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Medivir: New Phase IIa Data on TMC435 in Patients with Hepatitis C Presented at the Ongoing EASL - Meeting

STOCKHOLM, Sweden--(BUSINESS WIRE)--Apr 24, 2009 - Regulatory News: Data were presented from the phase IIa trial (OPERA-1) for TMC435 at the ongoing 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark, April 22-26.

TMC435 is an investigational protease inhibitor, being developed by Tibotec in collaboration with Medivir (STO:MVIRB), for the treatment of hepatitis C virus (HCV).

Data for TMC435 in treatment naïve genotype-1 HCV patients have been presented in an oral lecture. Furthermore, data in patients with genotype-1 HCV infection who failed previous IFN-based therapy were presented during a late breaker poster session.

TMC435 in treatment-naïve genotype-1 HCV patients
The results from 25, 75 and 200 mg in treatment-naive patients are summarized below:

1. Viral load reduction, (RNA log10 IU/mL), at week 4 on triple therapy groups (SoC and TMC435) was 5.5 and 5.4 log10 IU/mL for the 75 mg and 200 mg TMC435, QD respectively.

2. Undetectable levels (< 10 IU/mL) in 8/9 patients in the 75 mg group and 7/10 in the 200 mg group was observed after 4 weeks of treatment with triple therapy.

3. After 12 weeks (4 weeks triple + 8 weeks SoC), 6/9, 9/9 and 10/10 had undetectable virus (< 10 IU/mL) in the 25mg, 75 and 200 mg groups, respectively.

4. No breakthroughs observed after 4 weeks of triple therapy in any of the groups (25, 75 or 200 mg).

5. No treatment related discontinuations, most AEs were mild to moderate.

6. No evidence of TMC related hepatic, renal, CV or blood (haematopoietic) adverse events.

7. Mild and reversible increases in bilirubin observed in highest dose groups (200 mg).

8. Substantial decreases of liver transaminases were observed.

TMC435 in patients that failed previous IFN-based treatment
The results from 75, 150 and 200mg are summarized below:

1. Potent, dose-dependent, antiviral activity after 4 weeks treatment with triple therapy with 4.3, 5.5 and 5.3 log 10 IU/mL reduction for 75, 150 and 200 mg QD groups, respectively, compared to 1.5 in the placebo group

2. Three viral breakthroughs were observed in prior non-responders with G1b, 2 in 75 mg and 1 in the 150 mg QD group.

3. At Day 28, 4/9 (44%), 7/9 (78%) and 7/10 (70%) patients achieved plasma HCV RNA levels <25 iu>

4. 2/9 (22%), 5/9 (56%) and 3/10 (30%) patients in 75, 150 and the 200 mg groups reached undetectable levels (< 10 IU/mL) after 4 weeks of treatment, compared to 0/9 patients on placebo.

5. There were no serious adverse events and no treatment discontinuations due to adverse events, which generally were of mild to moderate grade.

6. Liver enzymes were reduced by TMC treatment.

7. Bilirubin increases were observed in some patients on TMC, mostly with the 200 mg group. These elevations were reversible and generally mild.

In treatment-naïve patients infected with HCV genotype-1, TMC435 in combination with SoC over 4 weeks of treatment:
demonstrated potent antiviral activity
was generally safe and well tolerated
was not associated with AE-related treatment discontinuations
These results support the development of TMC435 for treatment-naïve patients infected with HCV genotype-1.

In treatment experienced patients infected with HCV genotype 1, 28 days of once-daily treatment with TMC435 (75, 150 and 200 mg) as part of a triple therapy regimen with PEGIFN-2a and RBV:
demonstrated potent, dose-dependent antiviral activity.
was generally safe and well tolerated.
was not associated with AE-related treatment discontinuations.

About hepatitis C
According to the World Health Organization, about 170 million people around the world are infected with chronic HCV and 3 to 4 million people are newly infected each year Chronic infection with HCV can lead to cirrhosis and liver cancer, and is the most common cause of liver transplant in Europe.

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Rein Piir, CFO & VP Investor Relations
+46 708 537 292


Posted: April 2009