Testing Prior to the Initiation of Therapy Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with Harvoni [see Warnings and Precautions (5.1)].
Full Answer
How should I take Harvoni?
1 Take Harvoni exactly as your healthcare provider tells you to take it. ... 2 Do not stop taking Harvoni without first talking with your healthcare provider. 3 Take Harvoni tablets or oral pellets by mouth, with or without food. 4 It is important that you do not miss or skip doses of Harvoni during treatment. More items...
What is included in the monitoring of patients receiving Harvoni?
Clinical and hepatic laboratory monitoring, as clinically indicated, is recommended for patients with decompensated cirrhosis receiving treatment with Harvoni and ribavirin [see Adverse Reactions (6.1)]. No specific antidote is available for overdose with Harvoni. If overdose occurs, the patient must be monitored for evidence of toxicity.
What is the efficacy of Harvoni in the 1119 trial?
In the open-label 1119 trial, Harvoni was administered for 12 weeks to 41 treatment-naïve or previously treated adult subjects with genotype 5 HCV infection, with or without cirrhosis. The overall SVR12 was 93% (38/41). SVR12 was similar based upon prior HCV treatment history and cirrhosis status.
What are the warnings and precautions for Harvoni and ribavirin?
If Harvoni is administered with ribavirin, the warnings and precautions for ribavirin, in particular the pregnancy avoidance warning, apply to this combination regimen. Refer to the ribavirin prescribing information for a full list of the warnings and precautions for ribavirin [see Dosage and Administration (2.2) ].
What test will be done before prescribing treatment for the patient with HCV?
Testing for the presence of resistance-associated substitutions (RASs) prior to starting treatment should be performed as recommended in the Initial Treatment and the Retreatment sections. Additional information about RAS testing can be found in the HCV Resistance Primer.
What labs are elevated with hep C?
Here are some common tests that are used for people living with hepatitis C.LIVER PANEL. ... Alanine aminotransferase (ALT; sometimes listed as SGPT): ALT is a liver enzyme. ... Aspartate aminotransferase (AST; sometimes listed as SGOT): AST is also a liver enzyme, which is often elevated in people with chronic hepatitis C.More items...
Does CBC test for hep C?
A complete blood count (CBC) is one of the most commonly performed blood tests. Since it reveals peripheral blood changes, the CBC is routinely performed in health examinations, even in asymptomatic patients. However, there is no evaluation showing the screen for HCV potential infection by CBC data.
Why would my doctor order a hep C antibody test?
A hepatitis C antibody test is used to find out if you are infected with the hepatitis C virus (HCV). When your body is infected with a virus, it produces antibodies to fight the virus. The hepatitis C antibody test looks for antibodies that the body produces in response to the presence of HCV.
When should I worry about ALT?
What ALT level is considered high? The upper limit of normal for ALT is 55 IU/L. When an ALT level is double to triple the upper limit of normal, it is considered mildly elevated. Severely elevated ALT levels found in liver disease are often 50 times the upper limit of normal.
What is included in a hepatitis panel?
A hepatitis panel typically includes: Hepatitis A antibody, IgM. Hepatitis B tesing: Hepatitis B core antibody, IgM and Hepatitis B surface Ag. Hepatitis C antibody.
Will liver enzymes be elevated with hep C?
With hepatitis C there is an average incubation period of seven to eight weeks before a rise in liver enzymes levels occurs. As liver cells are damaged by the virus, enzymes leak into the bloodstream. This leads to a rise in specific enzyme levels.
Does a routine blood test check liver?
Blood tests used to assess the liver are known as liver function tests. But liver function tests can be normal at many stages of liver disease. Blood tests can also detect if you have low levels of certain substances, such as a protein called serum albumin, which is made by the liver.
Would hepatitis show up in a routine blood test?
Many people think that because they've had a blood test, they will have automatically been tested for hepatitis B and hepatitis C and therefore don't have to worry. In most situations this is not the case.
Can you have Hep C antibodies and not have hep C?
Hepatitis C is a viral liver infection that can become chronic. Some people have antibodies associated with the virus in their blood but do not have an active hepatitis C infection. These antibodies can lead to false-positive results on blood tests for an active infection.
What is liver SGPT test?
An ALT test measures the level of alanine aminotransferase, also called ALT or SGPT. ALT is one of the enzymes that help the liver convert food into energy. High levels of these enzymes can be a sign that the liver is injured or irritated, and the enzymes are leaking out of the liver cells.
What is HBsAg blood test?
HEPATITIS B SURFACE ANTIGEN (HBSAG): Tells if you have chronic hepatitis B. Only the HBsAg blood test can tell if you have chronic hepatitis B. HEPATITIS B SURFACE ANTIBODY (ANTI-HBS): Tells if you are protected against hepatitis B. Test Result.
Testing Prior to the Initiation of Therapy
Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with HARVONI [see Warnings and Precautions (5.1)].
Recommended Dosage in Adults
The recommended dosage of HARVONI in adults with genotype 1, 4, 5, or 6 HCV is one tablet (90 mg ledipasvir and 400 mg sofosbuvir) taken orally once daily with or without food [see Clinical Pharmacology (12.3)].
How is Harvoni used?
Harvoni is taken once daily, with or without food, for 8 to 24 weeks. Treatment length depends on HCV treatment history, whether a person has cirrhosis, and the amount of hepatitis C virus in a person’s bloodstream (called HCV RNA or viral load ). Some people will need to add another drug, called ribavirin (RBV), twice daily with Harvoni.
What is Harvoni for?
What is Harvoni? Harvoni is two HCV-fighting drugs (sofosbuvir and ledipasvir) in one pill. In the United States, Harvoni is approved for HIV-negative and HIV-positive people with hepatitis C genotypes 1, 4, 5, and 6 who are over 18 years old. Harvoni is also approved for people with HCV genotype 1 who have advanced (called decompensated) ...
How long does HCV resistance last?
Most people who are not cured have resistance to one or more of the HCV drugs they’ve taken. Resistance to certain hepatitis C drugs can disappear within months. But resistance to certain drugs, including Harvoni, can last for years and may limit re-treatment options.
How long does ribavirin stay in your system?
Ribavirin stays in a person’s body for months. Women and their male partners should avoid pregnancy for six months after they have stopped taking ribavirin. Using two forms of birth control to prevent pregnancy while taking ribavirin—and for six months afterwards—is recommended.
Does Harvoni harm babies?
It is not known whether Harvoni causes harm to unborn babies. If you are pregnant or planning pregnancy, talk with your health care provider about the risks and benefits of HCV treatment. It is not known whether Harvoni passes into breast milk. Harvoni is under study in children (ages 3 to 18).
What is support path for harvoni?
The criteria differ depending on the type of coverage and the state it is issued in. Support Path is Gilead’s patient assistance program for Harvoni. People with private insurance may be eligible for assistance with copayments. Uninsured people may be eligible for medication at no charge. Information about Support Path is available online at: http://www.gilead.com/responsibility/us-patientaccess/ support%20path%20for%20sovaldi%20and%20harvoni. Information about Support Path is also available by phone at 1.855.769.7284, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern Time), or online at: https://www.harvoni.com/support.
Can Harvoni be used with other drugs?
Harvoni should not be used with certain drugs. Combining medications can increase or lower drug levels (called drug-drug interactions ). Increasing drug levels can make side effects from each drug worse. If drug levels get too low, a drug can stop working, putting people at risk for drug resistance or not being cured.
When is Harvoni due out?
Discover all there is to know about this potent Hepatitis C treatment, including when a less costly, generic version is due out in 2019.
Can Hep C Come Back After Taking Harvoni?
Once treatment is complete, patients have a high chance of being cured of HCV. But they will still need to take certain precautions. 12 weeks after completing treatment, patients need to take a PCR viral detection test to confirm if they are cured. They will not know if they are cured till they take this test.
Medical uses
Administration
- The recommended dosage of Harvoni is one tablet (90 mg ledipasvir and 400 mg sofosbuvir) taken orally once daily with or without food [see Clinical Pharmacology (12.3)].
Prognosis
- Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups [see Clinical Studies (14)].
Treatment
- Table 1 shows the recommended Harvoni treatment regimen and duration based on patient population. Coadministration of amiodarone with Harvoni is not recommended. For patients taking amiodarone who have no other alternative, viable treatment options and who will be coadministered Harvoni: Patients who are taking Harvoni who need to start amiodarone therapy due to no other alternative, viable treatment options should under…
Description
- Harvoni is available as an orange colored, diamond shaped, film-coated tablet debossed with \"GSI\" on one side and \"7985\" on the other side of the tablet. Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Clinical significance
- Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg nega…
Pathophysiology
- HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.
Management
- Test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before initiating HCV treatment with Harvoni. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with Harvoni and during post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Side effects
- Postmarketing cases of symptomatic bradycardia, as well as fatal cardiac arrest and cases requiring pacemaker intervention, have been reported when amiodarone is coadministered with Harvoni. Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks after initiating HCV treatment. Patients also taking beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease…
Symptoms
- Patients who develop signs or symptoms of bradycardia should seek medical evaluation immediately. Symptoms may include near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, confusion or memory problems [see Adverse Reactions (6.2), Drug Interactions (7.2)].
Interactions
- The concomitant use of Harvoni and P-gp inducers (e.g., rifampin, St. John's wort) may significantly decrease ledipasvir and sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of Harvoni. Therefore, the use of Harvoni with P-gp inducers (e.g., rifampin or St. John's wort) is not recommended [see Drug Interactions (7.2)].
Results
- The proportion of subjects who permanently discontinued treatment due to adverse events was 0%, less than 1%, and 1% for subjects receiving Harvoni for 8, 12, and 24 weeks, respectively.
Adverse effects
- The most common adverse reactions (at least 10%) were fatigue and headache in subjects treated with 8, 12, or 24 weeks of Harvoni. The safety assessment of Harvoni was based on an open-label clinical trial in 335 genotype 1 or 4 subjects with HCV/HIV-1 coinfection who were on stable antiretroviral therapy in Study ION-4 [see Clinical Studies (14.4)]. The safety profile in HCV/HIV-1 coinfected subjects was similar to that observed in HCV mono-in…
Safety
- Table 3 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 Harvoni in clinical trials. The majority of adverse reactions presented in Table 3 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. The safe…