes, sometimes with blisters or angioedema-like swelling Lesovir contraindicationsSee also: If Lesovir Tablets are administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin. Active ingredient matches for Lesovir:
References
ReviewsThe results of a survey conducted on ndrugs.com for Lesovir are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Lesovir. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reportsConsumer reported usefulNo survey data has been collected yetConsumer reported price estimatesNo survey data has been collected yetConsumer reported time for resultsNo survey data has been collected yetConsumer reported ageNo survey data has been collected yetConsumer reviews
Information checked by Dr. Sachin Kumar, MD Pharmacology More about LesovirClinician Information
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