Reaching Undetectable HIV Viral Load Levels (MRK, BMY, GILD)
Merck & Co., Inc. (NYSE: MRK) has released some very positive data on its ongoing Phase II HIV study in data presented at the International AIDS Conference (AIDS 2008) in Mexico City, Mexico. The company’s ISENTRESS was shown to reduce HIV viral load and increased CD4 cell counts through 96 weeks in treatment. The efficacy and tolerability profile was also consistent with data seen in approved treatment-experienced indications.
ISENTRESS was put in combination with two other anti-HIV medicines, and the combined medicines was shown to have reduced HIV viral load to undetectable levels in 83% of previously untreated HIV-infected patients. This was comparable to results seen with efavirenz, which reduced HIV viral load to undetectable levels in 84% of untreated HIV-infected patients when combined with the same anti-HIV medicines in patients through 96 weeks of treatment.
Merck noted that patients taking ISENTRESS experienced a mean increase in CD4 cell counts of 221 cells/mm3 without adverse impact on total or low-density lipoprotein cholesterol, or triglycerides.
It looks like a comparable study was from Bristol-Myers Squibb (NYSE: BMY). Its CASTLE data showed that boosted REYATAZ and Lopinavir achieved similar results for undetectable viral load in previously untreated HIV-1 infected patients. A pre-specified subanalysis of the CASTLE study with once-daily boosted REYATAZ and twice-daily co-formulated lopinavir 400 mg and ritonavir 100 mg as part of H.I.V combination therapy showed similar results for undetectable viral load at 48 weeks regardless of gender in treatment-naive HIV-1 infected adults.
A Reuters report today showed scientists using monkeys to test a gel using Gilead Science’s (NASDAQ: GILD) VIREAD could also protect men from contracting HIV in anal sex tests rather than the goal of just protecting women. You can read about that study at the Reuters site.
While these are not cures, there are at least some better and better preventions and better medical treatment regimens than a decade ago.
Jon C. Ogg
August 5, 2008
Roche’s AIDS (Retinitis) & Organ Transplant Drug Going Generic?
Roche Holdings Ltd. appears to have lost some protection on Valganciclovir HCl. The FDA has granted Ranbaxy Laboratories Ltd. “tentative approval” to manufacture and market Valganciclovir Hydrochloride Tablets (450 mg).
Valganciclovir HCl Tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk.
The estimated total annual sales for Valganciclovir HCl Tablets were $239 million Ranbaxy also noted that it believes it has “First-to-File” status on on the generic AIDS drug tablets, which would give it a potential of 180-days of marketing exclusivity.
Roche Holdings Ltd. trades in the US on the Pink Sheets under the “RHHBY” ticker, so it isn’t exactly the easiest stock to play for most investors.
Jon Ogg
June 25, 2008