AEGiS-GMHC: Roche Puts Ganciclovir Prodrug Program On Hold

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Roche Puts Ganciclovir Prodrug Program On Hold

Treatment Issues, Vol 11, No. 4/5; April 1997
Jill Cadman

The current oral and intravenous formulations of ganciclovir call for arduous dosing regimens. Long-term treatment with these compounds is difficult and compliance can be problematic. Improved versions of ganciclovir are imperative. Roche's ganciclovir prodrug (RS 79070) would represent a significant improvement, requiring only one to two pills per day to achieve therapeutic levels of ganciclovir in the body.

Roche had planned three clinical trials for the prodrug: one for treatment, one for prevention and one for induction therapy. Two of those three trials are now on hold. According to a company letter sent to investigators, "A decision has been taken within Roche to reassess the development of the ganciclovir prodrug. This action has been precipitated by an apparent decrease in the incidence of new CMV disease which may be attributed to the wide availability of highly active antiretroviral therapies (HAART)."

The induction trial (Protocol WV 15376B) is currently the only one to go forward. About 20 sites across the country are now seeking to enroll a total of 70 participants. The trial will compare three weeks of intravenous ganciclovir induction therapy (two two-hour infusions a day) and one week of IV ganciclovir maintenance therapy (one two-hour infusion a day) with three weeks of prodrug induction therapy (two pills a day) and one week of prodrug maintenance therapy (one pill a day). After four weeks all participants will receive the prodrug.

Slow enrollment in this trial was another factor in Roche's decision to hold off on the other two studies. The induction trial is due to be fully enrolled by the end of July, but not all sites were ready to enroll participants until April. Quick enrollment now may cause Roche to reconsider its position. Anyone interested in participating should call 800/TRIALS-A for more information. The induction trial is too small to be decisive in the FDA approval process. Unless Roche makes a stronger commitment to the development of the prodrug, approval will be delayed indefinitely, and the drug will not reach the market any time soon.

Aside from being unconscionable, the decision to delay the prodrug's development is based on little hard information and runs counter to prevailing medical opinion. Although HAART may delay CMV emergence by slowing AIDS progression, most experts fear that this is only a temporary reprieve. Some clinicians feel that CMV incidence is already rebounding. As people with AIDS are living longer, the occasion to administer CMV medications for prophylaxis, induction or maintenance and the length of time on such medications may well increase.

Therapies that are easy to administer are vital to successful management of AIDS and HIV infection The dosing requirements of the current oral and intravenous formulations of ganciclovir make them unsuitable for extended use. The prodrug would improve the quality of life of many people. Roche needs to look beyond its own short-term profit margins to the larger picture.

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