Sofosbuvir/Daclatasvir-High SVR at 4 weeks for GT1
basser said
May 1, 2015
hi.i had the sof/daclatasvir and riba.i start tx in september.at wk 4 was virus undetected as was wk 8 and 12.was virus undetected at 12 post tx.next test in june.was geno1b and cirrotic .am hoping will still be virus undetected at 6th month test.am feeling so much better.brain fog has gone and cramps.i still get down days.but thats to be expected after what my bodys been through.wish everyone all the best william
Tig said
Apr 30, 2015
Hi Nirmalee,
This release by the EC/BMS last August stated Sov/Dak w/wo Riba, is approved for GT's 1,2,3 and 4.
Hi Malcolm, this treatment so far is only suitable for Geno 3 according to my nurse.
Nxxx
dragonfly said
Apr 30, 2015
I did this protocol for Geno 3. I was negative after 2 weeks but went into decompensated level. This suddenly resolved itself but I have been left with iron deficiencies but this week I had the results - clear, reversed to compensated. Every blood down. I have been going to the gym for 3 weeks at 8 in the morning before work and hope to do a charity run for our Hep C trust This treatment is relatively unknown and as my consultant says we're working in the dark. Dark is not so bad when there is light at the end. Good luck to all and please keep taking the treatment even if you feel horrid - I have had this since 1976 and now it has gone!
Keep on trucking,
Nirmalee xxx
maddie said
Apr 30, 2015
I agree, Malcolm...quite confusing. I was counting on you to come and make some sense out of it. Thanks. I found the conclusions to the study in another article just now and three are listed. http://natap.org/2015/EASL/EASL_44.htm Apparently, in the conclusions they definitely agree with you about 24 wks with riba for cirrhotics. Thanks for the clarification.
Thanks to you too Tig. Yes, it appears that riba still quite important for cirrhotics. Maybe with Sov/GS5816 protocol that you mentioned it will be possible without it. Time will tell, I guess.
mallani said
Apr 30, 2015
Hi maddie,
I found that paper very hard to comprehend. I wish these guys would forget the SVR 4's and just give us the SVR 12's.
I can't see that Sovaldi/Daclatasvir is much better than Harvoni. It certainly costs a lot more! In Europe Harvoni may not be readily available, but Sovaldi/ Daklinza is.
If I was treatment experienced and cirrhotic, I'd want 24 weeks of treatment. Obviously some patients may not get this due to cost. The Ribavirin question remains a puzzle- everyone is giving us different data.
Tig said
Apr 30, 2015
Thanks Maddie, that was very informative. Along with Gilead's new protocol coming soon Sov/GS5816, this combo if finally approved, would be another very effective weapon in the HCV drug arsenal.
It does seem that Ribavirin would still hold a critical position in this protocol though. Though it's not required, I would want it included in my treatment, even if I were a non cirrhotic Tx naive patient. I may be nuts but for 12 weeks I'd tough it out! Hopefully soon they'll be able to take it totally out of the equation.
Article pasted below in case above link does not work
Sofosbuvir Plus Daclatasvir Associated With High Sustained Virologic Response at 4 Weeks in Patients With Hepatitis C Virus Genotype 1 Infection
April 27, 2015
By Chris Berrie
VIENNA, Austria -- April 27, 2015 -- The combination of sofosbuvir plus daclatasvir is associated with high rates of sustained virologic response at 4 weeks (SVR4) in patients with difficult-to-treat hepatitis C virus (HCV) genotype 1 infection, according to study results presented at the International Liver Congress, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL).
Experienced patients and those with cirrhosis may benefit from the addition of ribavirin, although cirrhosis was strongly associated with treatment failure.
There has been little reported regarding the sofosbuvir plus daclatasvir treatment combination in patients with HCV, particularly for patients with genotype 1 infection, explained lead investigator Stanislas Pol, MD, PhD, Cochin Hospital, Paris, France, speaking here on April 25 on behalf of the French National AIDS Research Agency (ANRS)/French Association for the Study of the Liver (AFEF) HEPATHER study group.
Dr. Pol and colleagues studied all patients in the ANRS CO22 HEPATHER cohort who had HCV genotype 1 infection and were treated with sofosbuvir (400 mg/day) plus daclatasvir (60 mg/day) before July 2014 (n = 409).
Within this population, the sofosbuvir plus daclatasvir combination was provided without (n = 317; mean age, 60 years; male, 66%) or with ribavirin 1.0 to 1.2 g/day (n = 92; mean age, 58 years; male 66%).
Outcome data reported for this cohort included SVR4 and SVR12, for treatment durations of both 12 and 24 weeks, and were divided according to ribavirin use, cirrhosis, and treatment experience.
Considering sofosbuvir plus daclatasvir without versus with ribavirin for the 12/24-week treatments, SVR4 was reached by 85.2%/95.1% versus 100%/98.7% of patients, respectively, and SVR12 by 84.9%/93.4% versus 100%/98.4% of patients.
Considering just the SVR4 data, for patients without cirrhosis, there was no benefit for ribavirin (100%/100% vs 100%/100%), while for patients with cirrhosis, ribavirin did show benefits (76.5%/94.0% vs 100%/98.3%).
The investigators observed improved benefit with ribavirin in both treatment-naïve patients (87.1/88.7 vs 100%/100%) and treatment-experienced patients (82.6%/96.7% vs 100%/98.5%).
The researchers then used exact logistics-regression models to identify independent predictors of treatment failure according to SVR4. This indicated ribavirin (no vs yes; adjusted odds ratio [aOR] 6.4; P = .057), treatment duration (12 vs 24 weeks; aOR 3.2; P = .0085), and cirrhosis (yes vs no; aOR 12.5; P = .022).
When extended to examine patients with cirrhosis, specifically, the only independent predictors of treatment failure according to SVR4 remained ribavirin (aOR 6.3; P = .057) and treatment duration (aOR 4.3; P = .008).
Dr. Pol indicated that the sofosbuvir plus daclatasvir combinations are associated with high rates of SVR4 in patients infected with HCV genotype 1. In terms of treatment choices for patients without cirrhosis and with HCV genotype 1, he would choose the 12-week combination without ribavirin, he noted.
For experienced patients and those with cirrhosis, Dr. Pol proposed the 12-week combination with ribavirin. Regarding the economical consideration, we do consider that it is better to shorten the duration of the treatment, and to double the number of treated patients, he noted.
Overall, 78% of patients in this study had cirrhosis, 9% had decompensated cirrhosis, 18% had diabetes, 31% had hypertension, and 75% were previously treated with pegylated-interferon (PEG-interferon) plus ribavirin combinations. The HCV genotype 1a and 1b distributions were similar (50% vs 44%), with the remaining patients classified only as genotype 1 (6%).
Funding for this study is provided by Merck Sharp & Dohme (MSD), Janssen, Gilead, Bristol-Myers Squibb, Roche, and Abbvie, and it is conducted in collaboration with AFEF.
[Presentation title: Safety and Efficacy of the Combination Daclatasvir-Sofosbuvir in HCV Genotype 1-Mono-Infected Patients from the French Observational Cohort ANRS CO22 HEPATHER. Abstract L03
hi.i had the sof/daclatasvir and riba.i start tx in september.at wk 4 was virus undetected as was wk 8 and 12.was virus undetected at 12 post tx.next test in june.was geno1b and cirrotic .am hoping will still be virus undetected at 6th month test.am feeling so much better.brain fog has gone and cramps.i still get down days.but thats to be expected after what my bodys been through.wish everyone all the best william
Hi Nirmalee,
This release by the EC/BMS last August stated Sov/Dak w/wo Riba, is approved for GT's 1,2,3 and 4.
http://hepatitiscnewdrugs.blogspot.com/2014/08/bristol-myers-squibbs-daklinza.html
Hi Malcolm, this treatment so far is only suitable for Geno 3 according to my nurse.
Nxxx
I did this protocol for Geno 3. I was negative after 2 weeks but went into decompensated level. This suddenly resolved itself but I have been left with iron deficiencies but this week I had the results - clear, reversed to compensated. Every blood down. I have been going to the gym for 3 weeks at 8 in the morning before work and hope to do a charity run for our Hep C trust This treatment is relatively unknown and as my consultant says we're working in the dark. Dark is not so bad when there is light at the end. Good luck to all and please keep taking the treatment even if you feel horrid - I have had this since 1976 and now it has gone!
Keep on trucking,
Nirmalee xxx
I agree, Malcolm...quite confusing. I was counting on you to come and make some sense out of it.
Thanks. I found the conclusions to the study in another article just now and three are listed. http://natap.org/2015/EASL/EASL_44.htm Apparently, in the conclusions they definitely agree with you about 24 wks with riba for cirrhotics. Thanks for the clarification.
Thanks to you too Tig. Yes, it appears that riba still quite important for cirrhotics. Maybe with Sov/GS5816 protocol that you mentioned it will be possible without it. Time will tell, I guess.
Hi maddie,
I found that paper very hard to comprehend. I wish these guys would forget the SVR 4's and just give us the SVR 12's.
I can't see that Sovaldi/Daclatasvir is much better than Harvoni. It certainly costs a lot more! In Europe Harvoni may not be readily available, but Sovaldi/ Daklinza is.
If I was treatment experienced and cirrhotic, I'd want 24 weeks of treatment. Obviously some patients may not get this due to cost. The Ribavirin question remains a puzzle- everyone is giving us different data.
Thanks Maddie, that was very informative. Along with Gilead's new protocol coming soon Sov/GS5816, this combo if finally approved, would be another very effective weapon in the HCV drug arsenal.
It does seem that Ribavirin would still hold a critical position in this protocol though. Though it's not required, I would want it included in my treatment, even if I were a non cirrhotic Tx naive patient. I may be nuts but for 12 weeks I'd tough it out! Hopefully soon they'll be able to take it totally out of the equation.
http://dgnews.docguide.com/sofosbuvir-plus-daclatasvir-associated-high-sustained-virologic-response-4-weeks-patients-hepatitis?overlay=2&nl_ref=newsletter&pk_campaign=newsletter
Article pasted below in case above link does not work
Sofosbuvir Plus Daclatasvir Associated With High Sustained Virologic Response at 4 Weeks in Patients With Hepatitis C Virus Genotype 1 Infection
By Chris Berrie
VIENNA, Austria -- April 27, 2015 -- The combination of sofosbuvir plus daclatasvir is associated with high rates of sustained virologic response at 4 weeks (SVR4) in patients with difficult-to-treat hepatitis C virus (HCV) genotype 1 infection, according to study results presented at the International Liver Congress, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL).
Experienced patients and those with cirrhosis may benefit from the addition of ribavirin, although cirrhosis was strongly associated with treatment failure.
There has been little reported regarding the sofosbuvir plus daclatasvir treatment combination in patients with HCV, particularly for patients with genotype 1 infection, explained lead investigator Stanislas Pol, MD, PhD, Cochin Hospital, Paris, France, speaking here on April 25 on behalf of the French National AIDS Research Agency (ANRS)/French Association for the Study of the Liver (AFEF) HEPATHER study group.
Dr. Pol and colleagues studied all patients in the ANRS CO22 HEPATHER cohort who had HCV genotype 1 infection and were treated with sofosbuvir (400 mg/day) plus daclatasvir (60 mg/day) before July 2014 (n = 409).
Within this population, the sofosbuvir plus daclatasvir combination was provided without (n = 317; mean age, 60 years; male, 66%) or with ribavirin 1.0 to 1.2 g/day (n = 92; mean age, 58 years; male 66%).
Outcome data reported for this cohort included SVR4 and SVR12, for treatment durations of both 12 and 24 weeks, and were divided according to ribavirin use, cirrhosis, and treatment experience.
Considering sofosbuvir plus daclatasvir without versus with ribavirin for the 12/24-week treatments, SVR4 was reached by 85.2%/95.1% versus 100%/98.7% of patients, respectively, and SVR12 by 84.9%/93.4% versus 100%/98.4% of patients.
Considering just the SVR4 data, for patients without cirrhosis, there was no benefit for ribavirin (100%/100% vs 100%/100%), while for patients with cirrhosis, ribavirin did show benefits (76.5%/94.0% vs 100%/98.3%).
The investigators observed improved benefit with ribavirin in both treatment-naïve patients (87.1/88.7 vs 100%/100%) and treatment-experienced patients (82.6%/96.7% vs 100%/98.5%).
The researchers then used exact logistics-regression models to identify independent predictors of treatment failure according to SVR4. This indicated ribavirin (no vs yes; adjusted odds ratio [aOR] 6.4; P = .057), treatment duration (12 vs 24 weeks; aOR 3.2; P = .0085), and cirrhosis (yes vs no; aOR 12.5; P = .022).
When extended to examine patients with cirrhosis, specifically, the only independent predictors of treatment failure according to SVR4 remained ribavirin (aOR 6.3; P = .057) and treatment duration (aOR 4.3; P = .008).
Dr. Pol indicated that the sofosbuvir plus daclatasvir combinations are associated with high rates of SVR4 in patients infected with HCV genotype 1. In terms of treatment choices for patients without cirrhosis and with HCV genotype 1, he would choose the 12-week combination without ribavirin, he noted.
For experienced patients and those with cirrhosis, Dr. Pol proposed the 12-week combination with ribavirin. Regarding the economical consideration, we do consider that it is better to shorten the duration of the treatment, and to double the number of treated patients, he noted.
Overall, 78% of patients in this study had cirrhosis, 9% had decompensated cirrhosis, 18% had diabetes, 31% had hypertension, and 75% were previously treated with pegylated-interferon (PEG-interferon) plus ribavirin combinations. The HCV genotype 1a and 1b distributions were similar (50% vs 44%), with the remaining patients classified only as genotype 1 (6%).
Funding for this study is provided by Merck Sharp & Dohme (MSD), Janssen, Gilead, Bristol-Myers Squibb, Roche, and Abbvie, and it is conducted in collaboration with AFEF.
[Presentation title: Safety and Efficacy of the Combination Daclatasvir-Sofosbuvir in HCV Genotype 1-Mono-Infected Patients from the French Observational Cohort ANRS CO22 HEPATHER. Abstract L03