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Tenofovir Disoproxil Fumarate For Hepatitis B

Availability Of Data And Materials

Lamivudine, Tenofovir, and Adefovir – Treatment of Hepatitis B

The datasets used and/or analyzed during the current study can be requested for further research. Within 6 months of this publication, anonymized individual participant data, the annotated case report form, protocol, reporting and analysis plan, data set specifications, raw dataset, analysis-ready dataset, and clinical study report will be available for research proposals approved by an independent review committee. Proposals should be submitted to www.clinicalstudydatarequest.com. A data access agreement will be required.

Tenofovir May Cause Side Effects Tell Your Doctor If Any Of These Symptoms Are Severe Or Do Not Go Away:

  • yellowing of skin or eyes
  • feeling cold, especially in the arms or legs

Tenofovir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online or by phone .

How Should This Medicine Be Used

Tenofovir comes as a tablet and as an oral powder to take by mouth. The tablet is usually taken with or without food once daily. The powder is usually taken with food once daily. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tenofovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Tenofovir oral powder must be added to 2 to 4 ounces of soft food such as applesauce, baby food, or yogurt. Stir the mixture with a spoon until well mixed. Consume the mixture right away to avoid a bitter taste. Do not mix tenofovir oral powder with liquid.

Continue to take tenofovir even if you feel well. Do not stop taking tenofovir without talking to your doctor. If you stop taking tenofovir even for a short time, or skip doses, the virus may become resistant to medications and may be harder to treat.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

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Bulevirtide With Tenofovir Disoproxil Fumarate Shows Promise In Hepatitis B Hepatitis D Coinfection

Bulevirtide is a synthetic myristoylated peptide derived from the pre-S1 domain of the hepatitis B virus large surface protein.

A combination of bulevirtide with tenofovir disoproxil fumarate showed efficacy in treating patients coinfected with hepatitis B virus and hepatitis D virus in a recent phase 2 trial, published in The Lancet Infectious Diseases.

Investigators enrolled 120 patients with chronic HDV between February 2016 and December 2016, including 59 patients with cirrhosis. Patients were administered 2 mg, 5 mg, or 10 mg of bulevirtide in combination with TDF or TDF alone.

Blocking HBV and hepatitis D virus entry with bulevirtide is a safe and promising strategy to treat patients with chronic hepatitis D virus infection, even when cirrhosis has already been diagnosed, the study authors wrote.

HDV is dependent on HBV envelope proteins to complete its life cycle. Further, coinfection with HBV and HDV causes more rapid disease progression vs HBV infection alone. Coinfection can lead to cirrhosis within 5 to 10 years for 70% of patients and death within 10 years for 60% of patients.

Bulevirtide, a synthetic myristoylated peptide, is derived from the pre-S1 domain of the HBV large surface protein. The drug binds the sodium taurocholate contransporting polypeptide receptor, which is the entry pathway for the virus.

Reference

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Ethics Approval And Consent To Participate

tenohep Tenofovir Disoproxil Fumarate Tablets IP 300 Mg, Treatment ...

The study was approved by the ethics committee at every participating institution and was conducted according to the recommendations of Good Clinical Practice and the Declaration of Helsinki . All participants provided written informed consent to participate in the study. This manuscript was developed following the CONSORT guidelines as much as possible even through this is not a randomized control trial.

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How Should I Use This Medication

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked scoop that comes with your medicine to measure each dose. Mix the dose in a small amount of soft food and take it right away. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your treatment to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor’s advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

Clinical Trial Results In Adults With Hiv

Treatment-Naïve Subjects: Trial 903

Data through 144 weeks are reported for Trial 903, a double-blind, active-controlled multicenter trial comparing Tenofovir Disoproxil Fumarate tablets administered in combination with lamivudine and efavirenz versus stavudine , 3TC, and EFV in 600 antiretroviral-naïve subjects. Subjects had a mean age of 36 years 74% were male, 64% were Caucasian, and 20% were Black. The mean baseline CD4+ cell count was 279 cells/mm3 and median baseline plasma HIV-1 RNA was 77,600 copies/mL . Subjects were stratified by baseline HIV-1 RNA and CD4+ cell count. Forty-three percent of subjects had baseline viral loads > 100,000 copies/mL and 39% had CD4+ cell counts < 200 cells/mm3. Table 20 provides treatment outcomes through 48 and 144 weeks.

Table 20 Outcomes of Randomized Treatment at Week 48 and 144

Outcomes

  • Subjects achieved and maintained confirmed HIV-1 RNA < 400 copies/mL through Week 48 and 144.
  • Includes confirmed viral rebound and failure to achieve confirmed < 400 copies/mL through Week 48 and 144.
  • Includes lost to follow-up, subjectâs withdrawal, noncompliance, protocol violation and other reasons.
  • Through 144 weeks, 11 subjects in the Tenofovir Disoproxil Fumarate group and 9 subjects in the d4T group experienced a new CDC Class C event.

    Treatment-Naïve Subjects: Trial 934

    Table 21 Outcomes of Randomized Treatment at Week 48 and 144

    Outcomes

    Treatment-Experienced Subjects: Trial 907

    Table 22 Outcomes of Randomized Treatment

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    Hepatitis C Virus Drugs

    Taking certain hepatitis C drugs with tenofovir may increase the levels of tenofovir in your body. This can cause more side effects from the drug. Examples of these drugs include:

    • ledipasvir/sofosbuvir
    • sofosbuvir/velpatasvir/voxilaprevir

    Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

    All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

    • how severe your condition is
    • other medical conditions you have
    • how you react to the first dose

    Study Design And Data

    Tenofovir and Entecavir Are the Most Effective Antiviral Agents for Chronic Hepatitis B…

    We conducted a retrospective cohort study based on medical records, from the First Affiliated Hospital of College of Medicine of Zhejiang University, to compare the efficacy and safety of ETV and TDF in NA-naïve CHB patients. Patients receiving TDF 300 mg or ETV 0.5 mg daily between January 2017 and May 2019 were systematically reviewed with electronic medical records, laboratory inspection, and imaging examination.

    The following parameters were recorded in detail: demographic data , virological data , serological data , biochemical statistics , baseline and highest serum creatinine level, baseline and minimum blood phosphorus level), and imaging examination .

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    Who Should Not Take Tenofovir

    Anyone who is allergic to tenofovir shouldn’t take this drug. Also, it’s important to know your HIV status because taking tenofovir can significantly complicate treating HIV. If you have HIV and HBV, do not start therapy for either infection without consulting a physician experienced in treating both infections.

    Tenofovir is generally recognized as safe for use during pregnancy, as there is no evidence to suggest it is harmful to a pregnant mother or her fetus.

    What Should I Know About Storage And Disposal Of This Medication

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture .

    It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.

    Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.

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    Patient Reported Outcomes Definition

    In this study, the treatment results were divided according to the intervention time included in the article, and the same outcome was divided among different subgroups. Treatment outcomes included the first 24 and 48 weeks. This is because, after 48 weeks, the design of many studies and the disease status of the patients have changed. In this study, all outcomes included the following: ALT recovery rate , defined as the number of patients with serum ALT levels < 40 IU/mL virological response, defined as the number of patients with < 400 copies/mL of serum HBV-DNA the HBV-DNA negative rate HBeAg-negative rate the level of total bilirubin, serum creatinine, and prothrombin activity, the ratio of CD4+/CD8+, and the adverse reaction rate.

    Testing Prior To Initiation Of Tenofovir Disoproxil Fumarate Tablets For Treatment Of Hiv

    TENVIR ( Tenofovir Disoproxil Fumerate IP) TABLETS, Prescription ...

    Prior to or when initiating Tenofovir Disoproxil Fumarate tablets, test patients for HBV infection and HIV-1 infection. Tenofovir Disoproxil Fumarate tablets alone should not be used in patients with HIV-1 infection .Prior to initiation and during use of Tenofovir Disoproxil Fumarate tablets, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus .

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    Where Should I Keep My Medication

    Keep out of the reach of children.

    Store at room temperature between 15 to 30 degrees C . Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

    NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

    What Side Effects May I Notice From Receiving This Medication

    Side effects that you should report to your doctor or health care professional as soon as possible:

    Side effects that usually do not require medical attention :

    This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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    Drugs Affecting Renal Function

    Tenofovir is primarily eliminated by the kidneys . Coadministration of Tenofovir Disoproxil Fumarate with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the coadministered drug. Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides , and high-dose or multiple NSAIDs . Drugs that decrease renal function may increase concentrations of tenofovir.

    In the treatment of chronic hepatitis B, Tenofovir Disoproxil Fumarate should not be administered in combination with HEPSERA .

    Treating Hepatitis B With Tenofovir

    Hepatitis B: Treatment and care for a chronic condition

    Violetta Shamilova, PharmD, is a board-licensed pharmacist. She is an assistant professor at the Touro College School of Health Sciences, and has worked at CVS pharmacy for five years. She completed the certified APhA Delivering Medication Therapy Management Services course.

    Tenofovir, also called tenofovir disoproxil fumarate, is an antiviral drug for treating chronic hepatitis B in adults and children who are 12 years and older. It is also used, in combination with other drugs, to treat the human immunodeficiency virus or HIV. It’s sold under the brand name Viread by Gilead Sciences, Inc.

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    Third Issue: Differences In The Follow

    Because ETV was introduced earlier than TDF, ETV-treated patients had longer follow-up durations in most studies. In the study by Lee et al., for example, the median follow-up duration was longer in patients treated with ETV than in those treated with TDF . The difference in the follow-up duration due to the asynchronous introduction of the two treatments may cause a bias in either direction. Previous meta-analyses by Tseng et al. and Li et al. also noticed this point, and they performed subgroup analyses based on follow-up duration. In studies with a follow-up duration of ETV that was longer than TDF by more than one year, TDF was significantly associated with a lower risk of HCC . However, there was no difference in the risk of HCC between the two treatments in studies with a minimal disparity of less than one year in the follow-up duration . The patient warehousing phenomenon, which indicates postponing treatment until a new effective drug becomes available, may have contributed to the bias toward prescribing ETV to sicker and older patients before TDF became available. However, it should be noted that TDF consistently showed a superiority over ETV in pooled analysis of PS-matched cohorts from available studies in which the baseline characteristics were well balanced.

    Lc And Hcc Development

    During the 2-year follow-up, periodically monitored imaging examinations and alpha-fetoprotein diagnosed 2 ETV-treated patients with HCC after more than 6-month drug treatment, one of whom had LC at baseline. Two patients were older than 40 and achieved BR after 3 months. Both patients had high HBV DNA level , and achieved CVR after 18-month therapy, indicating poor effect of ETV in these 2 patients. Furthermore, both patients had high baseline HBsAg, and neither of them achieved HBeAg or HBsAg seroclearance. In addition, 2 patients in ETV group were detected to develop LC during the 2-year follow-up, with no patient in TDF group. Despite these 2 patients were HBeAg-positive and had high HBV DNA and HBsAg level at treatment initiation, both of them achieved sustained virological response and sustained BR after 3-month antiviral therapy, but neither of them achieved HBeAg or HBsAg seroclearance. Univariate and multivariate analyses revealed that there was no independent factor in the development of HCC and LC.

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    Clinical Trial Results In Adults With Chronic Hepatitis B

    HBeAg-Negative Chronic HBV Subjects: Trial 0102

    Trial 0102 was a Phase 3, randomized, double-blind, active-controlled trial of Tenofovir Disoproxil Fumarate 300 mg compared to HEPSERA 10 mg in 375 HBeAg- subjects with compensated liver function, the majority of whom were nucleoside-naïve. The mean age of subjects was 44 years 77% were male, 25% were Asian, 65% were Caucasian, 17% had previously received alpha-interferon therapy, and 18% were nucleoside-experienced . At baseline, subjects had a mean Knodell necroinflammatory score of 7.8 mean plasma HBV DNA was 6.9 log 10 copies/mL and mean serum ALT was 140 U/L.

    HBeAg-Positive Chronic HBV Subjects: Trial 0103

    Trial 0103 was a Phase 3, randomized, double-blind, active-controlled trial of Tenofovir Disoproxil Fumarate tablets 300 mg compared to HEPSERA 10 mg in 266 HBeAg+ nucleoside-naïve subjects with compensated liver function. The mean age of subjects was 34 years 69% were male, 36% were Asian, 52% were Caucasian, 16% had previously received alpha-interferon therapy, and < 5% were nucleoside experienced. At baseline, subjects had a mean Knodell necroinflammatory score of 8.4 mean plasma HBV DNA was 8.7 log10 copies /mL and mean serum ALT was 147 U/L.

    The primary data analysis was conducted after all subjects reached 48 weeks of treatment and results are summarized below.

    Table 23 Histological, Virological, Biochemical, and Serological Response at Week 48

    0102

  • NA = Not Applicable
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    Animal Toxicology And/or Pharmacology

    Tenofovir and TDF administered in toxicology studies to rats, dogs, and monkeys at exposures greater than or equal to 6 fold those observed in humans caused bone toxicity. In monkeys the bone toxicity was diagnosed as osteomalacia. Osteomalacia observed in monkeys appeared to be reversible upon dose reduction or discontinuation of tenofovir. In rats and dogs, the bone toxicity manifested as reduced bone mineral density. The mechanism underlying bone toxicity is unknown.

    Evidence of renal toxicity was noted in 4 animal species. Increases in serum creatinine, BUN, glycosuria, proteinuria, phosphaturia, and/or calciuria and decreases in serum phosphate were observed to varying degrees in these animals. These toxicities were noted at exposures 2 to 20 times higher than those observed in humans. The relationship of the renal abnormalities, particularly the phosphaturia, to the bone toxicity is not known.

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