TREATMENT INCLUDING FORTOVASE SHOWS SIGNIFICANT PROMISE TO ELIMINATE HIV TRANSMISSION FROM MOTHER TO INFANT

LISBON, 25 October, 1999 – A new study presented today has shown that the protease inhibitor FORTOVASE^® (saquinavir) in combination with AZT and the optional inclusion of 3TC shows significant promise as a treatment for avoiding transmission of HIV from a mother to her unborn child.

"Preventing vertical transmission of HIV is one key area where we can impact the spread of HIV in both developed and developing countries. It should be our aim to provide regimens which eliminate the possibility of transmission from mother to child," said David Hawkins, M.D., of the Chelsea and Westminster Hospital, London, and an investigator in the study. "The results we are seeing in this study applying a combination therapy including the protease inhibitor FORTOVASE clearly demonstrate the benefit which can be achieved with this type of intervention, along with important safety data. This is invaluable information for physicians and women with HIV."

The study of 18 HIV-infected women in both Thailand and the United Kingdom, presented at the Seventh European Conference on Clinical Aspects and Treatment of HIV-Infection, showed that none of the 13 infants for whom data were available showed any evidence of HIV infection, as determined by highly sensitive PCR diagnostic technology, at time points as long as 24 weeks after birth. All infants will be followed up to 48 weeks. Furthermore, 16 of 17 women remaining in the study (94%) had sustained HIV-RNA suppression below 400 copies/mL.

The women in the trial received 14 weeks of treatment with FORTOVASE + AZT + optional 3TC starting at 14 weeks’ pregnancy through to birth, and the infants received AZT alone for 6 weeks after birth.

Of the original 18 participants, one woman withdrew from the study, one fetus died in utero following an accident to the mother and one child was stillborn due to causes unrelated to the study.

The FORTOVASE containing regimen was generally well-tolerated. Few adverse events were reported in the study. Of four reported significant adverse events, only one (elevated liver enzymes) was considered by researchers to be related to therapy. Other less serious adverse events occurred in three cases and included moderate elevations in liver and other enzymes. No fetal abnormalities were reported, and birth weights and subsequent growth were considered normal.

FORTOVASE is available in North America, Europe and Australia. It continues to be introduced in other countries.

Roche – Innovating Healthcare