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New research finds no evidence of increased risk of all-cause and non-AIDS death with long-term ARV use
An important study has been published in AIDS that provides further evidence debunking one of the main claims of AIDS denialists, namely that ARVs do more harm than good (or even cause AIDS).
AIDS. 2012 Jan 28;26(3):315-323.
Long-term exposure to combination antiretroviral therapy and risk of death from specific causes: no evidence for any previously unidentified increased risk due to antiretroviral therapy.
Kowalska JD, Reekie J, Mocroft A, Reiss P, Ledergerber B, Gatell J, d'Arminio Monforte A, Phillips A, Lundgren JD, Kirk O; for the EuroSIDA study group.
Despite the known substantial benefits of combination antiretroviral therapy (cART), cumulative adverse effects could still limit the overall long-term treatment benefit. Therefore we investigated changes in the rate of death with increasing exposure to cART.
A total of 12 069 patients were followed from baseline, which was defined as the time of starting cART or enrolment into EuroSIDA whichever occurred later, until death or 6 months after last follow-up visit. Incidence rates of death were calculated per 1000 person-years of follow-up (PYFU) and stratified by time of exposure to cART (≥3 antiretrovirals): less than 2, 2-3.99, 4-5.99, 6-7.99 and more than 8 years. Duration of cART exposure was the cumulative time actually receiving cART. Read more »
South African study provides additional evidence that AIDS conspiracy theories are associated with risky sex
A study by two AIDSTruth contributors, Nicoli Nattrass and Eduard Grebe, has shown that belief in AIDS origin conspiracy theories like those promoted by AIDS denialists are associated with lower rates of condom usage among young adults. In addition, the study showed that young adults who trusted the denialist South African health minister (Manto Tshabalala-Msimang) more than her non-denialist successor were substantially more likely to believe conspiracy theories, while those who were not familiar with the denialiam-fighting activist group the Treatment Action Campaign were more likely to believe conspiracy theories and less likely to use a condom than those who were. This study adds to the evidence that state-supported denialism likely resulted (and continue to result) in unnecessary HIV infections in South Africa. Readers without subscriptions can access a preprint of the article. AIDS Behav. 2011 May 3. [Epub ahead of print]
AIDS Conspiracy Beliefs and Unsafe Sex in Cape Town
Grebe E, Nattrass N. Read more »
Mortality by baseline CD4 cell count among HIV patients initiating antiretroviral therapy: evidence from a large cohort in Uganda
Mills EJ, Bakanda C, Birungi J, Mwesigwa R, Chan K, Ford N, Hogg RS, Cooper C.
aFaculty of Health Sciences, University of Ottawa, Ottawa, Canada bThe AIDS Support Organization (TASO), Headquarters, Kampala, Uganda cBritish Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada dMédecins Sans Frontiers (MSF), Geneva, Switzerland eDivision of Infectious Diseases, The Ottawa Hospital, Ottawa, Canada.
OBJECTIVE: Evaluations of CD4 cell count and other prognostic factors on the survival of HIV patients in sub-Saharan are extremely limited. Funders have been reticent to recommend earlier initiation of treatment. We aimed to examine the effect of baseline CD4 cell count on mortality using data from HIV patients receiving combination antiretroviral therapy (cART) in Uganda.
DESIGN: Observational study of patients age ≥14 years) enrolled in 10 clinics across Uganda for which TASO has data.
METHODS: CD4 cell count was stratified into categories (<50, 50-99, 100-149, 150-199, 200-249, 250-299, ≥300 cells/mm) and Cox proportional hazards regression was used to model the associations between CD4 cell count and mortality. Read more »
Denialists frequently cite the well-known phenomenon of some individuals with HIV living healthily for long periods without treatment as evidence that HIV does not cause AIDS. However, the existence of these rare individuals do not in fact disprove the science on HIV/AIDS. We debunked that myth here. Also, despite denialist claims to the contrary, research on how these individuals' immune systems control HIV for longer than usual has in fact been a priority and several studies have shed light on the mechanisms involved. A new study has now found slight differences in five amino acids in the HLA-B protein between long-term non-progressors and people who do not control HIV for longer than normal.
You can read a Reuters report on the study here.
New England Journal of Medicine 363(3) July 15, 2010
Early versus Standard Antiretroviral Therapy for HIV-Infected Adults in Haiti
Patrice Severe et al.
For adults with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts that are greater than 200 and less than 350 per cubic millimeter and who live in areas with limited resources, the optimal time to initiate antiretroviral therapy remains uncertain.
We conducted a randomized, open-label trial of early initiation of antiretroviral therapy, as compared with the standard timing for initiation of therapy, among HIV-infected adults in Haiti who had a confirmed CD4+ T-cell count that was greater than 200 and less than 350 per cubic millimeter at baseline and no history of an acquired immunodeficiency syndrome (AIDS) illness. The primary study end point was survival. The early-treatment group began taking zidovudine, lamivudine, and efavirenz therapy within 2 weeks after enrollment. The standard-treatment group started the same regimen of antiretroviral therapy when their CD4+ T-cell count fell to 200 per cubic millimeter or less or when clinical AIDS developed. Participants in both groups underwent monthly follow-up assessments and received isoniazid and trimethoprim–sulfamethoxazole prophylaxis with nutritional support. Read more »
AIDS:15 May 2010 - Volume 24 - Issue 8 - p 1095–1105; doi: 10.1097/QAD.0b013e3283377a1e
HIV+ elite controllers have low HIV-specific T-cell activation yet maintain strong, polyfunctional T-cell responses
Owen, Rachel E; Heitman, John W; Hirschkorn, Dale F; Lanteri, Marion C; Biswas, Hope H; Martin, Jeffrey N; Krone, Melissa R; Deeks, Steven G; Norris, Philip J; the NIAID Center for HIV/AIDS Vaccine Immunology
Objective: HIV+ elite controllers are a unique group of rare individuals who maintain undetectable viral loads in the absence of antiretroviral therapy. We studied immune responses in these individuals to inform vaccine development, with the goal of identifying the immune correlates of protection from HIV.
Methods: We compared markers of cellular activation, HIV-specific immune responses and regulatory T (Treg) cell frequencies in four groups of individuals: HIV-negative healthy controls, elite controllers (HIV RNA level <75 copies/ml), individuals on HAART and individuals with HIV RNA level more than 10 000 copies/ml (noncontrollers). Read more »
Maternal mortality for 181 countries, 1980—2008: a systematic analysis of progress towards Millennium Development Goal 5
Maternal mortality remains a major challenge to health systems worldwide. Reliable information about the rates and trends in maternal mortality is essential for resource mobilisation, and for planning and assessment of progress towards Millennium Development Goal 5 (MDG 5), the target for which is a 75% reduction in the maternal mortality ratio (MMR) from 1990 to 2015. We assessed levels and trends in maternal mortality for 181 countries.
We constructed a database of 2651 observations of maternal mortality for 181 countries for 1980—2008, from vital registration data, censuses, surveys, and verbal autopsy studies. We used robust analytical methods to generate estimates of maternal deaths and the MMR for each year between 1980 and 2008. We explored the sensitivity of our data to model specification and show the out-of-sample predictive validity of our methods.
We estimated that there were 342 900 (uncertainty interval 302 100—394 300) maternal deaths worldwide in 2008, down from 526 300 (446 400—629 600) in 1980. The global MMR decreased from 422 (358—505) in 1980 to 320 (272—388) in 1990, and was 251 (221—289) per 100 000 livebirths in 2008. The yearly rate of decline of the global MMR since 1990 was 1·3% (1·0—1·5). During 1990—2008, rates of yearly decline in the MMR varied between countries, from 8·8% (8·7—14·1) in the Maldives to an increase of 5·5% (5·2—5·6) in Zimbabwe. More than 50% of all maternal deaths were in only six countries in 2008 (India, Nigeria, Pakistan, Afghanistan, Ethiopia, and the Democratic Republic of the Congo). In the absence of HIV, there would have been 281 500 (243 900—327 900) maternal deaths worldwide in 2008.
Substantial, albeit varied, progress has been made towards MDG 5. Although only 23 countries are on track to achieve a 75% decrease in MMR by 2015, countries such as Egypt, China, Ecuador, and Bolivia have been achieving accelerated progress.
Bill & Melinda Gates Foundation.
DART results show majority of HAART benefits can be achieved even without routine laboratory monitoring
The results from the DART trial, reported this week in The Lancet, provide important evidence for HAART programmes in resource-constrained settings. From commentary by Phillips & Oosterhout published alongside the results:
In much of sub-Saharan Africa, the scale-up of use of antiretroviral therapy has been so far achieved without routine laboratory monitoring of drug toxicity and efficacy. Until now, there has not been substantive evidence about the consequences of delivering antiretrovirals without such routine monitoring.
In The Lancet today, the DART Trial Team present the Development of AntiRetroviral Therapy in Africa (DART) trial. In DART at enrolment, all participants started triple-drug antiretroviral therapy and were randomised to clinically driven monitoring versus laboratory plus clinical monitoring for toxicity (haematology and biochemistry) and efficacy (CD4-cell counts). Over 5 years, the proportions who had one or more serious adverse events were almost identical, while there was a somewhat higher proportion in the group on clinically driven monitoring who had disease progression or death (28%, compared with 21% in the other group; hazard ratio 1·31, 95% CI 1·14—1·51). This benefit of laboratory plus clinical monitoring is probably due to the use of CD4 count rather than presence of clinical symptoms alone to decide on when to switch to a second-line regimen. This criterion for switching on the basis of CD4 count is just one of the CD4-count switch criteria recommended by WHO; the other criteria (on the basis of CD4-count change from baseline and from peak) are problematic to implement without a baseline CD4 count and frequent CD4 counts being available thereafter.
The other particularly striking result from DART is the 5-year survival in both groups: 87% for clinical monitoring and 90% for laboratory plus clinical monitoring. Such rates of survival are for people in whom the initial median CD4-cell count was 86 cells per μL. For comparison, the survival in the Entebbe cohort of untreated HIV-positive people in 5 years was below 10% (data presented in the DART report), which emphasises the huge clinical benefits of antiretroviral therapy. The DART Trial Team concluded from their results that antiretroviral therapy can be delivered safely with good-quality clinical care, which would allow treatment delivery to be decentralised, and that there is a role for CD4 testing from the second year on antiretrovirals to guide the switch to second-line therapy, which should encourage accelerated development of simpler and cheaper point-of-care CD4 tests. The DART investigators should be complimented for exceptional achievement by completing this important trial with such a low loss to follow-up (7%) in challenging circumstances, which shows that excellent trials can be done in Africa.
The results from DART are very important for antiretroviral programmes, no matter what their current level of routine laboratory monitoring. Programmes that currently deliver antiretrovirals without any laboratory monitoring can be reassured that the vast majority (but not all) of the potential survival benefit of such therapy can be realised with the use of such a simple approach (albeit with particularly intensive and high-quality clinical monitoring, which is a substantial challenge to achieve in routine settings throughout sub-Saharan Africa). Similarly, no antiretroviral programme should enhance laboratory monitoring at the expense of putting more people in need on these drugs. Those clinics that do use routine measurement of biochemistry and haematology can reduce their laboratory costs to enable spending on other aspects of the programme (which has already started in some programmes). Programmes that monitor people on antiretrovirals with CD4 counts should consider adopting the switch criterion used in DART of CD4 count below 100 cells per μL (ie, only this one of the WHO-recommended criteria, rather than all three), and apply this criterion to people who have been on therapy for at least 2 years. Such a delay should help to reduce the number of people in whom a switch is made when viral load is actually suppressed.
Details on the main paper below: Read more »
Also see the comment piece Still Crazy After All These Years (open access) by Nicoli Nattrass that appears in the same issue of AIDS & Behavior.
Update (22/01/2010): See AIDS Denialism Under Fire From Researchers by Nora Proops in The AIDS Beacon.
AIDS & Behavior. 2010 Jan 8. [Epub ahead of print]
AIDS Denialism and Public Health Practice
Chigwedere P, Essex M.
In this paper, we respond to AIDS denialist arguments that HIV does not cause AIDS, that antiretroviral drugs are not useful, and that there is no evidence of large-scale deaths from AIDS, and discuss the key implications of the relationship between AIDS denialism and public health practice. We provide a brief history of how the cause of AIDS was investigated, of how HIV fulfills Koch's postulates and Sir Bradford Hill's criteria for causation, and of the inconsistencies in alternatives offered by denialists. We highlight clinical trials as the standard for assessing efficacy of drugs, rather than anecdotal cases or discussions of mechanism of action, and show the unanimous data demonstrating antiretroviral drug efficacy. We then show how statistics on mortality and indices such as crude death rate, life expectancy, child mortality, and population growth are consistent with the high mortality from AIDS, and expose the weakness of statistics from death notification, quoted by denialists. Last we emphasize that when denialism influences public health practice as in South Africa, the consequences are disastrous. We argue for accountability for the loss of hundreds of thousands of lives, the need to reform public health practice to include standards and accountability, and the particular need for honesty and peer review in situations that impact public health policy.
Read the full article on SpringerLink (open access)
Declines in Mortality Rates and Changes in Causes of Death in HIV-1-Infected Children During the HAART Era
J Acquir Immune Defic Syndr. 2010 Jan;53(1):86-94.
Brady MT, Oleske JM, Williams PL, Elgie C, Mofenson LM, Dankner WM, Van Dyke RB; for the Pediatric AIDS Clinical Trials Group219/219C Team.
CONTEXT: Introduction of highly active antiretroviral therapy has significantly decreased mortality in HIV-1-infected adults and children. Although an increase in non-HIV-related mortality has been noted in adults, data in children are limited.
OBJECTIVES:: To evaluate changes in causes and risk factors for death among HIV-1-infected children in Pediatric AIDS Clinical Trials Group 219/219C.
DESIGN, SETTING, AND PARTICIPANTS:: Multicenter, prospective cohort study designed to evaluate long-term outcomes in HIV-1-exposed and infected US children. There were 3553 HIV-1-infected children enrolled and followed up between April 1993 and December 2006, with primary cause of mortality identified in the 298 observed deaths.
MAIN OUTCOME MEASURES:: Mortality rates per 100 child-years overall and by demographic factors; survival estimates by birth cohort; and hazard ratios for mortality by various demographic, health, and antiretroviral treatment factors were determined.
RESULTS:: Among 3553 HIV-1-infected children followed up for a median of 5.3 years, 298 deaths occurred. Death rates significantly decreased between 1994 and 2000, from 7.2 to 0.8 per 100 person-years, and remained relatively stable through 2006. After adjustment for other covariates, increased risk of death was identified for those with low CD4 and AIDS-defining illness at entry. Decreased risks of mortality were identified for later birth cohorts, and for time-dependent initiation of highly active antiretroviral therapy (hazard ratio 0.54, P < 0.001). The most common causes of death were "End-stage AIDS" (N = 48, 16%) and pneumonia (N = 41, 14%). The proportion of deaths due to opportunistic infections (OIs) declined from 37% in 1994-1996 to 24% after 2000. All OI mortality declined during the study period. However, a greater decline was noted for deaths due to Mycobacterium avium complex and cryptosporidium. Deaths from "End-stage AIDS," sepsis and renal failure increased.
CONCLUSIONS:: Overall death rates declined from 1993 to 2000 but have since stabilized at rates about 30 times higher than for the general US pediatric population. Deaths due to OIs have declined, but non-AIDS-defining infections and multiorgan failure remain major causes of mortality in HIV-1-infected children.
Science 11 December 2009: Vol. 326. no. 5959, pp. 1476 - 1477
Dozens of studies have been examining people who fend off HIV despite repeated exposures in an effort to find genetic or immunologic factors that can help guide AIDS vaccine research. But all too often the leads point in contradictory directions, in part because investigators use different assays to probe their samples, and there is little coordination among them. Many labs also use wildly varying criteria to decide who qualifies as HIV-resistant, making it difficult to sort out which study subjects were truly exposed and uninfected, were exposed and have an occult infection, or were never exposed in the first place. At the first-ever meeting on natural immunity to HIV, held from 15 to 17 November, researchers attempted to hammer out these and other issues.
AIDS. 2010 Jan 2;24(1):123-37.
OBJECTIVE: To estimate the effect of combined antiretroviral therapy (cART) on mortality among HIV-infected individuals after appropriate adjustment for time-varying confounding by indication. DESIGN: A collaboration of 12 prospective cohort studies from Europe and the United States (the HIV-CAUSAL Collaboration) that includes 62 760 HIV-infected, therapy-naive individuals followed for an average of 3.3 years. Inverse probability weighting of marginal structural models was used to adjust for measured confounding by indication. RESULTS: Two thousand and thirty-nine individuals died during the follow-up. The mortality hazard ratio was 0.48 (95% confidence interval 0.41-0.57) for cART initiation versus no initiation. In analyses stratified by CD4 cell count at baseline, the corresponding hazard ratios were 0.29 (0.22-0.37) for less than 100 cells/microl, 0.33 (0.25-0.44) for 100 to less than 200 cells/microl, 0.38 (0.28-0.52) for 200 to less than 350 cells/microl, 0.55 (0.41-0.74) for 350 to less than 500 cells/microl, and 0.77 (0.58-1.01) for 500 cells/microl or more. The estimated hazard ratio varied with years since initiation of cART from 0.57 (0.49-0.67) for less than 1 year since initiation to 0.21 (0.14-0.31) for 5 years or more (P value for trend <0.001). CONCLUSION: We estimated that cART halved the average mortality rate in HIV-infected individuals. The mortality reduction was greater in those with worse prognosis at the start of follow-up.
Survival of Children with HIV in the United States Has Improved Dramatically Since 1990s, New Analysis Shows
Mortality Rate Still Higher Than for Children without HIV
The death rates of children with HIV have decreased ninefold since doctors started prescribing cocktails of antiretroviral drugs in the mid-1990s, concludes a large-scale study of the long-term outcomes of children and adolescents with HIV in the United States. In spite of this improvement, however, young people with HIV continue to die at 30 times the rate of youth of similar age who do not have HIV, found researchers from the National Institutes of Health and other institutions.
Earlier studies have shown that adults with HIV are living longer because of improved multi-drug antiretroviral regimens known as highly active antiretroviral therapy (HAART). However, limited information has existed about the effectiveness of HAART in improving the survival of children with HIV. The current analysis, published in the Dec. 15 issue of the Journal of Acquired Immune Deficiency Syndromes, delineates the effects of HAART on the rates and causes of death for HIV-infected children and adolescents. Read more »
Six-month gain in weight, height, and CD4 predict subsequent antiretroviral treatment responses in HIV-infected South African children
AIDS. 2010 Jan 2;24(1):139-46.
Yotebieng M, Van Rie A, Moultrie H, Meyers T.
OBJECTIVES: Construct percentile curves for 6-month gain in weight, height, CD4 cell count, and CD4 percentage (CD4%) in children initiating ART, and to assess the association between lower percentiles and subsequent ART responses. DESIGN: Cohort of 1394 HIV-infected children initiating ART between April 2004 and March 2008, Johannesburg, South Africa METHODS: The generalized additive model for location, scale, and shape was used to construct percentile curves for 6-month gain in weight, height, CD4 cell count, and CD4%. Cox proportional models were used to assess the association between lower percentiles of each distribution and death, virological suppression, and treatment failure between 6 to 36 months post-ART initiation. RESULTS: Lower percentiles for gain in weight, CD4, and CD4% count after 6 months of ART, but not height, were associated with poor subsequent treatment outcomes independent of baseline characteristics, with increasing strength of association as percentiles decreased. Age-specific 6-month post-ART weight gain in our cohort was substantially higher compared with 6-month weight gain in non-HIV-infected American children of the Fels Institute cohort and the attained weight-for-age at 6 months post-ART plotted on WHO weight-for-age growth charts were not associated with subsequent treatment outcomes. CONCLUSION: Gain in CD4% in the first 6 months of ART was the best predictor of poor subsequent ART outcomes. In areas with limited access to CD4%, weight gain post-ART using our newly developed reference distributions for HIV-infected children on ART is a good alternative to CD4%, and clearly superior to the commonly used 'Road-to-Health' weight-for-age charts.
A new study has found poorer adherence to antiretroviral therapy among African-American men with HIV who hold conspiracy beliefs, e.g. that HIV is a man-made virus designed to kill Africans.
JAIDS. 2009 Dec 09.
Conspiracy Beliefs About HIV Are Related to Antiretroviral Treatment Nonadherence Among African American Men With HIV
Bogart, Laura M PhD; Wagner, Glenn PhD; Galvan, Frank H PhD; Banks, Denedria MSW
Background: Medical mistrust is prevalent among African Americans and may influence health care behaviors such as treatment adherence. We examined whether a specific form of medical mistrust-HIV conspiracy beliefs (eg, HIV is genocide against African Americans)-was associated with antiretroviral treatment nonadherence among African American men with HIV.
Methods: On baseline surveys, 214 African American men with HIV reported their agreement with 9 conspiracy beliefs, sociodemographic characteristics, depression symptoms, substance use, disease characteristics, medical mistrust, and health care barriers. Antiretroviral medication adherence was monitored electronically for one month postbaseline among 177 men in the baseline sample. Read more »
AIDS. 2010 Jan 2;24(1):123-37.
The effect of combined antiretroviral therapy on the overall mortality of HIV-infected individuals
The HIV-CAUSAL Collaboration
Objective: To estimate the effect of combined antiretroviral therapy (cART) on mortality among HIV-infected individuals after appropriate adjustment for time-varying confounding by indication.
Design: A collaboration of 12 prospective cohort studies from Europe and the United States (the HIV-CAUSAL Collaboration) that includes 62 760 HIV-infected, therapy-naive individuals followed for an average of 3.3 years. Inverse probability weighting of marginal structural models was used to adjust for measured confounding by indication. Read more »
AIDSTruth contributor Nicoli Nattrass writes in AIDS and Behavior:
In his new book, Denying AIDS, Seth Kalichman observes that people are surprised by the persistence of AIDS denialists: “Are they still around?”[1, p. 1] he is often asked. And it is a good question. Given the large body of scientific and clinical evidence on HIV disease and treatment (expertly summarized by Chigwedere and Essex in this issue of AIDS and Behavior) it is indeed strange that Peter Duesberg and his followers still claim HIV is harmless and that antiretrovirals cause rather than treat AIDS. While such dissident views were intellectually respectable in the 1980s when HIV science was new, they make little sense today. Thus Joseph Sonnabend, a doctor who treated some of the earliest AIDS cases in New York and was well known for arguing that environmental factors may be more important than a virus in driving AIDS, was quick to change his mind once antiretroviral treatment was shown to act against HIV and transform the health of his patients [2, p. 25]. Peter Duesberg, by contrast, refused to accept the evidence, thereby earning the label ‘denialist’ rather than ‘dissident’ [1, 2].
We endorse this call for mandatory disclosure.
Mandatory Disclosure of Pharmaceutical Industry-Funded Events for Health Professionals
Robertson J, Moynihan R, Walkom E, Bero L, Henry D (2009) PLoS Med 6(11): e1000128. doi:10.1371/journal.pmed.1000128
- There are moves internationally to ensure greater disclosure of gifts and educational events for doctors paid for by pharmaceutical manufacturers. However, there is no agreement on appropriate standards of disclosure. In Australia, since mid-2007, there has been mandatory reporting of details of every industry-sponsored event, including the costs of any hospitality provided.
- Examination of the Australian data shows that although expenditure at individual events is often modest, cumulative expenditure is high, particularly in the case of medical specialists prescribing high cost drugs—oncologists, endocrinologists, and cardiologists.
- Although a significant advance, the new Australian reporting standards do not allow assessment of the educational value of sponsored events, and do not include details of speakers or educational content for most events. However, doctors in training are often present at these events.
- At present, the standards of disclosure are inadequate and should not be tied to an arbitrary monetary value of gifts or sponsorship. Reporting standards should require the names of the speakers presenting, whether sponsors played a role in suggestion or selection of speakers or the development of the content of presentations, and the nature of any direct or indirect financial ties between the speakers and the sponsors.
Michael Carter writes on aidsmap:
Results of US research “challenge the notion that nevirapine is uniquely associated with hepatotoxicity during pregnancy.” The study did however show that pregnancy itself increased the risk of liver toxicities in women with HIV. The research is published in the November 27th edition of AIDS.
AIDS. 2009 Nov 27;23(18):2425-30.
Increased risk of hepatotoxicity in HIV-infected pregnant women receiving antiretroviral therapy independent of nevirapine exposure.
Ouyang DW, Shapiro DE, Lu M, Brogly SB, French AL, Leighty RM, Thompson B, Tuomala RE, Hershow RC.
OBJECTIVE: To estimate whether the association between nevirapine (NVP) and hepatotoxicity differs according to pregnancy status in HIV-infected women. METHODS: The present analysis included HIV-infected pregnant women on antiretroviral therapy (ART) from two multicenter, prospective cohorts - the Women and Infants Transmission Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials protocol P1025 - and HIV-infected nonpregnant women from one multicenter, prospective cohort - the Women's Interagency HIV Study. Using multivariate Cox proportional hazards regression, the interaction between NVP and pregnancy status in terms of hepatotoxicity was investigated. NVP use was dichotomized as use or no use and was further categorized according to ART exposure history. We investigated two outcomes: any liver enzyme elevation (LEE; grade 1-4) and severe LEE (grade 3-4). RESULTS: Data on 2050 HIV-infected women taking ART were included: 1229 (60.0%) pregnant and 821 (40.0%) nonpregnant. Among the pregnant women, 174 (14.2%) developed any LEE and 15 (1.2%) developed severe LEE as compared with 75 (9.1%) and 5 (0.6%), respectively, of the nonpregnant women. In multivariate adjusted models, NVP was not significantly associated with risk of LEE, regardless of pregnancy status; however, pregnancy was associated with an increased risk of any LEE (relative risk 4.7, confidence interval = 3.4-6.5) and severe LEE (relative risk 3.8, confidence interval = 1.3-11.1). The association of pregnancy and LEE was seen, regardless of prior ART and NVP exposure history. CONCLUSION: No significant association between NVP and LEE was observed, regardless of pregnancy status, but pregnancy was significantly associated with increased hepatotoxocity in HIV-infected women.
What are the causes of AIDS denialism? What are the factors that lead to a loss of public confidence in medical science? Often on aidstruth.org we have focused on debunking the false propaganda of prominent AIDS denialists, but there are other very important causes of people with chronic illnesses choosing to forsake scientifically based medical advice. A crucial one is the often substandard quality of care people receive from their medical practitioners. In the United States, tens of millions of uninsured and under-insured people experience the health system as uncaring and unproviding. In South Africa, where AIDS denialism had its worst effects, a study by Jane Goudge and colleagues at the Centre for Health Policy on the University of Witwatersrand found that "Poor provider-patient interaction led to inadequate understanding of illness, inappropriate treatment action, 'healer shopping', and at times a break down in cooperation, with the patient 'giving up' on the public health system." Healer shopping, or perhaps more appropriately quack shopping, is a consequence of poor health services characterised by disrespectful behaviour from overworked health staff, long waiting lists, queues, and the unavailability of essential medicines and diagnostics. Read more »