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The Hepatitis C Treatment Pipeline

September 2011

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Fig 2. Telaprevir: Treatment-Naive Algorithm

Fig 2. Telaprevir: Treatment-Naive Algorithm

Source: Prescribing information for telaprevir. (Accessed May 25, 2011.)


Table 3. Translating Trial Results Into Clinical Practice: Boceprevir and Telaprevir in Treatment-Experienced Persons
ParameterBoceprevirTelaprevir
SVR, responder-relapsers70-75%83-88%
SVR, partial responders40-52%54-59%
SVR, null respondersNot studied29-33%
SVR, cirrhosi F3 and F4 combined:
responder-relapsers: 50-83%
partial responders: 30-46%
null responders: not studied
F3:
responder-relapsers: 85%
partial responders: 56%
null responders: 39%

F4:
responder-relapsers: 84%
partial responders: 34%
null responders: 14%
Treatment duration recommended in labelingFor responder-relapsers and partialresponders: 36-48 weeks
For people with compensated cirrhosis and prior null responders, 48 weeks of treatment are recommended
For responder-relapsers; 24-48 weeks
For people with compensated cirrhosis and partial/null responders: 48 weeks
Discontinuation for treatment failure20%~37%
Discontinuation for AEs10%5-13% during telaprevir dosing

Sources:

Prescribing information for boceprevir and telaprevir. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf and www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf (accessed May 25, 2011).

Bacon BR, Gordon SC, Lawitz E, et al; HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1207-17.

Zeuzem S, Andreone P, Pol S, et al. REALIZE trial final results: telaprevir-based regimen for genotype 1 hepatitis C virus infection in patients with prior null response, partial response, or relapse to peginterferon/ribavirin (Opening and General Session 1) 46th Meeting of the European Association for the Study of the Liver. Berlin, Germany. March 30-April 3, 2011.


Fig 3. Boceprevir: Treatment-Experienced Algorithm
Data from prior responder-relapsers and partial responders; null responders excluded

Fig 3. Boceprevir: Treatment-Experienced Algorithm

Source: Prescribing information for boceprevir.. (Accessed May 25, 2011.)


Fig 4. Telaprevir: Treatment Experienced Algorithm*

Fig 4. Telaprevir: Treatment Experienced Algorithm

* Telaprevir labeling notes that a high proportion of null responders, especially those with cirrhosis, did not achieve SVR and developed drug resistance.

Source: Prescribing information for telaprevir. (Accessed May 25, 2011.)


HCV Protease Inhibitors

Boceprevir and telaprevir have the market to themselves for the next couple of years, but the next generation of HCV protease inhibitors is already nipping at their heels. These drugs offer advantages such as more convenient dosing, activity against other genotypes, and/or against protease resistant virus. Many are being studied in combination with other DAAs, with and without peginterferon, and with or without ribavirin.

Side effects include anemia, neutropenia, thrombocytopenia, photosensitivity, itching, rash, hemorrhoids, dysgeusia, headache, elevated alanine amino transferase (ALT) and bilirubin, jaundice, elevated uric acid and gout, dizziness, nausea, vomiting, and diarrhea.


Table 4. HCV Protease Inhibitors in Development
Agent/SponsorPhase and PopulationComments
ABT 450/r
Abbott Laboratories
Phase II, HCV genotype 1, treatment-naive (PEG-IFN-free studies limited to people with the IL-28B CC genotype)Once daily; ritonavir boosted; with PEG-IFN/RBV, and combination with ABT-333 (non-nucleoside polymerase inhibitor) plus ribavirin (not open as of May 2011)

With ABT-072 (non-nucleoside polymerase inhibitor) plus ribavirin
ACH-2684Phase I; healthy volunteers followed by HCV genotypes 1 and 3, treatment-naiveOnce daily; pan-genotypic activity
ACH-0141625
Achillion Pharmaceuticals
Phase II, HCV genotype 1, treatment-naiveOnce daily dosing; studied with PEG-IFN/RBV
BI 201335
Boehringer Ingelheim
Phase III, HCV genotype 1, treatment-naive, and treatment-naive/treatment-experienced (combination study)Once daily; with PEG-IFN/RBV for 12-48 weeks (treatment-naive)

With PEG-IFN/RBV for 24-48 weeks (treatment-experienced; not open as of 12 August 2011)

With BI 207127 (non-nucleoside polymerase inhibitor) with or without ribavirin (treatment-naive)
BMS 650032Phase II, HCV genotype 1 and 4, treatment naive; genotype 1, treatment experiencedTwice daily; with BMS 914143 (peginterferon lambda) with ribavirin; with or without BMS 790052 (NS5a inhibitor) 16-48 weeks (treatment-naive)

With PEG-IFN/RBV for 24-48 weeks (treatment-naive, genotypes 1 and 4)

With BMS 790052 (NS5a inhibitor), with or without ribavirin, and quad (PEG-IFN/RBV) prior null responders: HCV genotype 1b only in dual DAA arm
CTS-127
Conatus
Phase II; HCV genotype 1, null respondersTwice daily; with PEG-IFN/RBV
Danoprevir
(formerly ITMN-181 /RG 7227)
Genentech/Roche
Phase I/II, HCV genotype 1, treatment-naive and treatment-experiencedTwice daily; ritonavir boosted; with RG7128 (nucleotide polymerase inhibitor), with or without ribavrin (treatment-naive)

With PEG-IFNRBV in naive and experienced

With ribavrin, with or without RG7128 (nucleotide polymerase inhibitor), with or without PEG-IFN (partial and null responders)
GS9256
Gilead Sciences
Phase II; HCV genotype 1, treatment-naiveTwice daily; with tegobuvir (non-nucleoside polymerase inhibitor), with or without PEG-IFN/RBV
GS 9451
Gilead Sciences
Phase II; HCV genotype 1, treatment-naiveOnce daily; with PEG-IFN/RBV, with and without tegobuvir (non-nucleoside polymerase inhibitor)

With GS 5885 (NS5a inhibitor), tegobuvir (non-nucleoside polymerase inhibitor), and ribavirin

With PEG-IFN/RBV, with and without GS 5585 (NS5a inhibitor), IL 28B CC genotype only; 6-24 weeks of treatment. Not open as of 24 August 2011
GSK 2485852
Glaxo Smith Kline
Phase I; HCV genotype 1, treatment-naiveWith and without ritonavir boosting
MK-6335
Merck
Phase I, HCV genotypes 1 and 3, treatment-naive and treatment-experiencedNot open as of May 2011
MK-5172
Merck
Phase I, HCV genotypes 1 and 3; phase II, genotype 1, treatment-naiveOnce daily; may be active against resistant virus and across genotypes

Phase II study will be the first HCV treatment trial with an HCV protease inhibitor (boceprevir) in the control arm
Vaniprevir (MK-7009)
Merck
Phase II in HCV genotype 1, ongoing in treatment-experiencedTwice daily; study completed in treatment-naive; SVR rates were numerically higher than PEG-IFN/RBV + placebo, but the difference was not significant; additional trial in treatment-naive withdrawn

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This article was provided by Treatment Action Group and HIV i-Base. It is a part of the publication 2011 Pipeline Report.
 
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