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Viekira Pak and Technivie Fact Sheet

April 2016

Viekira Pak

Credit: AbbVie Inc.


The goal of hepatitis C virus (HCV) treatment is a cure (when there is no HCV in a person's bloodstream at least 12 weeks after treatment is finished).


What is Viekira Pak?

Viekira Pak is a combination of hepatitis C virus-fighting drugs (paritaprevir/ritonavir/ ombitasvir and dasabuvir) that block different steps of the virus life cycle. In the United States, Viekira Pak is approved for people with hepatitis C genotype 1 who are over 18 years old.


What is Technivie?

Technivie is a combination of paritaprevir/ritonavir and ombitasvir. Technivie is approved for people over 18 years of age who have hepatitis C genotype 4 without cirrhosis.


How is Viekira Pak used?

Viekira Pak is taken twice daily, with food, for 12 or 24 weeks. Viekira Pak comes in a box of 28 daily-dose packs (each has two pink tablets and two beige tablets). Both pink tablets are taken in the morning. One beige tablet is taken in the morning and one in the evening. Some people will need to take another drug, called ribavirin (RBV), twice daily with Viekira Pak.


How is Technivie used?

Technivie is taken once daily, with food, for 12 weeks. Technivie comes in a box of 28 daily-dose packs with two pink tablets. Both pink tablets are taken in the morning. It should be used with another drug, called ribavirin (RBV), which is taken twice daily. Using Technivie by itself can be considered for people who cannot take RBV if they are being treated for the first time.

It is important to make sure that you have gotten the right treatment (with or without RBV) for the recommended length of time (12 or 24 weeks).


Viekira Pak and Technivie With Cure Rates*

Viekira Pak and Technivie with Cure Rates*

* Cure rates in clinical trials are higher than in real life since the people in them are usually healthier and get extra monitoring and support.

Credit: Treatment Action Group


The most important thing a person can do to be cured is not to miss taking doses of HCV treatment -- called adherence. Adherence lowers the risk for drug resistance.


What is drug resistance?

Each day, HCV makes billions of copies of itself. Some of these copies are not the same as the original virus. They may have changes (called mutations) that can stop hepatitis C drugs from working. If people miss doses of their treatment, the virus gets a chance to reproduce -- and some of these copies can be resistant to HCV treatment. Some people have drug resistance even though they have never been on hepatitis C treatment -- but many can be cured anyway.

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 other drugs can last for years and might prevent re-treatment from working.


Viekira Pak or Technivie and age, gender, and race/ethnicity:

In clinical trials, cure rates did not differ by age (over 65 vs. under 65). Cure rates were the same for women and men. There is not much information about how well Viekira Pak or Technivie work by race or ethnicity because most people in the trials were white. But researchers noticed two things: adding RBV to Viekira Pak increased cure rates for African Americans with HCV genotype 1a (100% vs. 84%), and people with a common genetic factor among African Americans (called the IL28B TT genotype) were less likely to be cured by Viekira Pak (see TAG's Hepatitis C and the IL28B Gene fact sheet).


Side effects from Viekira Pak and Technivie:

Talk with your health care provider about possible side effects and how they will be managed. In clinical trials, the most common side effects from Viekira Pak or Technivie were nausea, itching, and insomnia. People taking RBV also experienced fatigue, weakness, rash, and other skin reactions (see TAG's RBV fact sheet for more information). Most of these side effects were mild.


Liver enzyme levels may increase while taking Viekira Pak or Technivie.

Your health care provider should check your liver with blood tests during the first four weeks of treatment -- and afterward as needed.


Do Viekira Pak and Technivie work for HIV-positive people?

Yes, but Viekira Pak or Technivie should not be used by coinfected people unless they are also being treated for HIV. This is because one of the drugs in Viekira Pak and Technivie can cause resistance to some HIV drugs. In a clinical trial of 63 people with HIV and hepatitis C genotype 1, 93.5% were cured after 12 weeks of Viekira Pak plus RBV. Technivie has not been studied in people coinfected with HIV and hepatitis C genotype 4.

Viekira Pak or Technivie can be used with these HIV drugs: Isentress or Reyataz (300 mg), which should be taken in the morning, without ritonavir (Norvir), plus Truvada or Viread with Epivir or Emtriva.


Viekira Pak or Technivie and other medications:

Viekira Pak or Technivie 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 a person at risk for drug resistance or not being cured.

Talk with your health care provider about starting or stopping any medications, supplements, or herbal remedies.

Some drugs should be switched, stopped, or avoided while using Viekira Pak or Technivie. More information is available in the prescribing information for Viekira Pak and Technivie (www.rxabbvie.com/pdf/viekirapak_pi.pdf and www.rxabbvie.com/htm/technivie/technivie_pi.htm) and at: www.hep-druginteractions.org.


Viekira Pak or Technivie and hormonal contraception (birth control):

Viekira Pak and Technivie cannot be used with medications containing ethinyl estradiol (women can use progestin-only birth control). Medications containing ethinyl estradiol can be restarted two weeks after stopping Viekira Pak or Technivie.


Viekira Pak or Technivie during pregnancy, nursing, and in children:

It is not known whether Viekira Pak or Technivie cause 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 Viekira Pak or Technivie pass into breast milk.

Viekira Pak and Technivie have not been studied in children and are not approved for people under 18 years old.

Ribavirin causes birth defects and miscarriage. Ribavirin should not be used by pregnant women or by male partners of pregnant women. 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 afterward -- is recommended. Nursing during treatment with ribavirin is not recommended.

There is a ribavirin pregnancy registry at: www.ribavirinpregnancyregistry.com.


Storing Viekira Pak:

Keep Viekira Pak or Technivie at room temperature (below 86°F).


Viekira Pak or Technivie in people with kidney disease:

Viekira Pak or Technivie can be used by people with mild or moderate kidney disease. People with severe kidney disease should consult with a specialist before using Viekira Pak or Technivie. They have not been studied in people on dialysis.


Viekira Pak or Technivie in people with cirrhosis:

Hepatitis C treatment guidelines recommend that people with serious liver damage (Child-Pugh Class B or C cirrhosis) be treated by a specialist. Technivie has not been studied in people with HCV genotype 4 and cirrhosis. Viekira Pak and Technivie should not be used in people with Child-Pugh Class B or Class C cirrhosis.


Access to Viekira Pak and Technivie:

Access may be restricted by public and private payers. The criteria differ by type of coverage and the state it is issued in. ProCeed is AbbVie's Viekira Pak patient assistance program. ProCeed may help people with private insurance with copayments. Uninsured people may be eligible for free medication through proCeed.

Information about proCeed is available by phone at 1.844.2PROCEED (1.844.277.6233), seven days a week between 7:00 a.m. and midnight (Eastern Time), or online at: www.viekira.com/proceed-support/proceed-benefit.

Information about the Technivie patient assistance program is also available by phone at 1.844.2PROCEED (1.844.277.6233), seven days a week between 7:00 a.m. and midnight (Eastern Time), or online at: www.Technivie.com.





This article was provided by Treatment Action Group.
 

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