WARNING: SERIOUS SKIN REACTIONS

Fatal and non-fatal serious skin reactions, including SJS, DRESS and TEN, have been reported in patients treated with INCIVEK combination treatment. For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be discontinued immediately. Patients should be promptly referred for urgent medical care. Go to additional important safety information

Definitions

In adults with genotype 1 chronic hepatitis C virus (HCV) and compensated liver disease

Powerful Results

Superior SVR (virologic cure) rates across all 4 patient treatment history types studied with INCIVEK combination treatment vs pegIFN-RBV alone

  • Treatment-naÏve: 79% (285/363) achieved SVR with INCIVEK combination treatment vs 46% (166/361) with pegIFN-RBV alone
  • Prior relapsers: 86% (246/286) achieved SVR with INCIVEK combination treatment vs 22% (15/68) with pegIFN-RBV alone
  • Prior partial responders: 59% (57/97) achieved SVR with INCIVEK combination treatment vs 15% (4/27) with pegIFN-RBV alone
  • Prior null responders: 32% (47/147) achieved SVR with INCIVEK combination treatment vs 5% (2/37) with pegIFN-RBV alone
    • A high proportion of previous null responders (particularly those with cirrhosis) did not achieve SVR and had telaprevir resistance-associated substitutions emerge on treatment with INCIVEK combination treatment

ADVANCE was a randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial in treatment-naïve patients with genotype 1 chronic HCV and compensated liver disease (N=1088). MORE+

REALIZE was a randomized, double-blind, placebo-controlled, Phase 3 trial in patients with genotype 1 chronic HCV and compensated liver disease who were previously treated with pegIFN-RBV (N=662). MORE+

INDICATION

INCIVEK® (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.

The following points should be considered when initiating treatment with INCIVEK:

  • INCIVEK must not be administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin
  • A high proportion of previous null responders (particularly those with cirrhosis) did not achieve a Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with INCIVEK combination treatment
  • INCIVEK efficacy has not been established for patients who have previously failed therapy with a treatment regimen that includes INCIVEK or other HCV NS3/4A protease inhibitors

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS SKIN REACTIONS
  • Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with INCIVEK combination treatment. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified
  • For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should be considered. Patients should be promptly referred for urgent medical care
Contraindications
  • Contraindications to peginterferon alfa and ribavirin also apply to INCIVEK combination treatment
  • INCIVEK combination treatment is contraindicated in women who are or may become pregnant. Ribavirin may cause fetal harm when administered to a pregnant woman. If ribavirin is used during pregnancy or in the event of a pregnancy while on treatment, inform the patient of the potential hazard to a fetus. INCIVEK combination treatment is also contraindicated in men whose female partners are pregnant
  • INCIVEK is a strong inhibitor of CYP3A. INCIVEK is contraindicated when combined with drugs that 1) are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events and 2) strongly induce CYP3A and thus may lead to lower exposure and loss of efficacy of INCIVEK. Contraindicated medications are alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John’s wort, lovastatin, simvastatin, pimozide, sildenafil (Revatio®) or tadalafil (Adcirca®) for pulmonary arterial hypertension, oral midazolam, and/or triazolam
Warnings and precautions
  • See Boxed Warning regarding serious skin reactions at beginning of Important Safety Information
  • In clinical trials, serious skin reactions, including DRESS and SJS were reported in <1% of subjects who received INCIVEK combination treatment compared to none who received peginterferon alfa and ribavirin alone. These serious skin reactions required hospitalization, and all subjects recovered. Presenting signs of these reactions may include rash, fever, facial edema, target lesions, mucosal ulcerations, and evidence of internal organ involvement
  • TEN and Erythema Multiforme (EM) have been observed in post-marketing experience
  • Rash events (all grades) developed in 56% of patients who received INCIVEK combination treatment compared to 34% with peginterferon alfa and ribavirin alone. Severe rash was reported in 4% of patients treated with INCIVEK combination treatment compared to <1% with peginterferon alfa and ribavirin alone. Severe rash may have a prominent eczematous component. Patients with mild to moderate rash should be followed for progression of rash or development of systemic symptoms. If rash becomes severe, discontinue INCIVEK. Peginterferon alfa and ribavirin may be continued. If improvement is not observed within 7 days of discontinuing INCIVEK, consider sequential or simultaneous interruption or discontinuation of ribavirin and/or peginterferon alfa; earlier interruption or discontinuation may be medically indicated. Monitor patients until the rash has resolved. INCIVEK must not be reduced or restarted if discontinued due to rash. Treatment of rash with systemic corticosteroids is not recommended
  • Anemia has been reported with peginterferon alfa and ribavirin treatment. Adding INCIVEK is associated with an additional decrease in hemoglobin compared to peginterferon alfa and ribavirin alone. Hemoglobin values of ≤10 g per dL were observed in 36% of patients, and <8.5 g per dL in 14% of patients who received INCIVEK combination treatment compared to 17% and 5%, respectively, with peginterferon alfa and ribavirin alone
  • Hemoglobin should be monitored prior to and at least at weeks 2, 4, 8, and 12 during INCIVEK combination treatment and as clinically appropriate. Earlier and more frequent monitoring for some patients should be considered. Use the labeled ribavirin dose modification guidelines to manage anemia; if ribavirin dose reductions are inadequate, consider discontinuing INCIVEK. If ribavirin is permanently discontinued, INCIVEK must also be permanently discontinued. The dose of INCIVEK must not be reduced and must not be restarted if discontinued
  • Pregnancy: Ribavirin may cause defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained just before initiation of therapy
  • Female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during combination treatment and for 6 months after all treatment has ended. Female patients should have monthly pregnancy tests during treatment and during the 6-month period after stopping all treatment. Female patients may continue hormonal contraceptives but they may not be reliable during INCIVEK dosing and for up to 2 weeks after stopping INCIVEK. During this time, female patients of childbearing potential should use 2 effective non-hormonal methods of contraception
  • A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes in patients exposed to ribavirin
  • Certain drugs are contraindicated for use with INCIVEK due to potentially life-threatening adverse events or potential loss of therapeutic effect to INCIVEK. See INCIVEK Prescribing Information Table 3 for contraindicated drugs, and Table 5 for established and other potentially significant drug interactions
  • Monitor HCV RNA levels at Weeks 4 and 12 and as clinically indicated. Use a sensitive real-time RT-PCR assay to monitor HCV RNA during treatment (lower limit of quantification should be ≤25 IU per mL and limit of detection approximately 10–15 IU per mL). To assess response-guided therapy eligibility, an “undetectable” HCV RNA (Target Not Detected) result is required; a confirmed “detectable but below limit of quantification” HCV RNA result should not be considered equivalent to an “undetectable” HCV RNA result (reported as “Target Not Detected” or “HCV RNA Not Detected”)
  • Hematology evaluations are recommended prior to and at weeks 2, 4, 8, and 12, and as clinically appropriate. Chemistry evaluations are recommended as frequently as hematology evaluations or as clinically appropriate
  • INCIVEK must not be administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin. There are no clinical data on retreating patients who have failed an HCV NS3/4A protease inhibitor-based treatment and no data on repeated courses of INCIVEK
  • INCIVEK is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh B or C, score ≥7) or patients with decompensated liver disease
  • The safety and efficacy of INCIVEK combination treatment have not been established in pediatric and liver transplant patients
  • Warnings and Precautions to peginterferon alfa and ribavirin also apply to INCIVEK combination treatment
Adverse reactions
  • Adverse reactions to peginterferon alfa and ribavirin also apply to INCIVEK combination treatment
  • The most common adverse reactions seen with an incidence ≥5% with INCIVEK over controls were rash (56% vs 34%), fatigue (56% vs 50%), pruritus (47% vs 28%), nausea (39% vs 28%), anemia (36% vs 17%), diarrhea (26% vs 17%), vomiting (13% vs 8%), hemorrhoids (12% vs 3%), anorectal discomfort (11% vs 3%), dysgeusia (10% vs 3%), and anal pruritus (6% vs 1%)

Please see the full Prescribing Information for INCIVEK, including Boxed Warning.

This site is intended for U.S. Healthcare Professionals only. All other audiences, please click here.

  1. Ghany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guidelines by the American Association for the Study of Liver Diseases. Hepatology. 2011;54:1433-1444.
  2. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405-2416.
  3. Data on file. Vertex Pharmaceuticals Incorporated, Cambridge, MA.
  4. Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011;364:2417-2428.
  5. Bastuji-Garin S, Rzany B, Stern RS, Shear NH, Naldi L, Roujeau JC. Clinical classification of cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme. Arch Dermatol. 1993;129:92-96.
  6. Burkhart CG, Burkhart CN. Use of informational/instructional sheets with eczema patients. Open Dermatol J. 2008;2:98-104.
  7. National Eczema Association. Bathing & moisturizing. http://www.nationaleczema.org/living-with-eczema/bathing-moisturizing. Accessed September 9, 2013.
  8. Pérez-Soler R, Delord JP, Halpern A, et al. HER1/EGFR inhibitor-associated rash: future directions for management and investigation outcomes from the HER1/EGFR inhibitor rash management forum. Oncologist. 2005;10:345-356.
  9. Potthoff K, Hofheinz R, Hassel JC, et al. Interdisciplinary management of EGFR-inhibitor-induced skin reactions: a German expert opinion. Ann Oncol. 2011;22:524-535.
  10. Ring J, Brockow K, Abeck D. The therapeutic concept of "patient management" in atopic eczema. Allergy. 1996;51:206-215.
  11. Strangways-Dixon S. Eczema and contact dermatitis—a review. SA Pharmacist’s Assistant. 2009;9:24-25.
  12. Esper P, Gale D, Muehlbauer P. What kind of rash is it? deciphering the dermatologic toxicities of biologic and targeted therapies. Clin J Oncol Nurs. 2007;11:659-666.
  13. Dick SE, Crawford GH. Managing cutaneous side effects of epidermal growth factor receptor (HER1/EGFR) inhibitors. Community Oncol. 2005;2:492-496.
  14. Carruthers SG. Eczema. J Natl Med Assoc. 1910;2:182-186.
  15. National Eczema Society. Itching & scratching. www.eczema.org/itching-scratching. Accessed September 9, 2013.
  16. Mistry N, Shapero J, Crawford RI. A review of adverse cutaneous drug reactions resulting from the use of interferon and ribavirin. Can J Gastroenterol. 2009;23:677-683.
  17. Lynch TJ Jr, Kim ES, Eaby B, Garey J, West DP, Lacouture ME. Epidermal growth factor receptor inhibitor–associated cutaneous toxicities: an evolving paradigm in clinical management. Oncologist. 2007;12:610-621.
  18. Erythema multiforme. Medscape Web site. http://emedicine.medscape.com/article/1122915-overview. Accessed September 9, 2013.
  19. Kelly AP, Taylor SC, eds. Dermatology for Skin of Color. New York, NY: McGraw-Hill Medical; 2009.
  20. Ely JW, Stone MS. The generalized rash: part II. Diagnostic approach. Am Fam Physician. 2010;81:735-739.
  21. American Academy of Dermatology. How to perform a total body skin exam. http://www.aad.org/education/medical-student-core-curriculum/the-skin-exam. Accessed September 9, 2013.
  22. COPEGUS [package insert]. South San Francisco, CA: Genentech Inc; February 2013.
  23. Sulkowski MS, Roberts S, Afdhal NH, et al. Ribavirin dose modification in treatment-naïve and previously treated patients who received telaprevir combination treatment: no impact on sustained virologic response in phase 3 studies. Poster presented at: 47th Annual Meeting of the European Association for the Study of the Liver (EASL), The International Liver Congress™; April 18-22, 2012; Barcelona, Spain.
  24. Beck DE, Roberts PL, Rombeau JL, Stamos MJ, Wexner SD, eds. Perianal dermatology and pruritus ani. In: The ASCRS Manual of Colon and Rectal Surgery. New York, NY: Springer Science + Business Media, LLC; 2009:343-361.
  25. American Society of Colon & Rectal Surgeons. Pruritus ani. http://www.fascrs.org/patients/conditions/pruritus_ani/. Accessed September 9, 2013.
  26. American College of Gastroenterology. Rectal problems in women. http://patients.gi.org/topics/rectal-problems-in-women/. Accessed September 9, 2013.
  27. Mayo Clinic. Anal itching. http://www.mayoclinic.com/health/anal-itching/DS00453/DSECTION=treatments-and-drugs. Accessed September 9, 2013.

HCV = hepatitis C virus. INCIVEK combination treatment = INCIVEK + pegIFN-RBV for 12 weeks, and an additional 12 or 36 weeks of pegIFN-RBV alone. pegIFN = peginterferon alfa. RBV = ribavirin. SVR (virologic cure) = sustained virologic response; defined as HCV RNA <25 IU/mL at last observation within the SVR visit window (ie, Weeks 32–78 for patients assigned to 24 weeks of treatment and Weeks 56–78 for patients assigned to 48 weeks of treatment). RVR = undetectable HCV RNA (Target Not Detected) at Week 4. eRVR = undetectable HCV RNA (Target Not Detected) at Weeks 4 and 12. Treatment-naïve = received no prior therapy for HCV, including interferon-based therapy or pegylated interferon monotherapy.  Prior partial responder = ≥2 log10 reduction in HCV RNA at Week 12, but not achieving undetectable HCV RNA at the end of a prior pegIFN-RBV therapy. Prior relapser = undetectable HCV RNA at the end of a prior pegIFN-RBV regimen, but detectable HCV RNA within 24 weeks of follow-up. Prior null responder = <2 log10 reduction in HCV RNA at Week 12 during a prior pegIFN-RBV therapy.

The Phase 2 clinical program includes findings from two Phase 2 clinical trials, PROVE3 (N=42 prior relapsers) and Study 107 (N=25 prior relapsers). PROVE3 was a randomized, partially placebo-controlled, partially double-blind, Phase 2 trial of INCIVEK in combination with peginterferon alfa with or without ribavirin in patients with genotype 1 chronic HCV and compensated liver disease who had not achieved SVR with a prior course of pegIFN-RBV. The data shown here included prior relapsers randomized to one treatment arm of PROVE3 who received INCIVEK in combination with pegIFN-RBV for the first 12 weeks of treatment followed by an additional 12 weeks of pegIFN-RBV alone. Study 107 was an open-label trial of INCIVEK combination treatment in patients with genotype 1 chronic HCV and compensated liver disease who did not achieve or maintain an SVR in the control arms of the PROVE1, PROVE2, and PROVE3 trials. The data shown here included prior relapsers from Study 107 treated with INCIVEK in combination with pegIFN-RBV for the first 12 weeks of treatment followed by an additional 12 weeks of pegIFN-RBV alone. To be eligible for this treatment regimen, patients were required to achieve eRVR.

ADVANCE was a randomized, double-blind, parallel-group, placebo-controlled trial in treatment-naÏve patients with genotype 1 chronic HCV and compensated liver disease (N=1088). INCIVEK was given for the first 8 weeks of treatment (T8/PR arm) or the first 12 weeks of treatment (T12/PR arm) in combination with pegIFN-RBV (PR) for either 24 or 48 weeks. Patients who had undetectable HCV RNA (Target Not Detected) at Weeks 4 and 12 (eRVR) received 24 weeks of pegIFN-RBV, and patients who did not have undetectable HCV RNA at Weeks 4 and 12 (no eRVR) received 48 weeks of pegIFN-RBV treatment. The control regimen had a fixed treatment duration, with telaprevir-matching placebo for the first 12 weeks and pegIFN-RBV for 48 weeks.

INCIVEK was administered at a dosage of 750 mg every 8 hours; the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1000 mg/day (patients weighing <75 kg) or 1200 mg/day (patients weighing ≥75 kg). SVR in all trials was defined as HCV RNA <25 IU per mL at last observation within the SVR visit window (i.e., Weeks 32–78 for patients assigned to 24 weeks of treatment and Weeks 56–78 for patients assigned to 48 weeks of treatment).

Eligible patients were/had: 1) 18 to 70 years of age and had HCV genotype 1 infection with evidence of chronic hepatitis, as confirmed by means of a liver biopsy within 1 year before screening for the study (patients with compensated liver cirrhosis were eligible); 2) seronegativity for hepatitis B surface antigen; 3) absence of antibodies against human immunodeficiency virus types 1 and 2; 4) absolute neutrophil counts of ≥1500/mm3; 5) platelet counts of ≥90,000/mm3; and 6) hemoglobin levels of ≥12 g/dL in women or ≥13 g/dL in men.1

Treatment arms

  • Treatment arm 1 (n=364): INCIVEK + pegIFN-RBV for 8 weeks, followed by pegIFN-RBV alone for 16 weeks in patients with eRVR
  • Treatment arm 2 (n=363): INCIVEK + pegIFN-RBV for 12 weeks, followed by pegIFN-RBV alone for 12 weeks in patients with eRVR
  • Treatment arm 3 (n=361): pegIFN-RBV alone for 48 weeks

Stopping rules1

  • Patients with HCV RNA >1000 IU/mL at Week 4 discontinued INCIVEK
  • Patients with HCV RNA <2 log10 decrease from baseline at Week 12 discontinued pegIFN-RBV; INCIVEK is complete
  • Discontinuation of all treatment if detectable between Weeks 24 and 40

Reference: 1. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405-2416.

ILLUMINATE was a randomized, open-label trial conducted in treatment-naÏve patients with genotype 1 chronic HCV and compensated liver disease (N=540). The trial was designed to compare SVR rates in patients achieving eRVR who were treated with INCIVEK for 12 weeks in combination with pegIFN-RBV for either 24 or 48 weeks.

INCIVEK was administered at a dosage of 750 mg every 8 hours; the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1000 mg/day (patients weighing <75 kg) or 1200 mg/day (patients weighing ≥75 kg). SVR in all trials was defined as HCV RNA <25 IU per mL at last observation within the SVR visit window (i.e., Weeks 32–78 for patients assigned to 24 weeks of treatment and Weeks 56–78 for patients assigned to 48 weeks of treatment).

Eligible patients had 1) presence of chronic infection with HCV genotype 1, indicated by a diagnosis at more than 6 months before the screening visit, with a detectable HCV RNA level at the visit, as well as no previous treatment for HCV infection; 2) age between 18 and 70 years; 3) seronegative test for hepatitis B virus and human immunodeficiency virus; 4) absolute neutrophil count of ≥1500/mm3; 5) platelet count of ≥90,000/mm3; 6) hemoglobin level of ≥12 g/dL in female patients and ≥13 g/dL in male patients; and 7) undergone a liver biopsy within 1 year before the screening visit or underwent the procedure during the screening period unless a biopsy more than 1 year previously showed evidence of cirrhosis.1

Treatment arms1

  • Patients who achieved undetectable HCV RNA at Weeks 4 and 12 and were on treatment at Week 20 were randomized either to stop all treatment at Week 24 or to receive an additional 24 weeks of pegIFN-RBV alone for a total of 48 weeks of therapy
  • Patients who did not achieve undetectable HCV RNA at Weeks 4 and 12 received an additional 24 weeks of pegIFN-RBV alone for a total of 48 weeks

Stopping rules1

  • Patients with HCV RNA >1000 IU/mL at Week 4 discontinued INCIVEK
  • Patients with HCV RNA <2 log10 decrease from baseline at Week 12 discontinued pegIFN-RBV; INCIVEK is complete
  • Discontinuation of all treatment if detectable between Weeks 24 and 36

Reference: 1. Sherman KE, Flamm SL, Afdhal NH, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011;365:1014-1024.

REALIZE was a randomized, double-blind, placebo-controlled trial in patients with genotype 1 chronic HCV and compensated liver disease who were previously treated with pegIFN-RBV (N=662). The trial enrolled prior relapsers and prior nonresponders (including partial responders and null responders). Patients received INCIVEK combination treatment for 12 weeks (with and without a 4-week lead-in of pegIFN-RBV alone) followed by treatment with pegIFN-RBV alone for a total of 48 weeks. The control regimen received a telaprevir-matching placebo for the first 16 weeks followed by pegIFN-RBV alone for a total of 48 weeks. The immediate-start and lead-in arms delivered comparable rates of SVR, relapse, and virologic failure; therefore, data were pooled.

INCIVEK was administered at a dosage of 750 mg every 8 hours; the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1000 mg/day (patients weighing <75 kg) or 1200 mg/day (patients weighing ≥75 kg). SVR in all trials was defined as HCV RNA <25 IU per mL at last observation within the SVR visit window (i.e., Weeks 32–78 for patients assigned to 24 weeks of treatment and Weeks 56–78 for patients assigned to 48 weeks of treatment).

Eligible patients were/had 1) 18 to 70 years of age, had chronic HCV genotype 1 infection, did not have a sustained virologic response to one previous course of pegIFN-RBV despite receiving at least 80% of the intended dose; 2) had well-characterized data on the previous treatment; 3) detectable HCV RNA; 4) undergone liver biopsy within 18 months before screening; 5) absolute neutrophil count of ≥1200/mm3; and 6) platelet count of ≥90,000/mm3, and a hemoglobin level of ≥12 g/dL in women and ≥13 g/dL in men.1

Treatment arms1

  • Treatment arm 1 (n=266): INCIVEK + pegIFN-RBV for 12 weeks, followed by pegIFN-RBV alone for 36 weeks
  • Treatment arm 2 (n=264): pegIFN-RBV for 4 weeks, followed by INCIVEK + pegIFN-RBV for 12 weeks, followed by pegIFN-RBV alone for 32 weeks
  • Treatment arm 3 (n=132): pegIFN-RBV alone for 48 weeks

Stopping rules1

  • Patients with HCV RNA >100 IU/mL at Weeks 4, 6, and 8 discontinued INCIVEK
  • Patients with HCV RNA <2 log10 decrease from baseline at Week 12 (Week 16 for lead-in arm) discontinued pegIFN-RBV; INCIVEK is complete
  • Discontinuation of all treatment if detectable at Week 24 or 36

Reference: 1. Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011;364:2417-2428.

The Phase 2 clinical program includes findings from two Phase 2 clinical trials, PROVE3 (N=42 prior relapsers) and Study 107 (N=25 prior relapsers). PROVE3 was a randomized, partially placebo-controlled, partially double-blind, Phase 2 trial of INCIVEK in combination with peginterferon alfa with or without ribavirin in patients with genotype 1 chronic HCV and compensated liver disease who had not achieved SVR with a prior course of pegIFN-RBV. The data shown here included prior relapsers randomized to one treatment arm of PROVE3 who received INCIVEK in combination with pegIFN-RBV for the first 12 weeks of treatment followed by an additional 12 weeks of pegIFN-RBV alone. Study 107 was an open-label trial of INCIVEK combination treatment in patients with genotype 1 chronic HCV and compensated liver disease who did not achieve or maintain an SVR in the control arms of the PROVE1, PROVE2, and PROVE3 trials. The data shown here included prior relapsers from Study 107 treated with INCIVEK in combination with pegIFN-RBV for the first 12 weeks of treatment followed by an additional 12 weeks of pegIFN-RBV alone. To be eligible for this treatment regimen, patients were required to achieve eRVR.

You are now leaving www.INCIVEK.com.

The link you've chosen will take you to a site maintained by a third party that is solely responsible for its content. Vertex Pharmaceuticals Incorporated does not control, influence, or endorse this site and is not responsible for the privacy policy of any third-party websites.