Predictive Factors For Virologic Response
A multivariate logistic regression model was used to identify the independent risk factors significantly associated with VR during the first year. In a univariate analysis, disease status , HBeAg status, serum HBV DNA levels and IVR-3 were candidate variables for the multivariate analysis. Of the clinical features, cirrhosis, HBeAg negativity, low serum HBV DNA levels and IVR-3 were considered favorable factors for VR, while other factors, including the type of antiviral used , were not significantly associated with VR . In the multivariate analysis, only IVR-3 remained independent predictors for one year VR .
Table 3 Comparison of clinical features between the groups according to one year virologic response
A cox proportional hazards model was used to identify the independent factors for long-term VR. In the multivariate analysis, HBeAg status, serum HBV DNA levels and IVR-3 were identified as predictive factors for long-term VR .
Table 5 Factors associated with long-term virologic response
Practical Management Of Drug Resistance
In cases of a confirmed virological breakthrough and exclusion of non-adherence , the patient should be either switched to another antiviral monotherapy with a high genetic barrier to resistance or a second antiviral drug with a complementary resistance profile should be added . Although it appears reasonable from a virological point to reduce resistance by combination therapy, there are no clear long-term data favoring the add-on over the switch concept . Table 2 summarizes current recommendations for the management of treatment failure.
Table 2
American Association For The Study Of Liver Diseases Recommendations
The 2016 AASLD guidelines for the treatment of chronic hepatitis B as well as select recommendations from the 2018 AASLD guidance update on the prevention, diagnosis, and treatment of chronic hepatitis B are outlined below and in the Guidelines section.
Adults with immune-active chronic hepatitis B infection
Administer antiviral therapy to lower the risk of morbidity and mortality associated with chronic hepatitis B infection.
The recommended initial agent for adults is PEG-IFN, entecavir, or tenofovir.
Adults with immune-tolerant chronic hepatitis B infection
Antiviral therapy is not recommended.
The AASLD suggests obtaining ALT levels at least every 6 months to monitor for potential transition to immune-active or -inactive chronic hepatitis B.
For select patients older than 40 years, the AASLD suggests antiviral therapy in the setting of normal ALT levels, elevated HBV DNA , and significant necroinflammation or fibrosis on liver biopsy specimens.
Adults with HBeAg-positive immune-active chronic hepatitis B who seroconvert to anti-HBe on nucleoside analog therapy
After a period of treatment consolidation , consider discontinuing NA therapy in noncirrhotic HBeAg-positive adults who seroconvert to anti-HBe while on NA treatment. If antiviral therapy is stopped, monitor the patient every 3 months for a minimum of 1 year for recurrent viremia, ALT flares, seroreversion, and clinical decompensation.
Adults with HBeAg-negative immune-active chronic HBV infection
Inpatient care
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Virologic Breakthrough During Long
VBT was experienced in 13 patients, with cumulative rates of 1%, 4% and 11% at 12, 24 and 36 months, respectively. There was no significant difference in the cumulative rates between the ETV and TDF groups . VBT developed in 9 cases in the ETV group and in 4 cases in the TDF group. The majority of VBT was related to medication adherence. As expected, mutations associated with drug resistance were detected in 2 patients in the ETV group .
Dosage: How Much Viread Should I Take
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms :
- For treatment of HIV infection:
- Adults and children 2 years of age and older and weighs 35 kilograms or more300 milligrams once a day.
- Children 2 years of age and older and weighing 28 to less than 35 kgDose is based on body weight and must be determined by your doctor. The dose is one 250 mg tablet once a day.
- Children 2 years of age and older and weighing 22 to less than 28 kgDose is based on body weight and must be determined by your doctor. The dose is one 200 mg tablet once a day.
- Children 2 years of age and older and weighing 17 to less than 22 kgDose is based on body weight and must be determined by your doctor. The dose is one 150 mg tablet once a day.
- Children younger than 2 years of age and weighing less than 10 kgUse and dose must be determined by your doctor.
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What Side Effects Can Tenofovir Disoproxil Fumarate Cause
Tenofovir DF may cause side effects. Some side effects of tenofovir DF can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.
Other possible side effects of tenofovir DF include:
- Changes in your immune system . IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
- Bone problems, including bone pain, or softening or thinning of the bones , which may lead to fractures.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of tenofovir DF. To learn more about possible side effects of tenofovir DF, read the drug label or package insert or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 or online.
Warning: Posttreatment Acute Exacerbation Of Hepatitis B
Severe acute exacerbations of hepatitis B virus have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including VIREAD. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in HBV-infected patients who discontinue anti-hepatitis B therapy, including VIREAD. If appropriate, resumption of anti-hepatitis B therapy may be warranted .
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What Should I Do If I Forget A Dose
If you miss a dose of tenofovir DF, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
What Other Information Should I Know
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a supply of tenofovir on hand. Do not wait until you run out of medication to refill your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Bone Loss And Mineralization Defects
Bone Mineral Density
In clinical trials in HIV-1 infected adults, VIREAD was associated with slightly greater decreases in bone mineral density and increases in biochemical markers of bone metabolism, suggesting increased bone turnover relative to comparators . Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving VIREAD.
Clinical trials evaluating VIREAD in pediatric subjects were conducted. Under normal circumstances, BMD increases rapidly in pediatric patients. In HIV-1 infected subjects 2 years to less than 18 years of age, bone effects were similar to those observed in adult subjects and suggest increased bone turnover. Total body BMD gain was less in the VIREAD-treated HIV-1 infected pediatric subjects as compared to the control groups. Similar trends were observed in chronic HBV-infected pediatric subjects 2 years to less than 18 years of age. In all pediatric trials, normal skeletal growth was not affected for the duration of the clinical trials .
The effects of VIREAD-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in adults and pediatric subjects 2 years and older are unknown. The long-term effect of lower spine and total body BMD on skeletal growth in pediatric patients, and in particular, the effects of long-duration exposure in younger children is unknown.
Mineralization Defects
Drugs Affecting Renal Function
Tenofovir is primarily eliminated by the kidneys . Coadministration of VIREAD 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, VIREAD should not be administered in combination with HEPSERA .
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Inclusion And Exclusion Criteria
Patients who met the following inclusion criteria were enrolled: HBsAg positivity for at least 6 months, oral antiviral therapy naïve, therapy with ETV 0.5 mg/day or TDF 300 mg/day for at least 2 years, regular monitoring every 3 months for the first year of treatment and every 6 months for the second year.
Patients younger than 18 years old, co-infected with hepatitis C, hepatitis D or human immunodeficiency virus, receiving immunosuppressive therapy or with history of immunodeficiency, previously treated with oral antiviral drugs or interferon, pregnant, diagnosed with HCC within the first 6 months of treatment, without regular monitoring records were excluded.
Tenofovir Disoproxil Fumarate Is Superior To Entecavir In Reducing Hepatitis B Surface Antigen For Chronic Hepatitis B In China: 2
- 1State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- 2Department of Neurosurgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- 3Department of Emergency Surgery, Tongji Medical College, Union Hospital, Huazhong University of Science and Technology, Wuhan, China
Aim: Tenofovir disoproxil fumarate and entecavir are equally recommended as the first-line antiviral treatments for chronic hepatitis B at present. We aimed to compare the long-term efficacy and safety between ETV and TDF therapy in CHB patients who had not received nucleoside analog treatment.
Method: In this single-center retrospective study, 414 patients who received ETV or TDF therapy at our center from January 2017 to May 2019 were included. To reduce the imbalance of baseline variables, propensity score matching was employed to yield 124 pairs of patients at a ratio of 1:1 based on the treatment regimen.
TDF has higher potency in reducing HBsAg than ETV in this study. Considering the effect still existed in patients with high HBsAg level , TDF might be a superior therapeutic regimen combining with its relatively safety.
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What Other Medications Interact With Viread
There are certain drugs you may need to avoid while taking Viread. This includes nephrotoxic drugs . When taken with Viread, these drugs can increase the risk of kidney injury.
Nephrotoxic drugs of concern include, among others:
- Aminoglycoside antibiotics like Gentak , neomycin, streptomycin, and Tobrex
- Antiviral drugs like Cytovene , Valcyte , Valtrex , Vistide , and Zovirax
- Nonsteroidal anti-inflammatory drugs like Aleve and Celebrex when taken in high doses
Other drug interactions can alter the concentration of Viread or the accompanying drug in the bloodstream. Decreased concentrations can reduce how well the drug works, while increased concentrations can enhance the risk of drug toxicity.
Let your provider know if you take any of the following:
- HIV protease inhibitor drugs like Norvir , Kaletra , Prezcoxib , or Reyataz
- Hepatitis C direct-acting antivirals like Harvoni , Epclusa , or Vosevi
To avoid interactions, always tell your provider about any drugs you take, including all prescription, over-the-counter, herbal, nutritional, or recreational substances.
Molecular Mechanisms Of Drug Resistance
Different types of mutations are associated with drug resistance and can emerge during antiviral therapy with nucleoside or nucleotide analogues. Primary mutations typically affect the reverse transcriptase domain of the HBV polymerase, thereby causing steric changes of the polymerase protein that escape the inhibitory effects of the nucleoside analogues . The most relevant hot-spot mutations in the HBV polymerase are displayed in Table 1. However, the polymerase mutants have a dramatically reduced viral replication efficacy in most cases . Secondary compensatory mutations occur in order to restore the viral replication fitness, thereby overcoming deleterious effects of the primary drug-resistant mutations . These mutations are not necessarily located within the enzymatically active sites of the polymerase, but oftentimes stabilize secondary or tertiary viral structures. The eight different HBV genotypes AH partly differ with respect to the position of secondary compensatory mutations and the rate of drug resistance development .
Table 1
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Established And Significant Interactions
Table 12 provides a listing of established or clinically significant drug interactions. The drug interactions described are based on studies conducted with TDF .
| Concomitant Drug Class: Drug Name | Effect on Concentration |
|---|
Study Design And Data
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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How To Take Viread
Viread is available as an oral tablet in four different strengths: 150 milligrams , 200 milligrams, 250 milligrams, and 300 milligrams. The tablet is taken by mouth with or without food.
If youre unable to swallow tablets, there is a powder form of Viread available for mixing into soft foods. Scoop the powder from the bottle using the dosing scoop included in the package. Only mix the powder with 2 to 4 ounces of soft foods, such as applesauce, baby food, or yogurt. Do not mix it with liquid. Ingest the mixture immediately to avoid a bitter taste.
Tdf Resistance And Multi
Although there is no signature mutation pattern conferring TDF resistance, cases of insufficient responses to TDF have been reported . Considering the noncross-resistance between ETV and TDF, the use of ETV should be effective in these cases, either as mono- or combination therapy . In vitro data indeed demonstrated that ETV is effective against TDF-resistant strains . The situation might be more complex in patients with multiple drug-resistant mutations due to an extended treatment history. A retrospective European multicenter study revealed that TDF monotherapy induced a potent and long-lasting antiviral response in LMV- and/or ADV-experienced patients with previous treatment failure . Moreover, the combination of ETV and TDF is a highly effective rescue therapy in patients with treatment failure after exposure to multiple drugs .
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Patients And Study Design
A total of 345 treatment-naïve CHB patients who received a single regimen of either TDF or ETV for at least 12 months were consecutively enrolled from 4 tertiary university hospitals in Korea between January 2011 and December 2014. Because TDF or ETV use was not randomly assigned, potential confounding and selection biases were accounted for by developing a propensity score. Among a total of 345 patients, 210 patients were selected using propensity score match, at a ratio of 1:1. Patients with the following characteristics were excluded: 1) other viral infections such as HCV, HDV and HIV, 2) other concomitant liver diseases such as alcoholic liver disease and autoimmune liver disease, or 3) HCC. Patients were monitored by clinical examination and biochemical and virologic assessments at least every 3 to 4 months during the antiviral therapy.
The study protocol was approved by the Hallym University Medical Center Institutional Review Boards .
How You Can Get Hepatitis B
You can get hepatitis B from:
- injecting drugs using shared needles
- being injured by a used needle
- having a tattoo or piercing with unsterilised equipment
- having a blood transfusion in a country that does not check blood for hepatitis B. Blood transfusions in the UK are checked for hepatitis B.
If you’re pregnant and have hepatitis B, you can also pass it onto your baby during pregnancy or birth.
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How Do I Get Hepatitis B Treatment
Usually for adults, hepatitis B goes away on its own and you wont need treatment. Your doctor might tell you to rest, eat well, and get plenty of fluids. You may also get medicines to help with any symptoms you might have but be sure to talk with your doctor or nurse before taking anything.
If you have chronic hepatitis, there are medicines you can take to treat it. Your doctor will tell you about your options and help you get whatever treatment you need.