6 November 2001 TAC Replies in MTCT Court Case Yesterday, TAC lodged its replying affidavits to the Department of Health's response to our founding affidavits. Some of our replying affidavits are available on our website: www.tac.org.za. The remainder will be put on the website over the next few days. Many thanks to the dozens of people, both locally and internationally, who assisted us. We are still putting together the names of everyone who was involved and will thank them all by name shortly. ------------ Tonight at 20:00 on SAFM (104-107FM), Pat Sidley will be hosting her show "Pat on their backs". The show will discuss consumer issues related to antiretroviral drugs. It promises to be informative. Her guests will include Judge Edwin Cameron, Dr. Jerry Friedland and Dr. Des Martin. ------------- Two interesting news articles are reprinted below: * Switching from a Protease Inhibitor: The Answers Are Known, It's Time to Move On - by Dr Stephen Becker (copied from Medscape) * Mbeki misinformed on AIDS drugs, says expert (copied from Business Day) ------------ Switching from a Protease Inhibitor: The Answers Are Known, It's Time to Move On Stephen Becker, MD San Francisco, Saturday, October 27, 2001 -- During the mid to late 1990s, +when the shine on the fresh concept of viral eradication and the newly available HIV protease +inhibitors (PIs) was still dazzling, legions of patients were started on triple-drug antiretroviral regimens that included +a PI. The demands of adherence with these complex regimens, treatment toxicities and tolerability, and the +availability of potent nucleoside reverse transcriptase inhibitor (NRTI) and non-nucleoside reverse transcriptase +inhibitor (NNRTI) agents soon prompted a series of "switch studies" designed to evaluate the feasibility and +virologic outcomes of changing the PI for either an NRTI (abacavir) or an NNRTI (efavirenz or nevirapine). These studies have revealed a certain consistency. First, virologic control+is generally well maintained in patients with demonstrated viral suppression on their PI-based therapy. This is the +case only in those patients who began their PI-based highly active antiretroviral therapy (HAART) without prior +mono- or dual-NRTI therapy. Second, the lipid abnormalities commonly seen in PI-treated patients generally +improve. Third, tolerability and, where studied, quality of life improves. Fourth, medication adherence improves. +In general, to the extent that this has been studied, body composition changes have not improved, however. Pulvirenti and colleagues[1] reported findings from COL30305, an American +trial of abacavir substitution. A total of 87 patients were randomly assigned (in a 2:1 ratio) either to switch +from their PI to abacavir or to remain on their PI. Like most similar trials, this study demonstrated that the +strategy was successful. Using an intention-to-treat analysis in which missing data were equal to failure, a +similar number of patients in each arm had plasma HIV-1 RNA levels < 400 and < 50 copies/mL at week 24. Increases inCD4+ cell count during the 24 weeks of analysis favored the PI group, but the difference did not reach +statistical significance. Adherence, measured using a validated, self-report questionnaire, favored the +simplified abacavir group. The mean triglyceride and total cholesterol levels improved from baseline in both groups, but to +a greater extent in the patients who switched to abacavir. Unless they use a novel design, no further switch studies appear to be +necessary. The accumulated weight of evidence from European and American studies suggests that a switch to a +simplified regimen, replacing a PI with abacavir, efavirenz, or nevirapine, is successful. Equally clear is that +this switch strategy should not be used in those patients whose antiretroviral regimen included NRTI agents before +their PI-based HAART. Tolerability, adherence, and quality of life can be expected to improve, while dysmorphic+changes are unlikely to show significant change. Reference 1. Pulvirenti J, Goodwin D, Slater L, et al. Simplification of protease +inhibitor (PI)-containing HAART regimens with abacavir (ABC) maintains viral suppression and favorable adherence in +HIV-1 infected adults (COLA 30305). Program and abstracts of the 39th Annual Meeting of the Infectious +Diseases Society of America; October 25-28, 2001; San Francisco, California. Abstract 689. Mbeki misinformed on AIDS drugs, says expert (copied from Business Day) -------------------------------------------------------------------------------- Washington Correspondent US GUIDELINES for treating HIV/AIDS do not support President Thabo Mbeki's decision to deny antiretroviral drugs to SA patients in the public health system, the co-chairman of the committee which drew up the guidelines for the US health department has said. Dr John Bartlett who with Dr Anthony Fauci of the National Institutes of Health heads the panel of experts responsible for the recommendations Mbeki has cited in defence of government's stance on antiretroviral drugs wrote: "I expect that this decision reflects either misinformation or a bias that has no scientific foundation". Bartlett, head of the infectious disease division of John Hopkins university medical school in Baltimore, was responding by e-mail to a request for comment on Mbeki's defence of his AIDS policy in Parliament last month. A spokesman for Fauci referred Business Day to Bartlett for reaction to Mbeki's +use of the guidelines. Mbeki said government's denial of antiretrovirals to+patients who cannot obtain them privately was supported by the gu idelines, specifically "where they have said these drugs are as dangerous to +health as the things they are supposed to treat". The US health department "strongly advocates antiretroviral drugs for patients +who qualify by the criteria that are stated in the guidelines," Bartlett wrote. Qualifying candidates are identified in the guidelines as "all patients with +acute HIV syndrome, those within six months of HIV seroconversion, and all +patients with symptoms ascribed to HIV infection." Asymptomatic patie nts should also receive antiretrovirals if their immune cell counts fall below a+certain level, the guidelines state. "This has been a miracle form of therapy that has resulted in a 60% to 80% +reduction in AIDS-related deaths, hospitalisations, and other complications +related to HIV," Bartlett wrote. "These drugs, like all drugs, have si de effects that need to be dealt with. The good outweighs the bad and it's not +close. I don't know of any respected physician who would deter the use of these+drugs in patients with AIDS because of side effects."Bartlett said that while he would not feel comfortable speaking for the entire panel without its specific approval, "it would be very safe to say that the panel strongly believes in the benefits of antiretroviral therapy".