Guest guest Posted June 3, 2011 Report Share Posted June 3, 2011 HCV Drug Pipeline Hepatitis C Treatments in Current Clinical Development Alan FranciscusEditor-in-Chief Updated June 2, 2011 PDF (download) How to use the new HCV Advocate HCV Drug Pipeline: The current page will list only HCV Direct-Acting Antivirals (DAAs). The first section is the Quick Reference Guide. You can click on the label “Company†and it will link you directly to the company that is developing the drug. Phase I studies will not include any additional information—except for DAAs. Phase 2 and Phase 3 studies will include a short recap or comments of the clinical trial results. You can access the comments by clicking on the “Drug Name.†The drugs that are being developed that are not DAA drugs can be accessed by clicking on the “Drugs in Development – General†link below this note. We will not include comments in this section unless the drug has advanced into a Phase 3 or Phase 4 study. In addition we have various educational materials below to help explain some of the clinical trial processes and help with interpreting clinical trial data. Drugs in Development - Direct-Acting Antivirals (DAA) Drugs in Development - General Clinical Trial Process: Making Sense of Clinical Trials How to Read an Abstract Cancelled Trials On Hold To locate clinical trials go to www.clinicaltrials.gov – type in HCV or hepatitis C and drill down to studies that are listed by this resource. Terms Used Dosing: BID = Taken Twice a Day QD = Taken Once a Day TID = Taken three times a Day Reponse: cEVR = Complete Early Virological Response — No Virus Detected after 12 Weeks. EVR = Early Virological Response — 2 log drop of HCV RNA after 12 Weeks. RVR=HCV No Virus Detected at Week 4 SVR12 = No Virus Detected at 12 Weeks after completion of treatment. SVR24 = No Virus Detected at 24 Weeks after completion of treatment. Quick Reference Guide Phase I Drug Name Drug Category Company ABT-072 Polymerase Inhibitor Abbott ABT-333 Polymerase Inhibitor Abbott AZD-7295 NS5A Inhibitor AstraZeneca BIT225 Protease Inhibitor Biotron BMS-824383 NS5A Inhibitor Bristol-Myers Squibb Clemizole NS4B Inhibitor Eiger BioPharmaceuticals IDX375 Polymerase Inhibitor Idenix INX-189 Polymerase Inhibitor Inhibitex ITX-5061 EntryInhibitor iTherX MK-3281 Polymerase Inhibitor Merck PPI-461 NS5A Inhibitor Presidio PSI-7977 Polymerase Inhibitor Pharmasset PSI-938 Polymerase Inhibitor Pharmasset TMC649128 Polymerase Inhibitor Medivir / Tibotec VX-500 Protease Inhibitor Vertex VX-916 Polymerase Inhibitor Vertex Note: Only drugs that have advanced into phase 2 and 3 studies will include comments DAA Combinations Drug Name/Category Drug Name/Category Company Phase / Updated ABT-450 Protease Inhibitor ABT-072 Polymerase Inhibitor Abbott / Enanta Phase II Jan 6, 2011 BI 201335 Protease Inhibitor BI 207127 Polymerase Inhibitor Boehringer Ingelheim Pharma Phase II Apr 5, 2011 BMS 790052 (NS5a Inhibitor) BMS 65032 (Protease Inhibitor) Bristol-Myers Squibb Phase II Apr 5, 2011 BMS 790052 (NS5a Inhibitor) PSI-7977 (Polymerase Inhibitor) Bristol-Myers Squibb / Pharmasset Phase 1 May 26, 2011 GS-9256 GS-9190 (Tegobuvir) Gilead Phase II Nov 11, 2010 PSI-7977 Polymerase Inhibitor PSI938 Polymerase Inhibitor Pharmasset Phase I Apr 5, 2011 RG7128 (Polymerase Inhibitor) RG7227(Danoprevir) Protease Inhibitor Genentech / Pharmasset Phase II Jan 19, 2011 Telaprevir (Protease Inhibitor) VX-222 (Polymerase Inhibitor) Vertex Phase II Apr 5, 2011 Back to top Phase 2 Drug Name Drug Category Company Updated ABT-450 Protease Inhibitor Abbott / Enanta Apr 5, 2011 ACH-1625 Protease Inhibitor Achillion Oct 2, 2010 ANA598(Setrobuvir) Polymerase Inhibitor Anadys Pharmaceuticals June 2 , 2011 BI 207127 Polymerase Inhibitor Boehringer Ingelheim Pharma June 29, 2010 BMS 650032 Protease Inhibitor Bristol-Myers Squibb Nov 11, 2010 BMS 790052 NS5A Inhibitor Bristol-Myers Squibb Apr 5, 2011 BMS 791325 Polymerase Inhibitor Bristol-Myers Squibb Sep 30, 2010 Filibuvir Polymerase Inhibitor Pfizer June 30, 2010 GS 9190 (Tegobuvir) Polymerase Inhibitor Gilead Nov 11, 2010 GS-9256 Protease Inhibitor Gilead Nov 11, 2010 MK-5172 Protease Inhibitor Merck May 26, 2011 PSI-7977 Polymerase Inhibitor Pharmasset Apr 5, 2011 RG7128(Mericitabine) Polymerase Inhibitor Pharmasset / Genentech Apr 5, 2011 RG7227 (Danoprevir) Protease Inhibitor InterMune / Genentech Apr 5, 2011 Vaniprevir (MK-7009) Protease Inhibitor Merck Nov 11, 2010 VX-222 Polymerase Inhibitor Vertex Nov 23, 2010 VX-759 Polymerase Inhibitor Vertex March 12, 2009 Back to top Phase 3 Drug Name Drug Category Company Updated BI 201335 Protease Inhibitor Boehringer Ingelheim Pharma Apr 5, 2011 TMC435 Protease Inhibitor Medivir / Tibotec May 26, 2011 Back to top ABT-450/rHCV Protease Inhibitor (with ritonavir) ABT-072 Polymerase Inhibitor Abbott / Enanta Jan 6, 2011 Comments: The combination of ABT-450 (combined with ritonavir), ABT-072 and ribavirin will be given to HCV genotype 1 treatment-naïve patients for 12 weeks. Patients will be followed for an additional 48 weeks after completion of study. Back to top BI 201335 Protease Inhibitor BI 207127Polymerase Inhibitor Boehringer Ingelheim Pharma Apr 5, 2011 Comments: AASLD 2010: In a study (without interferon) the triple regime of BI 201335 (protease inhibitor) plus BI 207127 (polymerase inhibitor) and ribavirin to treat HCV genotype 1 treatment-naïve patients was found to provide strong antiviral activity—additional studies with longer durations are planned to evaluate sustained virological response rates.This combination has been designated as Fast Track Development by the Food and Drug Administration Back to top BMS 790052 NS5A Inhibitor BMS 65032 Protease Inhibitor Bristol-Myers Squibb Apr 5, 2011 Comments: In an important study the combination of BMS-650032 (protease inhibitor) and BMS-790052 (NS5A inhibitor) was given to genotype 1 null-responders to a prior course of therapy. In the group that received BMS-790052, BMS-650032 in combination with pegylated interferon plus ribavirin for 24 weeks 10 out of 10 patients achieved an SVR12. In the group that received BMS-790052 and BMS-650032 (without pegylated interferon/ribavirin) 4 out of 11 patients achieved an SVR. This is the first combination DAA study that achieved SVR without the use of pegylated interferon plus ribavirin. Back to top BMS 790052 NS5A Inhibitor PSI-7977 Polymerase Inhibitor Bristol-Myers Squibb/ Pharmasset May 26, 2011 Comments: This proof of concept study will evaluate the potential to achieve sustained viral response 24 weeks post treatment with an oral, once-daily treatment regimen in patients across HCV genotypes 1, 2 and 3. Specifically, the study will assess the safety, pharmacokinetics and pharmacodynamics of BMS-790052 in combination with PSI-7977, with and without ribavirin, in 84 treatment-naïve patients chronically infected with HCV genotypes 1, 2, and 3. On May 25, 2011 Pharmasset , INC announced the start of the study. Back to top GS-9256(Protease Inhibitor) GS-9190(Tegobuvir)Polymerase Inhibitor Gilead Oct 11, 2010 Comments: In a study that included many doses and arms it was found that the combination of GS-9256 (HCV protease inhibitor) plus tegobuvir (GS-9190 – polymerase inhibitor) when combined with pegylated interferon plus ribavirin produced the best results. In the group that was given quadruple therapy for 4 weeks followed by 44 weeks of pegylated interferon plus ribavirin, 14 out of 14 patients were HCV RNA negative by day 28. There is an ongoing 4 month study of the quadruple therapy. PSI-7977 Polymerase Inhibitor PSI-938 Polymerase Inhibitor Pharmasset Apr 5, 2011 Comments: Phase 1 combination study to evaluate once daily doses of PSI-7977 and PSI-938 (both dosed QD) in 30 patients with HCV who have not been treated previously. The antiviral properties of the drugs (alone and in combination) will be observed for 14 days. EASL 2011: In the patients who received the PSI-7977 and PSI-938—92% were HCV RNA negative at day 14. The side effects were considered mild with no treatment discontinuations in the PSI containing arms. Back to top RG7128(Mericitabine)(Polymerase Inhibitor) RG7227 (ITMN-191) (Danoprevir) Protease Inhibitor Genentech /Pharmasset Apr 5, 2011 Comments: EASL 2010: A small study using ritonavir (100 mg) to boost danoprevir (200 mg) both given twice a day achieved 100% undetectable HCV RNA after 15 days and was generally well-tolerated. Based on these findings an additional two study arms of prior complete non-responders will be retreated with danoprevir, ritronavir, PEG/RBV for 12 weeks. A larger study titled INFORM-3 is being planned that will include ritonavir. On October 7th, 2010, Genentech announced that it had purchased the full rights to Danoprevir from InterMune. Back to top Telaprevir (Protease Inhibitor VX-222 (Polymerase Inhibitor) Vertex Apr 5, 2011 Comments: On March 2, 2010 Vertex announced the initiation of a phase II trial of telaprevir/VX-222 (2 arms with and 1 arm without pegylated interferon/ribavirin). The 3 treatment arms will include HCV genotype 1 treatment-naïve patients in each arm. The treatment duration (12 weeks, 24 weeks) will be guided by response at certain time points during the trial. EASL 2011: Interim results found that at week 12 up to 90% of patients (27 of 30 patients) receiving the telaprevir/VX-222 (plus pegylated interferon/ribavirin) were HCV RNA negative. The third arm of the study is being initiated that will include telaprevir/VX-222 plus ribavirin (without pegylated interferon) to treat HCV genotype 1b patients. Back to top ABT-450 Protease Inhibitor Abbott / Enanta Apr 5, 2011 Comments: ABT-450 (50, 100, 200 mg- once a day— boosted with ritonavir) plus pegylated interferon and ribavirin will be given to HCV genotype 1 treatment-naïve patients for 12 weeks followed by 36 weeks of pegylated interferon plus ribavirin (without ABT-450) for a total treatment duration of 48 weeks.Interim 12 week data found that 92% (22 of 24) of patients were HCV RNA negative. Back to top ACH-1625 Protease Inhibitor Achillion Apr 5, 2011 Comments: Recently, Achillion announced a placebo-controlled phase IIa study to evaluate the safety, tolerability and antiviral activity of ACH-1625 (200, 400, 800 mg – QD) in conjunction with pegylated interferon alfa-2a and ribavirin. The study will evaluate 64 HCV genotype 1 patients after 4 and 12 weeks of dosing. On March 30, 2011 Achillion announced that 75 to 81% achieved an RVR. The side effects reported were mild to moderate with no treatment discontinuations. Back to top ANA598(Setrobuvir) Polymerase Inhibitor Anadys Pharmaceuticals June 2, 2011 Comments: There is an ongoing study of ANA598 (in multiple doses) combined with pegylated interferon plus ribavirin. 29 HCV genotype 1 treatment-naïve patients received the triple therapy for 12 weeks and were randomized (depending of treatment response) to an additional 12 or 36 weeks. The SVR 12 results in the patients who completed 24 weeks of treatment was 73% (in eight patients). The most common side effect was rash and it was observed in 59% of the patients who received the 400 mg dose. On January 26, 2011 Anadys began dosing ANA598 (with pegylated interferon plus ribavirin) in the Phase IIb study that is expected to enroll 275 HCV genotype 1 treatment-naïve and treatment-experienced patients. Back to top BI 207127 Polymerase Inhibitor Boehringer Ingelheim Pharma June 29, 2010 Comments: In a 5-day monotherapy study of HCV genotype 1 patients reported a median 3.8 log10 viral load decrease. The combination of BI 201335 and 20127 is being studied (see DDA combinations). Back to top BMS 650032 Protease Inhibitor Bristol-Myers Squibb Nov 11, 2010 Comments: AASLD 2010: In a study (without interferon) the triple regime of BI 201335 (protease inhibitor) plus BI 207127 (polymerase inhibitor) and ribavirin to treat HCV genotype 1 treatment-naïve patients was found to provide strong antiviral activity—additional studies with longer durations are planned to evaluate sustained virological response rates.The combination of BMS 650032 and BMS 790052 are being studied (see DAA combinations). Back to top BMS 790052 NS5A Inhibitor Bristol-Myers Squibb Apr 5, 2011 Comments: BMS 790052 is being given QD for 12-24 weeks with pegylated interferon and ribavirin, or for 24 or 48 weeks guided by on-treatment response. There are various separate studies of BMS 790052 being conducted in HCV genotype 1 treatment-naïve, non-response and treatment-intolerant patients. A study of 48 HCV genotype 1 treatment-naïve patients treated with various doses of BMS 790052 in combination with pegylated interferon plus ribavirin for 48 weeks has been completed. EASL 2011: In the group that was treated for 48 weeks SVR12 rates ranged from 42% to 92% in the BMS 790052 containing groups vs. 25% in the group that received pegylated interferon plus ribavirin (without BMS 790052).. BMS 790052 is also being studied in combination with BMS 65032 and with PSI 79-77 (see DAA combination above). Back to top BMS 791325 Polymerase Inhibitor Bristol-Myers Squibb September 30, 2010 Comments: A new trial will evaluate the safety, tolerability and efficacy of BMS 791325 in combination with pegylated interferon in HCV genotype 1 treatment-naïve patients. Treatment duration will be guided by on-treatment response. Back to top Filibuvir Polymerase Inhibitor Pfizer June 30, 2010 Comments: EASL 2010: Study results from 35 patients who were treated with filibuvir, pegylated interferon and ribavirin found that 75% were HCV RNA negative after 4 weeks of treatment. Back to top GS 9190(Tegobuvir) Polymerase Inhibitor Gilead Nov 11, 2010 Comments: AASLD 2010: A study of HCV genotype 1 treatment-naïve patients in single and multiple doses found HCV RNA reductions ranging for -1.22 to -1.95 log10. The combination of GS 9190 and GS9256 are being studied (see DAA Combinations above). Back to top GS 9256 Protease Inhibitor Gilead Nov 11, 2010 Comments: EASL 2010: Results from a three day 6-arm safety and dose-ranging study of 54 HCV genotype 1 treatment-naïve patients was released. It was found that GS-9256 was safe and generally well-tolerated and showed dose dependant antiviral activity. Phase II studies of GS-9256 with or without ribavirin are underway. (April 29, 2010)The combination of GS 9190 and GS9256 are being studied (see DAA Combinations above). Back to top MK-5172 Protease Inhibitor Merck May 26, 2010 Comments: Phase I – multiple dosing trial with MK-5172 compared to placebo.Phase II – Multiple dosing ranging study compared MK-5172 in combination with Victrelis, PegIntron and ribavirin to study the safety and efficacy compared to PegIntron plus ribavirin. Back to top PSI-7977 Polymerase Inhibitor Pharmasset Apr 5, 2011 Comments: AASLD 2010: PSI-7977, a polymerase inhibitor, dosed (QD 100, 200 and 400 mg) combined with pegylated interferon plus ribavirin for 28 days produced 4 week RVRs of 88 to 94% compared to 21% in the pegylated interferon plus ribavirin group (without PSI-7977). At week 12 the cEVR was highest in the 200 mg QD (94%) and 400 (87%) compared to 64% cEVR in the pegylated interferon plus ribavirin (placebo) group. Based on these results a 12 week study is being planned. In addition PSI-7977 appears to work against different genotypes. On December 14, Pharmasset announced the commencement of an exploratory study. The trial will evaluate PSI-7977 400mg QD in combination with ribavirin , with 0, 4, 8, or 12 weeks of pegylated interferon alfa 2a in treatment-naive patients infected with HCV genotype 2 or 3. About 40 patients infected with HCV genotype 2 or 3 who have not been previously treated are expected to be enrolled. The primary endpoint of the trial will be the assessment of safety and tolerability of PSI-7977 400mg QD and RBV for 12 weeks, administered with or without pegylated interferon in treatment-naïve patients with HCV genotypes 2 or 3. EASL 2011: 25 (15 genotype 2; 10 genotype 3) treatment- naïve patients treated with PSI-7977(400mg QD) plus pegylated interferon plus ribavirin for 24 weeks all patients who completed treatment (24 out of 25 pts (one pt lost to follow-up) all achieved SVR12. EASL 2011: 95 HCV genotype 1 treatment naïve patients received 200mg or 400 mg QD in combination with pegylated interferon and ribavirin. Treatment was guided by on-response—12 weeks (triple therapy) followed by 12 weeks of pegylated interferon and ribavirin (without PSI-7977) if HCV RNA negative at week 4 (RVR). Patients with detectable HCV RNA at week 4 received the 12 weeks of triple therapy followed by an additional 36 weeks of pegylated interferon plus ribavirin. The interim results reported were 98% achieved an RVR in the PSI-7977 treatment groups. Based on the results, Pharmasset has initiated a Phase 2b study in multiple HCV genotypes: 1, 4, 5 or 6 treatment-naïve patients who will receive PSI-7977—400 mg QD with pegylated interferon plus ribavirin for either 12 or 24 weeks—the 24 week group will receive PSI-7977 with and without pegylated interferon/ribavirin. PSI 79-77 BMS 790052 is also being studied in combination with BMS 790052 (see DAA combination above). Back to top RG7128(Mericitabine) Polymerase Inhibitor Pharmasset / Genentech Apr 5 , 2011 Comments: EASL 2011: RG7128 (1000 mg - BID) combined with pegylated interferon plus ribavirin was given to treat HCV genotype 1 and 4 treatment naive patients and treatment-duration was guided by on-treatment response (RVR). After 24 weeks SVR12 was 91%. The medications were well-tolerated. RG7128 appears to have a high barrier to drug resistance. Back to top RG7227 (Danoprevir) Protease Inhibitor InterMune / Genentech Apr 5, 2011 Comments: AASLD 2010: Interim results using various doses of danoprevir combined with pegylated interferon plus ribavirin found that 88 to 92% were HCV RNA negative by week 12 compared to 43% in the placebo group. In another study, danoprevir (boosted with ritonavir) BID used in combination with pegylated interferon plus ribavirin for 12 weeks in treatment-naïve patients (genotype 1) found high response rates in HCV Genotype 1b. Due to the high viral breakthrough seen in HCV genotype 1a all patients with HCV genotype 1a discontinued treatment after week 8. The side effects were well-tolerated. Back to top Vaniprevir(MK-7009) Protease Inhibitor Merck Nov 11, 2010 Comments: AASLD 2010: A study of 45 HCV genotype 1 treatment-naïve patients who were administered 1 of 5 regimens—placebo, 300 mg BID, 600 mg BID, 600 mg QD or 800 mg QD in combination with pegylated interferon plus ribavirin for 4 weeks followed by an additional 44 weeks of pegylated interferon plus ribavirin resulted in SVR rates of 78 to 84% compared to 63% in the placebo (only pegylated interferon and ribavirin). Note: the high SVR rate in the placebo group is likely due to the small patient population in this group. Back to top VX-222 Polymerase Inhibitor Vertex Nov 23, 2010 Comments: EASL 2010: The results from a small study of 32 HCV genotype 1 treatment-naïve patients treated with various doses of VX-222 (250, 500 and 750 BID; 1500 mg QD) found a viral load reduction of -3.1 to 3.4 log10 IU/mL) by day 4 of treatment. VX-222 was generally safe and well-tolerated. VX-222 is also being studied in combination with telaprevir (see DAA combinations). Back to top VX-759 Polymerase Inhibitor Vertex March 12, 2009 Comments: In a 10 day phase I study in which 32 treatment- naïve HCV patients received different doses of VX-759 (400 mg TID, 800 mg BID, and 800 mg TID) all patients achieved a 1 log10 decrease in HCV RNA but the higher dose arm of 800 mg TID achieved 2.5 log10 decrease. The drug was generally well-tolerated. A Phase 2, multicenter, randomized, double-blinded, and placebo-controlled study of the antiviral activity, safety and pharmacokinetics of VX-759 is underway. Additional studies will combine VX-759 and other DAAs. VX-759 is considered to be a back-up drug to VX-222. Back to top BI 201335 Protease Inhibitor Boehringer Ingelheim Pharma Apr 5, 2011 Comments: EASL 2011: The results from the SILEN-C2 study (Phase II) of 280 HCV genotype 1 patients who were prior non-responders treated for 24 weeks with either 240mg BI 201335 (QD), 240 mg BI 201335 (QD) after a 3-day lead-in of PEG/RBV or 240 BI 201335 (BID) after a 3-day lead-in period of PEG/RBV. After 24 weeks of treatment the participants were continued on PEG/RBV for an additional 24 weeks. The highest SVR rates were up to 50% in prior partial-responders and 35% in prior null-responders in the groups that received 240 mg QD —the dose that was selected for the phase III trials. The side effects attributed to BI 201335 were jaundice (no severe cases) and rash (severe cases–0.7 to 5.8%) and were found to be dose dependent. It was also found that a 3-day lead-in period in the phase II studies did not increase the response rates. A Phase II study of 429 HCV genotype 1 (SILEN-C1) treatment- naïve patients treated with various doses of BI 201335 (QD) plus pegylated interferon and ribavirin reported SVR rates up to 83% in the 240 mg QD dose. SVR was similar in the 24-week and 48-week treatment groups. BI 201335 (QD) in combination with pegylated interferon entered into Phase 3 studies that will include 3 arms: BI201335 in combination with pegylated interferon plus ribavirin for 12 weeks or 24 weeks of treatment compared to 48 weeks of pegylated interferon plus ribavirin (without BI 201335). The FDA has granted Fast Track designations for BI 201335 plus standard-of care (SOC), and as part of the interferon-free combination with the polymerase inhibitor, BI 207127, in chronic genotype-1 HCV patients.The combination of BI 201335 and BI 20127 is being studied (see DDA combinations) Back to top TMC435 Protease Inhibitor Medivir / Tibotec Mar 26, 2011 Comments: Phase III Studies: Tibotec announces on February 19, 2011 that it expects to enroll 1,125 HCV genotype 1 patients in 24 countries with a total of 160 clinical trial sites worldwide to study TMC435 plus pegylated interferon plus ribavirin for 12 weeks followed by either 12 or 36 weeks of pegylated interferon plus ribavirin (without TMC435). The studies will be guided by on-treatment response. The three clinical trials are listed below: • QUEST-1 (TMC435-C208): Treatment-naïve (never been treated) patients will receive either TMC435 (100 mg) QD (once-a day) or placebo in combination with Pegasys/ribavirin. • QUEST-2 (TMC435-C216): Treatment-naïve patients will receive either TMC435 QD (150 mg) or placebo plus pegylated interferon and ribavirin. In this trial different treatment arms use either Pegasys or PegIntron. • PROMISE (TMC435-C3007): Patients who had been previously treated with interferon-based therapy, but who relapsed (the viral load becomes undetectable, then detectable) during therapy will receive TMC435 QD (100 mg) or placebo plus Pegasys/ ribavirin. Phase II Interim Results: On February 22, 2011 interim results from a phase 2 study were released and 278 patient results were made available: For HCV genotype 1 treatment-naïve patients using TMC435 QD (75 or 150 mg) the sustained virological response (SVR) rates were 76 to 84% in the groups that received TMC435. The study was response-guided with 83% of patients being able to stop all therapy at 24 weeks. Interim results from another phase 2 study of 462 HCV Genotype 1 patients who had not achieved an SVR with a previous course of interferon plus ribavirin therapy were released late last year. The patients in the study received either TMC435 QD 100 or 150 mg plus pegylated interferon/ribavirin for a period of either 12, 24 or 48 weeks. All of the patients in the trial received TMC435, but some took TMC435 for a shorter period of time; however, all of the patients in the trial continued on with pegylated interferon plus ribavirin, but without TMC435. The 24-week interim results found that 96% of relapsers, 89% of partial responders, and 87% of null responders were HCV RNA undetectable at week 24. In both trials the side effect profile was similar between all treatment arms and consistent with side effects seen with pegylated interferon plus ribavirin therapy. Phase II Interim (4-week post treatment) Results: Interim results from another phase 2 study of 462 HCV Genotype 1 patients who had not achieved an SVR with a previous course of interferon plus ribavirin therapy were released late last year. The patients in the study received either TMC435 QD 100 or 150 mg plus pegylated interferon/ribavirin for a period of either 12, 24 or 48 weeks. All of the patients in the trial received TMC435, but some took TMC435 for a shorter period of time; however, all of the patients in the trial continued on with pegylated interferon plus ribavirin, but without TMC435. The 4-week post treatment interim results found that 88% of relapsers, 77% of partial responders, and 57% of null responders were HCV RNA undetectable. In both trials the side effect profile was similar between all treatment arms and consistent with side effects seen with pegylated interferon plus ribavirin therapy. Back to top Cancelled Trials Drug Name Drug Category Company Updated IDX320 Protease Inhibitor (Phase II) Idenix Feb 10, 2011 SCH900518 Protease Inhibitor (Phase II) Merck Apr 5, 2011 Back to top On Hold Drug Name Drug Category Company Updated IDX184 Polymerase Inhibitor (Phase II) Idenix Feb 10, 2011 http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.