Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt

Shiha, Gamal; Esmat, Gamal; Hassany, Mohamed; Soliman, Reham; Elbasiony, Mohamed; Fouad, Rabab; Elsharkawy, Aisha; Hammad, Radi; Abdel-Razek, Waël; Zakareya, Talaat; Kersey, Kathryn; Massetto, Benedetta; Osinusi, Anu; Lu, Sophia; Brainard, Diana M.; McHutchison, John G.; Waked, Imam; Doss, Wahid

doi:10.1136/gutjnl-2017-315906

Cited by 38 publications

(29 citation statements)

References 29 publications

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“…The effectiveness of these combinations among non-cirrhotic patients was of 93.9%; Meanwhile, in cirrhotic patients it represented only 81.3% (P value = 0.049). These results are comparable to those reported by many studies from neighboring countries with similar HCV genotype distributions [32] [33]. A study done by Feld et al, showed similar result despite using of this regimen for different HCV genotypes (genotype 3) this could be explained by the potency of ledipasvir in combination with other DAA against all HCV genotypes [29].…”

Section: Discussionsupporting

confidence: 89%

Response of HCV Yemeni Patients to Sofosbuvir/Ledipasvir in Combination with Ribavirin

Kassim¹,

Alathwary²,

Al-hogami³

2019

OALib

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Objectives: To study the effectiveness and safety of ledipasvir-sofosbuvir plus ribavirin treatment in Yemeni patient with HCV infection. Design: Prospective study of sixty-five Yemeni patients confirmed with HCV infection during the period from January 2017 to April 2018. Setting: Gastrointestinal and liver diseases specialized center in Ibb city, Yemen. Subjects: Patients with proved HCV infection by PCR. Results: We collected 65 cases with HCV infection. They were 19 (29.2%) males and 46 (70.8) females with age ranged between 18 years and 70 years and the mean age was 47.98 ± 11.90 years. sixteen (24.6%) of them had compensated liver cirrhosis and the remainder were non-cirrhotic healthy individual. The early virological response reported in 100% of cases while the sustained virological response (SVR) reported in 90.8%. The reported side effects of our patients were fatigue in (24.6%), abdominal pain in (13.8%), diarrhea in (10.8%), insomnia in (9.2%), headache in (7.7%), and nausea/vomiting in (7.7%). Conclusion: The Sofosbuvir-ledipasvir plus Ribavirin treatment was highly effective and safe for the treatment of hepatitis C patients in Yemen.

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Section: Discussionsupporting

confidence: 89%

Response of HCV Yemeni Patients to Sofosbuvir/Ledipasvir in Combination with Ribavirin

Kassim¹,

Alathwary²,

Al-hogami³

2019

OALib

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“…In the present study, patients who received 8 weeks of treatment regimen showed a response rate of 100% that is higher than that previously reported among patients with genotype 4 infection. Shiha et al (21) reported an SVR12 of 95% (41 of 43 patients) in naïve non-cirrhotic Egyptian patients chronically infected with HCV genotype 4 who received SOF/LDV for 8 weeks while SVR12 was 98% (42 of 43 patients) in patients who received the same regimen for 12 weeks.…”

Section: Discussionmentioning

confidence: 99%

Generic Sofosbuvir/Ledipasvir for Treatment of Naïve, Non-Cirrhotic, Easy to Treat Patients with Chronic Hepatitis C Genotype 4: 8 Vs. 12 Weeks of Treatment

Shousha

Akl

Ragheb³

et al. 2018

Hepat Mon

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Background: 12-week sofosbuvir/ledipasvir combination is approved for the treatment of HCV genotype 4. Objectives: The study aimed to evaluate the safety and efficacy of generic sofosbuvir/ledipasvir for 8 and 12 weeks in easy to treat patients infected with the hepatitis C virus (HCV) genotype 4. Methods: In this prospective randomized study, 40 naïve non-cirrhotic easy to treat patients were randomized to receive 8 or 12 weeks (groups 1 and 2, respectively) of generic ledipasvir/sofosbuvir (MPIviropack-Plus provided by Marcyrl Pharmaceutical Industries). A simple randomization was done using computer-generated random numbers by Microsoft Excel. The primary endpoint was the sustained virological response 12 weeks post-treatment (SVR12). Results: There was no significant difference between the two groups of 8 and 12 weeks of therapy in pre-treatment demographics, laboratory parameters, and viral load. A more significant reduction in liver enzymes was noticed in group 2. No adverse events were recorded. SVR12 was 100% with 8 weeks of generic sofosbuvir/ledipasvir and 95% with 12 weeks of the same regimen. Conclusions: Generic sofosbuvir/ledipasvir for 8 weeks is highly effective with a high rate of SVR12 among naïve non-cirrhotic easy to treat patients with HCV genotype 4 infection. No additional benefit was associated with the extension of the treatment duration to 12 weeks.

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“…A recent study of 8 weeks of therapy with LDV/SOF found that SVR12 was achieved in 97% of treatment-naïve HCV GT1 patients overall, but the SVR12 rates were lower (93%) in patients with stage 3 ibrosis and in African Americans (83%), warranting some consideration in these speci ic patient populations [5]. Of note, there is also emerging evidence of SVR rates ≥ 95% with the use of 8 weeks of LDV/SOF therapy in GT4 in noncirrhotic treatment-naïve patients; however, this is an offlabel use [6,7].…”

Section: More Informationmentioning

confidence: 99%

Evaluation of outcomes of 8-week therapy with ledipasvir/sofosbuvir or glecaprevir/pibrentasvir in veterans with hepatitis C infection

Lemoine¹,

Segarra‐Newnham²

2019

Ann Clin Gastroenterol Hepatol

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Hepatitis C Virus (HCV) infection is usually treated with direct acting antivirals (DAAs) for 12 weeks. In treatment naive patients with genotype (GT) 1 infection without cirrhosis and baseline viral load <6 million, 8 weeks of Ledipasvir/Sofosbuvir (LDV/SOF) is an option. Eight weeks with Glecaprevir/Pibrentasvir (GLE/PIB) is an option for patients with GT 1 through 6 without cirrhosis. Our objective was to evaluate achievement of Sustained Virologic Response (SVR) after 8 weeks of LDV/SOF or GLE/PIB in our HCV-infected veterans. Patients with HCV infection that received GLE/ PIB or LDV/SOF for a planned 8 weeks of therapy in the past four years were reviewed (January 2015-September 2018). Treatment outcomes were evaluated through medical record review. Two hundred sixty-fi ve veterans were initiated on 8 weeks of therapy with either GLE/PIB or LDV/SOF. Of these, 231 (87%) were initiated on 8 weeks of LDV/SOF and 34 (13%) were initiated on 8 weeks of GLE/PIB. The majority of patients had GT 1 (93%) infection. One hundred and ninetyfi ve veterans who completed 8 weeks of LDV/SOF and 30 veterans on GLE/PIB had follow-up viral loads. The overall SVR was 95%. Treatment with GLE/PIB resulted in a higher SVR rate (100%) compared to LDV/SOF (95%). Elderly patients had similar SVR rates. Treatment with 8 weeks of DAA is effective in our veteran population and showed an SVR rate similar to literature reports. The SVR for patients treated with 8 weeks LDV/SOF was slightly lower than the SVR for GLE/PIB; however, the GLE/PIB population was smaller.

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Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt

Abstract: NCT02487030.

Cited by 38 publications

References 29 publications

Response of HCV Yemeni Patients to Sofosbuvir/Ledipasvir in Combination with Ribavirin

Response of HCV Yemeni Patients to Sofosbuvir/Ledipasvir in Combination with Ribavirin

Generic Sofosbuvir/Ledipasvir for Treatment of Naïve, Non-Cirrhotic, Easy to Treat Patients with Chronic Hepatitis C Genotype 4: 8 Vs. 12 Weeks of Treatment

Evaluation of outcomes of 8-week therapy with ledipasvir/sofosbuvir or glecaprevir/pibrentasvir in veterans with hepatitis C infection

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