By Andrew Reynolds @projectinform

The HCV Drug Guide includes medications that are FDA approved, expected to be approved this year, or are likely to be approved through June of 2016. The information provided on FDA-approved drugs comes from the package labels, as well as other sources such as conference presentations and medical journals. For the drugs not yet approved, the information comes from conference presentations and medical journals.

All current HCV medications must be taken in combination with other medications (with the exception of Harvoni and Viekira Pak). Pegylated interferon is injected, but all other HCV medications are taken as pills. HCV treatment may comprise two or more medications taken together, but there are also fixed-dose combination (FDC) pills which contain two medications from different classes.

Each drug page will include:

DRUG NAMES

Drug names can be very confusing. We include the brand name, the generic name, and often an abbreviation. For example, Sovaldi is the brand name of sofosbuvir. Sovaldi can be abbreviated as SOV, and sofosbuvir is abbreviated as SOF. Drugs that have been FDA approved will have a brand name, while those that have not yet reached that stage will only have a generic (or common) name. In some cases, it might not even have a name, but rather a series of letters and numbers. For those drugs which have been FDA approved, the brand name will appear first, at the top of the page, followed by the common name(s); for all other drugs the common or generic name will appear first.

FDA STATUS

We will indicate if a drug is approved, and any drug that has been submitted for FDA approval will have an estimate of its approval date.

DRUG CLASS

Just as HIV medications are divided into several different drug classes, the “DAA” (direct acting antiviral) era of HCV treatment has seen the development of several different classes as well. Currently, there are six classes of HCV drugs, and two multi-class combination options:

• NS3/4A protease inhibitors

• Nucleoside and nucleotide NS5B polymerase inhibitors

• NS5A inhibitors

• Non-nucleoside NS5B polymerase inhibitors

• Multi-class combination drugs

• Pegylated interferon alfa (no longer recommended)

• Nucleoside analogs

GENOTYPE

Genotype (GT) refers to the strain or variation of HCV. Worldwide, there are probably 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). Different genotypes can play a role in disease progression or severity, but it is especially important to know one’s genotype to determine the correct treatment. Some genotypes can be treated for a shorter amount of time and do not need interferon or even ribavirin. We will list the genotype(s) that the specific HCV medication works against, both those for which there is FDA approval as well as those with enough evidence for “off-label” use.

APPROVED FOR HIV/HCV CO-INFECTION

Information about the HCV drugs for use in HIV/HCV co-infected patients will appear in this section, both those that are FDA approved as well as those for off-label use.

DOSAGE

HCV drugs are taken in a variety of ways, 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 they pay for prescription drugs. HCV drugs are very 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 have a general idea of 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. We provide a list of HCV drug patient assistance and co-pay programs.

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 clinical trial data for the ones that have yet to receive FDA approval. 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 would 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 such as anemia (low red blood cell count) or neutropenia (low white blood cell count).

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 the most important ones for drugs that are commonly used by people living with HCV. 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, and clinical trial data for the ones that have yet to receive FDA approval.

MORE INFORMATION

This section contains general information that does not fit in any of the above sections, but is still important for you to know, including opinions from treatment advocates.

What’s new in 2015?

We have seen several changes since last year’s publication of the HCV Drug Guide: Victrelis and Incivek, two first-generation HCV protease inhibitors, have been discontinued and are no longer available in the United States. These have been removed from this year’s guide, but are still available for review on the PA website. We saw the FDA approval of the drugs that comprise Harvoni and Viekira Pak, and the withdrawal of the FDA submission for the approval of asunaprevir. Daclatasvir has been re-submitted for approval in genotypes 1 and 3 (used with the already approved Sovaldi), as has the Merck FDC, grazoprevir and elbasvir. Stay tuned to Positively Aware (positivelyaware.com) and Project Inform (projectinform.org) for updates and news on hepatitis C medications, prevention, and treatments.