Daklinza

Manufactured by Bristol-Myers Squibb

Sourced in United States

Daklinza is a prescription medication used in the treatment of chronic hepatitis C virus (HCV) infection. It is a direct-acting antiviral agent that inhibits the function of the HCV NS5A protein, which is essential for viral replication. Daklinza is typically used in combination with other antiviral medications to treat HCV.

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Lab products found in correlation

Sunvepra, by Bristol-Myers Squibb (4 mentions) Sovaldi, by Gilead Sciences (2 mentions) Pegasys, by Roche (1 mentions) Viekirax, by Abbvie (1 mentions) Exviera, by Abbvie (1 mentions)

10 protocols using daklinza

Oral Daclatasvir and Asunaprevir Regimen

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For 24 weeks, daclatasvir (Daklinza; Bristol-Myers Squibb, Tokyo, Japan) was orally administered as a 60 mg tablet once daily and asunaprevir (Sunvepra; Bristol-Myers Squibb) was orally administered as a 100 mg soft gel capsule twice daily.

Taki S., Tamai H., Ida Y., Shingaki N., Kawashima A., Shimizu R., Moribata K., Maekita T., Iguchi M., Kato J., Nakao T, & Kitano M. (2017). The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients. Gut and Liver, 12(1), 86-93.

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Hepatitis C Patients with Virologic Failure

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Of the 322 hepatitis C patients who received dual oral therapy of ASV (Sunvepra; Bristol-Myers Squibb, New York, NY, at 200 mg/day twice per day) plus DCV (Daklinza; Bristol-Myers Squibb, at 60 mg/day once per day) for 24 weeks from September 2014 to August 2015 at Osaka University Hospital and other institutions participating in the Osaka Liver Forum (OLF), 14 patients with genotype 1b who had never undergone DAA treatment developed VF with ASV/DCV treatment. We analysed the 14 patients in this study using deep sequencing followed by phylogenetic tree analysis. This study was conducted according to the ethical guidelines of the Declaration of Helsinki amended and was approved by the ethics commission of Osaka University Hospital and the institutional review boards of the participating hospitals. Written informed consent was obtained from all patients.

Kai Y., Hikita H., Morishita N., Murai K., Nakabori T., Iio S., Hagiwara H., Imai Y., Tamura S., Tsutsui S., Naito M., Nishiuchi M., Kondo Y., Kato T., Suemizu H., Yamada R., Oze T., Yakushijin T., Hiramatsu N., Sakamori R., Tatsumi T, & Takehara T. (2017). Baseline quasispecies selection and novel mutations contribute to emerging resistance-associated substitutions in hepatitis C virus after direct-acting antiviral treatment. Scientific Reports, 7, 41660.

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HCV-Positive Kidney Transplant Pilot

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After approval from the Institutional Review Board at the University of Utah (U of U) (approval #IRB_00081664), a single center prospective pilot study enrolled patients with a known history of HCV approved for KTX by the U of U Transplant Selection Committee into this study. Risks and benefits were clearly discussed with potential patients as well as the need for treatment with direct-acting antivirals after transplantation. Patients were then consented to receive HCV-positive donor organs.
Upon successful kidney transplantation and after immunosuppression stability, a time frame from three to six months, patients were treated for HCV with a combination antiviral therapy commensurate with their HCV genotype and prior experience with antiviral treatment pre-kidney transplant. Five patients infected with genotype 1 were treated with ledipasvir, 90 mg, and sofosbuvir, 400 mg (Harvoni®) (Gilead, Foster City, CA), with or without ribavirin (600 - 1,200 mg/daily), depending on patient tolerance, for a total of 12 weeks (the seventh patient also has genotype 1 and will receive the same medications). One patient with genotype 2b infection was treated with a combination of sofosbuvir, 400 mg (Sovaldi®) (Gilead, Foster City, CA), and daclatasvir, 60 mg (Daklinza®) (Bristol-Myers Squibb, Princeton, NJ) daily for 24 weeks.

Gallegos-Orozco J.F., Kim R., Thiesset H.F., Hatch J., Lynch K., Chaly, Jr T., Shihab F., Ahmed F., Hall I, & Campsen J. (2016). Early Results of Pilot Study Using Hepatitis C Virus (HCV) Positive Kidneys to Transplant HCV Infected Patients with End-Stage Renal Disease Allowing for Successful Interferon-Free Direct Acting Antiviral Therapy after Transplantation. Cureus, 8(11), e890.

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Pricing of Hepatitis C Antivirals in Brazil

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Drug costs were collected in a web-based public domain site that describes the prices paid by the BMoH for all drugs incorporated in the Public Health System and purchased from the pharmaceutical industry (Database of Health Prices – “Banco de Preços em Saúde” - accessible at: http://www.saude.gov.br/bps). A weighted-mean price for each antiviral drug was estimated taking into account all drug payments made by the BMoH from January to December 2015. We then calculated the price for a single-dose of PEG-interferon α-2a 180 mcg (PEG-IFN) [Pegasys® - Roche] and a single capsule or tablet for ribavirin (RBV) [generic by BMoH], boceprevir (BOC) [Victrelis® – Merk], telaprevir (TEL) [Incivek® - Vertex Pharmaceuticals], sofosbuvir (SOF) [Sovaldi® – Gilead], daclastavir (DCV) [Daklinza® - Bristol-Myers Squibb] and simeprevir (SIM) Olysio® – Janssen Pharmaceuticals].

Perazzo H., Jorge M.J., Silva J.C., Avellar A.M., Silva P.S., Romero C., Veloso V.G., Mujica-Mota R., Anderson R., Hyde C, & Castro R. (2017). Micro-costing analysis of guideline-based treatment by direct-acting agents: the real-life case of hepatitis C management in Brazil. BMC Gastroenterology, 17, 119.

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HCV Genotype 1 Treatment with DCV/ASV

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Patients infected with genotype 1 HCV diagnosed by board‐certified hepatologists were enrolled in a Japanese Red Cross Liver Study Group from 2015 to 2020. Patients judged unsuitable by their principal physician were excluded. The patients received DCV (Daklinza; Bristol‐Myers Squibb) plus ASV (Sunvepra; Bristol‐Myers Squibb) according to the prescribing guidelines for 24 weeks. DCV/ASV therapy was started in patients who did not have obvious HCC, as revealed by imaging studies (abdominal ultrasonography and/or computed tomography and/or magnetic resonance imaging), or did not have life‐threatening comorbidities. The period between the last HCC treatment and DCV/ASV therapy was not specified. The study protocols were approved by the ethics committees of each institution. This study was conducted in accordance with the ethical guidelines of the Declaration of Helsinki and International Conference on Harmonization Guidelines for Good Clinical Practice.

Fujii H., Kimura H., Hasebe C., Akahane T., Satou T., Kusakabe A., Kojima Y., Kondo M., Marusawa H., Kobashi H., Tsuji K., Ogawa C., Uchida Y., Joko K., Mitsuda A., Kurosaki M, & Izumi N. (2022). Real‐world long‐term analysis of daclatasvir plus asunaprevir in patients with hepatitis C virus infection. JGH Open: An Open Access Journal of Gastroenterology and Hepatology, 6(5), 344-352.

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Sofosbuvir and Daclatasvir/Ledipasvir Therapy for Chronic Hepatitis C

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Patients received 400 mg SOF (Sovaldi, Gilead, Cambridge) once daily plus DCV (Daklinza, Bristol-Myers Squibb, Uxbridge, UK; n = 31, 93.9%), 2 patients received the fixed dose-combination SOF 400 mg plus LDV 90 mg (Harvoni, Gilead, Cambridge; n = 2, 6.1%) once daily according to ION-1 study.^{[25 (link)]} Once-daily dosing of DCV was performed according to the ALLY-2 study^{[16 (link)]} with 30, 60, or 90 mg/d depending on the concomitant antiretrovirals used for HIV treatment. The following treatment duration regimens were used for SOF/DCV-therapy: HCV-GT 1/4 without cirrhosis: 12 weeks, HCV-GT 1/4 with cirrhosis: 24 weeks; HCV-GT 3: 24 weeks. SOF/LDV-therapy was given 24 weeks for GT-1 treatment-experienced with cirrhosis, and 24 weeks for GT-3 treatment-naïve without cirrhosis. If HCV-RNA was still detectable 4 weeks before the planned end of treatment, treatment was extended for 4 additional weeks.^{[21 (link)]} High HCV-RNA was defined as 6∗10^6 IU/mL or more as previously described.^{[26 (link)]}

Scheiner B., Schwabl P., Steiner S., Bucsics T., Chromy D., Aichelburg M.C., Grabmeier-Pfistershammer K., Trauner M., Peck-Radosavljevic M., Reiberger T, & Mandorfer M. (2016). Interferon-free regimens improve health-related quality of life and fatigue in HIV/HCV-coinfected patients with advanced liver disease: A retrospective study. Medicine, 95(27), e4061.

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HCV Treatment Regimens - Efficacy and Safety

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A combination therapy of DCV (Daklinza^Ⓡ, Bristol-Myers Squibb, New York, USA) (60 mg, once daily) and ASV (Sunvepra^Ⓡ, Bristol-Myers Squibb) (100 mg, twice daily) was taken orally for 24 weeks, SOF (400 mg, once daily) and LDV (90 mg, once daily) (Harvoni^Ⓡ, Giliad Sciences, Foster City, USA) for 12 weeks, and SOF (Sovaldi^Ⓡ, Gilead Sciences) (400 mg once daily) and RBV (600 mg, 800 mg, or 1,000 mg daily according to body weight) for 12 weeks. DCV/ASV and SOF/LDV were administered to patients infected with HCV genotype 1b, and SOF/RBV was administered to patients infected with HCV genotype 2a/2b. The SVR was determined by confirming the negativity of HCV-RNA at 12 weeks after DAA administration.

Hino N., Sasaki R., Takahashi Y., Koike M., Fukushima M., Haraguchi M., Honda T., Miuma S., Ozawa E., Miyaaki H., Ichikawa T, & Nakao K. (2021). Treatment of Hepatitis C Virus Infection with Direct-acting Antiviral Agents Elevates the Serum Small-dense Low-density Lipoprotein Cholesterol Level. Internal Medicine, 60(2), 191-199.

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Hepatitis C Treatment Regimens in China

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Drugs included Sofosbuvir (SOF, oral 400 mg per day), Velpatasvir (VEL, oral 100 mg per day), Daclatasvir (DCV, oral 60 mg per day), and Ribavirin (RBV, oral 10∼15 mg/kg per day). SOF (Sovaldi, GILEAD) was officially launched in China on October 21, 2017. SOF/VEL (Epclusa, GILEAD) was officially launched in China on May 30, 2018. DCV (Daklinza, Bristol-Myers Squibb) was officially launched in China on August 24, 2017. Patients can obtain these drugs about 2 months thereafter.
According to guideline [4 (link), 10 (link), 11 (link)] of HCV treatment, drug instructions, and drug accessibility in China, the treatment regimens included SOF + RBV for 24 weeks, SOF + DCV ± RBV for 12/24 weeks, and SOF/VEL ± RBV for 12 weeks. RBV was used in singular DAA regimen of SOF for chronic hepatitis and cirrhosis patients or in SOF-based DAAs regimens for cirrhosis patients.

Mei Y.Y., Chen Y.M., Wu Y.K., Zhang X.H, & Xu W.X. (2020). Efficacy and Safety of Sofosbuvir-Based Direct-Acting Antiviral Agents Treatment for Patients with Genotype 3/6 Hepatitis C Virus Infection. Canadian Journal of Gastroenterology & Hepatology, 2020, 8872120.

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Antiviral Therapy for HCV in Hemodialysis Patients

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The antiviral treatment regimen consisted of one half of a tablet containing 400 mg of SOF (Sovaldi^®; Gilead Sciences Inc., Foster City, CA, USA) once daily and one entire tablet containing 60 mg of DCV (Daklinza^®; Bristol-Myers Squibb, New York, NY, USA) once daily. The treatment period was 12 weeks. The original tablets Sovaldi containing 400 mg of SOF were split by means of a blade tablet splitting device so that we obtained two equal doses (~200 mg). The splitting was performed by the healthcare personnel. SOF was administered in combination with DCV once daily regularly in the morning independently of the hemodialysis session. SOF administration in patients with glomerular filtration rate ≤30 mL/min and the splitting of the tablets were considered to be off-label use of the drug and the patients gave consent to the off-label therapy before its initiation according to the local law.24 ,25 Other contraindications included in the Standard Product Characteristics of SOF and DCV, especially drug–drug interactions, were respected. Sustained virological response (SVR) was assessed as HCV RNA negativity 12 weeks posttreatment.

Sperl J., Frankova S., Kreidlova M., Merta D., Tothova M, & Spicak J. (2017). Combination of sofosbuvir and daclatasvir in the treatment of genotype 3 chronic hepatitis C virus infection in patients on maintenance hemodialysis. Therapeutics and Clinical Risk Management, 13, 733-738.

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Hepatitis C Treatment Regimens Evaluation

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Patients were treated with sofosbuvir (SOF) in combination with simeprevir (SMV), daclatasvir (DCV), or ledipasvir (LDV), or the 3D regimen. SOF (Sovaldi (Gilead, Cambridge, UK) 400 mg once daily), SMV (Olysio (Janssen, Beerse, Belgium) 150 mg once daily), DCV (Daklinza (Bristol-Myers Squibb, Uxbridge, UK) 60 mg once daily), SOF/LDV (Harvoni (Gilead, Cambridge, UK) 400 mg/ 90 mg once daily), and the 3D regimen (Viekirax (AbbVie, Maidenhead, UK) 12.5 mg ombitasvir, 75 mg paritaprevir, and 50 mg ritonavir once daily plus Exviera (AbbVie, Maidenhead, UK) 250 mg dasabuvir twice daily) were either prescription drugs or provided by pharmaceutical companies. Treatment durations ranged from 12 to 24 weeks.

Haider L., Mandorfer M., Güngören Z., Reiberger T., Bastati N., Hodge J.C., Chromy D., Trauner M., Herold C., Peck-Radosavljevic M, & Ba-Ssalamah A. (2018). Noninvasive Monitoring of Liver Disease Regression after Hepatitis C Eradication Using Gadoxetic Acid-Enhanced MRI. Contrast Media & Molecular Imaging, 2018, 8489709.

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