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7593014 tn?1414212474

SVR For 12 weeks Sofosbuvir+peg/rbv for GT3a

Hi I  am cirrhotic and genotype 3a my IL28b is ct  I have been ofered a trial therapy sofosbuvir +peg+ribavarin for 12 weeks only .I am thinking maby is not eficient . Therapy already aproved  for genotye 3 is 24 weeks sofosbuvir +ribavirin.I cant fint any data about SVR  for the 12 weeks therapy .I have to deside in few days.i f I dont take this therapy I have to wait maybe a  year approximately to take the 24 weeks wich is already aprouved. I live in England. if any one have any information
please let me know.
5 Responses
Avatar universal
Have you asked your provider about your proposed trial treatment?

Of course as HectorSF pointed out
Sovaldi is not to be used with ribavirin for 12 weeks in genotype 3 patients

That is not the same as sofosbuvir +peg+ribavirin for 12 weeks only.
This is an alternative recommended treatment

Recommendations for Testing, Managing,
and Treating Hepatitis C
http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment

Alternative regimens for treatment-naive patients with genotype 3 who are eligible to receive IFN.Daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 12 weeks is an acceptable regimen for IFN-eligible persons with HCV genotype 3.
Rating: Class IIa, Level A
The combination of sofosbuvir plus PEG/RBV has been evaluated in patients with genotype 3 infection. In 2 phase 2 clinical trials, PROTON and ELECTRON, 38 of 39 (97%) treatment-naive patients with genotype 3 infection achieved SVR with sofosbuvir plus PEG (4 to 12 weeks of therapy)/RBV.  For many patients with genotype 3, the adverse effects and increased monitoring requirements of PEG make this less acceptable than the recommended regimen of sofosbuvir plus weight-based RBV.

http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Alternate regimen for HCV genotype 3 PEG/RBV nonresponder patients who are eligible to receive IFN.
Retreatment with daily sofosbuvir (400 mg) and weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 12 weeks is an alternative for IFN-eligible persons with HCV genotype 3 infection.
Rating: Class IIa Level B

In the LONESTAR-2 study, adding 12 weeks of PEG to the sofosbuvir and RBV regimen resulted in numerically higher response rates among persons with HCV genotype 3 than those obtained with sofosbuvir and RBV for 24 weeks. Of HCV genotype 3-infected patients with and  without cirrhosis, 10 (83%) of 12 achieved SVR. Given the limited number of patients in this demographic in both the VALENCE and LONESTAR-2 studies, these differences in response rates should be interpreted with caution.

My opinion the trial phase 3 will help to substantiate the prior limited phase 2 results.     For those who can well tolerate 12 weeks of PEG with minimal side effects (especially as opposed to 24 or 48 weeks) limited phase 2 results indicate a SVR as good as or slightly better(treatment non-responders) than 24 weeks of SOV & RBV.  

Plus about $80,000 retail price cheaper than 24 weeks of SOV & RBV.  

I would think that your trial provider and your doctor decided your condition was good enough to use PEG for 12 weeks.  Did you ask your trial provider if during the 12 weeks a medical condition occurred that required stopping PEG but not SOV & RBV could you continue with that treatment for 24 weeks?

YannisGT3  It's your decision. Either way I support you, good luck and let us know.
446474 tn?1446347682
" I have been ofered a trial therapy sofosbuvir +peg+ribavarin for 12 weeks only .I am thinking maby is not eficient ."

It is a trial so no one knows what the results will be.

"I cant fint any data about SVR  for the 12 weeks therapy "

Sovaldi is not to be used with ribavirin for 12 weeks in genotype 3 patients.
The FISSION trial proved SRV rates are very poor especially in hard to treat patients like cirrhotics. Even those who were treatment naive, which will have the best outcomes compared with those who treated before had poor outcomes. When using Sovaldi treatment duration is a critical factor in hard to treat patients (such as cirrhotics).
Treatment naive Genotype 3 SOVALDI + RBV 12 weeks  with Cirrhosis = 34% (13/38)

compared to

Treatment Naive Genotype 3 SOVALDI + RBV 24 weeks with Cirrhosis = 92% (12/13)

compared to

Treatment-Experienced Genotype 3 SOVALDI + RBV 24 weeks with Cirrhosis =60% (27/45)
--------------------------------------------------------------------------------------------------------

Treatment-Naïve Adults ─ FISSION (Study 1231)

FISSION was a randomized, open-label, active-controlled trial that evaluated 12 weeks of treatment with SOVALDI and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 2 and 3 HCV.

The ribavirin doses used in the SOVALDI + ribavirin and peginterferon alfa 2a + ribavirin arms were weight-based 1000-1200 mg per day and 800 mg per day regardless of weight, respectively. Subjects were randomized in a 1:1 ratio and stratified by cirrhosis (presence vs. absence), HCV genotype (2 vs. 3) and baseline HCV RNA level (<6 log10IU/mL vs. ≥6 log10IU/mL). Subjects with genotype 2 or 3 HCV were enrolled in an approximately 1:3 ratio.

Treated subjects (N=499) had a median age of 50 years (range: 19 to 77); 66% of the subjects were male; 87% were White, 3% were Black; 14% were Hispanic or Latino; mean body mass index was 28 kg/m2
(range: 17 to 52 kg/m2); 57% had baseline HCV RNA levels greater than 6 log10 IU per mL; 20% had cirrhosis; 72% had HCV genotype
3. Table 10 presents the response rates for the treatment groups of SOVALDI + ribavirin and peginterferon alfa + ribavirin.

Genotype 3 with Cirrhosis treated for 12 weeks

SOVALDI + RBV 12 weeks = 34% (13/38)
----------------------------------------------------------------------------------------------
Previously Treated Adults ─ FUSION (Study 108)

FUSION was a randomized, double-blinded trial that evaluated 12 or 16 weeks of treatment with SOVALDI and ribavirin in subjects who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders). Subjects were randomized in a 1:1 ratio and stratified by cirrhosis (presence vs. absence) and HCV genotype (2 vs. 3).  

Treated subjects (N=201) had a median age of 56 years (range: 24 to 70); 70% of the subjects were male; 87% were White; 3% were Black; 9% were Hispanic or Latino; mean body mass index was 29 kg/m2  (range: 19 to 44 kg/m2
); 73% had baseline HCV
RNA levels greater than 6log10 IU per mL; 34% had cirrhosis; 63% had HCV genotype 3; 75% were prior relapsers. Table 14 presents the response rates for the treatment groups of SOVALDI + ribavirin for 12 weeks and 16 weeks.

SOVALDI + RBV 12 weeks = 19% (5/26)
SOVALDI + RBV 16 weeks = 61% (14/23)

NOTE: Huge difference based on duration of treatment!
-----------------------------------------------------------------------------------
Treatment-Naïve and Previously Treated Adults ─ VALENCE (Study 133)

The VALENCE trial evaluated SOVALDI in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects with compensated cirrhosis. The original trial design was a 4 to 1 randomization to SOVALDI
+ ribavirin for 12 weeks or placebo. Based on emerging data, this trial was unblinded and all genotype 2 HCV-infected subjects continued the original planned treatment and received SOVALDI + ribavirin for 12 weeks, and duration of treatment with SOVALDI + ribavirin in genotype 3 HCV-infected subjects was extended to 24 weeks. Eleven genotype 3 subjects had already completed SOVALDI + ribavirin for 12 weeks at the time of the amendment.

Treated subjects (N=419) had a median age of 51 years (range: 19 to 74); 60% of the subjects were male; mean body mass index was 26 kg/m2
(range: 17 to 44 kg/m2); the mean baseline HCV RNA level was 6.4 log10 IU per mL; 78% had HCV genotype 3; 58% of the subjects were treatment-experienced and 65% of those subjects experienced relapse/breakthrough to prior HCV treatment.

Table 16 presents the response rates for the treatment groups of SOVALDI + ribavirin for 12 weeks and 24 weeks.

Genotype 3 SOVALDI + RBV 24 weeks with Cirrhosis = 60% (27/45)


Best of luck with your treatment!
Hector
Avatar universal
I have posted a new topic in detail.  For genotype 3 Interferon-eligible very limited information appears that SOF + PR (12) is about as effective for treatment naive or slightly better for previously treated than SOF + R (24)

http://www.medhelp.org/posts/Hepatitis-C/CA-SVR-Sim--Sof-SVR-cost-compare-Draft-2-7-14/show/2101511

What ever you decide i wish my best for you. if you can tolerate Interferon for only 12 weeks.and achieve SVR your participation in this trial. That will help to confirm this treatment and offer more info if they are specifically looking at sub genotype and IL28b?  The decision is your to make. Please read or reread all the details of the treatment and the clinical trial phase (number) pros and cons. If there is anything you don't understand ask the trial provider and/or your personal hep doctor.
Avatar universal
You posted while i was creating my post so didn't see it until afterwards.

Of course the patients condition including Cirrhosis could be a huge factor.  

YannisGT3  My opinion you may want ask your provider about the trial info HectorSF mentioned, the info in the link in my other post and how that applies to your specific condition. Even get a second opinion if you like.  You can also make copies to hand to them, email or other protocol recommended for discussion with the provider
7593014 tn?1414212474
HECTOR  THANK YOU VERY MUCH VERY IMPORTANT INFORMATION
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