24 weeks Harvoni, benefits of adding Ribavirin

[Bilrac]

I am a HIV/HCV coinfected 52 year old female, genotype 1a, two time INF/RIBA relapser, compensated cirrhosis.  My HIV is well controlled with meds.  I am extremely fortunate in having secured 24 weeks of Harvoni.  My question is, does anyone think adding Ribavirin for duration of treatment (24 weeks) will up my odds of SVR?  I have been on the Harvoni and Ribavirin (10000mg) for a week and can only say that I feel better than I have in a long time.  I'm aware that anemia may hit later, but am willing to deal with this.  This is a wonderful community, thank you for your knowledge and support.  We live in interesting times!

[JimmyMose]

I'm confused first you mention you are taking Harvoni and Ribavirin for a week. Then you mention that your trying to decide whether to throw in 24 weeks of Riba with the Harvoni
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Did your doctor prescribe Harvoni and Ribavirin with option to discontinue RBV ?  Did you add Ribavirin yourself?

WorriedMom and Hector provided correct current recommenced treatment either Harvoni 24 weeks or Harvoni plus RBV 12 weeks for INF/RIBA relapser, compensated cirrhosis.  RBV

Does your treatment doctor have expertise in the treatment of HIV & HCV co-infection and cirrhosis close monitoring.or collaboration with the HIV practitioner.  Some Antiretroviral treatment drugs shouldn't be used with Harvoni and may need to be switched if currently using.

RBV has the potential for dangerous drug interactions with didanosine resulting in mitochondrial toxicity with hepatomegaly and steatosis, pancreatitis, and lactic acidosis; thus, the concomitant administration of these 2 drugs is contraindicated. (Fleischer, 2004) The combined use of RBV and zidovudine has been reported to increase the rates of anemia and the need for RBV dose reduction; thus, zidovudine is not recommended for use with RBV

AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C

http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-hivhcv-coinfection
accessed February 22, 2015

Wish you the best in achieving SVR

[Bilrac]

Thank you WorriedMom and Hector for your input and referencing those trials.  I guess what I'm trying to decide is whether to throw in 24 weeks of Riba with the Harvoni in the hope of upping my chances, even minimally.  My instinct is that it would give my treatment that extra edge.  Thanks again.  

[HectorSF]

As "mom" said there is no currebt data from studies treating coinfected people who have cirrhosis with Harvoni (with or without Ribavirin). The Hep C Guidelines states..."coinfected persons should be treated and retreated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications".

I have excerpted the main points below.

The AASLD/IDSA http://www.hcvguidelines.org

Here are the current AASLD/IDSA treatment recommendations for Cirrhotics who have Failed a previous peginterferon based treatment.
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"Recommended regimens for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.

Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level A

Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) plus weight-based RBV (1000 mg [75 kg]) for 12 weeks is recommended for patients with HCV genotype 1a or 1b infection who have compensated cirrhosis, in whom prior PEG-IFN and RBV treatment has failed.
Rating: Class I, Level B"
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NOTE: The trial and data for the 12 weeks of Harvoni treatment with the addition of ribavirin was NOT done with the participation of coinfected folks. So there is no current published data, that I am aware of, cpncerning the use of 12 weeks of Harvoni treatment with the addition of Ribavirin for coinfected folks. Only a hepatologist familiar with the latest thoughts on this matter within the hepatology community would know if 12 weeks may also work for the coinfected population.

The Effect of the Addition of Ribavirin with Harvoni treatment..
With the addition of Ribavirin, Harvoni treatment time can be reduced to 12 weeks with similar to the SVR rates for 24 weeks of Harvoni used without Ribavirin! That is 12 weeks less time dealing side effects if a person can tolerate 12 weeks of Ribavirin. Plus a reduced cost of treatment.
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For those with HIVHCV -COINFECTION
http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-hivhcv-coinfection
........
UNIQUE PATIENT POPULATIONS: PATIENTS WITH HIV/HCV COINFECTION

Recommended regimens for HIV/HCV-coinfected individuals.
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"HIV/HCV-coinfected persons should be treated and retreated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications (see Initial Treatment of HCV Infection and Retreatment of Persons in Whom Prior Therapy Has Failed sections).
Rating: Class I, Level B"
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"Although fewer HIV/HCV-coinfected patients have been treated than HCV-monoinfected patients in trials of DAAs, efficacy rates thus far have been remarkably similar between the groups. (Sulkowski, 2013a); (Sulkowski, 2013d); (Sulkowski, 2014); (Dieterich, 2014b); (Rodriguez-Torres, 2013); (Townsend, 2014); (Wyles, 2014a); (Dieterich, 2014c) Thus, results from HCV monoinfection studies largely justify the recommendations for HIV/HCV coinfection (discussed in the Initial Treatment and Retreatment sections). Discussion specific to HIV/HCV coinfection studies is included here.

The safety and efficacy of 12 weeks of ledipasvir/sofosbuvir was evaluated in the phase II ERADICATE study, which treated
50 HIV/HCV-coinfected
HCV genotype 1
* treatment-naive patients
* without cirrhosis
from an urban population in a single-center, open-label clinical trial. Thirteen patients were not receiving antiretroviral therapy and 37 patients were on protocol-allowed medications (tenofovir, emtricitabine, rilpivirine, raltegravir, and efavirenz). Although the inclusion criteria for patients receiving antiretroviral therapy allowed CD4+ T cell counts of greater than 100/µL, the median CD4+ T cell count was 576/µL.

Overall, 98% achieved sustained virologic response at 12 weeks (SVR12; 13/13 in treatment-naive arm and 36/37 in treatment-experienced arm).

There were no deaths, discontinuations, or clinically significant serious adverse events. Renal function was monitored frequently during this trial and after administration of study drugs using a battery of tests (serum creatinine, estimated GFR, CrCl, urinary beta-2 microglobulin, proteinuria, and glycosuria). No clinically significant changes in these parameters or renal toxicity were observed. There were no clinically significant changes in CD4+ T cell counts or HIV RNA levels in the study subjects.

Thus, these early data suggest that 12 weeks of ledipasvir/sofosbuvir may be a safe and effective regimen for HIV/HCV-coinfected patients with HCV genotype 1 without cirrhosis taking select antiretroviral therapy. (Townsend, 2014)

There are no data regarding an 8-week duration of ledipasvir/sofosbuvir in HIV/HCV-coinfected patients; therefore, the shortened course that is considered for persons without HIV and cirrhosis who have HCV RNA levels less than 6 million IU/mL cannot yet be endorsed.

So SVR rates of co-infected people appear similar to those mono-infected  but expertise in the treatment of co-infection and cirrhosis close monitoring is required."
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Good luck with your treatment!
Hector  

[AWorriedMom]

You might be interested in reading the Eradicate study. While there were no cirrhotics, the results for co-infected patients were as good as for mono-infected patients.

24 weeks of Harvoni are as good as 12 weeks with ribavirin in the vast majority of patients. What does your doc say?