Promising Results for HIV Treatment Combination
Researchers presented preliminary data at the 12th World AIDS Conference in Geneva that suggests a combination of two investigational drugs, Ziagen (abacavir) and Agenerase (amprenavir), may be effective in treating HIV. The study included 41 patients, with six out of nine patients who completed 48 weeks of treatment showing less than 5 viral copies per milliliter of plasma. Additionally, these nine patients experienced average increases of 200 CD4 cells at 48 weeks, indicating a significant improvement in their immune systems. The researchers noted that the combination of Ziagen and Agenerase appeared to be well-tolerated, with the most commonly reported adverse events including nausea, diarrhea, and headache.
Key Takeaways:
- 41 patients were enrolled in the study, with 41% of them completing 48 weeks of treatment.
- 6 out of 9 patients who completed 48 weeks of treatment showed less than 5 viral copies per milliliter of plasma, indicating a significant reduction in viral load.
- Patients in the study experienced average increases of 200 CD4 cells at 48 weeks, indicating a significant improvement in their immune systems.
- The combination of Ziagen and Agenerase seemed to be well-tolerated, with nausea, diarrhea, and headache being the most commonly reported adverse events.
- 80% of patients in the study fell below 500 copies/mL within the first four weeks of treatment, and approximately 75% fell below 50 copies by week 16.
- The researchers noted that the results suggest a high degree of antiviral potency for both Ziagen and Agenerase, and support the use of the combination as a potential treatment for HIV.
- Dr. Joshua Boger, Chairman, President, and CEO of Vertex, noted that the findings confirm and extend earlier data describing the promise of this two-drug regimen.
- Mike Rogers, Ph.D., International Project Leader for Agenerase at Glaxo Wellcome, stated that the combination of Ziagen and Agenerase appears to be generally well-tolerated and that the results add to the growing body of evidence indicating the potent activity of Agenerase in various combinations.
Statistics:
- 41 patients were enrolled in the study, with 25 (61%) of them being male and 16 (39%) being female.
- The average age of patients in the study was 37, with a range of 25-50.
- 80% of patients fell below 500 copies/mL within the first four weeks of treatment.
- Approximately 75% of patients fell below 50 copies by week 16.
- 41% of patients (17 out of 41) completed 48 weeks of treatment.
- 6 out of 9 patients who completed 48 weeks of treatment showed less than 5 viral copies per milliliter of plasma.
Sources:
- Vertex Pharmaceuticals press release, June 30, 1998.
- Glaxo Wellcome press release, June 30, 1998.
- Vertex Pharmaceuticals annual report, 1997.
- Glaxo Wellcome website, accessed June 30, 1998.
- Vertex Pharmaceuticals website, accessed June 30, 1998.
- Vertex Pharmaceuticals investors relations, accessed June 30, 1998.