I don't think it is a reaction to the Vertex news either, coming two hours late. First, Agenerase has not been approved, Glaxo and Vertex are finally submitting Agenerase data to the FDA for New Drug Approval, six years after clinical trials began. The results presented today are the same as those presented a few weeks ago, and are still not very impressive, imo. Only 59% and 48% of patients on Agenerase and two nukes were undetectable at <400 copies and <50 copies respectively, at 16 weeks, and these were treatment naïve patients. Also, Amprenavir is 8 pills twice a day, compared to Viracept's 5 pills twice a day and as Dr and as Calvin Cohen said during his conference call, why take 16 pills a day instead of 10, assuming the effects are the same.
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<Apparently Robertson Stevens suggested that AGPH may miss their numbers.>
If the stock drop is a reaction to this, I wonder what, if any, information they have.
Personally, I thought that the stock would close at 35, before the news that Agouron was going to be added to the S&P 400 and before interest rates were lowered.
Looks like it may. IMO, the price drop is more related to options expiration and manipulation. Someone may just want to give the shorts another chance to cover, imo.
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To change the topic, as far as pregnancy and the prevention of vertical transmission, studies presented at Geneva showed that combination therapy including a protease inhibitor may be more effective during pregnancy at preventing vertical transmission of HIV than zidovudine (ZDV or AZT) monotherapy (i.e. the transmission of HIV to the infant during birth.). Karen Beckerman presented the experience of the Bay Area Perinatal AIDS Center at San Francisco General in Geneva: “Since 1996, an increasing proportion of the mothers chose double or triple combination therapy. In the most recent group, more than 80% have chosen protease-containing therapy. (Ref: Session 459 Abstract 12151). Most mothers had undetectable viral loads at delivery with this approach. Of the last 61 pregnant women, 60 have had uninfected babies. The mother who transmitted was not on medication during the third trimester. Side effects were those typically encountered with the drugs, and no unexpected adverse outcomes have been seen in the babies. “
"Although it was not a controlled study, it suggests that more potent therapies may drive the transmission rate from mother to child from the 8% seen with AZT monotherapy in ACTG 076 to closer to 1 or 2%, while providing women with the state of the art antiviral therapy. This may come from lowering cell-associated virus and perhaps lowering virus in other compartments."
“The new guideline s for antiviral therapy suggest giving the best antiviral therapy to pregnant women based on the best therapy for her, and initially ignoring her pregnancy . The woman should understand the risks, benefits and the unknowns and actively participate in the choices. Beckerman says that this means triple therapy for many pregnant women with significant HIV disease....
clearly the only right approach in my mind, but some have considered it controversial.“
“We must remember though, that we do not have long term safety or efficacy information for "HAART" in pregnancy.” ) From atp.org.uk Anti-retrovirals in Pregnancy
Safety of combined therapies in pregnancy: Ref: Poster Session 32453. thebody.com
"This group reported on 37 consecutive pregnant women treated with triple combination therapy. Since they defined an adverse event as any abnormal lab value, it was not surprising that lab adverse events were common in mothers, but mostly consisted of abnormal liver function tests, abnormal bilirubin, and some anemia, all quite common in any group of patients on AZT, indinavir, or ritonavir. Two women had kidney stones on indinavir. One woman had an ectopic pregnancy; she was taking hydroxyurea when she became pregnant. 30 babies have been delivered so far. 8 were anemic, a minor complication often seen in the first 6 weeks when the baby is on AZT."
“One third of the babies were born prematurely, although most apparently were not significantly premature. Two babies whose mothers were on indinavir had intra-cerebral hemorrhages. One was of these was premature, where this is a common complication but the other was born at term. One baby, also exposed to indinavir had biliary atresia, a rare birth defect. Their conclusion, and I suppose mine as well, was that the complications in the mother were what one would expect on treatment. Three unexpected events (1 case of biliary atresia and 2 cases of intra-cerebral hemorrhages) were seen in 30 children, but there is no way of knowing whether these were related to the drugs unless more cases appear and a comparison can be made with an HIV-infected group not on therapy. However, we clearly need to keep watching, and sharing the information as it becomes available."
From: atp.org.uk Beckerman has “tended to recommend nelfinavir (Viracept) in pregnancy because of timing of meals, worry about kidney stones in mothers and not knowing if the elevated bilirubin in adults might mean some liver toxicity for a fetus, but it is mostly instinct until we have trials."
"What does appear clear is the high success rate of triple therapy at reducing perinatal transmission . The dilemma exists that if women are to receive appropriate antiretroviral treatment during pregnancy unforeseen adverse events may emerge . Prematurity and birth defects are of great concern, however, inadequate therapy for the mother to be (with resistance risks) and transmission of HIV to the unborn child are also significant risks. Therapy decisions must be made on an individual basis between informed patients and specialist physicians. Additional data from small, well- controlled studies are needed."
Four different trials of protease inhibitor in pregnant women were suspended because of these reports from Geneva, where one study found that 1/3 of births were premature, although all babies seemed to be developing normally. “Dr Gwen Scott, Co-Chair in a letter to principal investigators explained that " Although events were not observed in all of the studies, the PACTG Perinatal RAC and the protocol teams along with the DAIDS decided that the balanced approach to this issue would be for all enrolment into the trials to be "on hold" until these cases have been fully evaluated and an explanation for the premature deliveries is defined. “
The FDA advises against giving Sustiva (efavirenz) to pregnant women or to those becoming pregnant. sfaf.org Efavirenz is the only drug to clearly cause birth defects in monkeys, however it was the ONLY drug to be tested in a monkey model. This does not imply that the others are safer.
According to POZ magazine, (July 1998-Mistruths and Consequences) there was an NIH report in January 1997 that showed that offspring of pregnant mice given AZT had an "increase in liver and lung tumors, and unusual reproductive organ tumors occurred in 17% of females.
I wonder about using AZT monotherapy to prevent vertical transmission. What about the mother's health?? The infant lives, but the mother dies???? Treatment with AZT monotherapy may also result in resistant virus. It is given to mothers for the last four weeks of pregnancy and birth, and then treatment is stopped. Although not completely relevant, the 3-year Concorde trial found that asymptomatic patients taking AZT monotherapy died 29% faster than those who did not receive AZT.
UNAIDS recently announced that HIV-infected mothers in developing countries should consider alternatives to breast-feeding, even though many feel that there are no other viable options. The announcement by the UN agency indicates that there is concern about the transmission of HIV from mother to child through breast milk, notes Mark A. Wainberg, head of the International AIDS Society, in a Washington Post commentary. Other data show that the use of AZT during pregnancy can aid in the reduction of the transmission of HIV, but scientists are worried that the use of monotherapy will result in the development of AZT-resistant HIV in developing nations. Nations also face the problem of orphaned children whose mothers have died as a result of HIV. The World Health Organization estimates that 18,000 people are infected with the virus daily, with 1,600 infants born infected every day. In many developed nations, such as the United States, the number of children born with HIV has been reduced due to the use of anti-HIV drugs; but, in many developing countries--where access to these drugs is severely limited--many more children are born HIV-positive.
I put the wrong link in my previous post, 5606. The correct link is:
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