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Easy way to take HARVONI

Harvoni proved that hep C can be treated in less complicated way. It doesn’t require taking interferon or follow difficult regimens. It’s as easy as it can be: just 1 pill on a daily basis. It is not important if you take it with or without food.
The time-frame of your treatment should be provided by your physician based on your personal health state and test results. The regular length of treatment that is being adopted for most of the patients is 12 weeks. However, the time-frame may vary from 8 to 24 weeks.
Please remember that treatment itself depends on a number of features that should be taken into account:

  •  Personal therapy history
  •  Hep C GT
  •  The level of hep C virus in your blood
  •  Any level of liver damage
  •  If there was or was not a liver transplantation.

The results of clinical studies

Successful cure rate

The term ‘cure’ and related terms mean that the blood tests taken in 3 months after the treatment course has been completed do not show the presence of Hep C virus.

Genotype 1 Adults Without Cirrhosis

Hep C
Treatment History
Duration of
Treatment
Cure
Rate
Never Treated With Lower Levels of Virus in Body (Less Than 6 million UI per mL) 8 Weeks 97%
Never Treated 12 Weeks 96-99%
Previously Treated 12 Weeks 95%

Genotype 1 Adults With Compensated Cirrhosis

Hep C
Treatment History
Duration of
Treatment
Cure
Rate
Never Treated 12 Weeks 94%
Previously Treated 24 Weeks 97-100%

Please note that the information above is not valid for those patients who have advanced cirrhosis or the individuals who had liver transplantation. Please learn more about Harvoni treatment options for these patients in the «Advanced Cirrhosis/Liver Transplant» tab

  • *The the clinical study of 647 patients who had GT 1 hep C without cirrhosis, who did not have prior-treatment with HARVONI, and with lower virus levels (< 6 million IU/mL) showed 97% (119 out of 123) cure result in 8 weeks.
  • *In case of genotype 1 Hep C and no prior Hep C treatment of 865 patients having or without cirrhosis (compensated), treatment results show 99% (210 out of 213) taking HARVONI (1 pill a day for 12 weeks). In case of GT1 Hep C, 648 patients (without prior Hep C treatment and with no cirrhosis) participated in a special study that resulted in 96% (208 out of 216) successfully treated people after taking only 1 pill of HARVONI once a day during 12 weeks.
  • *It is highly advisable to use HARVONI with ribavirin for the same 12 weeks treatment period together for patients with compensated cirrhosis who previously had been treated from Hep C GT 1. *Please read medicine instruction for ribavirin when adding it to your Harvoni treatment (contradictions, drug combination and pregnancy/lactation period).
  • *HARVONI plus ribavirin for 12 weeks can be considered in previously treated genotype 1 patients with compensated cirrhosis who are eligible for ribavirin. *If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.
  • *The study that was comprised of 155 individuals with Hep C GT 1 whose prior treatment failed twice and who had compensated cirrhosis. It showed successful cure results for 96% (74 out of 77) of individuals who were treated with HARVONI plus ribavirin (1 pill daily for 12 weeks) and even higher 97% (75 out of 77) of individuals that took HARVONI less ribavirin for 24 weeks.
  • The the clinical study of 440 people who had GT 1 hep C with compensated cirrhosis, whose Hep C treatment previously failed twice , after taking HARVONI (1 pill daily for 24 weeks) were 100% cured (22 out of 22).
See possible side effects of Harvoni

Genotype 1 Adults With Compensated Cirrhosis

Hep C
Genotype
Duration of
Treatment
Cure
Rate
4 12 Weeks 93%
5 12 Weeks 93%
6 12 Weeks 96%

Please note that this information is not valid for those patients who have advanced cirrhosis or the individuals who had liver transplantation. Please learn more about Harvoni treatment options for these patients in the «Advanced Cirrhosis/Liver Transplant» tab

The results of the study on GT 4, 5, and 6 that were based on a defined number of individuals who previously had Hep C treatment, it also included patients with compensated cirrhosis.

* 85 individuals with Hep C genotype 4 or 5 that previously had/didn’t have Hep C treatment with no cirrhosis or with compensated cirrhosis, the study showed 93% (41 out of 44) with GT 4 and 93% (38 out of 41) of those with GT 5 that were treated with HARVONI for 12 weeks, taking 1 pill a day were cured.

** 25 individuals with Hep C GT 6 that previously had/didn’t have Hep C treatment with no cirrhosis or with compensated cirrhosis, the study showed 96% (24 out of 25) successful cure with HARVONI for 12 weeks, taking 1 pill a day.

*** Decompensated cirrhosis means that the patient’s liver is not longer functioning in a healthy and effective way because it’s heavily scarred.

See possible side effects of Harvoni

HIV-1 and Hep C

HARVONI regimen is the same both for patients with Hep C and HIV-1 or with Hep C only. You may find the information on taking HARVONI in the charts 1 and 2 based on genotype.

All drug interactions of HARVONI and HIV antiretroviral medicines should be prior discussed with your physician.

See possible side effects of Harvoni

Advanced Cirrhosis or Liver Transplant

For individuals with decompensated* cirrhosis who have Hep C GT 1 it is important to add ribavirin to the treatment with HARVONI. Total therapy period in most patients takes 12 weeks.

For individuals with liver transplant without advanced cirrhosis who have Hep C GT 1 or 4, it is important to add ribavirin to the treatment with HARVONI. Total therapy period in most patients takes 12 weeks.

It is highly recommended to consult your physician in order to get the exact and suitable for you scheme and regiment of your total treatment.

Please read medicine instruction for ribavirin when adding it to your Harvoni treatment (contradictions, drug combination and pregnancy/lactation period).

*Decompensated cirrhosis means that the patient’s liver is not longer functioning in a healthy and effective way because it’s heavily scarred.

See possible side effects of Harvoni

Genotype 1 Adults Without Cirrhosis

Hep C
Treatment History
Duration of
Treatment
Cure
Rate
Never Treated With Lower Levels of Virus in Body (Less Than 6 million UI per mL) 8 Weeks 97%
Never Treated 12 Weeks 96-99%
Previously Treated 12 Weeks 95%

Genotype 1 Adults With Compensated Cirrhosis

Hep C
Treatment History
Duration of
Treatment
Cure
Rate
Never Treated 12 Weeks 94%
Previously Treated 24 Weeks 97-100%

Please note that the information above is not valid for those patients who have advanced cirrhosis or the individuals who had liver transplantation. Please learn more about Harvoni treatment options for these patients in the «Advanced Cirrhosis/Liver Transplant» section

  • *The the clinical study of 647 patients who had GT 1 hep C without cirrhosis, who did not have prior-treatment with HARVONI, and with lower virus levels (< 6 million IU/mL) showed 97% (119 out of 123) cure result in 8 weeks.
  • *In case of genotype 1 Hep C and no prior Hep C treatment of 865 patients having or without cirrhosis (compensated), treatment results show 99% (210 out of 213) taking HARVONI (1 pill a day for 12 weeks). In case of GT1 Hep C, 648 patients (without prior Hep C treatment and with no cirrhosis) participated in a special study that resulted in 96% (208 out of 216) successfully treated people after taking only 1 pill of HARVONI once a day during 12 weeks.
  • *It is highly advisable to use HARVONI with ribavirin for the same 12 weeks treatment period together for patients with compensated cirrhosis who previously had been treated from Hep C GT 1. *Please read medicine instruction for ribavirin when adding it to your Harvoni treatment (contradictions, drug combination and pregnancy/lactation period).
  • *HARVONI plus ribavirin for 12 weeks can be considered in previously treated genotype 1 patients with compensated cirrhosis who are eligible for ribavirin. *If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.
  • *The study that was comprised of 155 individuals with Hep C GT 1 whose prior treatment failed twice and who had compensated cirrhosis. It showed successful cure results for 96% (74 out of 77) of individuals who were treated with HARVONI plus ribavirin (1 pill daily for 12 weeks) and even higher 97% (75 out of 77) of individuals that took HARVONI less ribavirin for 24 weeks.
  • The the clinical study of 440 people who had GT 1 hep C with compensated cirrhosis, whose Hep C treatment previously failed twice , after taking HARVONI (1 pill daily for 24 weeks) were 100% cured (22 out of 22).
See possible side effects of Harvoni

Genotype 4, 5 and 6 Adults With or Without Compensated Cirrhosis

Hep C
Genotype
Duration of
Treatment
Cure
Rate
4 12 Weeks 93%
5 12 Weeks 93%
6 12 Weeks 96%

Please note that this information is not valid for those patients who have advanced cirrhosis or the individuals who had liver transplantation. Please learn more about Harvoni treatment options for these patients in the «Liver Transplant/Advanced Cirrhosis» section

The results of the study on GT 4, 5, and 6 that were based on a defined number of individuals who previously had Hep C treatment, it also included patients with compensated cirrhosis.

* 85 individuals with Hep C genotype 4 or 5 that previously had/didn’t have Hep C treatment with no cirrhosis or with compensated cirrhosis, the study showed 93% (41 out of 44) with GT 4 and 93% (38 out of 41) of those with GT 5 that were treated with HARVONI for 12 weeks, taking 1 pill a day were cured.

** 25 individuals with Hep C GT 6 that previously had/didn’t have Hep C treatment with no cirrhosis or with compensated cirrhosis, the study showed 96% (24 out of 25) successful cure with HARVONI for 12 weeks, taking 1 pill a day.

*** Decompensated cirrhosis means that the patient’s liver is not longer functioning in a healthy and effective way because it’s heavily scarred.

Learn about side effects with Harvoni

Hep C & HIV-1

HARVONI regimen is the same both for patients with Hep C and HIV-1 or with Hep C only. You may find the information on taking HARVONI in the charts 1 and 2 based on genotype.

All drug interactions of HARVONI and HIV antiretroviral medicines should be prior discussed with your physician.

Learn about side effects with Harvoni

Liver Transplant or Advanced Cirrhosis

For individuals with decompensated* cirrhosis who have Hep C GT 1 it is important to add ribavirin to the treatment with HARVONI. Total therapy period in most patients takes 12 weeks.

For individuals with liver transplant without advanced cirrhosis who have Hep C GT 1 or 4, it is important to add ribavirin to the treatment with HARVONI. Total therapy period in most patients takes 12 weeks.

It is highly recommended to consult your physician in order to get the exact and suitable for you scheme and regiment of your total treatment.

Please read medicine instruction for ribavirin when adding it to your Harvoni treatment (contradictions, drug combination and pregnancy/lactation period).

* Decompensated cirrhosis means that the patient’s liver is not longer functioning in a healthy and effective way because it’s heavily scarred.

Learn about side effects with Harvoni

HARVONI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype (GT) 1, 4, 5 or 6 infection with or without cirrhosis (compensated). In those with GT 1 and advanced cirrhosis (decompensated) or with GT 1 or 4 with or without cirrhosis (compensated) who have had a liver transplant, HARVONI is used with ribavirin.

Safety Instructions

What is the basic important information about HARVONI?

Please find below HARVONI side effects:

Attention for Hep B: If you have had Hep B virus or you have it right now, it is important to consult your physician, because when treated with Harvoni inactive/cured Hep B virus have chance to be reactivated again. Please ask your physician to make the necessary blood tests to check if you have Hep B also. Hep B virus can be reactivated even after the treatment with Harvoni has been completed or during treatment. This may cause aggravating liver status, its failure or death. You should be monitored by your physician during and after your treatment with Harvoni if you have both Hep C and Hep B viruses or you have had Hep B in your medical history.

What obligatory information should I provide to my physician before taking HARVONI?

It is obligatory to tell your physician about your past and present medical conditions. Please pay attention to the fact if you have or had Hep B virus, light or serious liver problems that are not related to hepatitis virus or liver transplantation. It’s important to inform your physician about having HIV. If you have any kidney issues or you are on dialysis. Lease inform your doctor it you plan or are pregnant/breastfeeding, because there were no studies in women that were pregnant or breastfeeding. Please study ribavirin medicine instruction before taking it in combination with HARVONI.

You must inform your physician about the list of drugs, medicines, vitamins and food supplements you take at present. Side effects may be caused by taking HARVONI with certain medicines.

Continued below

What does cirrhosis mean?

Hep C that is not treated correctly may lead to liver cirrhosis with time.

  • Cirrhosis is a complication of liver condition that implies the damage of liver cells and irreversible scarring of the liver. Long term damage leads to the appearance of scarred tissue that replaces the healthy one.
  • Advanced (decompensated) cirrhosis is the next level damage condition when scar tissue starts to prevail the healthy one and the liver itself doesn’t function as it should.
Read more Question/Answer

Safety Instructions

What side effects can be expected while taking HARVONI?

Here is the list of severe possible side effects:

Bradycardia (meaning slowing heart rate): Do not take HARVONI with medicines that are meant for curing heart problems, for example amiodarone (Cordarone®, Nexterone®, Pacerone®). This combination may lead to slower heart rate and possible lethal outcome. If you took the above medicines together and you feel the following: shortness of breath, confusion, dizziness, fainting, lightheadedness, extreme tiredness, memory problems or chest pains URGENTLY get medical help.

Regular side effect of HARVONI are as follows: headache, tiredness and weakness. Please find on other pages essential information about HARVONI, as well as Important Warning.