HIV-2 Treatment
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Clinicians should:
- Use the preferred standard First-Line regimen TDF (or TAF) + XTC + DTG If unable to tolerate DTG, substitute with a Lopinavir-ritonavir when prescribing ART for HIV-2 mono-infected or HIV-1/ HIV-2 co-infected individuals.
- Not prescribe NNRTIs (NVP, EFV or RPV) or the PI Atazanavir-ritonavir as part of an ART regimen against HIV-2 mono-infection.
- Consult with a provider with the ATCs in the management of HIV-2 where there are doubts before initiating ART in HIV-2-infected patients.
- Educate patients with confirmed HIV-2 infection about the types of drugs that can be used to treat it.
Although HIV-2 is generally less aggressive, and progression to AIDS is less frequent, HIV-2 responds less predictably to ART when progression occurs, and response is more difficult to monitor. The standard methods and interpretation protocols that are used to monitor ART for HIV-1 infected patients may not apply for HIV-2-infected patients. Some ART regimens that are appropriate for HIV-1 infection may not be as effective for HIV-2. The following factors should be considered:
- The majority of HIV-2 infected patients are long-term non-progressors.
- HIV-2 may confer more rapid resistance to ART agents because of wild-type genetic sequence that results in a significant increase in resistance to ART agents compared with HIV-1.
- Pathways for the development of drug mutations may differ between HIV-1 and HIV-2.
Preferred 1st line and alternative ART regimens for HIV-2
| Specific population | Description | Preferred 1st line regimen | Alternative regimen(s) |
| HIV-1/HIV-2 co-infected | Adolescents and adults | TDF (or TAFa) + XTC + DTGb | TDF or TAF + XTC + LPV-rd (or DRV-r) or ABC + 3TC + LPV-r or (DRV-r) ABC + 3TC +DTGf |
| HIV-1/HIV-2 co-infected | Children | ABC + 3TC + LPV-r | |
a. TAF should also be avoided in pregnancy and HIV/TB patients on Rifampicin
b. DTG is active against HIV-1 and 2.
d. LVP-r is the only PI that actively works against HIV-2
e. For the alternative regimen for children, refer for consultation or call the Toll-Free line 7040.
f. ABC + 3TC + DTG could be used as an alternative for those with renal insufficiency or where
TAF is not available and LPV-r is not tolerated.
† Positive Health Dignity and Prevention (PHDP) includes: risk reduction, ART adherence, correct condom use, family planning, STI screening, and partner HIV testing
Follow-up clinical and laboratory monitoring for HIV patients on ART
| Timeline | Clinical task | Laboratory tests |
| Enrollment and ART initiation | - History and examination - Screen for TB, Cryptococcus - Adherence counselling - PHDP† messages - Initiate ART after adherence counselling - If no signs and symptoms of active TB disease, initiate IPT (i.e. after ruling out TB) |
- Serum creatinine - ALT - Hb or FBC - Blood glucose - CD4 count - CrAg Tests for those with CD4 cell count <100 cells/microL or WHO Stage III/IV - Urine-LAM CrAg Tests for those with CD4 count <100 cells/microL or WHO Stage III/IV - HBsAg - Syphilis test - Urinalysis for protein and glucose, RBCs - Cholesterol, and triglycerides (especially if starting PI) |
| Week 2 post-initiation | - Targeted history & examination - Screen for TB, Cryptococcus - Review adherence, side effects, toxicity - Review laboratory tests - Adherence counselling |
- Serum creatinine (if in TDF) - Urinalysis (if on TDF) |
| Week 4 post-initiation | - Targeted history & examination - Screen for TB, Cryptococcus - Review adherence, side effects, toxicity - Review laboratory tests - Adherence counselling |
- Serum creatinine (if on TDF) - Urinalysis (if on TDF) |
| Week 12 post-initiation | - Review adherence, side effects, toxicity - Adherence counselling - PHDP† messages - Review laboratory tests - Refill ART with enough supply to next visit (max. 3 months supply). |
- Serum creatinine (if on TDF) - Urinalysis (if on TDF) |
| 6 months post- initiation | - Review adherence, side effects, toxicity - Adherence counselling - PHDP† messages - Review laboratory tests - Refill ART with enough supply to next visit (max. 3 months supply unless transferred to appropriate DSD models). |
- Serum creatinine (if on TDF) - Urinalysis (if on TDF) - Viral load - CD4 cell count - Cholesterol and triglycerides (if on PI) |
| 12 months post- initiation and every 12 months | - Review adherence, side effects, toxicity - Adherence counselling - PHDP† messages - Review laboratory tests - Refill ART with enough supply to next visit (max. 3 months supply unless transferred to appropriate DSD models). |
- Serum creatinine (if on TDF) - Urinalysis (if on TDF) - Viral load - CD4 cell count - Cholesterol and triglycerides (if on PI) |
| Those with CD4 cell count >350 cell/microL at baseline and 6 months of ART with. Suppressed viral load should NOT have subsequent repeat CD4 cell count monitoring as long as the viral load remain suppressed | ||
Clinical and laboratory monitoring for HIV-infected pregnant and breastfeeding women Timeline Clinical tasks Laboratory tests
| Timeline | Clinical tasks | Laboratory tests |
| Day 0: Enrollment & ART initiation | - History and examination - If pregnant, focussed ANC (FANC) - Screen for TB, Cryptococcus - Adherence counselling - PHDP† messages - Initiate ART after adherence counselling - If no signs and symptoms of active TB disease, initiate IPT (i.e. after ruling out TB) |
- Serum creatinine - ALT - Hb or FBC - CD4 count - HBsAg - Syphilis test - Viral load testing at first contact if eligible for those on ART - Urinalysis - Cholesterol and triglycerides (especially if on PI) |
| Week 2 post-initiation | - Targeted history & examination | - Serum creatinine - Urinalysis |
| Week 4 post-initiation | - Screen for TB, Cryptococcus, and other OIs | - As needed |
| Subsequent visits to occur per: - ANC if pregnant - HEI schedule if postnatal and breastfeeding - Adult ART schedule if postnatal and not breastfeeding |
- If pregnant, ANC - Review adherence, side effects, toxicity - Adherence counselling - PHDP messages - Review laboratory tests - Refill ART with enough supply to next visit (max. 3 months supply). |
- Viral load to be done every 3 months during pregnancy and breastfeeding period - Serum creatinine and urinalysis at every ANC visit - Laboratory testing to occur per ANC while pregnant except for viral load - VL within 4 weeks before labour & delivery - Cholesterol and triglycerides to be done at 6 months post- ART initiation during pregnancy - Follow adult ART schedule when postnatal except for viral load |
| First postnatal visit | CD4 cell count to determine the need for continuation of Co-trimoxazole | |
| 24 months after delivery | - ART dispensed in MNCH until transferred - Transfer to ART clinic for the continuum of HIV care and treatment - Earlier transfer or referral may be done for logistical reasons or complicated cases |
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| † Positive Health Dignity and Prevention (PHDP) includes: risk reduction, ART adherence, correct condom use, family planning, STI screening, and partner HIV testing | ||
Monitoring Side Effects and Toxicities on ART Changing an ARV drug should be done only after careful review of adherence. The indication for changing needs to be addressed. A specific ARV drug may be changed (substitution) because of:
- Toxicity, such as anaemia, peripheral neuropathy, lipodystrophy, liver or renal abnormalities
- Intolerance or unresolved and prolonged side effects
- Poor adherence: change indicated only to simplify dosing schedule and to improve adherence
- Occurrence of active TB (refer to the section on TB-HIV co-infection)
- Failure (clinical, immunologic, or virological)
When HIV patients are switched to alternative regimen the goals are to achieve HIV viral suppression, avoid adverse events, and optimize adherence. Always do viral load and ensure that the patient is suppressed before switching across cases.
Treatment Failure
Clinical
Treatment failure should be considered when clinical symptoms appear whilst on therapy that is suggestive of deteriorating status.
Immunological
Treatment failure is indicated by a drop of CD4 values to below pre-treatment levels or 50 % from the peak value on treatment or persistent CD4 levels below 50 cells/mm3 after 12 months on therapy.
Note:
Patients initiating at very low CD4 may not be able to mount an adequate CD4 recovery; in this case, viral load is indicated.
Virologic
Wherever facilities are available to test for viral load, the following may suggest failure:
- Plasma HIV viral load >400 copies/ml after 6 months on therapy.
Note:
Blips (single level of 50-1000 c/ml are not considered as failure, repeat viral load as soon as possible.
And patients who appear to be failing on treatment while the viral load is undetectable should be considered to have undiagnosed opportunistic infections or other concomitant illness.
It should not be concluded, based on clinical criteria, that an ARV regimen is failing until there has been a reasonable trial of first-line therapy lasting at least six months, adherence has been assessed and optimized, intercurrent opportunistic infections have been treated and resolved, and IRIS has been excluded. Clinica l events that occur before the first six months of therapy are excluded from this definition of failure because they often represent immune reconstitution inflammatory syndromes related to pre-existing conditions.
Factors leading to treatment failure
- Poor adherence to treatment
- Prior exposure to antiretroviral treatment with the development of resistance
- Primary viral resistance (infected with resistant HIV strain)
- Inadequate drug absorption
- Suboptimal dosing (e.g. sharing dose because of side effects)
- Inadequate or inconsistent drug therapy
- Drug interactions.
Management of Treatment Failure
Patients on ART who have a viral load >1000 copies/mL are failing the treatment and at risk of progression of the HIV disease. Poor adherence is the commonest cause of treatment failure. Adherence barriers must be evaluated and corrected before the therapy is changed.
Patients failing treatment are prone to opportunistic infections and a comprehensive evaluation of the opportunistic infections, especially Tuberculosis, must be done before therapy is changed.
When patients are switched to Second-Line ART regimens, the goals are to achieve HIV viral suppression resulting in reconstitution of the clinical and immunologic status, avoid adverse events, and optimize adherence. LPV-r is the primary recommended Second-Line PI.
| Specific populations | Failing 1st line ART | 2nd line ART |
| Children <5 years old | ABC + 3TC + LPV-r | AZT + 3TC + RAL |
| Children 5-10 years old | ||
| ABC + 3TC + EFV | AZT + 3TC + LPV-r | |
| Adolescents and Adults | TDF + XTC + DTG* TAF + XTC + DTG* ABC + 3TC + DTG* TDF + XTC + EFV* ABC + 3TC + EFV** |
AZT + 3TC + LPV-r (or ATV-r) |
| Pregnant & Breastfeeding Women | TDF + XTC + EFV** ABC + 3TC + EFV** |
AZT + 3TC + LPV-r (or ATV-r) |
| * Represents newer regimens **Represents older regimens |
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Summary of preferred 2nd line ART regimens
| Specific population | Preferred 2nd line ART regimen | |
| Adults and adolescents | If AZT was used in 1st line ART | TDF + XTC + LPV-r (or ATV-r) |
| If TDF or TAF was used in first-line ART | AZT + 3TC + LPV-r (or ATV-r) | |
| Pregnant and breastfeeding women | Same regimens as recommended for adults and adolescents if no previous NVP exposure without tail coverage. | |
| HIV & TB co-infection | On Rifampicin-based TB treatment: If AZT +3TC + EFV was used in the first-line ART | TDF (or TAF) + XTC+ DTG (50mg twice daily) If DTG not available: Double dose LPV-r (LPV-r- 800mg/200mg twice daily) |
| On Rifampicin-based TB treatment: If TDF (or ABC) + XTC + EFV was used in first-line ART | AZT + 3TC + DTG (50mg twice daily) If DTG is not available: Double dose LPV-r (LPV-r- 800mg/200mg twice daily) |
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| If Rifabutin available use same PI regimens as recommended for adults and adolescents | ||
| HIV & HBV co-infection | AZT + TDF + XTC* + LPV-r (or ATV-r) * TDF+XTC should always be part of the combination in HBV/HIV co-infections |
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| HIV-1/HIV-2 co-infected | TDF + XTC + DTG | AZT + 3TC + LPV-ra |
| HIV-2 mono-infected | ABC + 3TC + DTG | AZT + 3TC + LPV-ra |
| a DO NOT substitute with Atazanavir in HIV-1/HIV-2 con-infection or HIV-2 mono-infection. Atazanavir is not active against HIV-2 |
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