hepatitis drug receives approval

1
Following its approval in November by Health Canada’s Therapeutic Products Program, lamivu- dine (Fig. 1) has become the first orally available antiviral drug for the treatment of hepatitis B. Both Glaxo Wellcome (Stevenage, UK), the drug’s manufacturer, and BioChem Pharma (Quebec, Canada), the company that discovered the drug, have said that a single, daily dose of lamivudine, or Heptovir, retards the progression of liver disease and, in some patients, can even stop it in its tracks. According to Sam Lee, president of the Canadian Association for the Study of the Liver and associate professor of medicine at the University of Calgary (Alberta, Canada), Heptovir is a very potent inhibitor of hepatitis B viral replication, and it has been shown to de- crease the amount of virus to undetectable lev- els in up to 98% of patients when placed on the treatment. He adds that the potential longer- term benefits of Heptovir might be to stave off the development of cirrhosis or liver cancer in hepatitis B patients. Hepatitis B There are an estimated 250,000 Canadians with chronic hepatitis B infection. The World Health Organization (WHO) conservatively estimates that there are 350 million chronic carriers worldwide. According to the WHO, hepatitis B is one of the most common infectious diseases and the ninth most common cause of death. It also estimates that there are between one and two million deaths each year from compli- cations associated with the disease. Sexual transmission is the most common transmission route of the virus in Europe and North America, with those aged between 15 and 24 at the greatest risk. In addition however, other risk fac- tors include contact with infected blood or dur- ing the first year of life from mother to child. As yet there is no cure and vaccination through interferon therapy, which is aimed at boosting cytokine activity, leads to side-effects in some patients and does not protect those already infected. Therefore, an effective oral drug to control the disease is clearly very desirable. Hepatitis B can cause serious liver disease (cirrhosis) and can lead to liver failure, liver can- cer and death. Infection in early childhood can lead to premature death in adulthood from hepatitis B complications. A drug such as lamivudine controls the disease by slowing the rate of viral replication and thus allows patients to seroconvert and develop an immunity. Irrespective of whether immunity is produced, however, the drug retains benefits in terms of slowing the rate of progress of the disease. Lamivudine, also known as 3TC, is a nucleo- side analogue reverse transcriptase-inhibitor and has become an active combatant in the fight against AIDS. Further trials performed by Glaxo Wellcome on the drug showed that over the course of a year more than half the patients given the drug for hepatitis B showed improved liver function and histology, compared with 36% of patients given interferon therapy and only 25% taking a placebo. Lamivudine is not without problems, how- ever. According to a report in the British Medical Journal 1 , some patients who demon- strated signs of improvement actually had in- creased viral load, whereas in some patients re- lapses were seen following cessation of the treatment. Although the US Food and Drug Administration granted approval last October, it has recommended the continuation of further studies into the drug’s efficacy. According to A.J. Zuckerman, director of the WHO Centre at the Royal Free and University College Medical School, UCL (London, UK), ‘there is a need to extend antiviral therapy in HBV carriers in order to prevent transmission of the infection and progression to chronic liver disease.’ Lamivudine represents ‘a very signifi- cant advance’ in antiviral therapy against chronic hepatitis B, but he points out that uni- versal immunization would lead to the eradi- cation of the virus. Reference 01 British Medical Journal (1998) 317, 1034 update news PSTT Vol. 2, No. 2 February 1999 1461-5347/99/$ – see front matter ©1999 Elsevier Science. All rights reserved. PII: S1461-5347(99)00118-7 44 Hepatitis drug receives approval David Bradley, tel/fax: 144 1954 202218, Web: http://www.camsoft.com/elemental/ Figure 1. Lamivudine, the first orally available antiviral drug for the treatment of hepatitis B. The drug is claimed to retard the progression of liver disease and, in some cases, halt its advancement. In brief… Cambridge Antibody Technology (CAT) (Cambridge, UK) is the re- cipient of the 1998 UK Prix Gallien Research Award for its phage anti- body technology. The UK biotech- nology company, which uses its proprietary technologies in fully human monoclonal antibodies for drug discovery and development, demonstrated its technology to the judging panel through the develop- ment of 6B1, its fully human anti- TGFb 2 monoclonal antibody used to prevent scarring in and around the eye after surgery. According to the company, both 6B1 and D2E7, an anti-TNFa monoclonal antibody for rheumatoid arthritis, are cur- rently in clinical trials.

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Page 1: Hepatitis drug receives approval

Following its approval in November by Health

Canada’s Therapeutic Products Program, lamivu-

dine (Fig. 1) has become the first orally available

antiviral drug for the treatment of hepatitis B.

Both Glaxo Wellcome (Stevenage, UK), the drug’s

manufacturer, and BioChem Pharma (Quebec,

Canada), the company that discovered the drug,

have said that a single, daily dose of lamivudine,

or Heptovir, retards the progression of liver disease

and, in some patients, can even stop it in its tracks.

According to Sam Lee, president of the

Canadian Association for the Study of the Liver

and associate professor of medicine at the

University of Calgary (Alberta, Canada),

Heptovir is a very potent inhibitor of hepatitis B

viral replication, and it has been shown to de-

crease the amount of virus to undetectable lev-

els in up to 98% of patients when placed on the

treatment. He adds that the potential longer-

term benefits of Heptovir might be to stave off

the development of cirrhosis or liver cancer in

hepatitis B patients.

Hepatitis BThere are an estimated 250,000 Canadians with

chronic hepatitis B infection. The World Health

Organization (WHO) conservatively estimates

that there are 350 million chronic carriers

worldwide. According to the WHO, hepatitis B is

one of the most common infectious diseases

and the ninth most common cause of death. It

also estimates that there are between one and

two million deaths each year from compli-

cations associated with the disease. Sexual

transmission is the most common transmission

route of the virus in Europe and North America,

with those aged between 15 and 24 at the

greatest risk. In addition however, other risk fac-

tors include contact with infected blood or dur-

ing the first year of life from mother to child.

As yet there is no cure and vaccination

through interferon therapy, which is aimed at

boosting cytokine activity, leads to side-effects

in some patients and does not protect those

already infected. Therefore, an effective oral drug

to control the disease is clearly very desirable.

Hepatitis B can cause serious liver disease

(cirrhosis) and can lead to liver failure, liver can-

cer and death. Infection in early childhood can

lead to premature death in adulthood from

hepatitis B complications. A drug such as

lamivudine controls the disease by slowing the

rate of viral replication and thus allows patients

to seroconvert and develop an immunity.

Irrespective of whether immunity is produced,

however, the drug retains benefits in terms of

slowing the rate of progress of the disease.

Lamivudine, also known as 3TC, is a nucleo-

side analogue reverse transcriptase-inhibitor

and has become an active combatant in the

fight against AIDS. Further trials performed by

Glaxo Wellcome on the drug showed that over

the course of a year more than half the patients

given the drug for hepatitis B showed improved

liver function and histology, compared with

36% of patients given interferon therapy and

only 25% taking a placebo.

Lamivudine is not without problems, how-

ever. According to a report in the BritishMedical Journal1, some patients who demon-

strated signs of improvement actually had in-

creased viral load, whereas in some patients re-

lapses were seen following cessation of the

treatment. Although the US Food and Drug

Administration granted approval last October, it

has recommended the continuation of further

studies into the drug’s efficacy.

According to A.J. Zuckerman, director of the

WHO Centre at the Royal Free and University

College Medical School, UCL (London, UK),

‘there is a need to extend antiviral therapy in

HBV carriers in order to prevent transmission of

the infection and progression to chronic liver

disease.’ Lamivudine represents ‘a very signifi-

cant advance’ in antiviral therapy against

chronic hepatitis B, but he points out that uni-

versal immunization would lead to the eradi-

cation of the virus.

Reference01 British Medical Journal (1998) 317, 1034

update news PSTT Vol. 2, No. 2 February 1999

1461-5347/99/$ – see front matter ©1999 Elsevier Science. All rights reserved. PII: S1461-5347(99)00118-744

Hepatitis drug receives approvalDavid Bradley, tel/fax: 144 1954 202218, Web: http://www.camsoft.com/elemental/

Figure 1. Lamivudine, the first orallyavailable antiviral drug for the treatment ofhepatitis B. The drug is claimed to retardthe progression of liver disease and, in somecases, halt its advancement.

In brief…Cambridge Antibody Technology(CAT) (Cambridge, UK) is the re-cipient of the 1998 UK Prix GallienResearch Award for its phage anti-body technology. The UK biotech-nology company, which uses itsproprietary technologies in fullyhuman monoclonal antibodies fordrug discovery and development,demonstrated its technology to thejudging panel through the develop-ment of 6B1, its fully human anti-TGFb2 monoclonal antibody usedto prevent scarring in and aroundthe eye after surgery. According tothe company, both 6B1 and D2E7,an anti-TNFa monoclonal antibodyfor rheumatoid arthritis, are cur-rently in clinical trials.