Scaling Up Treatment for the Global AIDS Pandemic Challenges and Opportunities (2005) / Chapter Skim
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4 Principles of Scale-Up
4 Principles of Scale-Up
Pages 89-133
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From page 89... ...
Before this can happen, however, the stigma and discrimination that can hamper efforts to curb the global HIV/AIDS pandemic must be addressed. To initiate the scale-up process, countries will have to identify those needing treatment, as well as the various possible points of entry into treatment programs.
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From page 90... ...
By providing hope to people living with HIV/AIDS, the widespread availability of ART may reduce the stigma associated with seeking testing and treatment. Unfortunately, the literature documenting effective methods for reducing the stigma associated with HIV/AIDS in resource-poor settings needs to
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From page 91... ...
Governmental and community leaders at all lev els of civic life should spearhead an effort to create a culture of open ness and support in order to eliminate stigma and ensure the successful continuance of antiretroviral treatment and HIV prevention programs. IDENTIFYING POINTS OF ENTRY Identifying persons in immediate need of treatment provides one challenge for the efficient and effective scale-up of ART.
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From page 92... ...
At the same time, the challenges of beginning care and treatment for those in the latest stages of disease include reconstituting a highly suppressed immune system and the necessity of treating opportunistic infections, such as TB. For these and other reasons, mortality may be higher for patients entering care at later disease stages, as was the case for patients enrolled in treatment programs in Haiti (Fitzgerald, 2004)
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From page 93... ...
Mother-to-Child Transmission Prevention Programs Pregnancy can provide an opportune point of entry for women who might not otherwise seek health care for themselves. In addition, antenatal clinics are used to collect data for HIV prevalence estimates (UNAIDS, 2003a)
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From page 94... ...
The guidelines provide a framework that can be used to standardize and simplify treatment for this complex disease and encompasses the point at which to start therapy; first- and second-line combination regimens; considerations involved in treating subgroups of patients, such as those coinfected with TB, pregnant women, and children; means of monitoring therapy; and indicators for changing regimens. As noted earlier, these recommendations are based on scientific and clinical experience and evidence, drug availability and cost, the requirement to refrigerate some ARVs, the need for and availability of laboratory monitoring, drug toxicity profiles, and the risk of drug interactions.
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From page 95... ...
Relevant training in longitudinal medical record keeping and changes in patient flow through the clinic should be considered, where needed, to facilitate this process. The remainder of this section reviews in turn considerations involved in using the laboratory to diagnose, initiate, and monitor ART; selecting a treatment regimen; treating dual epidemics of HIV and TB; treating women; treating pregnant women; treating children; and addressing the role of nutrition in HIV/AIDS and its treatment.
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From page 96... ...
When laboratory tests such as CD4 T cell count and viral load are not available, the WHO guidelines recommend the use of clinical criteria for symptomatic appraisals to ensure that therapy can be monitored in settings without sophisticated laboratory capacity or personnel. Finally, because of potential side effects and toxicities of ARVs -- and the progression of HIV infection -- additional baseline laboratory tests obtained in less resource-constrained countries include determinations of red blood cell count, renal function, liver enzymes and function, and lipid status (U.S.
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From page 97... ...
Because of these concerns and limited formal evaluation, WHO has recommended that both methods be evaluated in a multicenter study before being officially recommended to laboratories in the developing world. As noted, TLC has been suggested as a surrogate for CD4 T cell count; indeed, it is recommended by WHO.
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From page 98... ...
ii) For persons with WHO Stage III disease, therapy should begin with consideration of using CD4 cell count < 350 /mm3.
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From page 99... ...
To better facilitate the diagnosis and treatment of HIV infection in infants less than 18 months of age, the laboratory networks should put in place a capacity for the direct detection of HIV, such as HIV DNA, HIV RNA, or HIV p24 antigen. Clinical criteria for monitoring treatment progress have been used in developing countries.
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From page 100... ...
100 of of zidovudine. Settings because marrow because marrow = Laboratory Monitoring Requirements No Yes, ZDV-associated bone suppression No Yes, ZDV-associated bone suppression ZDV FDC)
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From page 101... ...
At the same time, FDCs pose several challenges: · Allergies to one or more components · Different pharmokinetic or pharmodynamic profiles · Dose titration SOURCES: MSF Briefing Note, 2004; WHO, 2003b. Cochrane review of randomized controlled trials comparing the effects of three- or four-drug ARV regimens versus two-drug regimens, the latter were associated with higher levels of failure of viral suppression and resistance (Rutherford et al., 2004)
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From page 102... ...
With advanced immune compromise, such as when a person has AIDS (CD4 cell count < 200 /mm3) , extrapulmonary or disseminated disease is more likely.
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From page 103... ...
and Section VIII C.) Directly observed therapy for TB has been shown to be effective in both the developed and developing worlds and may be considered, when feasible, for im proving adherence and treatment outcomes.
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From page 104... ...
104 2000. in country by virus immunodeficiency human to attributable cases tuberculosis adult of 2003.
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From page 105... ...
The immune deficiency created by HIV infection increases the risk of developing active TB, while TB increases the mortality of those with HIV (Havlir and Barnes, 1999)
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From page 106... ...
WHO has suggested initial guidelines but recognizes that data are limited on which to base specific treatment recommendations for this special population. In cases in which HIV disease stage cannot be determined by CD4 T cell count, WHO recommends ART for all HIV-positive patients with TB.
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From page 107... ...
Overcrowded, poorly ventilated clinics that bring together large numbers of HIV-infected persons, some with active TB, will be a recipe for disaster. As important as TB is among the opportunistic infections in HIV/AIDS patients, it is only one of several for which an intervention may be beneficial.
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From page 108... ...
. A recent study in South Africa also found that women in controlling or violent relationships were at higher risk of contracting HIV infection (Dunkle et al., 2004)
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From page 109... ...
. European countries have reported similar successes (European Collaborative Study, 2001; The Italian Register for Human Immunodeficiency Virus Infection in Children, 2002)
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From page 110... ...
Results from the South African Intrapartum Nevirapine Trial demonstrated the similar efficacy and safety of two intrapartum/postpartum prevention regimens in breastfeeding women: multiple-dose zidovudine/lamivudine and single-dose nevirapine (Moodley et al., 2003)
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From page 111... ...
. In the South African Intrapartum Nevirapine Trial, which included both formula-fed and breastfed infants, all of whom received effective prophylaxis against intrapartum HIV transmission, breastfeeding was identified as the most significant risk factor for MTCT.
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From page 112... ...
. Recent data show that women with advanced HIV disease (i.e., with higher viral loads in their breastmilk)
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From page 113... ...
, a belief that therapy in children may not be effective, and a lack of pediatricians and social workers specializing in the care and treatment of this population. Despite these potential limitations, pediatric ART programs in Romania and Botswana have demonstrated success in treating HIV/AIDS (Baylor International Pediatric AIDS Initiative, 2004)
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From page 114... ...
Many of the complications of HIV infection and the associated opportunistic infections can result in micro- and macronutrient deficiencies and weight loss (Nerad et al., 2003; Kotler, 2000)
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From page 115... ...
It is clear that many people living with HIV/AIDS in the developing world lack access to sufficient quantity and quality of nutritious foods. In a May 2003 report entitled Nutrient Requirements for People Living with HIV/AIDS, WHO recognizes the limited research done in this area -- specifically in resource-constrained settings -- and poses research questions viewed as crucial for gaining a better understanding in this area (WHO, 2003d; see also Chapter 6)
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From page 116... ...
Indicative of the challenge is that investigators have pursued multiple approaches to ascertain different aspects of compliance, including the following: · Percentage of doses taken -- total doses taken/number of prescribed doses · Proportion of days correct doses taken -- number of days correct doses were taken/number of days of follow-up · Mean doses per day -- number of doses taken/number of days cap was opened · Mean interdose interval -- sum of all intervals between doses/number of doses taken · Drug holidays -- count of intervals that were more than 3 days · Proportion of days with no doses taken -- number of days with no recorded dose/number of days of follow-up · Dose difference -- mean difference between the time each dose was taken and the "correct time" as projected from the first dose · Proportion of doses in dosing periods -- two periods defined around the prescribed interval (either 4-hour or ±25 percent interval length) The problem of poor adherence, however measured, to prescribed, selfadministered medications generally is well documented, particularly for chronic and asymptomatic conditions (WHO, 2003e)
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From page 117... ...
study, nearly 33 percent of patients reported having missed a medication dose in the past 5 days, and 18 percent had missed doses weekly over the past 3 months; the frequency of missed doses correlated with detectable viral loads (Catz et al., 2000)
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From page 118... ...
. It is possible, however, that these successful outcomes are not attributable solely to the program, but may be due in part to intensive community support for these people living with HIV/AIDS (Liechty and Bangsberg, 2003)
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From page 119... ...
PRINCIPLES OF SCALE-UP 119 BOX 4-4 At a Glance: Factors That May Affect Adherence to Medical Therapy Patient variables · Education level · Economic situation · Mental health (e.g., depression) · Substance abuse · Fear of stigma and discrimination Treatment regimen · Continuous supply of medications · Cost burden to patient · Number of pills · Number of times during the day that therapy is required · Side effects · Toxicity · Food restrictions or requirements Disease characteristics · Degree of symptoms · Illness severity Patientprovider relationship · Patient's perception of provider's competence · Trust · Open communication · Willingness to include patient in treatment decisions · Common language shared between patient and provider Clinical setting · Clinic distance from home · Access to transportation · Access to child care · Convenience in scheduling appointments · Assurance of confidentiality · Participation in a clinical trial · Involvement of community support, such as other people living with HIV/AIDS SOURCES: Ickovics and Meade, 2002; Laniece et al., 2003; Orrell et al., 2003; Weiser et al., 2003.
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From page 120... ...
This has the clinical benefit of preventing a patient from using only mono or dual therapy, which, as noted previously, has been shown to cause treatment failure and drug resistance. In a meta-analysis of 23 clinical trials involving 31 independent treatment groups, higher pill burden was associated with fewer patients with plasma HIV RNA levels 50 copies/ml at 48 weeks (p < 0.01)
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From page 121... ...
Prevention initiatives should focus on those at risk for acquiring or transmitting HIV infection, in addition to those receiv ing treatment. To be optimally successful, voluntary counseling and testing programs and programs to prevent mother-to-child transmis sion should encompass both preventive and therapeutic dimensions.
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From page 122... ...
screening for HIV transmission risk behaviors, for sexually transmitted diseases (whose presence is often an indication of potential risk for acquiring HIV) , and for pregnancy; (2)
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From page 123... ...
. While treatment for HIV/AIDS could positively impact the prevention of new cases by decreasing viral load and reducing the infectiousness of those already afflicted with the disease, past experience with the introduction of treatment in the developed world has highlighted the potential for an increase in behaviors linked to HIV/AIDS transmission (Blower and Farmer, 2003; Blower et al., 2000, 2001)
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From page 124... ...
Palliative care of terminal AIDS patients often centers on pain management. A Ugandan study found that more than half of terminally ill patients cited pain as their chief problem (Kikule, 2003)
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From page 125... ...
This may be due to many reasons, or barriers, involving pain relief being a low healthcare priority in cancer and AIDS, lack of infrastructure to deliver medical care and pain relief, lack of medical demand (prescriptions) for opioids, inadequate education of physicians, general misunderstanding and fear of morphine, and lack of governmental action.
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From page 126... ...
The principal objectives are as follows (WHO, 2004b) : · To develop/reinforce palliative care programs with a public health approach in response to the needs and gaps identified, considering: -- A holistic approach to palliative care, giving special emphasis to pain relief.
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From page 127... ...
or vis ceral · Progressive multifocal leucoencephalopathy · Any disseminated endemic mycosis · Candidiasis of esophagus, trachea, bronchi · Atypical mycobacterioris, disseminated or lungs · Nontyphoid salmonella septicemia · Extrapulmonary tuberculosis · Lymphoma · Kaposi's sarcoma · HIV encephalopathy And/or performance scale 4: bedridden > 50% of the day during the last month 1Appendix B WHO Staging System for HIV Infection and Disease in Adults and Adolescents.
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From page 128... ...
2003a. Predicting the impact of antiretrovirals in resource poor settings: Preventing HIV infections whilst controlling drug resistance.
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From page 129... ...
2001. Community-based treatment of advanced HIV disease: Introducing DOT-HAART (directly observed therapy with highly active antiretroviral therapy)
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From page 130... ...
1999. Tuberculosis in patients with human immunodeficiency virus infec tion.
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From page 131... ...
2003. General nutrition management in patients infected with human immunodeficiency virus.
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From page 132... ...
2000. Viral load and heterosexual transmission of human immunodeficiency virus type 1.
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From page 133... ...
2004b. A Community Health Approach to Palliative Care for HIV and Cancer Patients in Africa.
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