The POSITIVELY AWARE Hepatitis Drug Guide includes FDA-approved medications for the treatment of hepatitis B (HBV) and those that cure hepatitis C (HCV). Currently, there are no new HBV treatments that are close enough for FDA approval to be included this year, and there are no new HCV drugs at the development stage either. 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, safe, and effective to use according to medical providers and other experts). The information provided about these drugs comes from the package labels and other sources such as the AASLD/IDSA Recommendations for Testing, Managing and Treating Hepatitis C (HCV Guidance), AASLD Hepatitis B Guidance, conference presentations, and medical journals.
Hepatitis C treatment comprises two or more medications—all of which are pills—taken together. Some treatments are a fixed-dose combination (FDC) pill which contains medications from two (or more) different classes—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. Pegylated interferon is no longer used for the treatment of HCV.
Hepatitis B is treated with one medication at a time—either an antiviral such as Viread (tenofovir) or Baraclude (entecavir), or with pegylated interferon.
What’s new in 2019?
There is really nothing new in the hepatitis C treatment field: No new drugs are in development, because the ones we have available can treat and cure nearly everyone. If anything, we are removing drugs from this year’s guide that have been discontinued. This year, Daklinza (daclatasvir, made by Bristol-Myers Squibb) was discontinued as of June, 2019.
In the area of hepatitis B, we have no new drugs—while there are a number of potential new treatments in the pipeline, none are readily available. The field of drug development in HBV is exciting; while we don’t have a cure yet, there is optimism that we are getting closer and closer to that goal. The World Health Organization reports that there are about 50 HBV (and hepatitis D) drugs in development, with about 17 of those in the phase 2 clinical trial stage. As new drugs are developed and get closer to FDA approval, Positively Aware will report on them and include them in future editions of the Drug Guide.
Where applicable, each drug page will include:
Drug names
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 FDA-approved drugs, the brand name will appear first, at the top of the page, followed by the common name(s).
FDA status
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.
Drug class
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; however, for this guide 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, GT 1b, etc.). Although different genotypes can play a role in disease progression or severity, it is especially important to know a person’s genotype to determine the correct treatment. Each drug page will list the genotype(s) that the drug is effective against, both those that are FDA approved as well as those that have enough evidence to be used “off-label.”
Dosage
HBV drugs are either oral tablets or an injectable. HCV drugs are all oral, 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.
Manufacturer
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 will place on programs such as 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 28.
Potential side effects and adverse events
This section offers information about side effects and adverse events associated with the 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 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 among people who were cured of HCV using DAAs, leading to hepatic flares, liver failure (requiring transplant), or, in some cases, death. See the Black Box Warning 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 with 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.
More information
This section contains information that does not fit in any of the above sections, but is still important for you to know.