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Huge Growth Seen in Hepatitis C Market

Kunj Gohil PharmD, RPh

Hepatitis C is a significant public health concern that affected approximately 100.2 million patients globally in 2012. Even more alarming, only 0.4 million were treated that year, showing the need for increased screening and timely diagnosis.

Treatment options in 2012 yielded sales of $4.4 billion globally and $2.1 billion in the U.S. This is expected to rise to $10.8 billion globally and $6.5 billion in the U.S. by 2022 as pharmaceutical makers develop treatments with improved outcomes and safety profiles.1

Traditional treatment consisted of an interferon, associated with severe flu-like symptoms, and ribavirin, associated with severe anemia.2 In 2013, Gilead was the first to develop a novel treatment option for hepatitis C, but this regimen still requires ribavirin and, potentially, interferon.3 Future therapies, which use neither of these traditional drugs, will revolutionize management of this disease.4

Future Therapies

Drug
Manufacturer
Status Indication Regimen Information Pivotal Studies Expected Approval Anticipated Peak Year Sales/Pricing
Ledipasvir/sofosbuvir Gilead NDA filed HCV (gen 1) One pill daily, fixed dose, 8 or 12 wks, interferon-free ION 1, 2, 3 Oct. 10, 2014 $4,261M in 2019; combination expected to be priced about 85% over telaprevir in U.S.
ABT-450/r + ombitasvir (ABT-267) + dasabuvir (ABT-333) AbbVie/Enanta NDA filed HCV (gen 1): For treatment-naïve, treatment-experienced, HIV co-infected, and cirrhotic patients Oral, interferon-free, twice daily, 12–24 wks SAPPHIRE 1, 2 TURQUOISE 1, 2 Late 2014 or early 2015 $3,110M in 2018; combination expected to be priced about 85% over telaprevir in U.S. and to replace interferon-based regimens
Daclatasvir + asunaprevir NDA filed HCV (gen 1b) Oral, interferon-free, 24–48 wks HALLMARK-DUAL 2014 Daclatasvir, $795M in 2018; expected to be priced about 40% over telaprevir in U.S. Asunaprevir, $91M in 2019; expected to be priced about 10% over the most prescribed peginterferon in U.S.
Daclatasvir + sofosbuvir Phase 3 HCV (gen 1–6) Oral, interferon-free, 8–36 wks ALLY 1, 2, 3 2015 or 2016
Daclatasvir + asuna-previr + BMS-791325 Bristol-Myers Squibb Phase 3 HCV (gen 1) Oral, interferon-free, 12 wks UNITY 1, 2 2015 Fixed-dosed combination expected to be priced about 85% over telaprevir in U.S.
Faldaprevir Boehringer Ingelheim NDA filed HCV (gen 1) Oral, interferon-sparing, 12–24 wks STARTverso 1, 2, 3, 4 Late 2014 $275M in 2018; expected to be priced about 40% over telaprevir in U.S.

Gen = genotype; HIV = human immunodeficiency virus; M = million; HCV = hepatitis C virus infection; NDA = new drug application; wks = weeks Sources: GlobalData; Redbook; FDA

Current Therapies

Drug / Manufacturer Approval Date Indication Regimen Information Cost of Course of Therapy
Sovaldi (sofosbuvir) / Gilead Dec. 6, 2013 Gen 1–4 chronic HCV Oral (q.d., 12–24 wks) 12-wk regimen: $84,000
Olysio (simeprevir) / Janssen Nov. 22, 2013 Gen 1 chronic HCV Oral (q.d., 12 wks) 12-wk regimen: $66,360
Incivek (telaprevir) / Vertex May 23, 2011 Gen 1 chronic HCV Oral (2 tabs t.i.d., 12 wks) 12-wk regimen: $11,025.85
Victrelis (boceprevir) / Merck May 13, 2011 Gen 1 chronic HCV Oral (4 caps t.i.d., 24–44 wks) 24-wk regimen: $3,343.36

Caps = capsules; Gen = genotype; HCV = hepatitis C virus infection; q.d. = once daily; t.i.d. = three times daily; tabs = tablets; wk = week Sources: GlobalData; Redbook; FDA; prescribing information for Sovaldi, Olysio, Incivek, and Victrelis

References

  1. GlobalData. Hepatitis C Virus: Global Drug Forecast and Market Analysis to 2022 May 2014;
  2. Lexicomp Philadelphia, Pennsylvania: Wolters Kluwer Health.
  3. Sovaldi (sofosbuvir), package insert Foster City, California: Gilead Sciences, Inc.. December 2013;
  4. Swan T. Hepatitis C drug development catapults onward. Pipeline Report June 2013;Available at: www.pipelinereport.org/2013/hcv. Accessed May 20, 2014