Background As 2nd-line antiretroviral therapy (ART) availability raises in resource-limited settings questions about the value of laboratory monitoring remain. Results Compared with 1st-line ART only 2 ART increased life expectancy by 24% with medical monitoring only 46 with CD4 monitoring and 61% PSC-833 with HIV RNA monitoring. The incremental CE percentage of switching based on medical monitoring was $1 670 of existence gained (YLS) compared to 1st-line ART only; biannual CD4 monitoring was $2 120 The CE percentage of biannual HIV RNA screening ranged from $2 920 ($87/test) to $1 990 ($25/test). If 2nd-line ART costs were reduced the CE of HIV RNA monitoring improved. Conclusions In resource-limited settings CD4 count and HIV RNA monitoring to guide switching to 2nd-line ART improve survival and under most conditions are cost-effective. represents the effectiveness of current ART routine after virologic failure due to accumulated resistance from prior regimens; “after virologic failure in the absence of resistance from prior ART regimens; “represents the fractional reduction in the initial probability of success of routine represents the current ART regimen is an integer value beginning with 1 and continuing toward the maximum quantity of sequential lines of ART available. We presume that the resistance penalty does not impact CD4 response to subsequent regimens conditional upon virologic response. We also presume that the penalty applies only to the initial 24-week efficacy of a subsequent regimen and not to an individual’s probability of virologic failure at later time points. Derivation of the baseline value for the resistance penalty is demonstrated in the Data section. Patient-Level Monitoring of Clinical Immunologic and Virologic Status Patient-level HIV disease progression and treatment effectiveness are monitored through medical immunologic (via CD4 counts) and/or PSC-833 virologic (via HIV RNA checks) assessments. Clinical assessments happen upon access into care demonstration with any acute event and at 3-month intervals. CD4 and HIV RNA checks if available happen upon access into care and at 6-month intervals thereafter.4 Treatment-related decisions (i.e. starting switching or preventing ART regimens) are made based on info from medical assessments and if available CD4 counts and/or HIV RNA checks. Clinical and Cost Data Cohort Characteristics and Natural History Data were derived mainly from tests and cohort studies carried out in C?te d’Ivoire from the Programme PAC-CI. Initial distributions of age sex and CD4 count were Rabbit polyclonal to AGTRAP. derived from the ACONDA cohort an observational cohort of HIV-infected adults and a continuation of the ANRS 1203 Cotrame cohort study in Abidjan C?te d’Ivoire (Table 2).43 44 Incidence of opportunistic infections (a function of CD4 count) HIV-related mortality (a function of both CD4 count and history of opportunistic infection) and efficacy and toxicity of cotrimoxazole prophylaxis were estimated from ANRS 059 trial data as well as data from your ANRS PSC-833 1203 and 1220 study cohorts.23 24 45 Risk PSC-833 of non-HIV-related mortality was derived from country-specific life tables for C?te d’Ivoire.46 Table 2 Selected Model Variables Antiretroviral Therapy Performance of non-nucleoside reverse transcriptase inhibitor- (NNRTI-) based 1st-line ART was derived from a prospective cohort study of treatment-na?ve individuals in Abidjan.44 At 24 weeks 80.2% of individuals experienced HIV RNA suppression to ≤300 copies/mL and a median CD4 count increase of 127 cells/μL (IQR 64 201 We assumed that in the absence of resistance the effectiveness of protease inhibitor- (PI-) based 2nd-line ART was similar to that for 1st-line ART (at 24 weeks 77 suppressed to <400 copies/mL and a mean CD4 count increase of 186 cells/μL).47 Incidence of ART-related severe adverse events was 10.8 (95% CI: 5.4-12.0) per 100 person-years;48 these events led to a switch in drug of similar cost effectiveness and drug class. To derive the baseline value for the resistance penalty we used 3 pieces of info: PI-based ART effectiveness in the absence of resistance PI-based ART efficacy in the presence of resistance (i.e. thymidine analogue mutations resulting from failure of 1st-line nucleoside reverse transcriptase inhibitors) and time spent on virologically failed ART. For PI-based ART effectiveness in the absence of resistance 24 virologic suppression (<400 copies/mL) was 77.0%.47 In the presence of resistance 24 virologic suppression (<400 copies/mL) was 73.3% for individuals on a 2nd-line PI-based routine.49 For.