The POSITIVELY AWARE/Project Inform Viral Hepatitis Drug Guide includes medications for the treatment of hepatitis B (HBV) and hepatitis C (HCV) that are FDA approved. Currently, there are no HBV or HCV treatments that are close enough for FDA approval to be included this year. The guide lists FDA-recommended treatment regimens, as well as “off-label” recommendations (that is, treatment options that may not yet be FDA approved, but which are acceptable according to medical providers and other experts). The information provided on the FDA-approved drugs comes from the package labels, as well as other sources such as the AASLD/IDSA Recommendations for Testing, Managing and Treating Hepatitis C (HCV Guidance), AASLD Hepatitis B Guidance, conference presentations, medical journals and other sources.
Hepatitis C treatment comprises two or more medications—all pills—taken together. Some treatments are a fixed-dose (FDC) pill that contains medications from two (or more) different classes in one pill (for example, Epclusa, which is one pill containing velpatasvir and sofosbuvir), or they may be two (or more) separate pills. Some regimens may include weight-based ribavirin. There is no pegylated interferon used for the treatment of HCV any longer.
Hepatitis B is treated with one medication at a time: Either an antiviral like Viread (tenofovir) or Epivir-HBV (lamivudine) or with pegylated interferon.
What’s new in 2018?
In short, not much. Since last year’s publication, two new HCV drugs—Vosevi and Mavyret—received FDA approval, so we updated those to include their brand names and other information from their package insert. We have removed several drugs from the hard copy version of the guide: Viekira XR, Technivie, Daklinza, and Olysio. None of these drugs are recommended as first-line choices by the AASLD/IDSA HCV Guidance panel, and they are not prescribed very much (if at all) when compared to other, more preferred treatments. In fact, AbbVie recently announced that they will stop the production of Viekira XR and Technivie at the end of 2018. We will keep these drugs available in our online version of the guide.
Each drug page will include, where applicable:
Drug names can be confusing. We include the brand name, the generic name, and an abbreviation. For example, Sovaldi is the brand name of sofosbuvir. Sovaldi can be abbreviated as SOV, and sofosbuvir is abbreviated as SOF. For these FDA-approved drugs, the brand name will appear first, at the top of the page, followed by the common name(s).
The medications this year are all FDA approved. There are no new hepatitis C or B drugs in development at a stage where we can report on them.
The “direct-acting antiviral” or DAA era of HCV treatment has seen the development of several different classes of hepatitis medications. Currently, there are five classes of HCV drugs, and six multi-class fixed-dose combinations:
- Nucleoside analogs
- NS3/4A protease inhibitors
- Nucleotide NS5B polymerase inhibitors
- Non-nucleoside NS5B polymerase inhibitors
- NS5A inhibitors
Genotype (HCV only)
Genotype (GT) refers to the strains or variations of HCV. Worldwide, there are as many as 11 distinct genotypes, but for this guide we will only refer to GT 1–6. In the United States, GT 1–4 are most prevalent, with GT 1 the most common overall. Within each genotype, there are several subtypes that are indicated by numbers and letters (GT 1a and GT 1b and so on). Although different genotypes can play a role in disease progression or severity, it is especially important to know one’s genotype to determine the correct treatment. We will list the genotype(s) that the specific HCV medication works against, both those that are FDA approved as well as those that have enough evidence to be used “off-label.”
Approved for HIV/HCV co-infection
We will note HCV drugs approved for use in HIV/HCV co-infected patients, both those that are FDA approved and those that are off-label.
HBV drugs are either oral tablets or an injectable. HCV drugs are all oral, and may need to be taken at different times and with differing food restrictions. Sometimes, the same drug is taken differently depending upon a variety of factors like genotype or liver health. This section will describe the dosage requirements for the drug, as well as provide details about restrictions and other relevant information.
This section includes the name of the company that makes the drug.
Average Wholesale Price (AWP)
The AWP is the measure used by insurance companies—both private and public—to determine the average cost of prescription drugs. HCV drugs can be expensive, and there is much concern over the burden these high costs are going to place on programs like Medicaid and Medicare, as well as the Veterans Administration and private insurance carriers. Patients should never have to pay for medications at this price, but it’s still important to know these costs when shopping for health insurance coverage. Each of the pharmaceutical companies has a Patient Assistance Program (PAP) to help uninsured and underinsured people cover all or part of the costs. There are also pharmaceutical co-pay programs and non-profit organizations that can help with some additional support for co-pays. A list of HCV drug patient assistance and co-pay programs appears on page 29; HBV drug patient assistance programs are listed on page 40.
Potential side effects and adverse events
This section offers information about side effects and adverse events associated with HBV and HCV drugs. It’s not an exhaustive list, but rather a selection of the most commonly reported side effects. The information comes from the package insert and study data for the FDA-approved drugs, and real world data from patients who have taken them. Since HCV medications are never taken alone, we’ll cover potential side effects that are associated with the entire regimen, as opposed to a single drug. It may be hard to separate one cause of a side effect from another, and in the end, it doesn’t really matter what the cause is but only that you are experiencing it. Everyone experiences side effects differently: Just because it’s listed doesn’t mean you will automatically have it. Talk to your medical provider about side effects before starting treatment, communicate with him or her about any you may have during treatment, and get blood tests as directed to look for side effects.
A note on the risk of hepatitis B reactivation in some patients treated with Direct-Acting Antivirals (DAAs) for hepatitis C
On October 4, 2016 the FDA made a safety announcement, also known as a “Boxed Warning,” about the potential risk of HBV reactivation in some patients taking all hepatitis C DAAs. A Boxed Warning is the most important warning the FDA can issue. In this case, there were a number of unexpected cases of hepatitis B reactivation in people who were cured of HCV using the DAAs, leading to hepatic flares, liver failure (requiring transplant), or, in some cases, death. Read Hepatitis B Reactivation for more information on this warning.
Potential drug interactions
This section provides information about the variety of known and potential drug interactions. Like the side effects section, it’s not an exhaustive list of interactions, but rather a list of the most important ones. You can find a complete list in the package insert, but you should also talk to your medical provider and/or pharmacist about any medications you are taking so you can minimize drug interactions. The information comes from the package insert and clinical trial data for the FDA-approved drugs.
This section contains information that does not belong in any of the above sections, but is still important for you to know.