| Title |
Very rapid virologic response and early HCV response kinetics, as quick measures to compare efficacy and guide a personalized response-guided therapy
|
|---|---|
| Published in |
Drug Design, Development and Therapy, August 2016
|
| DOI | 10.2147/dddt.s111496 |
| Pubmed ID | |
| Authors |
Mostafa Yakoot, Alaa M Abdo, Ahmed Yousry, Sherine Helmy |
| Abstract |
This is the second and final report for our study designed to compare two generic sofosbuvir products for the degree and speed of virologic response to a dual anti-hepatitis C virus (HCV) treatment protocol. We aimed to test the applicability of the early virus response kinetics and the very rapid virologic response (vRVR) rate as quick outcome measures for accelerated comparative efficacy studies and as a foundation for a personalized response-guided therapy. Fifty eligible chronic HCV patients were randomized to either one of two generic sofosbuvir products (Gratisovir or Grateziano) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose. Data were compared between the groups for early virus response kinetics and vRVR rates in relation to the rates of final sustained virologic response at week 12 posttreatment (SVR12). The Log10 transformed virus load (Log polymerase chain reaction) curves showed fairly similar rapid decline during the first 2 weeks, with no significant difference between the groups at four analysis points throughout the study by repeated-measures factorial analysis of variance test (P=0.48). The SVR12 rates were 96% (95% confidence interval, 79.6%-99.9%) in Gratisovir group (24/25) and 95.7% (95% confidence interval, 78%-99.9%) in Grateziano group (22/23). There was no statistically significant difference found by exact test (P>0.999). There was a significant association between the vRVR and the SVR12, with 100% positive predictive value (38/38 of those who had vRVR, achieved a final SVR12) and 82.6% sensitivity (among the total 46 with SVR12, 38 were having vRVR). We can conclude from our study that the early HCV response kinetics and the vRVR rates could be used as sensitive quick markers for efficacy (with a very high positive predictive value for SVR12), based on our accelerated comparative efficacy research model. This might open the way for new models of accelerated equivalence efficacy studies along with the bioequivalence kinetics studies to test a generic drug against a reference. Also, the early response kinetics and the vRVR might be used as qualifiers for a personalized course of treatment. This could shorten unnecessarily long treatment courses in rapid responders and might help to avoid relapses in slow responders. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 2 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 50% |
| Practitioners (doctors, other healthcare professionals) | 1 | 50% |
Mendeley readers
The data shown below were compiled from readership statistics for 28 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 28 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 6 | 21% |
| Student > Bachelor | 4 | 14% |
| Researcher | 4 | 14% |
| Student > Ph. D. Student | 2 | 7% |
| Other | 2 | 7% |
| Other | 2 | 7% |
| Unknown | 8 | 29% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 7 | 25% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 7% |
| Biochemistry, Genetics and Molecular Biology | 2 | 7% |
| Psychology | 2 | 7% |
| Agricultural and Biological Sciences | 1 | 4% |
| Other | 5 | 18% |
| Unknown | 9 | 32% |
Attention Score in Context
This research output has an Altmetric Attention Score of 5. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 08 March 2020.
All research outputs
#7,333,477
of 25,728,855 outputs
Outputs from Drug Design, Development and Therapy
#477
of 2,280 outputs
Outputs of similar age
#116,466
of 382,448 outputs
Outputs of similar age from Drug Design, Development and Therapy
#14
of 76 outputs
Altmetric has tracked 25,728,855 research outputs across all sources so far. This one has received more attention than most of these and is in the 71st percentile.
So far Altmetric has tracked 2,280 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.3. This one has done well, scoring higher than 78% of its peers.
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We're also able to compare this research output to 76 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 81% of its contemporaries.