Guía de Terapia Antirretroviral en Adultos

Objectives

Bolivia’s clinical guidance for HIV care aims to reduce HIV-related illness, deaths and transmission through an integrated, universal, rights-based and intersectoral response, aligned with the Family and Community Intercultural Health policy framework and Sustainable Development Goal 3.3 on ending AIDS and other epidemics by 2030.[1][2]It combines prevention, diagnosis, treatment, infection control and improved quality of life for people living with HIV, including prevention of mother-to-child and sexual transmission.[1][3]

• Standardise HIV diagnosis, clinical assessment, classification and antiretroviral care across all three levels of care.[1][4][5]
• Increase diagnosis and expand antiretroviral treatment coverage through simplified diagnostic procedures and broader service availability.[6]
• Achieve sustained viral suppression, ideally below 40 HIV RNA copies per millilitre, restore and preserve immune function, reduce morbidity and mortality, and improve quality of life.[3][7]
• Initiate antiretroviral therapy for all people with confirmed HIV diagnosis, normally within one week, while accounting for clinical circumstances and readiness to adhere.[8]
• Use effective first-line combinations, principally two nucleoside or nucleotide reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor, while preserving protease inhibitors and other options for subsequent treatment lines.[9]
• Prevent avoidable transmission after occupational, non-occupational or sexual-violence exposure through timely post-exposure prophylaxis, testing, risk assessment and related preventive care.[10][11][12]
• Protect the effectiveness of available regimens by supporting adherence, detecting toxicity and treatment failure early, managing resistance, and using second-line or rescue regimens only when clinically supported.[13][14][15][10]

Implementation

The guidance uses a decentralised, multidisciplinary clinical delivery model linking people, families, communities and health services.[1]HIV care is to be extended to first- and second-level facilities, supported by specialised centres, laboratory testing, referral to higher-level hospitals for complex cases, and national technical oversight.[6][16][17]The Ministry of Health, through the National Programme for Sexually Transmitted Infections, HIV/AIDS and Viral Hepatitis, is central to medicine provision, guideline implementation and workforce training, with technical support from the National HIV/AIDS Therapeutic Medicines Committee and departmental pharmacotherapeutic committees.[6][18][19]

• Provide voluntary HIV testing with pre-test and post-test counselling and informed consent, subject to specified legal exceptions, using rapid tests, confirmatory enzyme-linked immunosorbent assay testing, and polymerase chain reaction testing for children under 18 months.[20][16]
• Repeat the full diagnostic algorithm with a new sample after one month when results are indeterminate, and complete medical history, examination, laboratory investigation and clinical-immunological classification after HIV is confirmed.[4][5]
• Base treatment selection on clinical stage, CD4 cell count, viral load, comorbidities, toxicity, drug interactions, previous treatment history, potential benefits and risks, and patient acceptance.[21][8]
• Deliver adherence counselling before treatment and throughout life, provide psychosocial support, involve peers, families or communities where appropriate, and reduce practical barriers such as pill burden.[13][18]
• Use fixed-dose, once-daily tenofovir, lamivudine and efavirenz as the preferred first-line regimen where clinically suitable; tailor alternatives for renal impairment, anaemia, hepatitis B co-infection, tuberculosis treatment, psychiatric conditions, intolerance or toxicity.[9][22][23]
• Monitor CD4 counts, viral load and clinical stage together. Viral load is generally monitored every six months during antiretroviral therapy, with more frequent testing when clinically indicated, and confirmed viral load above 1,000 copies per millilitre supports assessment for treatment failure.[21][15]
• Address suspected failure through adherence assessment, clinical review, repeat viral-load testing, review of medicine supply and treatment history, and genotype testing where available before changing treatment.[24][7][19]
• Construct second-line treatment with at least two, and ideally three, active new medicines, including a medicine from a new class where possible; seek committee review for regimens outside the guideline and reserve darunavir or raltegravir rescue therapy for resistance-supported cases.[7][19][10]
• Manage adverse effects through toxicity grading, medicine substitution where appropriate, temporary interruption of all antiretrovirals for life-threatening toxicity, and reporting through Bolivia’s National Pharmacovigilance System, including Form 020 or the yellow card.[25][26][14][27]
• Maintain treatment during immune reconstitution inflammatory syndrome where possible, treat associated infections or inflammatory conditions, and distinguish this syndrome from treatment failure before changing regimens.[28][15]
• Provide four weeks of three-drug post-exposure prophylaxis within 72 hours of potential exposure, alongside immediate wound or mucosal decontamination, source and exposed-person assessment, testing, occupational-incident reporting and follow-up.[10][29][12]
• Use the Information System for Monitoring and Evaluation of the National Programme for Sexually Transmitted Infections, HIV/AIDS and Viral Hepatitis to track epidemiological trends, treatment access, enrolment and viral-load outcomes.[2][6]

Monitoring & Evaluation

Monitoring combines national epidemiological surveillance, programme information management, clinical follow-up, pharmacovigilance and event-specific reporting. The Information System for Monitoring and Evaluation of the National Programme for sexually transmitted infections, HIV/AIDS and viral hepatitis monitors national HIV trends and treatment access, while the guidance does not define a comprehensive evaluation timetable or formal accountability framework.[2][6]

• Track new HIV infections, people living with HIV, antiretroviral therapy access, AIDS-related deaths, treatment enrolment and viral-load outcomes through the national programme information system.[2][6]
• Use the 90-90-90 cascade as a global treatment-performance benchmark; the source identifies global gaps of 7.5 million people for diagnosis, 10.2 million for treatment access and 10.8 million for viral suppression.[30]
• Monitor CD4+ cell counts, viral load and clinical stage together to assess immune recovery, disease progression, treatment effectiveness, adherence concerns and possible treatment failure.[21][8][31]
• Measure viral load at diagnosis and, for people receiving antiretroviral therapy, generally every six months, with additional testing where clinically indicated.[21][15]
• Assess early virological response four weeks after treatment initiation and repeat viral-load testing every six months thereafter.[7]
• Interpret confirmed plasma viral load above 1,000 copies/mL after more than six months of treatment as virological failure, rather than relying on a single increasing result; provide adherence support and repeat testing before changing therapy.[15][24][7]
• Recognise virological success where HIV-1 RNA is below the assay detection limit; the locally cited real-time polymerase chain reaction threshold is 40 copies/mL after six months of treatment.[24]
• Repeat potentially decisive CD4+ results after four weeks, account for transient changes caused by intercurrent illness, and interpret immunological failure through sustained CD4+ decline, return to baseline or below, a 50% fall from the treatment peak, or persistent counts below 100 cells/mm³.[24][31]
• Conduct laboratory follow-up through CD4 counts, viral load, full blood count, blood chemistry, lipid profile, urinalysis, relevant serology and other clinically indicated assessments.[32]
• Monitor medicine-specific safety risks, including haemoglobin during zidovudine treatment, renal markers during tenofovir treatment, allergic and hepatic reactions with nevirapine, and adverse effects or interactions associated with other antiretroviral medicines.[33][34][35][22]
• Report suspected adverse drug reactions through Bolivia’s National Pharmacovigilance System, which uses Form 020, known as the yellow card, to detect, collect, analyse, evaluate and prevent adverse reactions and related problems.[14][27]
• Monitor adherence as a lifelong component of treatment; early warning studies cited approximately 33% treatment abandonment during the first year of antiretroviral therapy.[13]
• Assess and report occupational exposure incidents within 72 hours using the relevant AFP occupational-accident form, alongside HIV testing of the exposed worker for legal purposes.[10]
• Follow exposed personnel at three and six months after occupational blood exposure, with notifications to the sexually transmitted infections and HIV/AIDS programme and biosafety subcommittee recorded in the relevant flowchart.[12]

Clinical monitoring requirements are detailed, but the supplied material does not specify routine national reporting frequencies, public reporting outputs, audit mechanisms, named accountability holders, or a programme-wide set of targets beyond the Sustainable Development Goal and treatment-cascade context.[2][24][31]

Costing & Financing

Financial information is limited. The publication received Global Fund financial support for printing, while the guidance confirms the national provision of antiretroviral treatment and reports continuous medicine availability without recorded national stock-outs.[36][2][6]

• Identify the Global Fund as the financial supporter of publication printing in 2017.[36]
• Describe lamivudine as relatively inexpensive to produce and widely available.[33]
• Describe first-line regimens as generally less costly than other regimens, supported by generic formulations and no cold-chain requirement.[9]
• Note that heat-stable lopinavir/ritonavir tablet formulations remove the need for refrigeration, representing a potential logistical resource advantage without a quantified value.[37]
• Identify dolutegravir as affordable, without providing a medicine price, procurement allocation or budget value.[38][39]
• Record that the National Programme for Sexually Transmitted Infections, HIV/AIDS and Viral Hepatitis does not finance HLA-B*5701 testing, whose availability in Bolivia was uncertain at the time.[34]
• Characterise phenotypic resistance testing as more costly and difficult to access than genotyping; phenotyping was unavailable in Bolivia at the time covered by the guidance.[40]
• Support rational use of viral-load testing on cost-effectiveness grounds, without specifying unit costs or economic thresholds.[15]
• Identify prophylaxis kits held by secondary- and tertiary-level hospitals as a service-delivery resource for post-exposure prophylaxis, while noting that levonorgestrel was not supplied by the relevant national programme.[11]

No overall treatment budget, expenditure plan, financing-source breakdown, resource-mobilisation strategy, procurement allocation, funding-gap estimate, unit cost, or quantified economic assumption is specified in the supplied material.[2][21][7][40]